HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis
Phase: NA
Conditions: Opioid Use Disorder (OUD)
Sponsor: RTI International

 
The HEALing Communities Study 
Protocol Number: Pro00038088 
National Clinical Trial (NCT) Identified Number: NCT04111939 
Principal Investigators 
DCC: Charles Knott, MPA; Gary Zarkin, PhD; LaShawn Glasgow, DrPH, MPH 
KY: Sharon Walsh, PhD 
MA: Jeffrey H. Samet, MD, MA, MPH 
NY: Nabila El-Bassel, PhD 
OH: Bridget Freisthler, PhD 
NIDA: Redonna Chandler, PhD 
SAMHSA: Yngvild Olsen, MD, MPH 
 
Sponsor: RTI International 
Grant Title: Data Coordinating Center 
Grant Numbers 
DCC: 1 UM1 DA049394 
KY: 1 UM1 DA049406 
MA: 1 UM1 DA049412 
NY: 1 UM1 DA049415 
OH: UM1DA049417 
 
Funded by the National Institute on Drug Abuse 
Version 1.22 
March 12, 2025 
 

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CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigators or other participating study leadership and consistent with the 
National Institutes of Health terms of awards. 
 

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CONTENTS 
Contents 
STATEMENT OF COMPLIANCE ................................................................................................................. 6 
1. PROTOCOL SUMMARY ........................................................................................................................ 6 
1.1 
Synopsis ....................................................................................................................................... 6 
1.2 
Timeline ........................................................................................................................................ 8 
2. INTRODUCTION .................................................................................................................................... 9 
2.1 
Study Rationale ............................................................................................................................ 9 
2.2 
Background ................................................................................................................................. 10 
2.3 
Risk/Benefit Assessment ............................................................................................................ 11 
2.3.1 
 Known Potential Risks .................................................................................................. 11 
2.3.2 
 Known Potential Benefits .............................................................................................. 13 
2.3.3 
 Assessment of Potential Risks and Benefits ................................................................ 14 
3. OBJECTIVES AND OUTCOMES ......................................................................................................... 14 
4. STUDY DESIGN ................................................................................................................................... 20 
4.1 
Overall Design ............................................................................................................................ 20 
4.1.1 
 Trial Duration ................................................................................................................ 20 
4.1.2 
 Wave 1 Communities .................................................................................................... 20 
4.1.3 
 Wave 2 Communities .................................................................................................... 20 
4.1.4 
 Assignment to Study Wave 1 and Wave 2 Communities ............................................. 20 
4.2 
Scientific Rationale for Study Design ......................................................................................... 21 
4.3 
Justification for Intervention ........................................................................................................ 21 
4.4 
End-of-Study Definition ............................................................................................................... 21 
5. STUDY POPULATION ......................................................................................................................... 22 
5.1 
Inclusion Criteria ......................................................................................................................... 22 
5.2 
Exclusion Criteria ........................................................................................................................ 23 
5.3 
Strategies for Recruitment and Retention .................................................................................. 23 
6. STUDY INTERVENTION(S) ................................................................................................................. 24 
6.1 
Study Intervention(s) Administration ........................................................................................... 24 
6.1.1 
 Study Intervention Description ...................................................................................... 24 
6.2 
Fidelity......................................................................................................................................... 55 

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6.2.1 
 Fidelity Measures for CTH Community Engagement Intervention ............................... 55 
6.3 
Implementation Science Measures for Communities That HEAL .............................................. 60 
6.3.1 
 Study Participants ......................................................................................................... 61 
6.3.2 
 Recruitment Procedures ............................................................................................... 62 
6.3.3 
 Compensation ............................................................................................................... 64 
6.3.4 
 Instruments ................................................................................................................... 64 
6.4 
Toxicology Survey ...................................................................................................................... 68 
6.5 
Measures to Minimize Bias: Randomization and Blinding .......................................................... 68 
7. STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL................................................................................................... 69 
7.1 
Discontinuation of Study Intervention ......................................................................................... 69 
7.2 
Participant Discontinuation/Withdrawal From the Study ............................................................ 70 
7.3 
Lost to Follow-Up ........................................................................................................................ 70 
8. INSTRUMENTS AND PROCEDURES ................................................................................................ 70 
8.1 
Instruments ................................................................................................................................. 70 
8.2 
Safety Assessments ................................................................................................................. 129 
8.3 
Adverse Events ......................................................................................................................... 131 
8.3.1 
 Definition of Adverse Events and Serious Adverse Events ........................................ 131 
8.3.2 
 Time Period and Frequency for Event Assessment and Follow-Up ........................... 132 
8.4 
Unanticipated Problems............................................................................................................ 133 
8.4.1 
 Definition of Unanticipated Problems ......................................................................... 133 
8.4.2 
 Unanticipated Problem Reporting ............................................................................... 133 
8.4.3 
 Reporting Unanticipated Problems to HCS Communities .......................................... 134 
9. STATISTICAL CONSIDERATIONS ................................................................................................... 134 
9.1 
Statistical Hypotheses .............................................................................................................. 134 
9.2 
Sample Size Determination ...................................................................................................... 134 
9.3 
Populations for Analyses .......................................................................................................... 136 
9.4 
Statistical Analyses ................................................................................................................... 136 
9.4.1 
 General Approach ....................................................................................................... 136 
9.4.2 
 Analysis of the Primary Outcome ............................................................................... 137 
9.4.3 
 Analysis of the Secondary Outcomes ......................................................................... 138 
9.4.4 
 Baseline Descriptive Statistics .................................................................................... 138 

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9.4.5 
 Subgroup Analyses ..................................................................................................... 138 
9.4.6 
 Exploratory Analyses .................................................................................................. 138 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 139 
10.1 Regulatory, Ethical, and Study Oversight Considerations ........................................................ 139 
10.1.1 Informed Consent ........................................................................................................ 139 
10.1.2 Certificate of Confidentiality ......................................................................................... 140 
10.1.3 Confidentiality and Privacy .......................................................................................... 141 
10.1.4 Future Use of Stored Specimens and Data ................................................................. 141 
10.1.5 Key Roles and Study Governance .............................................................................. 141 
10.1.6 Safety Oversight .......................................................................................................... 143 
10.1.7 Quality Assurance and Quality Control ........................................................................ 144 
10.1.8 Data Handling and Record Keeping ............................................................................ 145 
10.1.9 Protocol Deviations ...................................................................................................... 149 
10.1.10 Publication and Data Sharing Policy ........................................................................... 149 
10.2 Abbreviations and Special Terms ............................................................................................. 151 
10.3 Protocol Amendment History .................................................................................................... 153 
11. REFERENCES ................................................................................................................................... 158 
12. APPENDICES ..................................................................................................................................... 165 
12.1 Appendix A: Study Outcomes ................................................................................................... 165 
12.1.1 Primary Outcomes ....................................................................................................... 165 
12.1.2 Secondary Outcomes .................................................................................................. 166 
12.1.3 Structural Outcomes .................................................................................................... 178 
12.2 Appendix B: Health Message Testing Service Questions—Centers for 
Disease Control and Prevention ............................................................................................... 188 
12.3 Appendix C: Justice Community Opioid Innovation Network (JCOIN) and 
HCS Annual Jail Survey ........................................................................................................... 204 
12.4 Appendix D: Additional Site-Led HCS Research Activities ...................................................... 208 
12.4.1 Group Model Building Workshop ................................................................................. 208 
12.4.2 GetNaloxoneNow ......................................................................................................... 208 
12.4.3 Brandeis University Collaboration to Conduct Interviews with Health Care Payers .... 209 
12.4.4 Academic Detailing and CECentral Online Modules ................................................... 210 
12.4.5 MOUD Organization Interview Guide .......................................................................... 211 

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12.4.6 Pharmacy Study Interview Guide & Survey ................................................................. 212 
12.4.7 CE Facilitator Community Genogram Model ............................................................... 213 
12.4.8 Policy Barriers and Facilitators Tracking ..................................................................... 214 
12.4.9 Costing the Evidence Based Practices ........................................................................ 215 
12.4.10 Identifying the Municipal Policies that Impact the Implementation of the EBP Strategies
 ..................................................................................................................................... 216 
12.4.11 Photovoice Participatory Research Technique ............................................................ 217 
12.4.12 Race and Ethnicity Data Collection Readiness Survey ............................................... 221 
12.4.13 PARTNER Tool ............................................................................................................ 221 
12.4.14 Medication Disposal Program Pharmacy Interviews ................................................... 222 
12.4.15 Mobile Interventions for Increasing Access to Medications for Opioid Use Disorder 
(MOUD) ........................................................................................................................ 223 
12.4.16 A Cost Analysis of Peer Recovery Support Services .................................................. 224 
12.4.17 Wave 1 Partner Organization Sustainability Interview ................................................ 226 
 
TABLES 
Table 1: Primary and Key Secondary Study outcomes .............................................................. 15 
Table 2: Other Secondary Study outcomes ............................................................................... 16 
Table 3: Additional RS-specific inclusion criteria for communities enrolled in the HCS .............. 22 
Table 4: Overview of communication campaigns ...................................................................... 44 
Table 5: Campaign Prepare-Plan-Implement process steps...................................................... 47 
Table 6a: Timeline for Stages of Communication Campaigns (Wave 1) .................................... 48 
Table 6b: Timeline for Stages of Communication Campaigns (Wave 2) .................................... 49 
Table 7: Measures by data collection point ............................................................................... 53 
Table 8: Fidelity measures and implementation strategies ........................................................ 56 
Table 9: Instrument name and associated informed consent form name ................................... 71 
Table 10: Instrument Summaries .............................................................................................. 76 
Table 11: Metrics Used to Declare a Safety Signal in AE/SAE Review Process ...................... 132 
Table 12: Power calculation for underlying reduction in risk of opioid overdose fatalities 
between Wave 1 and Wave 2 communities ........................................................... 135 
Table 13: Key roles and study governance ............................................................................. 141 
Table 14: Data and Safety Monitoring Board members ........................................................... 144 
Table 15: Protocol Amendment History ................................................................................... 153 

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FIGURES 
Figure 1: HEALing Communities Study timeline .......................................................................... 9 
Figure 2: Three components of the CTH intervention ................................................................ 24 
Figure 3: Conceptual framework of the CTH intervention .......................................................... 25 
Figure 4a: CTH intervention phases (Wave 1) .......................................................................... 26 
Figure 4b: CTH intervention phases (Wave 2) .......................................................................... 27 
Figure 5: Phase 3 parallel processes for developing community profiles and data 
dashboards (Wave 1) .............................................................................................. 33 
Figure 6: Schedule of Activities for Maintaining the CTH Beyond Year 1 (Wave 1) ................... 37 
Figure 8: The Plan-Prepare-Implement model for campaign development and community 
engagement............................................................................................................. 46 
Figure 9: RE-AIM/PRISM model adapted for HCS .................................................................... 61 
Figure 10: Two-Step AE/SAE Review Process........................................................................ 130 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Conference for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice 
(GCP). 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed human subjects protection and ICH GCP training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval. Approval of the 
protocol and the consent forms must be obtained before the communities are randomized or 
any participant is consented. Any amendment to the protocol will require review and approval by 
the IRB before the changes are implemented in the study. All changes to the consent forms will 
be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent. 
1. 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Title 
The HEALing Communities Study (HCS) 
Grant Numbers 
UM1-DA049415, UM1-DA049417, UM1-DA049412, 
UM1-DA049406, UM1-DA049394  
Study Description 
The HCS is a multi-site trial evaluating the impact of the 
Communities That HEAL (CTH) intervention compared with 
usual care in wait-list communities. The CTH is a 
community-engaged intervention that provides a 
comprehensive, data-driven community response plan to 
deploy evidence-based practices (EBPs) across multiple 
sectors to reduce opioid-related overdose deaths and 
associated outcomes. 
The HCS refers to the communities randomized to receive 
the CTH intervention first as “Wave 1 communities” and 
those in the wait-list comparison arm as “Wave 2 
communities.” Wave 1 communities will implement the CTH 
intervention for 30 months, during which time Wave 2 
communities will provide usual care. At month 31, Wave 2 
communities begin to implement the CTH intervention. 
Objectives 
The HCS will test the impact of the CTH intervention on 
opioid overdose deaths and associated outcomes in 67 
highly affected communities in Kentucky, Massachusetts, 
New York, and Ohio. The goal is to reduce opioid overdose 
deaths by 40%. 

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Outcomes 
The primary outcome is the number of opioid overdose 
deaths. Secondary outcomes include (1) the number of 
naloxone units distributed, (2) the number of individuals with 
opioid use disorder who receive buprenorphine for opioid 
use disorder, and (3) incident high-risk opioid prescribing. 
The primary comparison of interest is between Wave 1 
communities compared with Wave 2 communities during 
the second 12-month period after Wave 1 communities are 
activated. The primary analysis will use an intention-to-treat 
design with the population defined as any community 
randomized into the HCS. 
The HCS will measure additional outcomes for secondary 
data-analytic purposes. A full list of outcomes appears in 
Appendix A. 
Study Population 
A total of 67 communities across four states (Kentucky, 
Massachusetts, New York, Ohio) were selected to 
participate in the HCS. At least 30% of the communities 
selected in each state were required to be rural. 
Collectively, the communities in each state were required to 
have at least 150 opioid-related overdose fatalities (at least 
15% occurring in rural communities) and a rate of 25 opioid-
related overdose fatalities per 100,000 people or higher in 
2016. Kentucky selected 16 counties to participate, 
Massachusetts selected 16 cities/towns, New York selected 
13 counties and 3 cities/towns, and Ohio selected 19 
counties. 
Study Design 
The HCS is a multi-site, parallel arm, cluster randomized, 
wait-list controlled trial evaluating the impact of the CTH 
intervention compared with usual care in wait-list 
communities. 
Description of Study 
Intervention 
The CTH is a community-engaged intervention that 
provides a comprehensive, data-driven community 
response plan to deploy EBPs across multiple sectors to 
reduce opioid overdose deaths and associated outcomes 
across HCS communities. The CTH intervention seeks to 
promote a common vision, shared goals, and tailored 
strategies to mobilize HCS communities to adopt EBPs 
using a stepwise community change process that integrates 
three components. The first CTH component, community 
engagement, includes seven phases to assist communities 
in developing a response specific to their opioid crisis: (0) 
Preparation (pre-intervention), (1) Getting Started, (2) 

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Getting Organized, (3) Community Profiles and Data 
Dashboards, (4) Community Action Planning, (5) Implement 
and Monitor, and (6) Sustainability Planning (ongoing). The 
second CTH component, the Opioid-Overdose Reduction 
Continuum of Care Approach (ORCCA), facilitates each 
community’s implementation of system- and practice-level 
changes to increase adoption of EBPs and reduce opioid 
overdose deaths. The ORCCA provides a menu of 
strategies for implementing three required EBPs: (1) opioid 
overdose prevention education and naloxone distribution 
(OEND) in high-risk populations; (2) effective delivery of 
MOUD maintenance treatment, including agonist/partial 
agonist medication, and including outreach and delivery to 
high-risk populations; and (3) safer opioid prescribing and 
dispensing. The third CTH component is a communication 
campaign. Community-based communication campaigns in 
each year will focus on different messages and priority 
groups in the communities. Campaign objectives support 
CTH implementation and outcomes and include (1) 
increasing demand for OEND and MOUD EBPs, (2) 
increasing availability and access to MOUD and naloxone, 
(3) increasing treatment retention, (4) increasing recovery 
support, (5) reducing stigma, and (6) reducing high-risk 
prescribing. 
Study Duration 
78 months 
 
 
1.2 
Timeline 
The duration of the HCS is April 2019 through September 2025 (Figure 1). During this 6.5-year 
period, the CTH intervention will be carried out in two waves. Startup activities for the four 
academic Research Sites and the Data Coordinating Center began in April 2019 and continued 
through December 2019. Wave 1 communities have begun implementing the CTH intervention 
for 30 months (January 2020 through June 2022), during which time Wave 2 communities are 
providing usual care. The primary outcome measurements will be assessed in Wave 1 
communities compared with Wave 2 communities from July 2021 through June 2022. At month 
31 (July 2022), Wave 2 communities will begin to implement the CTH intervention for 18 months 
(July 2022 through December 2023). After the intervention period, Wave 1 communities will be 
observed for sustainment of the intervention for an 18-month period (July 2022 through 
December 2023). Data analysis and project closeout will occur from July 2023 through 
September 2025.  
 

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Figure 1: HEALing Communities Study timeline 
 
 
2. 
INTRODUCTION 
2.1 
Study Rationale 
Communities across the United States are dealing with the catastrophic consequences of 
excessive availability and use of prescription opioids and illicit opioids such as heroin and illicitly 
manufactured fentanyl (and related analogs). Millions of Americans are struggling with 
inappropriate use of opioids and opioid use disorder (OUD). The consequences of this crisis are 
grave with tens of thousands continuing to die each year in the United States from opioid 
overdose. In addition, rates of OUD, injection drug use, acute hepatitis C virus infections, 
localized outbreaks of the human immunodeficiency virus, and other serious health conditions, 
such as endocarditis and neonatal abstinence syndrome, continue to rise. 
One driver of the opioid crisis is the recognized gap between the number of individuals who 
could benefit from evidence-based treatment and prevention interventions to reduce opioid 
misuse and OUD versus those actually engaged in care. The National Survey on Drug Use and 
Health (NSDUH) estimates that 2.1 million Americans have OUD, yet fewer than 20% of those 
individuals receive specialty care in a given year. A menu of evidence-based practices (EBPs) 
exists, including opioid overdose education and naloxone distribution (OEND) programs; 
prescription drug monitoring programs and other strategies to reduce inappropriate opioid 
prescribing; Food and Drug Administration–approved medication for opioid use disorder 
(MOUD) including methadone, buprenorphine, and naltrexone; behavioral therapies; and 
recovery support services. Unfortunately, these EBPs have largely failed to penetrate 
community settings including addiction treatment, general medical care, social support services, 
schools, and the justice system. This failure is in part due to a lack of evidence-based 
approaches for assisting communities in the development and deployment of a data-driven, 
customized response strategy to adopt, deliver, and use comprehensive integrated EBPs. 
The HEALing Communities Study (HCS) is a 5-year multi-site, parallel arm, cluster randomized, 
wait-list controlled trial to test the impact of a community-engaged intervention designed to 
increase the adoption of an integrated set of EBPs delivered across health care, behavioral 
health, justice, and other community-based settings. The primary goal is to reduce opioid-
related overdose deaths by 40% in highly affected communities. A total of 67 communities in the 
states of four RSs (Kentucky, Massachusetts, New York, and Ohio) will be enrolled in the study 
to measure the impact of the intervention. 

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The HCS will test the Communities That HEAL (CTH) intervention, a conceptually driven 
framework based on the Communities That Care model, for its effectiveness in organizing 
evidence-based overdose prevention efforts in communities. The CTH intervention seeks to 
promote a common vision, shared goals, and tailored strategies to mobilize HCS communities 
to adopt EBPs using a stepwise community change process that integrates three components. 
The first CTH component, community engagement, includes a seven-phase coalition-driven 
process designed to promote community-specific approaches. The second component of the 
CTH intervention entails facilitating each community’s implementation of system- and practice-
level changes to rapidly reduce the rate of opioid-related overdose fatalities. The conceptual 
and operational framework guiding this component is titled the Opioid-Overdose Reduction 
Continuum of Care Approach (ORCCA). The ORCCA provides a menu of strategies for 
implementing EBPs designed to help communities reduce opioid overdose deaths and includes 
three mandatory EBPs: (1) OEND in high-risk populations; (2) effective delivery of MOUD 
maintenance treatment, including agonist/partial agonist medication, and including outreach and 
delivery to high-risk populations; and (3) safer opioid prescribing and dispensing. As noted in 
required EBPs 1 and 2, identification of, and intervention with, high-risk populations is an 
ORCCA requirement. The third CTH component utilizes the Prepare-Plan-Implement (PPI) 
model to design five community-based communication campaigns that focus on different 
messages and priority groups in the HCS communities (e.g., community leaders; criminal 
justice, public health, public safety, and medical staff; people with an OUD and their families; at-
risk patients and their families). Campaign objectives include (1) obtaining and carrying 
naloxone; (2) decreasing MOUD stigma; (3) raising awareness of MOUD treatment; (4) initiating 
MOUD treatment; and (5) staying in MOUD treatment. Another overarching objective is for the 
campaigns to set a public agenda to increase community efforts to reduce opioid OD deaths.  
2.2 
Background 
The U.S. opioid overdose epidemic has been declared a national emergency.1,2 Overdose 
deaths from prescription opioids, illicit synthetic opioids, and heroin continue to increase. There 
were more than 350,000 deaths from 1999 to 20163 and 47,600 deaths in 2017.4 In recent 
years, the deadly surge of the availability and use of illicit fentanyl and fentanyl analogs has 
been driving increases in overdose deaths.5 
These opioid-related overdose deaths reflect, in large part, a lack of treatment of OUD.6 As 
mentioned, the most recent NSDUH indicates that 2.1 million Americans have OUD, although 
other sources suggest the number is closer to 5 million.7-9 Fewer than 20% of individuals with 
OUD have received any form of OUD treatment in the past year.10 In a cohort of opioid 
overdose survivors, fewer than one-third received any MOUD treatment within a year of the 
overdose event.11 
The treatment gap reflects three major challenges: (1) many individuals with OUD do not 
perceive a need for treatment, (2) there is insufficient treatment capacity, and (3) treatment 
retention is suboptimal. National data indicate that among individuals with OUD who are not in 
treatment, a lack of recognition of the disorder is a major impediment to seeking treatment.12,13 
Furthermore, many individuals have internalized stigma about OUD that prevents them from 
seeking treatment.14 In addition to these challenges, capacity for delivering MOUD is an ongoing 
problem in many areas. Most of the nation’s 1,100 opioid treatment programs (i.e., federally 
licensed methadone programs; OTPs) are located in urban centers, and growth in the number 

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of OTPs has been modest in the past decade.15 Buprenorphine, in contrast to methadone, is 
more widely delivered in office-based addiction treatment in the United States.16 The number of 
U.S. buprenorphine-waivered physicians17 and buprenorphine dispensing have increased18 but 
remain insufficient to meet the national need for treatment. Even with increasing numbers of 
patients receiving MOUD, treatment retention is poor, and the percentage of coverage has 
declined from 2010 (25%) to 2014 (16%) due to increasing numbers of affected individuals.19 
In addition to treatment-related challenges that are fueling the opioid epidemic, two other 
factors—the suboptimal uptake of overdose prevention and the opioid-prescribing behaviors 
that enhance overdose risks—are significant drivers of the national epidemic. Naloxone 
effectively reverses opioid overdose, thus preventing fatalities. Although demonstration projects 
have shown that community distribution of naloxone can reduce the rate of opioid fatalities, 
national data show very limited prescribing of naloxone (including distribution through standing 
orders at pharmacies).20 Opioid overdose deaths also reflect continuing patterns of risky 
prescribing, such as the co-prescription of benzodiazepines with opioids, the prescription of high 
doses of opioids (i.e., >90 morphine milligram equivalents per day), and long-term prescriptions 
of opioids. These prescribing behaviors increase the risk of overdose even among individuals 
without OUD and heighten the risk of developing an OUD. 
For these reasons, it is necessary to change the course of the epidemic using a data-driven, 
multi-pronged approach. The HCS will test the immediate impact of implementing the CTH 
intervention on opioid overdose deaths in highly affected communities with the goal of reducing 
opioid overdose deaths by 40%. A recent modeling study considered multiple interventions 
across the spectrum of prevention to treatment and concluded that the most effective policy 
interventions for reducing overdose deaths are the expansion of naloxone availability and 
access to MOUD.2 Therefore, the HCS will engage communities to reach individuals who are at 
highest risk of overdose death (e.g., out of treatment, leaving jail) and (1) expand access to and 
receipt of MOUD and behavioral treatment, (2) increase the number of individuals retained in 
treatment beyond 6 months, (3) reduce the risk of fatal overdose through expansion of OEND, 
and (4) improve prescription opioid safety. 
2.3 
Risk/Benefit Assessment 
2.3.1 
Known Potential Risks 
This section considers immediate potential risks that affect the following categories of 
participants: 
● Communities enrolled in the study 
● Individual study participants: Research Site (RS) Community Advisory Board 
members, community coalition members, and professionals working in service 
venues in a community who will provide data 
● People with lived experiences in the communities 
● Individuals whose records are included as part of the secondary data analyses 

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2.3.1.1 
Communities Enrolled in the Study 
The reputation of the participating communities could be put at risk through identification as 
areas where opioid use and misuse have had significant impact. This could affect such things 
as tourism, desire for workers or employers to relocate to a community, housing and other real 
estate values, and the general sense of well-being in a community. However, the information on 
the level of impact of opioid misuse and OUD on communities is already widely available to the 
public. News coverage on opioid-related information, such as overdose deaths, by county or 
other local geographic area, is regularly publicized. Information about the number of opioid 
deaths by county is also widely available. Thus, community participation in the HCS is unlikely 
to affect the reputation of a community beyond what is known based on currently available 
information. In fact, a community will likely consider participation in the HCS a positive action. 
Stigma reduction is also embedded in messaging campaigns in all participating communities. 
These messaging campaigns will raise public awareness of participating communities’ 
commitment to mobilizing an effective response that will address the opioid overdose epidemic 
with the potential to strengthen the delivery of health care and behavioral health services 
overall. Furthermore, participation in the HCS may result in a reduction of opioid-related 
morbidity and mortality, thereby yielding long-term economic benefit. 
2.3.1.2 
Individual Study Participants 
Individual stakeholders in a community will be asked to provide information about the opioid-
related services currently being offered, their ability to offer new services, attitudes that might 
affect the success of service offerings, and the cost of offering services. It is expected that risks 
with such data collection will be minimal. Participants will not be asked to provide personal 
information other than basic demographic information and perceptions of access and barriers to 
community services. Participants will also not be asked questions that would put them at risk of 
criminal or civil liability or cause damage to financial standing, employability, or reputation. 
Some questions, although not structured or intended to do so, could invite feelings of discomfort 
for respondents. Informed consent will acknowledge this risk of discomfort, consent documents 
will clearly state that participation is entirely voluntary, and individuals may refuse to answer any 
or all questions and stop participating at any time without penalty. 
As with all research, there is a risk of breach of confidentiality. To minimize this risk, RSs will 
use practices to securely store data and to separate identifying information from research data. 
Research staff will make every effort to protect participant privacy and confidentiality of the 
Community Advisory Board, community coalition members, communication research 
participants, and other key stakeholders, who will be providing data. Involvement in the study or 
data collected by the study could become known to other participants. The following steps will 
be taken to protect against a breach of confidentiality. First, all data, including quantitative 
assessments, digital recordings, and qualitative interview transcripts will be labeled only with 
study/subject identification numbers, and no participant names or other identifying information 
will be attached to study data. Second, any document with study coding that assigns an 
identification number to a participant name will be kept by project directors or study staff 
designated by the Principal Investigator in locked file cabinets separate from research data or in 
a password-protected file on an encrypted endpoint device. Third, electronic data files or 
databases will be stored in secure, password-protected systems that use appropriate 
safeguards against unauthorized access. Data sent from the research sites to the Data 

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Coordinating Center (DCC) at RTI International will be securely transferred and encrypted (see 
10.1.8 Data Handling and Record Keeping for additional information).  Fourth, all research data 
on paper will be kept in locked file cabinets and will be available only to research staff directly 
involved in this project and National Institute on Drug Abuse and Substance Abuse and Mental 
Health Services Administration staff, or their designees. Fifth, all study staff will receive training 
on procedures to protect participant confidentiality and will take all required courses and 
certification tests (e.g., human subjects protection and International Conference for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical 
Practice training). Sixth, participants will be informed that all data are confidential within the 
limits of the law. 
2.3.1.3 
People With Lived Experiences in the Communities 
The most affected people living in a community are those with OUD and their friends and 
relatives. The risks to these individuals are low because the CTH intervention is a process of 
community engagement designed to help communities select and implement EBPs to mitigate 
the impacts of the opioid epidemic in the community. The HCS will not be testing new programs 
where the risks and potential adverse effects are unknown. Previously proven EBPs will be 
selected by the communities where the risks and benefits have been previously studied and 
found to be properly balanced. 
2.3.1.4 
Individuals Included in Secondary Data 
RSs will have access to identified data and protected health information from secondary 
administrative data sources. The main risk to individuals is related to data security; there are no 
health risks to participants. All individual-level data will be stored on local secured servers, with 
dedicated Information Systems personnel managing data security. Access to the data will only 
include Information Systems personnel responsible for their security and specified HCS 
personnel. No hard copies of raw data will be made. To protect participant welfare, all data from 
secondary sources will be generalized and de-identified before publication. As required by the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA), if participants request, they 
would be allowed to know that their records were used in this study, as their rights allow. Any 
secondary data transmitted to the Data Coordinating Center will be de-identified; no individually 
identifiable data will be released outside of the RS’s secured data environment. 
2.3.2 
Known Potential Benefits 
Participation in the HCS has the potential to assist communities by developing an effective 
response to reduce opioid-related overdose fatalities and by improving the delivery of health 
and behavioral health treatment. HCS participation may also yield long-term economic benefits 
due to the reduction of opioid-related morbidity and mortality. Communities will receive 
resources from the HCS (e.g., personnel) to assist in the development of a data-driven 
response strategy to reduce opioid-related overdose fatalities. Resources will also be provided 
to assist in the selection and implementation of EBPs. These will include increasing the delivery 
of OEND and MOUD and identifying people who may have lost tolerance for opioids and are at 
a high risk for overdose in order to engage them in care. Communities will also receive support 
for the implementation of messaging campaigns. Communities participating in the HCS may 
also benefit from greater coordination and integration of efforts among agencies and 

The HEALing Communities Study 
March 12, 2025 
14 
stakeholders in the community. As part of their involvement with the HCS, communities will 
have not only better monitoring and decision tools and processes for the community, but also 
better coordination and partnerships across different sectors of the community to address the 
opioid crisis and related problems. 
2.3.3 
Assessment of Potential Risks and Benefits 
Communities participating in the HCS experience higher-than-average opioid-related overdose 
fatalities. The potential benefits of participating in the HCS outweigh the potential risk of 
negative community perception. Furthermore, some individuals participating in interviews, focus 
groups, or surveys may experience psychological distress; however, these risks are minimal 
and not long lasting. 
3. 
OBJECTIVES AND OUTCOMES 
The HEALing Communities Study (HCS) will test the impact of the Communities That HEAL 
(CTH) intervention on opioid overdose deaths and associated outcomes in 67 highly affected 
communities in Kentucky, Massachusetts, New York, and Ohio. The goal is to reduce opioid 
overdose deaths by 40%. 
The HCS is a multi-site, parallel arm, cluster randomized, wait-list controlled trial evaluating the 
impact of the CTH intervention compared with usual care in wait-list communities. The CTH is a 
community-engaged intervention that provides community-based communication campaigns 
along with a comprehensive, data-driven community response plan to deploy evidence-based 
practices across multiple sectors to reduce opioid-related overdose deaths and associated 
outcomes. 
As described, the HCS refers to the communities randomized to implement the CTH 
intervention first as Wave 1 communities and those in the wait-list comparison arm as Wave 2 
communities. Wave 1 communities will implement the CTH intervention for 30 months, during 
which time Wave 2 communities will provide usual care. At month 31, Wave 2 communities will 
begin to implement the CTH intervention. 
The HCS has one primary hypothesis (H1) and three secondary hypotheses (H2, H3, H4). 
Compared with Wave 2 communities, we hypothesize that Wave 1 communities will accomplish 
the following: 
H1:  Reduce opioid overdose deaths. 
H2:  Increase naloxone distribution. 
H3:  Expand use of buprenorphine for opioid use disorder. 
H4:  Reduce high-risk opioid prescribing. 
The primary analysis will compare Waves 1 and 2 during the 12-month period of July 2021 
through June 2022. This comparison period begins 18 months after Wave 1 communities 
implement the CTH intervention and before Wave 2 communities implement the CTH 
intervention. 
The primary outcome is the number of opioid overdose deaths. Key secondary outcomes 
include (1) the number of naloxone units distributed in the community, (2) the number of 

The HEALing Communities Study 
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15 
individuals with opioid use disorder (OUD) who receive buprenorphine, and (3) incidents of high-
risk opioid prescribing. The primary comparison of interest is between Wave 1 and Wave 2 
communities during the 12-month parallel-arm period. The primary analysis will use an 
intention-to-treat design with the population, defined as any community randomized into the 
HCS. 
In addition to testing these hypotheses, the HCS seeks to determine (1) the factors that 
contribute to or impede successful implementation of the CTH intervention, (2) the factors that 
contribute to or impede sustainment of CTH intervention, and (3) the incremental costs and cost 
effectiveness of the CTH intervention. 
The HCS will measure additional outcomes for secondary data-analytic purposes. Lists of 
primary and secondary study outcomes appear in Tables 1 and 2, respectively. A more 
complete description of each outcome and its data source appears in Appendix A. 
Table 1: Primary and Key Secondary Study outcomes 
Hypothesis 
Associated Outcomes 
Appendix A 
Reference 
Number 
Data Source 
1 
Number of opioid overdose 
deaths (Primary Outcome) 
1 
Death certificates, 
supplemented (if needed) with 
medical examiner, coroner, and 
toxicology data 
2 
Number of naloxone units 
distributed in communities 
(Secondary Outcome) 
2.14.3 
Combination of dispensed 
prescriptions data purchased 
from IQVIA and state 
administrative sources on 
naloxone distribution 
3 
Number of individuals 
receiving buprenorphine 
products that are approved by 
the Food and Drug 
Administration (FDA) for 
treatment of OUD (Secondary 
Outcome) 
2.5.1 
Prescription drug monitoring 
programs 
4 
Incidents of high-risk opioid 
prescribing (Secondary 
Outcome) 
2.13 
Prescription drug monitoring 
programs 
 

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Table 2: Other Secondary Study outcomes 
Hypothesis Associated Outcomes 
Appendix 
A 
Reference 
Number  
Data Source 
N/A 
Number of drug overdose 
deaths 
2.1 
Death certificates, medical examiner, 
coroner, and toxicology data 
N/A 
Number of non-fatal drug 
overdose events 
2.2 
Hospital inpatient and emergency 
department (ED) billing claims  
N/A 
Number of non-fatal 
opioid overdose events 
2.3 
Hospital inpatient and ED billing claims 
N/A 
Number of individuals 
with OUD (prevalence) 
2.4 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of individuals 
receiving methadone 
2.5.2 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of individuals 
receiving naltrexone 
2.5.3 
Medicaid administrative data, including 
claims and eligibility files 
NA 
Number of individuals 
with OUD receiving 
MOUD 
2.5.4 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of individuals 
with OUD receiving 
behavioral health 
treatment 
2.6 
Medicaid administrative data, including 
claims and eligibility files, and all-payer 
claims data if available 
N/A 
Number of individuals 
receiving 
buprenorphine/naloxone 
retained beyond 6 months 
2.7.1 
Prescription drug monitoring programs 
N/A 
Number of individuals 
receiving methadone 
retained beyond 6 months 
2.7.2 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of individuals 
receiving naltrexone 
retained beyond 6 months 
2.7.3 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of individuals 
with MOUD retained in 
treatment beyond 6 
months 
2.7.4 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Person-months in MOUD 
2.7.5 
Medicaid administrative data, including 
claims and eligibility files 

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Hypothesis Associated Outcomes 
Appendix 
A 
Reference 
Number  
Data Source 
N/A 
Number of emergency 
medical services (EMS) 
naloxone administration 
events 
2.8.1 
State EMS data collected for national 
reporting to the National Emergency 
Medical Services Information System 
(NEMSIS) 
N/A 
Number of EMS runs for 
opioid-related 
incidents/overdoses 
2.8.2 
State EMS data collected for national 
reporting to the National Emergency 
Medical Services Information System 
(NEMSIS) 
N/A 
Number of individuals 
linked to MOUD after 
opioid overdose 
2.9 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of individuals 
linked to MOUD after 
release from prison 
2.10 
Medicaid administrative data, including 
claims and eligibility files linked to 
incarcerated individual files from state 
departments of corrections 
N/A 
Number of individuals 
provided MOUD while in 
jail 
2.11 
Primary data collection—survey 
(Justice Community Opioid Innovation 
Network [JCOIN] and HCS Annual Jail 
Survey) 
N/A 
Number of individuals 
linked to MOUD after an 
opioid-related ED visit 
2.12 
Medicaid administrative data, including 
claims and eligibility files  
N/A 
Number of individuals 
with OUD who are 
screened, diagnosed, and 
treated for hepatitis C 
2.15 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of newly 
diagnosed HIV cases 
2.16 
State registry for HIV/AIDS reporting 
N/A 
Number of opioid-related 
overdoses treated in EDs 
and captured by 
syndromic surveillance 
data 
2.17 
Syndromic surveillance records 
(accessed via the Centers for Disease 
Control and Prevention’s National 
Syndromic Surveillance Program 
Electronic Surveillance 
System for the Early Notification of 
Community-based Epidemics (NSSP-
ESSENCE) application or other state-
based platforms) 

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Hypothesis Associated Outcomes 
Appendix 
A 
Reference 
Number  
Data Source 
N/A 
Number of new acute 
opioid prescriptions 
limited to a 7-day supply 
2.18 
Prescription drug monitoring program 
N/A 
Opioid prescriptions from 
multiple prescribers or 
pharmacies 
3.1 
Prescription drug monitoring programs 
N/A 
Number of providers with 
a waiver under the Drug 
Addiction Treatment Act 
of 2000 (DATA 2000) 
3.2 
U.S. Drug Enforcement Administration’s 
(DEA) Active Controlled Substances 
Act (CSA) Registrants Database 
N/A 
Number of providers with 
a DATA 2000 waiver who 
actively prescribe 
buprenorphine products 
that are FDA approved for 
OUD 
3.3 
DEA’s Active CSA Registrants 
Database linked to prescription drug 
monitoring program data 
N/A 
Number of providers who 
actively prescribe 
buprenorphine products 
that are FDA approved for 
OUD 
3.4 
Prescription Drug Monitoring Program 
(PDMP) data 
N/A 
Number of jails initiating 
and linking people to 
MOUD 
3.5 
Primary data collection—survey 
(Justice Community Opioid Innovation 
Network [JCOIN] and HCS Annual Jail 
Survey) 
N/A 
Number of take-back drug 
drop boxes and events 
3.8 
State administrative data and DEA’s 
Active CSA Registrants Database 
N/A 
Number of ED visits for 
BH (count visits) 
4.1.1 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of ED visits for 
non-BH (count visits) 
4.1.2 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of 
hospital/inpatient nights 
for non-detox BH (count 
nights) 
4.2.1 
Medicaid administrative data, including 
claims and eligibility files 

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Hypothesis Associated Outcomes 
Appendix 
A 
Reference 
Number  
Data Source 
N/A 
Number of 
hospital/inpatient nights 
for detox (count nights) 
4.2.2 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of 
hospital/inpatient nights 
for non-BH (count nights) 
4.2.3 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of non-detox BH 
residential nights (count 
nights) 
4.3.1 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of BH detox 
residential nights (count 
nights) 
4.3.2 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of intensive BH 
outpatient visits (count 
nights) 
4.4.1 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of outpatient 
visits BH (count visits) 
4.5.1 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of outpatient 
visits non-BH (count 
visits) 
4.5.2 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of non-pain 
buprenorphine days 
supplied (count days 
supply) 
4.6.1 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of non-pain 
buprenorphine injections 
(count injections) 
4.6.2 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of opioid-related 
oral naltrexone days 
supplied (count days 
supply) 
4.6.3 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of opioid-related 
naltrexone injections 
(count injections) 
4.6.4 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of methadone 
days supplied (count 
calculated days supply) 
4.6.5 
Medicaid administrative data, including 
claims and eligibility files 

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Hypothesis Associated Outcomes 
Appendix 
A 
Reference 
Number  
Data Source 
N/A 
Number of opioid pain 
medication days supplied 
(count days supply) 
4.7.1 
Medicaid administrative data, including 
claims and eligibility files 
N/A 
Number of non-opioid 
pain medication days 
supplied (count days 
supply) 
4.7.2 
Medicaid administrative data, including 
claims and eligibility files 
 
4. 
STUDY DESIGN 
4.1 
Overall Design 
The HEALing Communities Study (HCS) is a multi-site, parallel arm, cluster randomized, wait-
list controlled trial evaluating the impact of the Communities That HEAL (CTH) intervention 
compared with usual care in wait-list communities. 
4.1.1 
Trial Duration 
The HCS goes from April 2019 through September 2025. During this 6.5-year period, the CTH 
intervention will be carried out in two waves. 
4.1.2 
Wave 1 Communities 
The HCS refers to the communities randomized to receive the CTH intervention first as Wave 1 
communities. Wave 1 communities will implement the CTH intervention for 30 months (January 
2020 through June 2022). After the intervention period, they will be observed for sustainment of 
the intervention for 18 months (July 2022 through December 2023). 
4.1.3 
Wave 2 Communities 
The HCS refers to the communities randomized to receive the CTH intervention second (in the 
wait-list comparison arm) as Wave 2 communities. During the 30 months that the Wave 1 
communities are receiving the intervention, Wave 2 communities will provide usual care (but not 
the CTH intervention). At month 31 (July 2022), Wave 2 communities will begin to implement 
the CTH intervention for 18 months (July 2022 through December 2023). 
4.1.4 
Assignment to Study Wave 1 and Wave 2 Communities 
The 67 HCS communities will be randomly assigned to Wave 1 communities or Wave 2 
communities. Randomization will be stratified by Research Site (RS) (i.e., Kentucky, 
Massachusetts, New York, and Ohio). In each RS, we will use covariate-constrained 
randomization21,22 to ensure balance between Wave 1 and Wave 2 communities on three key 

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21 
community characteristics at baseline: (1) opioid overdose death rate averaged over the prior 2 
years, (2) population size, and (3) urban versus rural status. Covariate-constrained 
randomization sets limits on the differences in select variables between arms in a trial. For the 
HCS, we will cluster-randomize communities in each site (state) and constrain randomization to 
balance three community-level factors at baseline: (1) rural/urban status (equal for even 
numbers; no more than a difference of 1 for odd numbers), (2) less than 0.2 standard deviation 
difference in community population, and (3) opioid death rate. Given the nature of the research, 
there will be no blinding in this study. 
4.2 
Scientific Rationale for Study Design 
The effectiveness of the CTH intervention is unknown but is designed to significantly reduce 
opioid-related mortality. Therefore, we chose to adopt the proposed parallel arm, cluster 
randomized, wait-list controlled trial design because it is feasible, ethically justified, and 
scientifically sound. We expect that there will be a lag (approximately 18 months) between the 
time that a community introduces the CTH intervention and when its effect on opioid overdose 
deaths will be observed; time is needed to ramp up programs and deliver services in order to 
accrue the benefit of the components of the CTH intervention. Furthermore, our calculations 
indicate that we have high power to detect the expected impact of the CTH intervention. Our 
trial design is ethically sound as Wave 2 (waitlist) communities will receive the CTH intervention 
after the primary outcome assessment period is completed in June 2022. The CTH intervention 
will be delayed for communities randomized to Wave 2, but Wave 2 communities will continue to 
provide usual care and will not be prohibited from using their own resources to adopt, enhance, 
or implement new methods of prevention and treatment during this time. 
4.3 
Justification for Intervention 
One driver of the opioid epidemic is the recognized service access gap for individuals who could 
benefit from an evidence-based practice (EBP) to reduce opioid-related overdose fatalities. 
Unfortunately, the penetration of these EBPs into community settings has been insufficient. This 
inadequacy is due, in part, to a lack of evidence-based implementation approaches to assist 
communities in the development and deployment of a data-driven customized response strategy 
to comprehensively integrate and implement EBPs. 
The CTH intervention is intended to assist communities in identifying community leaders, 
champions, and stakeholders willing to work collaboratively (through a local coalition) and 
develop a community response strategy to implement communication campaigns and EBPs 
with the goal of reducing opioid-related overdose mortality. 
4.4 
End-of-Study Definition 
Study completion for Wave 1 communities is defined for the intervention and sustainment 
stages. The intervention ends when Wave 1 communities complete 30 months of CTH; the 
sustainment stage ends 18 months after completion of CTH. The primary outcome will be 
assessed in months 19–30, and sustainment will be measured in months 31–42. Study 
completion for Wave 2 communities will occur at the end of the 18-month CTH intervention. 

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5. 
STUDY POPULATION 
The HEALing Communities Study (HCS) will enroll communities in Kentucky, Massachusetts, 
New York, and Ohio. In addition, interviews, surveys, and focus groups will be conducted with 
the Community Advisory Board and community coalition members, service providers, and 
individuals and families affected by the opioid crisis. 
5.1 
Inclusion Criteria 
The National Institute on Drug Abuse (NIDA) selected four Research Sites (RSs) (in Kentucky, 
Massachusetts, New York, Ohio) for the HCS. In these four states, 67 communities were 
selected. To be selected for this study, a community must meet all the following criteria 
established by NIDA: 
● The community must be located in one of the four participating states: Kentucky, 
Massachusetts, New York, or Ohio. 
● Of the communities selected in each state, 30% or more must be rural. 
● Across all the HCS communities in each state, there must be a minimum of 150 
opioid-related overdose fatalities (at least 15% of which come from rural 
communities) and a rate of at least 25 opioid-related overdose fatalities per 100,000 
people, based on 2016 data. 
● The community must express willingness to address in its response strategy the 
implementation of medication for opioid use disorder, overdose prevention training, 
and naloxone distribution across the community. 
● The community must express willingness to develop partnerships across health care, 
behavioral health, and justice settings for evidence-based practices to address opioid 
misuse, opioid use disorder, and overdoses. 
In addition to the NIDA-defined eligibility criteria listed earlier, the RSs used additional eligibility 
criteria to further refine their site selection (see Table 3). 
Table 3: Additional RS-specific inclusion criteria for communities enrolled in the HCS 
Criteria 
Kentucky 
Massachusetts 
New York 
Ohio 
Number of 
communities 
16 counties 
16 cities/towns 
13 counties, 3 
cites/towns  
19 counties 
Additional 
criteria  
Selected counties 
that had (1) a 
syringe service 
program (marker 
of community 
readiness), (2) a 
jail, (3) ≥1 
buprenorphine-
waivered provider, 
and (4) ≥5 opioid 
Selected to 
minimize proximity 
and contamination, 
favored 
communities with 
an anchor office-
based addiction 
treatment (OBAT) 
program and a 
pre-existing 
Selected the 
communities of 
Buffalo in Erie 
County, Rochester 
in Monroe County, 
and the 
Brookhaven 
township in Suffolk 
County to keep 
size comparable 
Randomly 
selected 
counties 
stratified by 
urban/rural that 
(1) were not 
contiguous and 
(2) did not share 
an alcohol, drug 

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23 
overdose deaths in 
2017 
substance use 
coalition  
and mental 
health board 
 
5.2 
Exclusion Criteria 
Communities that did not meet the aforementioned inclusion criteria were excluded from the 
HCS. Massachusetts and New York did not have any further exclusion criteria. Kentucky 
excluded three counties because they are actively engaged in two National Institutes of Health–
funded community-level interventions; inclusion would confound respective outcomes, and 
these communities could not be randomized. Ohio excluded 10 counties for lack of available 
opioid-related data. 
5.3 
Strategies for Recruitment and Retention 
Each of the four RSs conducted its own recruitment process for engaging communities. 
Kentucky identified possible counties based on the aforementioned inclusion criteria, then 
partnered with the Kentucky Agency for Substance Abuse Policy (KY-ASAP) and the local KY-
ASAP boards located in the counties that met the inclusion criteria. The mission of the KY-
ASAP and its local boards is to develop a long-term strategy designed to reduce the incidence 
of youth and adult smoking and tobacco addictions, promote resistance to smoking, reduce 
incidence of substance use disorders, and promote effective treatment of substance use 
disorders. Local KY-ASAP boards signed a letter of support indicating their willingness to 
participate. 
Massachusetts identified towns/cities with high opioid mortality rates, then sought geographic 
diversity by convenience sampling, mindful of community proximity and its potential 
contamination. Communities were prioritized with an “anchor” community health center in which 
an OBAT program could be established or expanded, as well as communities with a pre-existing 
substance use coalition. An explicit expectation for inclusion was willingness to participate fully 
in the study as a Wave 1 or Wave 2 community. We excluded Boston and adjacent communities 
because many intervention components (e.g., OBAT, addiction consult service, bridge clinic) 
were already well developed in this metropolitan area. 
New York identified counties with high opioid overdose death rates, then worked through the 
existing research team networks to reach out to the local health or mental health department of 
each county. Counties signed a letter of support indicating their willingness to participate. 
Ohio identified highly affected communities in two steps. Step 1 involved a comprehensive 
environmental scan of ongoing interventions funded by federal, state, and local entities and 
community organizations, containing latest available data for the primary and secondary 
outcomes. In step 2, the final set of communities was identified via a sampling design that 
minimized spillover effects. All randomly selected communities committed to partnering in the 
HCS as demonstrated by letters from leadership from the local county opioid coalitions, 
including representation from health care, behavioral health, and justice settings. 

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6. 
STUDY INTERVENTION(S) 
6.1 
Study Intervention(s) Administration 
This section describes in more detail the three components of the Communities That HEAL 
(CTH) intervention: (1) a community-engaged change process that forms the backbone of the 
HEALing Communities Study (HCS); (2) the Opioid-Overdose Reduction Continuum of Care 
Approach (ORCCA), a menu of strategies to implement evidence-based practices (EBPs) as a 
key component of the CTH intervention; and (3) community-based health communication 
campaigns designed to increase community engagement (CE), reduce stigma, and increase 
demand and utilization of EBPs. See Figure 2 for a depiction of the three components of the 
CTH intervention. 
Figure 2: Three components of the CTH intervention 
 
6.1.1 
Study Intervention Description 
6.1.1.1 
     Communities That HEAL Intervention 
The HCS investigators hypothesize that the fastest and most sustainable way to achieve a 
relative 40% reduction in opioid-related overdose deaths is to support local community 
coalitions and their stakeholders in building and enhancing a comprehensive, data-driven 
community response to the opioid crisis in their community. The CTH intervention seeks to 
promote a common vision, shared goals, and tailored strategies to mobilize HCS communities 
to implement communication campaigns and adopt EBPs using a stepwise community change 
process. Drawing on community-based participatory research principles, the CTH intervention 

The HEALing Communities Study 
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25 
will partner HCS researchers with multi-sector coalitions to develop a community-driven change 
process that will enable communities to be more effective in preventing deaths from opioids. 
The conceptual framework of the CTH intervention is shown in Figure 3. Briefly, the CTH 
includes co-creation, or participatory, approaches that lead to coalition-driven community 
change, enhanced decision making with data dashboards, and the design and implementation 
of communication campaigns that focus on increasing demand for EBPs and reducing stigma. 
The implementation of EBPs in each community is guided by the ORCCA that prioritizes EBPs, 
populations, and venues most likely to reduce opioid overdose fatalities. The ORCCA approach 
is supported by data from implementation science research and will be a focus of our cost-
effectiveness research. These intervention components are then hypothesized to lead to the 
primary outcomes described earlier. 
Embedded in this work is the belief that the primary responsibility for practice change lies in the 
community. Further, it is recognized that communities are complex and that distinct priorities 
exist across and within them. Thus, community members, particularly those who are most 
affected, have a nuanced understanding of the best ways to implement and promote EBPs 
locally. This dynamic interplay of theories of change, EBPs, and the realities in each community 
will establish a data-driven learning system to facilitate a greater understanding of principles 
needed for community change. 
Figure 3: Conceptual framework of the CTH intervention 
 
 
6.1.1.2 
The Community Engagement Process 
The CTH intervention is an adaptation of the Communities That Care model.23-25 CTH is a 
stepwise but also iterative learning process for engaging communities in a partnership that 

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26 
enables the adoption of EBPs chosen collaboratively to address the opioid crisis. The CTH is a 
non-linear, dynamic, and co-learning CE process that incorporates principles of systems and 
implementation science, health communications targeting stigma reduction and demand 
creation, and sustainability planning. The CTH CE process will involve seven phases, within 
which the ORCCA implementation and communication campaigns are operationalized, as 
shown in Figure 4a for Wave 1 and Figure 4b for Wave 2.  
 
Figure 4a: CTH intervention phases (Wave 1) 
 

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Figure 4b: CTH intervention phases (Wave 2) 
 
Phase 0: Preparation (Pre-Intervention) 
This phase refers to the period of the study before the launch of the CTH intervention (as 
described in the ensuing phases 1–6). Tasks 1-3 below cover Wave 1 and Wave 2 communities 
and are completed at the start of the study. 
1. 
Establish a statewide Community Advisory Board (CAB): CABs will serve as 
leadership bodies for community-based participatory research partnerships, ensuring 
that research activities are reflective of community priorities. As such, CAB 
composition typically reflects the communities of interest. CABs serve as a mechanism 
for community members to voice concerns and priorities that otherwise might not be 
on the researchers’ agenda. The CAB may also advise on the research process to 
help ensure that methods and procedures are acceptable to community members and 
aligned with local norms and values.26 
2. 
Establish communication strategies between CABs and government stakeholders: 
Possible options may include progress reports, sharing of CAB meeting minutes, and 
structured or unstructured opportunities for participation by federal officials in CAB 
meetings. 

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3. 
Share information with communities about randomization: This activity seeks to 
develop and implement a strategy to communicate effectively and sensitively about 
randomization in a way that is acceptable to Wave 1 and Wave 2 communities, state 
officials, and other stakeholders. In particular, we want to avoid dropout and maintain 
cooperation of Wave 2 communities. 
4. 
Identify and designate the HCS coalitions: During this pre-intervention phase, HCS 
teams will identify existing coalitions in their communities to inform designation of HCS 
coalitions and to facilitate collaboration among local alliances and stakeholders doing 
CTH-relevant work. In some communities, HCS coalitions may need to be created or 
modified to ensure representation of diverse groups, including those with lived 
experience, as well as racial and ethnic minorities and other groups disproportionately 
burdened by the opioid crisis. In other communities, existing coalitions or other 
established community advisory groups will be designated as HCS coalitions. 
Additionally, select members from different existing community coalitions may be 
brought together to form the new HCS coalition. In Wave 2, work under this task may 
also involve RSs sharing published HCS protocol papers, sample coalition charters, 
and sample champion descriptions with community stakeholders, as part of providing 
an overview of the HCS.  
5. 
Conduct Landscape Analysis (LA) and Baseline Assessments: An LA will be 
conducted to capture prevention, treatment, recovery support services, and 
infrastructure in health care, behavioral health, and criminal justice organizations, 
along with other key community features, such as local political context, that can be 
gathered from publicly available data sources. Specifically, the LA is designed to (1) 
describe the assets and gaps in the community that are relevant to HCS and CTH; (2) 
support collaboration with the coalitions as they make decisions about which EBPs are 
needed or could be enhanced in their communities and what venues may need to be 
engaged in the delivery of EBPs; and (3) help each HCS coalition and RS staff 
supporting the coalition to generate a list of potential key agencies and groups with 
which to partner for EBP delivery. Scientific team members will search publicly 
available, online and secondary data sources to identify relevant assets that exist in 
Wave 1 and Wave 2 communities. The LA report generated at the end of this exercise 
will provide key community context and directly inform CE efforts of the HCS. The LA 
for Wave 1 has two phases: LA Phase 1, which involves research staff searching 
publicly available information (primarily online) to identify assets in the communities; 
and LA Phase 2, which involves research teams contacting a subset of assets by 
email, by telephone, and/or in person to administer follow-up questions about the 
agencies’ services. Also, in Phase 0, RSs will collect pre-intervention (baseline) data 
from coalition members, CABs, and key stakeholders and community service providers 
to gather their input on the opioid crisis in their communities, ongoing efforts to 
address the crisis, and community or coalition factors that may affect the 
implementation of EBPs in HCS communities.  
Based on lessons learned and efficiencies gained in Wave 1, the LA for Wave 2 
communities consists of three steps. During Phase 0, two steps of the LA will occur 
either sequentially or concurrently. In step 1, RS staff will enter/update preliminary data 
in the REDCap tool from existing reports or data sources and from web searches in 

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the REDCap tool and identify & engage key community informants to elicit information 
on additional assets and gaps. In step 2, RS staff will refine, complement, and 
synthesize existing data by conducting systematic searches of publicly available data 
(e.g., using Google) and using this data to support interactive asset mapping. 
Organizational questionnaires, equivalent to the LA Phase 2 conducted in Wave 1 
communities, may be conducted as an optional activity.   
6. 
Train research site staff on the CTH intervention: RS staff will be trained on the CTH 
intervention, including principles of CE. Based on suggested competencies for 
implementation scientists doing community-engaged research, trainings will focus on 
skill development. Educational strategies may include in-person workshops, web-
based didactics, and longitudinal debriefing sessions with CE staff. 
7. 
Initiate preliminary activities for communication campaigns: This activity aims to lay the 
foundations for a health communication campaign (third component of the CTH). 
During this process, HCS teams will develop campaign playbooks and messages, 
conduct interviews with media gatekeepers, and perform message testing. Wave 2 
communities will tailor campaign materials developed with Wave 1 communities. 
Phase 1: Getting Started 
This phase commences the CTH intervention. According to Figure 1, Wave 1 communities will 
begin Phase 1 in January 2020, and Wave 2 communities will begin Phase 1 in July 2022. 
Stakeholder identification and engagement is an iterative process of relationship development 
with community stakeholders to foster effective collaboration to support HCS aims. This 
includes (1) partnering with and strengthening local coalitions to provide leadership and 
contextualize the opioid crisis for the EBPs; and (2) collaborating with state and local 
governments to strengthen the policy environment, expand resources, and support 
communities’ capacity to accelerate and expand delivery of EBPs to prevent opioid overdose 
deaths. 
In Wave 1, coalitions developed a distribution plan for the Year 1 communication campaign 
during Phase 1. However, this task was moved to Phase 2 for Wave 2 to allow more time for 
building communities’ capacity for community campaign work.  
1. 
Establish a structure for working with HCS coalitions: Each community participating in 
the HCS will develop or engage a standing body of stakeholders to support this study, 
referred to as the HCS coalitions. Coalitions are the primary locus for CE in this study. 
In some communities, pre-existing local coalitions established through state policy will 
be designated HCS coalitions. In other communities, new coalitions will be formed. 
Given the anticipated variation in HCS coalitions’ structures and practices, RS staff will 
need to work with coalitions to determine and document feasible protocols and 
procedures for partnering on CTH. Documenting protocols and procedures can help 
bolster RS–coalition partnerships and promote efficient implementation of the CTH 
intervention. Another key tool for bolstering the RS–coalition partnership through 
effective communication is the CTH portal, an online platform RSs will develop and 
customize for each HCS community. In Wave 2, HCS researchers agreed that RSs will 
work with coalitions to determine whether members, champions, or chairs should be 
reimbursed for their time, travel, or other resources committed to the CTH intervention. 

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Reimbursement is a community-driven decision, so may vary across sites. In Wave 2, 
HCS researchers also decided to include explicit guidance in the CTH implementation 
manual around meaningfully engaging people who use drugs or are in recovery. 
People with lived or living experience may be engaged through membership in the 
coalition, as champions, or through one-on-one consultation. The approach to 
engaging people who use drugs or are in recovery may vary across HCS communities, 
but HCS researchers have committed to the following principles: 
• 
Respect the engagement preferences of people who use drugs, including 
ensuring anonymity, if requested 
• 
Protect the safety of people who use drugs and address any concerns related 
to criminalization 
• 
Address any barriers to participation, such as limited transportation, mobility, 
schedule, or internet access 
• 
Aim for diverse representation of people who use drugs (e.g., age, gender, 
race and ethnicity, and sexual orientation diversity) 
• 
Include protocols for addressing any stigma or related conflict within the 
coalition 
• 
Comply with sIRB requirements 
2. 
Recruit champions introduce data-driven decision-making approach, and initiate 
review of community assets data from the Landscape Analysis: The objective of this 
activity is to identify coalition members who can facilitate communication and activities 
between the coalitions, the HCS research team, and partner organizations. This 
process involves orienting coalitions to data-driven decision-making approaches and 
identifying and engaging multi-sector coalition members who are willing and able to 
serve in leadership roles.27 For Wave 2 communities, the third step of the Landscape 
Analysis consists of inviting coalition members to review data collected from the 
Landscape Analysis. 
3. 
Train HCS coalitions: It is important to ensure that designated coalition members have 
the necessary background knowledge and skills to carry out their roles and fully 
participate in meetings. Specialized training modules for designated coalition members 
will ensure that they have a foundation of information that will allow them to participate 
meaningfully in discussions and decisions. These modules serve as a prelude to more 
in-depth discussions of surveillance, treatment, implementation in practice settings, 
and evaluation in subsequent steps. 
The development of an HCS-related coalition training plan is critical to facilitating 
coalition-led HCS activities. Coalition members should be provided with an overview of 
the HCS. This may include grant materials describing the HCS design and the overall 
leadership structure including the role of the CAB. The orientation should also include 
a detailed overview of the CTH process and planned menu items associated with the 
ORCCA menu of EBPs. Additionally, community stakeholders should understand the 
rationale underlying study activities, including constraints dictated by research 
requirements. It should be made clear how action-oriented implementation research 

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differs from routine service delivery on the one hand and traditional clinical research on 
the other. To be most effective in their roles, members of coalitions must be able to 
understand and challenge data that are presented, to inform their decisions and 
strategies. 
4. 
Introduce the ORCCA menu and EBPs: In this phase, community coalitions begin to 
convene and engage in the HCS. The HCS team will introduce the ORCCA-required 
objectives and the menu of EBP strategies. Community champions, one for each of 
the three required objectives, would have been identified and recruited. In the context 
of the community-specific LA, they will begin developing a shared understanding of the 
local epidemic, current services to address overdose, and relevant settings. 
Phase 2: Getting Organized 
In Phase 2, community coalitions and HCS teams will review and discuss the menu of EBP 
strategies and the strategy selection process. Through review and discussion of the EBP 
strategies, coalitions will begin to develop a shared vision for implementing the EBPs, which will 
facilitate data review and action planning in subsequent CTH phases. During Phase 2, HCS 
teams will also develop a distribution plan for Campaign 1 in partnership with the coalitions. 
1. 
Discuss ORCCA menu options and decision procedure for selecting EBP strategies: 
The purpose of this activity is to ensure that designated coalition members understand 
the rationale for emphasizing EBPs, the range of differences among ORCCA menu 
options, and how to evaluate anticipated risks and benefits of different approaches 
with different populations in different settings. Coalitions will review options and make 
recommendations to guide partner organizations’ decisions about selection of options. 
Deliberations about choices should address appropriateness, preferences, and 
feasibility, as well as the ability to monitor implementation and fidelity. The process 
here will focus on coalitions’ identification and selection of EBPs that best suit their 
community needs.  
 
2.Develop a distribution plan for Campaign 1: RS staff will collaborate with community 
coordinators, CAB members, program managers, community engagement facilitators, 
communication champions, subcommittee or coalition members, and partner 
organizations to develop a plan for disseminating materials for Campaign 1. 
 
Phase 3: Community Profiles and Data Dashboards 
This phase will focus on the collaborative improvement or development of data systems and 
surveillance infrastructure to allow systems integration and inform decision making. Surveillance 
will support establishment of community-facing dashboards that will provide multi-level data 
necessary to support action planning and improvement in practice and outcomes. This phase 
will involve sequential and parallel processes as depicted in Figure 5 and described below for 
Wave 1.  
1. 
Create version 1.0 of the community profile: The purpose of this activity is to 
collaborate with state and local stakeholders to collect or review data that describe the 

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state of the opioid epidemic and treatment and opioid overdose prevention resources 
across sectors of participating communities. Data for the community profiles will 
include existing assessments completed by the community, existing or updated LAs, 
and new data collection to supplement existing profiles or create new profiles. Also, in 
this phase, the research teams will present the results of prior LAs conducted in Phase 
0 for their feedback to solicit input on missing elements and make corrections in the 
data. Data to be collected may vary across sites but could include epidemiological data 
on the epidemic, contextual information on county conditions, assessment of stigma in 
the county, network analysis of organizations, and an inventory of providers and 
services across the continuum of care and in multiple settings.  
2. 
Create version 1.0 of the data dashboard: Access to integrated data from different 
sectors can improve communities’ capacity to plan, monitor, innovate, respond, and 
support community health improvement. At this step, we will facilitate discussion in the 
CAB, coalitions, or across organizations to define what data sources are important to 
profile the crisis in their community and develop a system for sharing and displaying 
data that meet community needs. To develop and/or improve data sharing 
relationships across community organizations, study teams will facilitate discussions 
about data sharing, including identifying key stakeholders and community partners that 
collect and use data, identifying enablers or barriers to using and sharing data, and 
developing a shared understanding of the potential benefits of data sharing and data 
visualization. Once this shared understanding is developed, researchers will assist in 
assessing the types of data they collectively like to share and will assist in developing 
a data visualization tool or dashboard that meets identified community needs. 
3. 
Map the existing services and programs to ORCCA: Working together, the community 
coalitions and HCS teams will review the community’s inventory of existing resources, 
identify gaps in services for people at high risk for opioid overdose, and identify 
barriers to addressing service gaps. This process will be completed for all currently 
available services that address the three ORCCA-required EBPs. 
4. 
Engage HCS coalitions on data visualizations: In this phase, HCS researchers will 
engage coalitions and other key stakeholders on the visualization of the community 
profiles and the use of dashboards. 
5. 
Co-create version 2.0 of the community profile: RS staff and coalitions collaborate to 
develop version 2.0 of the community profile. Version 2.0 of the community profile is a 
written document that demonstrates shared understanding of the existing ORCCA 
services, who is currently engaged, and who can and should be engaged in 
implementing EBPs. The development process for this final document will likely 
include iterative drafts of a written profile that is shared with the community coalition for 
feedback and final approval. 
6. 
Co-create version 2.0 of the data dashboard: RS staff will collaborate with coalitions to 
develop version 2.0 of the community-tailored dashboard. This task builds on 
discussions from version 1.0, where coalition members and stakeholders discuss 
community-specific data issues and recommendations. Co-creating version 2.0 of 
dashboard involves ensuring that version 2.0 dashboards are responsive to the 

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community needs identified by coalitions, and this may require adding new metrics or 
visualizations to the dashboards. 
7. 
Conduct Stakeholder Trainings on Content and Use of Community Profiles and Data 
Dashboards: After community profiles are developed, coalitions will be offered training 
and support to work with and understand data, in order to consider this information in 
setting goals and action plans. The purpose of this activity is to ensure that designated 
coalition members understand how to interpret and work with community profile data. 
Figure 5: Phase 3 parallel processes for developing community profiles and data dashboards 
(Wave 1) 
 
 
For Wave 2, research sites will draw on lessons from the development of Wave 1 community 
profiles and dashboards, and only one version of the profile and dashboards will be developed 
for Wave 2 communities. Additionally, the training conceptualized as a separate task in Wave 1 
(task 7 above) has been incorporated into the ”Engage HCS coalitions on data visualizations” 
task (4 above), as research sites experienced that engagement on visualizations and training 
often went hand-in-hand during Wave 1. In Wave 2, the implementation of Campaign 1 will 
occur in Phase 3. 
Phase 4: Community Action Planning 
In collaboration with stakeholders and coalitions, we will use community profiles and data 
dashboards to identify key gaps and areas of unmet need evident in the data. Planning will 
entail a data-driven facilitation process during which EBPs are discussed, considered, and 
chosen (as applicable). Further, planning will detail how EBPs will be implemented and how 
progress will be monitored and reported to others and by whom. These plans will draw on the 
best available scientific evidence and stakeholder experience regarding individual, 
organizational, and community change. Leaders of organizations involved in implementing the 
designated EBPs will be encouraged to be fully engaged in this process. 

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1. 
Develop ORCCA-specific goals for the community: Coalitions will drive goal setting 
with support from RS staff. Community ORCCA-specific goals must align with the HCS 
goal to reduce opioid overdose mortality. Coalitions can also consider whether it is 
beneficial to adapt goals from previous plans or related efforts to address the opioid 
crisis. HCS coalitions can select goals using ORCCA-specific resources. 
2. 
Discuss and prioritize EBP strategies that align with community goals: Coalitions will 
work with RS staff to discuss and prioritize EBP strategies that (1) align with the 
ORCCA-specific goals developed under the previous task, (2) address the gaps 
identified through review of the community profile and data presented on dashboards, 
and (3) are high impact and highly feasible. To the extent possible, coalitions should 
engage potential partner organizations in this selection process. Potential partner 
organizations can help assess the feasibility of implementing the EBP strategies under 
consideration. In some cases, these organizations will be members of the coalition. 
However, if potential partner organizations are not also coalition members, they can be 
invited to participate in strategy setting meetings or invited to provide timely input via 
email or separate meetings. 
3. 
Establish community action plans: The format of action plans may vary across RSs 
and communities, but, at a minimum, action plans across all sites will capture the 
prioritized EBP strategies under each of the three required ORCCA components 
(OEND, MOUD, and prescription opioid safety). Recommended steps for completing 
this task include reviewing the priorities set in the previous task with the coalition, then 
drafting action plans and identifying high-priority strategies to move forward for 
development of implementation plans. When possible, coalitions and research teams 
should engage partner organizations in the action planning process. Of note, as 
communities move through Phase 5, action plans may need to be revisited and 
revised in response to challenges encountered and lessons learned during the 
implementation process or evolving community needs and resources. Starting in 
Phase 4, RSs will complete the ORCCA Tracker (ORCCAT) monthly for each 
community to document the selection of EBPs and any changes to action plans over 
time. As communities progress to Phase 5, the ORCCAT will also be used to track 
EBP implementation. See Table 10 for additional instrument details.   
In Wave 1, this phase included two communication campaign tasks (4 and 5 below). 
However, as noted above, the cadence for the planning, implementation, and monitoring of 
communication campaigns was refined for Wave 2 based on lessons from Wave 1 and in 
response to the shorter timeline Wave 2 communities have for implementing the CTH. Tasks 
4 and 5 below are not included in Phase 4 for Wave 2, rather a combined task to plan, 
implement, and monitor Campaigns 2 and 3 was added to Phase 5 for Wave 2.  
4. 
Conduct qualitative review of Year 1 communication campaigns in partnership with the 
HCS coalition: Coalitions will review their dissemination activities to date for each of 
the three Year 1 communication campaigns (1- Naloxone, 2- Stigma, and 3- MOUD) 
with RS staff. As part of this review, RS staff will guide coalitions in a qualitative 
assessment to discuss what is working, what can be improved, and what additional 
resources can be leveraged to improve the reach, frequency, and effectiveness of 
Year 2 campaign activities. 

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5. 
Develop the Stay in Treatment Campaign Messages and Materials: RS staff and 
coalitions will apply the Prepare-Plan-Implement steps in Figure 28 to develop 
additional messages and materials for the Stay in Treatment campaign. Completing 
the Prepare-Plan-Implement steps involves RS staff working with coalitions to answer 
essential questions at each step in the process, including questions about the 
resources needed for success.  
Phase 5: Implement and Monitor 
This phase involves developing implementation plans for selected EBP strategies, implementing 
EBP strategies, and planning, implementing, and monitoring Campaigns 2 and 3 in partnership 
with HCS coalitions (Wave 2). 
1. 
Develop initial implementation plans for selected EBP strategies: This task involves 
building on the action plans developed under Phase 4 to create plans that will detail 
how partner organizations will execute the specific EBP strategies they agree to 
implement, with support from RS staff and coalitions.  
2. 
Implement ORCCA EBP strategies: Using implementation plans as a guide, partner 
organizations will implement selected EBP strategies with support from RS staff and 
HCS coalitions. As partner organizations monitor and learn from implementation 
efforts, they may identify opportunities to improve the implementation of EBP 
strategies and can work with RS staff and coalitions to modify implementation plans as 
needed. 
3. 
Troubleshoot and provide technical assistance (TA): RS staff supporting EBP 
implementation will troubleshoot implementation problems with partner organizations 
and provide TA as needed to support optimal implementation of EBPs. Coalition 
members may also assist with troubleshooting and TA. Learning collaboratives (LCs) 
or communities of practice may be launched under this task to help address coalitions’ 
and partner organizations’ training and TA needs and to provide a forum for sharing 
successful strategies and lessons learned from EBP implementation. 
4. 
Plan, implement and monitor Stay in Treatment campaign activities and a “Community 
Choice’ campaign (a refresh and repeat of one of the previous four campaigns) in 
partnership with HCS coalitions (Wave 1): After completing the Prepare step in Phase 
4 that concludes with the draft campaign plan, RS staff will partner with coalitions to 
plan, implement, and monitor Year 2 activities for: (1) Stay in Treatment and (2) 
Community Choice. Stay in Treatment materials will be distributed in communities 
starting in June 2021. Community Choice campaign materials will be distributed 
starting no later than January 2022.This Wave 1 task was changed to plan, implement, 
and monitor Campaigns 2 and 3 in partnership with HCS coalitions for Wave 2.  
Phase 6: Sustainability Planning 
Training and data-driven decision making are key CTH elements that help position coalitions 
and partner organizations to sustain EBP implementation after HCS ends. Phase 6 involves 
setting up training and data tools and resources used in previous phases to be available to 
coalitions over the course of the intervention period and beyond. RSs will also assist coalitions 
and partner organizations with developing a sustainability plan. 
 

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1. Promote sustainability through local hiring and training: Over the course of the 
intervention, RSs will recruit and train local community members for key CTH roles (see 
Phases 0, 1, and 2). Hiring and training community members to implement the CTH 
intervention helps build local expertise related to data-driven action planning and EBP 
selection, which can support long-term EBP implementation that in turn leads to 
improved health outcomes. 
2. Support sustainability through training, TA, and learning collaboratives: RSs provide 
training and TA for HCS communities over the course of the intervention to support data-
driven planning, EBP implementation, and communication campaigns. As communities 
make progress on these key CTH components, the focus of training and TA shifts to 
sustainability. Areas of focus for sustainability TTA may include obtaining financial 
resources to continue CTH efforts beyond HCS, maintaining the data infrastructure (e.g., 
data dashboards and data sharing protocols) to continue data-driven planning, and 
leveraging HCS communication campaign strategies and materials for dissemination 
beyond HCS. 
3. Support development of coalition-driven sustainability plans: A coalition-driven 
sustainability plan is required for all HCS communities. RSs will assist coalitions and 
partner organizations with developing a sustainability plan. Sustainability planning is a 
community-driven process; therefore, planning activities and plans are expected to vary 
within and across communities and RSs. RSs will encourage the adoption of 
sustainability planning best practices, including developing plans that specify 
measurable sustainability goals for core CTH components—community-engaged, data-
driven action planning; EBP implementation; and a communication strategy to support 
the uptake of EBPs—and markers of success. 
6.1.1.3 
Maintaining CTH Beyond Year 1 (Wave 1) 
Wave 1 communities are expected to maintain and deepen the core elements of the CTH—
community engagement, ORCCA, and health communications—in an integrated manner 
throughout the intervention period, which ends June 30, 2022. RSs, coalitions, and partner 
organizations will continue collaborating to maintain and expand EBP implementation and other 
elements listed in Figure 6. As needed, RSs may support coalitions in cycling back to any CTH 
phases to address emerging community concerns related to the opioid crisis. Note that this work 
to maintain CTH beyond Year 1 only applies to Wave 1 communities. Wave 2 communities will 
be implementing CTH on a truncated timeline and therefore are not required to complete these 
maintenance activities.  

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Figure 6: Schedule of Activities for Maintaining the CTH Beyond Year 1 (Wave 1)  
 
6.1.1.4 
The Opioid-Overdose Reduction Continuum of Care Approach (ORCCA) 
The ORCCA prioritizes practices, populations, and venues most likely to reduce opioid-related 
overdose fatalities (see Figure 7) and can be mapped to the OUD cascade of care model.28 This 
model describes the stepwise progression from initial opioid exposure to a diagnosis of OUD, 
initiation, engagement, and retention in treatment. The ORCCA provides strategies to reduce 
overdose deaths along this OUD cascade of care.

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Figure 7: The HCS ORCCA with sample strategies
 
Source: Figure and conceptual model adapted from Williams and colleagues.28 

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ORCCA Requirements 
The ORCCA menu of strategies will evolve over time based on emergent community needs as 
new evidence and resources are collected. Through the CTH intervention, each coalition will 
use the ORCCA menu of strategies to facilitate community adaptation and implementation of 
the three required EBPs. 
ORCCA EBP Requirement 1: OEND in high-risk populations 
Opioid overdose victims die when they do not receive an antidote in time. In many cases, 
naloxone can completely reverse opioid overdoses. To implement ORCCA EBP Requirement 1, 
community action plans will need to include strategies that actively distribute naloxone and 
provide overdose prevention education to high-risk individuals and their social networks at high-
risk venues. Optional strategies that can be included in the community action plan are OEND by 
referral, OEND by self-request, naloxone availability for immediate use in overdose hotspots, 
and capacity for first responder administration. 
ORCCA EBP Requirement 2: Effective delivery of MOUD, including agonist/partial agonist medication and 
outreach and delivery to high-risk populations 
Reducing opioid overdose fatalities and improving secondary study outcomes will require 
increasing the availability of MOUD.6 Improved access to evidence-based MOUD treatment, 
particularly agonist/partial agonist treatment, can significantly reduce the risk of overdose 
death.11 The most effective treatment for OUD is MOUD, including methadone maintenance, 
buprenorphine maintenance, and naltrexone. MOUD significantly reduces the likelihood of 
opioid overdose,29-32 human immunodeficiency virus transmission,33,34 and hepatitis C virus 
transmission.33,35,36 MOUD is also associated with increased employment rates,37 increased 
quality of life,38 decreased crime, and decreased utilization of high-cost health care services.39 
Expanding MOUD treatment availability 
In the absence of evidence that MOUD treatment is readily available on demand and with few or 
no barriers (i.e., multiple settings with no waitlists for MOUD, adequately covered by insurance), 
efforts to expand MOUD treatment (i.e., capacity building) are required as part of the CTH 
intervention. These efforts could include making MOUD treatment available in settings currently 
lacking MOUD, such as criminal justice, general medical, and addiction treatment settings, and 
expanding the capacity of settings that already offer MOUD to treat more individuals. 
Linking to MOUD services 
Techniques to target individuals at heightened risk and link them to services are required. In 
particular, providing MOUD treatment (e.g., buprenorphine) on a short-term basis outside 
addiction treatment settings is an effective adjunct to linkage-to-care practices that significantly 
increase subsequent engagement in structured and sustained MOUD treatment programs.40,41  

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Enhancing MOUD treatment retention 
Although MOUD is effective for those engaged in treatment, retention rates in MOUD are 
disappointing.42-45 Thus, strategies to increase treatment engagement and retention are required 
as part of the CTH and are shown in Figure 7. 
ORCCA EBP Requirement 3: Safer opioid prescribing and dispensing 
Pharmaceutical opioid supply is a key source of opioid exposure, contributing to OUD and 
opioid overdose. Specific prescribing practices, including excessive prescribing for acute or 
postoperative pain, prescribing ≥90 morphine milligram equivalents per day for chronic pain, or 
co-prescribing opioids and benzodiazepines, increase the risk of opioid overdose. Promoting 
safer, more judicious opioid prescribing, dispensing, storage, and disposal practices can 
increase opioid safety, reduce the excess opioid supply in communities, and decrease the risk 
of overdose.  
Identifying and engaging high-risk populations 
As noted in Required EBPs 1 and 2, identification of and intervention with high-risk populations 
is an ORCCA requirement. 
● 
Definition of populations at substantially heightened risk for opioid overdose death: 
Any individual with OUD is at risk for opioid overdose death, particularly if he or she 
is not engaged in MOUD. Characteristics that further elevate risk of overdose and 
death in individuals who use opioids include use of opioids and (1) a prior opioid 
overdose,1,2 (2) reduced opioid tolerance1,3-5 (e.g., completing detox or release from 
an institutional setting such as jail, residential treatment, or hospital), (3) use of other 
substances6 (e.g., alcohol, benzodiazepines, cocaine, and amphetamine-like 
substances), (4) concomitant major mental illness1 (e.g., major depression, bipolar 
disorder, schizophrenia, anxiety disorders), (5) concomitant major medical illness1 
(e.g., cirrhosis, chronic renal insufficiency, chronic obstructive pulmonary disease, 
asthma, sleep apnea, congestive heart failure; infections related to drug use), and/or 
(6) injection of drugs.1,7 
● Venues with populations at heightened risk for opioid overdose death: These venues 
include (1) criminal justice settings8,9 (e.g., pre-trial, jails, probation, parole, drug and 
problem-solving courts, police and narcotics task forces, halfway houses and 
community-based correctional facilities, departments of youth services); (2) syringe 
service programs,10 (3) health care facilities11-14 (e.g., emergency departments; 
safety net clinics; health departments, pharmacies, and hospitals), (4) first responder 
stations15 (e.g., police and fire stations), (5) addiction treatment and recovery 
facilities, (6) mental/behavioral health treatment facilities, (7) community-based social 
service agencies (e.g., homeless shelters or other temporary housing, services 
agencies for transactional sex workers, halfway houses and/or other sober living 
facilities), and (8) hotlines (telephone or Internet) responding to service requests. 

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Process of EBP Strategy Selection 
The general process for coalitions to review and select specific EBP implementation strategies 
was described in the CE phases. The process for determining what system and practice 
changes will be pursued can be divided into two levels: (1) the overall community level 
(stakeholder coalitions, etc.) and (2) the care delivery system level (e.g., system administrators 
and service providers), detailed as follows. 
Community Level 
Community action planning efforts will involve a bi-directional and iterative exchange in which 
community needs and capacity are matched to evidence about which approaches are available 
to rapidly affect opioid overdose mortality. Using decision aids and a shared decision-making 
process can facilitate this approach.46,47 The goal of this exchange is to efficiently identify the 
most promising approaches, settings, and populations for a given community and to create a 
rationale from the community-wide perspective that can be helpful in motivating individual 
systems, administrators, and providers to implement the EBPs. 
Care Delivery System Level 
Ideally, the majority of interaction at the system administrator and service provider level will 
involve facilitation and operationalization of selected EBP strategies. This will be more likely if 
(1) setting-specific administrator and provider perspectives are adequately represented in 
coalitions, and (2) there is collaboration between service settings and the communities they 
serve. 
Nonetheless, there is the potential for disconnect in which the coalition selects EBP strategies 
that are not feasible or acceptable to the administrators or providers of a given service setting. If 
this disconnect were to occur, it would entail three complementary responses. The first level of 
response would be to reiterate the coalition’s rationale and EBP implementation selection 
process with individual administrators and providers. The second level of response would be to 
explore the barriers within that setting or service to determine whether there is a possible 
solution. In many cases, overall concern about a change in practice is specific to components 
that, once defined, can be addressed to mutual satisfaction. The third level of response would 
be returning to the coalition with the administrator or provider concerns to refine the community 
action plan, search for solutions, or define alternate EBP implementation strategies. 
Expected Changes in Systems and Practices 
Several factors mediate the relationship between the CTH intervention and the expected 
changes in systems and practices that will be facilitated and measured as part of the study 
protocol. 
1. 
Decisions and actions to implement system and practice changes as well as the actual 
services provided at the individual level are a clinical (non-experimental) matter that is 
not explicitly determined by the research protocol, so long as the implemented EBPs 
are aligned with the requirement and priority populations and settings. Although the 
CTH will work to facilitate the communities’ focus on effective practices and high-
fidelity implementation that are evidence based, there is uncertainty as to whether this 

The HEALing Communities Study 
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42 
facilitation will be successful. It is possible that communities will adapt existing EBP 
strategies, embrace approaches that were not initially selected for the list of EBP 
strategies, or even withdraw from the study altogether. Nonetheless, at no point will 
study resources be allocated to the testing of novel practices that are deemed 
experimental. 
2. 
The premise of the CTH intervention is that with facilitation and technical support, it is 
possible for communities to modify existing system structure and practice to reduce 
opioid overdose deaths. This approach will necessarily involve helping coalitions 
devise ways to do more with existing resources and pursue additional resources. 
However, although direct service support by study funds (paying for treatment or other 
service delivery personnel, purchasing medications or supplies, etc.) is not inherently 
sustainable beyond the duration of the study, such service support is allowed. 
3. 
Although we anticipate that there may be RS-to-RS and community-to-community 
variability in the system by which CTH facilitation is delivered, there will be a 
component of central, common, and more content-based leadership that is extended 
throughout the communities by a complementary component that is more local, more 
clinically experienced, and more focused on operations and TA. Although content 
expertise of centrally located academic experts is essential, effective facilitation at the 
level of individual settings and EBPs requires an intimate and sustained understanding 
of the personnel, practices, and systems in each EBP location. This technical and 
operational insight is most reliably found within individuals who have relevant practical 
and clinical experience for the setting and/or EBP. More importantly, these individuals 
are most likely to be viewed as credible by local administrators and practitioners. 
Community-Based Communication Campaigns 
The CTH intervention includes a series of communication campaigns that build on the empirical 
foundations of health communication and mass communication for behavior change.48-51 The 
development and implementation of these campaigns have the following objectives: 
1.  
Enhancing the adoption of EBPs in each community and heightening CE; 
2.  
Developing a cohesive set of communication objectives, priority groups, strategies, 
and tactics that can be applied across all communities in the HCS; 
3.  
Providing message materials for coalitions that can be tested and tailored to reflect the 
unique assets and characteristics of each community; and 
4.  
Integrating approaches to reduce stigma. 
Integrating health communication EBPs, social-behavioral theories, and insights from people we 
seek to serve, the campaigns described here are a common set of activities, using a campaign 
guidebook and messages developed and vetted by the RSs, that will be implemented in each of 
the Wave 1 communities. The campaigns are designed to use only locally accessible media 
resources to avoid potential spillover effects into Wave 2 communities before their activation. 
The structure of the campaigns is designed to provide a minimum protocol for communities to 
follow. Individual community coalitions may elect to add other components onto their campaign 
for local tailoring (e.g., communities may create materials for specific population groups based 

The HEALing Communities Study 
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43 
on socio-demographic characteristics). Some communities may be able to use television and 
radio, whereas others may not, due to potential spillover effects. Communities may choose to 
focus on specific social media platforms, such as Facebook, Instagram, Snapchat, Reddit, or 
Nextdoor, or use paid targeted advertising on such social media and other outlets. 
Each campaign provides the opportunity to leverage communication and media assets in the 
local community to reach a larger and broader part of each community to engage in the study 
and to spur demand for EBPs such as (1) increasing OEND; (2) enhancing delivery of MOUD; 
and (3) identifying, reaching, and engaging high-risk populations in OEND and MOUD. 
An overview of the approach for the Wave 1 communities’ campaigns is shown in Table 4. 
Briefly, an HCS website with a dedicated page for each Wave 1 community is updated as new 
campaigns are launched in the communities. Planning activities for the first three campaigns are 
carried out by the HCS campaign team, including message concept testing for each campaign 
among community representatives of the priority groups. A similar planning and formative 
research process will be taken for the final two campaigns that are intended to focus more 
deeply on increasing MOUD retention and a refresh and repeat of a previous campaign 
(Community Choice). Each campaign includes a Prepare phase that involves co-creation of 
distribution plans with coalitions that leads to the successive launch of each campaign with core 
digital and print assets (e.g., digital advertisements, social media posts, and print posters and 
handouts) along with a campaign message guidance document for coalitions that wish to create 
additional materials to support the campaign. The Implement phase is coalition led with 
technical assistance and support provided by each RS and communications staff.  
In a process identical to that conducted with the Wave 1 communities, Wave 2 communities will 
also conduct campaigns using the same campaign guidebook and messages as originally 
presented to the Wave 1 communities. These coalitions will go through a tailoring process to 
allow for potential targeting of high-priority groups, focusing on specific objectives or EBPs, and 
include revised messages and/or new media distribution channels. 
Each campaign has pre-specified relevant priority groups of community leaders, health care 
providers, and people with lived experience (PwLE). Communication objectives include: (1) 
obtaining and carrying naloxone; (2) decreasing MOUD stigma; (3) raising awareness of MOUD 
treatment; and (4) staying in MOUD treatment. We will incorporate messages in each campaign 
directed toward stigma reduction as they relate to OUD, MOUD, OEND, and recovery. The key 
issues as they relate to each campaign are identified under the stigma targets column in Table 
4. 
 
 
 
 
 
 

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44 
Table 4: Overview of communication campaigns  
Campaign 
Theme 
Priority Groups 
Objectives 
Stigma Targets 
April 2020-
July 2020 
Naloxone 
Community leaders, 
public safety, criminal 
justice,  
Health care providers 
People with OUD and 
their families 
Increase demand and 
access to naloxone. 
 
Carry naloxone.  
OUD is a medical 
disease 
People with OUD 
deserve the best 
medical care possible 
July 2020-
November 
2020 
Stigma 
Community leaders, 
public safety, criminal 
justice,  
Health care providers 
People with OUD and 
their families 
Reduce stigma 
OUD is a medical 
disease 
People with OUD 
deserve the best 
medical care possible 
Anyone could develop 
an OUD 
MOUD is a safe and 
effective path to 
recovery for many 
people 
October 
2020–
March 
2021 
MOUD – Seek 
Treatment  
Community leaders, 
public safety, criminal 
justice,  
Health care providers 
People with OUD and 
their families 
Increase demand for 
MOUD  
Increase MOUD 
prescribing 
Increase access to, and 
availability of, MOUD 
OUD is a medical 
disease 
People with OUD 
deserve the best 
medical care possible 
Anyone could develop 
an OUD 
MOUD is a safe and 
effective path to 
recovery for many 
people 
 June 2021 
– Dec 2021  
 
MOUD - Stay 
in treatment 
and recovery 
High-risk patients and 
families, their health 
care providers, 
friends, religious 
leaders, employers, 
and co-workers 
Community agencies, 
businesses, and 
organizations that can 
support treatment 
referral and retention  
Increase access and 
coordination for seeking 
and being referred to 
treatment for OUD 
Increase treatment 
retention 
 
Treatment is effective 
Increase support for 
people with OUD and 
their families 
Increase public 
acceptance and 
support for non-
discrimination of 
people with OUD in 
employment, health 
care, and housing 

The HEALing Communities Study 
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45 
Jan 2022 –
June2022 
Community 
Choice 
Selected by a coalition  Consistent with objectives 
of the selected campaign 
Consistent with 
targets of the selected 
campaign 
 
Communication Campaign Development and Implementation Protocol 
The LA conducted in CTH Phase 0 and the study baseline periods will identify local media 
outlets. Interviews with up to 10 media representatives in each Wave 1 community will provide 
more context for understanding those communities and their unique media environments that 
can be used in the CTH efforts. 
The key steps for the implementation of each campaign as described in Table 4 are outlined in 
Figure 8. These steps will be codified in a campaign guidebook that the RS staff and coalitions 
will use to facilitate discussion of each campaign’s priority groups, objectives, message maps, 
communication strategies and tactics, monitoring metrics, and milestones. As we expect, there 
will be limited capacity within coalitions to develop and launch campaigns along with other 
implementation goals (e.g., adoption of EBP strategies by community organizations and 
groups), and the compressed time frame in which to develop and field campaigns to affect study 
outcomes, the guidebook, and messages are a way to present options for quickly deciding the 
direction and content of the campaigns. We will also conduct message testing for the first three 
campaigns followed by more extensive concept and message testing for the Stay in Treatment 
campaign. 

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46 
Figure 8: The Plan-Prepare-Implement model for campaign development and 
community engagement 
 
 
 
 
Formative research activities for each campaign will follow a standard set of methods and 
procedures that also allow for each community to adopt campaign practices and messages that 
are best suited to their local context, the capacities and assets of their coalition, current 
perceptions of the opioid overdose challenges in the community by different priority groups, and 
any unique preferences for messages and communication channels. In at least three Wave 1 
communities, the RS will conduct up to 5 focus groups or up to 25 individual interviews for 
message testing per campaign. The number of groups or interviews in each community will be 
dependent on the size of the community (i.e., smaller communities may require fewer focus 
groups than larger ones), the desired priority groups to recruit (i.e., some communities may 
choose to focus on one group; others may choose to focus a campaign on more), and how 
many groups or individuals per priority group are judged as necessary to validate results (one 
may be enough in some circumstances such as with coalition members or stakeholders; two to 
three may be needed for people with OUD or high-risk users, especially in larger communities). 
Each of these groups will be composed of up to 10 representatives from a stakeholder group 
(e.g., community leaders, public safety or criminal justice, health care providers, treatment 
centers) or priority population (e.g., people with OUD, family members, heroin users, high-risk 
patients or people from their social networks, people currently taking prescription opioids). We 
anticipate that up to 1,800 people across all HCS communities may be included in these focus 
groups, individual interviews, or research design workshops for each campaign (see the 
following moderator and facilitator guides: Focus Group CAB, Coalition, and Partner 
Level of Community Engagement  

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47 
Organizations Guide; Focus Group for Persons with OUD; Focus Group Testing of Launch 
Messages; Communication Design Workshop Guide; Interview Guide Message Testing; 
Interview Guide Message Testing Persons with OUD), for an average of 54 participants per 
community. 
Throughout the campaign development process, we will test specific concepts and messages to 
express the theme in a way that is most relevant, compelling, and useful for the priority groups 
in each community. Appendix B contains the pool of items that we will pull from for these 
message testing and formative research activities. The community coalition, local partners, and 
their respective communication assets (e.g., community-hosted websites, social media pages, 
newsletters) will be a critical part of the campaign message dissemination process. In Table 5, 
we present more details about the key steps in the Prepare-Plan-Implement process. 
Table 5: Campaign Prepare-Plan-Implement process steps 
Prepare 
1.  Develop campaign guidebooks, campaign resources for coalitions, and messages materials. 
2. Conduct a literature review and environmental scan of previous communication efforts around opioids 
and EBPs. 
a. 
Conduct a literature review and environmental scan of previous campaigns. 
b. 
Extract data collected in the LA and qualitative interviews with coalition members to understand 
what communication assets and capabilities are available in communities to design, produce, 
and implement a communication campaign. 
c. 
Conduct interviews with media representatives.  
d. 
Perform online searches and seek information from the LA (asset mapping) and interviews with 
coalition leaders to learn about state or local communication efforts (previously conducted and 
currently on the ground); capture lessons learned from previous campaigns and note potential 
“competing messages” from current efforts. 
Plan 
1. Conduct up to five focus groups or up to 25 individual interviews for message testing groups in at 
least three Wave 1 communities with key stakeholders and/or representatives of priority groups for 
these interviews, focus groups, and design workshops (see Focus Group for Persons with OUD; 
Focus Group CAB, Coalition, and Partner Organizations Guide; Focus Group Testing of Launch 
Messages; Communication Design Workshop Guide; Interview Guide Message Testing Persons with 
OUD; and Interview Guide Message Testing). 
2. Introduce campaign objectives, proposed priority groups, message materials, and findings from 
message testing and development timeline to community coalitions (via in-person or virtual 
meetings/presentations); solicit input and refine. 
3. Introduce communication product ideas to each coalition; solicit input and refine ideas (e.g., social 
media copy, advertisements, sample op-eds, infographics). 
4. Decide on message dissemination strategies and tactics with coalitions. 
5. Articulate the implementation plan and review collaboration and integration touchpoints with CE and 
ORCCA teams. 

The HEALing Communities Study 
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48 
6. Develop an implementation plan with the coalition including timelines, responsibilities, and 
milestones. 
Implement 
1. Coordinate release of first messages in the community (media choices to be determined via 
Landscape Analyses and media asset analyses) with kickoff events in each community. 
2. Assist (where necessary) each community with selecting, using, and placing messages via previously 
selected/agreed-upon channels. 
3. Engage partners to release campaign social media posts. 
4. If placing paid advertisements (not required across communities), monitor advertisement placement 
and reach. 
5. Hold monthly monitoring and feedback meetings of coalition/community implementation staff and RS. 
6. Monitor social media and traditional media coverage of stories/trends surrounding naloxone, OUD, 
and MOUD. 
7. Use monitoring data to make corrections to campaign implementation strategies/protocol and 
messages in each community (measures of campaign outputs including primary content, number and 
frequency of social media posts, advertisements, and earned media placements; feedback from 
coalition members and other community stakeholders). 
 
In summary, the communication campaign will start from an HCS-produced campaign 
guidebook and message maps that will be taken to each community coalition for discussion, 
refinement, testing, and implementation. Although core objectives and messages will be 
common across Wave 1 communities, there are opportunities for coalitions to refocus priority 
groups and co-create the strategies and tactics later in the campaign that will be empty in the 
final implementation plan. The campaign schedule for the entire intervention period, across both 
waves of communities and including each phase of the Prepare (for Wave 1), Plan, and 
Implement process, is summarized in Table 6a for Wave 1 and 6b for Wave 2. 
Table 6a: Timeline for Stages of Communication Campaigns (Wave 1) 
Stage 
Naloxone 
Campaign 
Wave 1 
Stigma 
Campaign 
Wave 1 
MOUD 
Campaign 
Wave 1 
Stay in 
Treatment 
Campaign  
Wave 1 
Community/
Coalition 
Choice 
Wave 1 
 
Prepare 
Sep 2019–
Feb 2020 
Sep 2019–
Mar 2020 
Sep 2019–
Apr 2020  
Nov 2020 – 
Apr 2022 
Aug 2021 – 
Oct 2021 
Plan with 
coalition 
Feb–Apr 
2020 
Apr–Jun 
2020 
Sep–Nov 
2020  
Apr 2021 – 
Jun 2021  
Oct 2021 – 
Dec 2021 
Implement 
Apr–Jul 
2020 
Jul–Nov 
2020 
Oct 2020 –
May 2021  
Jun 2021 – 
Dec 2021 
Jan 2022 – 
May 2022 

The HEALing Communities Study 
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49 
Table 6b: Timeline for Stages of Communication Campaigns (Wave 2) 
Stage 
Campaign 1 
Campaign 2 
Campaign 3 
Plan with 
coalition 
Aug-Sept 2022 
Jan-Feb 2023 
Jun-Jul 2023 
Implement 
Oct 2022 – 
Feb 2023 
Mar-Jul 2023 
Aug-Dec 2023 
 
Note, all campaigns were prepared during Wave 1. Each Wave 2 community will choose three 
of the four campaigns developed during Wave 1 (Naloxone, Stigma, MOUD, Stay in Treatment) 
to implement in three of separate campaign periods. 
Overview of the HCS Communication Campaign Evaluation Study (HCS-CES) 
Given the investment in health communication campaigns as a pillar of the HCS, a rigorous 
scientific evaluation is proposed across the 67 HEALing communities of the four RSs. Central to 
this evaluation is a cross-sectional, repeated-measure, longitudinal community-level 
measurement of the attitudes, intentions, and perceptions of EBPs to prevent and treat OUD 
among the recipients of the campaign in HCS communities. Furthermore, the evaluation will 
measure the impact of the health communication messages for persuading individuals to seek 
out EBPs for OUD and the campaign’s impact on reducing stigma surrounding OUD, OEND, 
and MOUD. All data collection points in the evaluation will coincide directly with the campaign 
activities for each wave of the HCS, allowing for rigorous measurement of impacts at the 
community level and among the recipients of the campaign in the HCS communities. Campaign 
evaluations are also necessary to guide mid-course adjustments of strategies and tactics and 
arrive at sound, evidence-based recommendations for the use of campaigns to address opioid 
and other substance use epidemics.  
The HCS-CES therefore has three primary components: 
1. 
A tracking study of the impact of HCS messages through daily monitoring and analysis 
of message dissemination activities and citizen exposure to them. The tracking study 
will also measure responses to action steps contained in the messages (i.e., 
community-specific URLs directing users to the HCS campaign webpage on the HCS 
website). Time-series analyses will be used to detect dose-response associations 
between the level of campaign activity and audience information-seeking on the HCS 
campaign webpage. 
2. 
Monitoring of other opioid-related communication campaigns sponsored by state and 
national organizations will document other sources of information that residents of 
HCS communities may have been exposed to during the CTH intervention. Salient and 
frequent messages from one or more of these external campaigns may be 
incorporated into the longitudinal surveys to assess their recognition relative to the 
HCS campaign materials. 
3. 
Survey data collection of community residents to assess changes in specific 
components of stigma toward individuals with OUD, the acceptability of naloxone 

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50 
(OEND), and the acceptability of MOUD treatment in the Wave 1 and Wave 2 
communities (see Figure 9 for a timeline and visual representation of data collection 
points for the HCS-CES community surveys). Survey data will be collected from a 
sample generated from social media recruitment (Facebook). In addition, participants 
may opt in to be part of a longitudinal panel in which they are surveyed at each time 
point. These changes will be assessed across communities using differences between 
treatment and control communities and within communities over time by dose-
response effects associated with exposure to campaign messages and other 
messages in the community environment. See Campaign Evaluation Questionnaire. 
HCS-CES Research Hypotheses 
H1: Time-series analyses of tracking data will indicate positive associations between 
higher levels of message dissemination activities and audience information-seeking on 
the website. 
H2: The number of campaign messages correctly recognized, and the reported frequency 
of exposure to these messages, will be positively associated with desired attitudinal 
outcomes regarding stigma, naloxone distribution, and MOUD treatment at the 
individual respondent level. 
H3: In intervention communities receiving the health communication campaigns, self-
reported stigma toward individuals with OUD will decline, and acceptance of EBPs will 
increase significantly over time at the community level. 
H4: In intervention communities receiving the health communication campaigns, self-
reported awareness and acceptance of MOUD and OEND at the community level will 
significantly increase over time. 
Because components 1 and 2 of the HCS-CES do not involve human subjects or collection of 
personally identifiable information (PII), the rest of the discussion of the HCS-CES will focus on 
the third component: the survey data collection of community residents. There will be seven 
data collection phases:  
(1) CEQ1: March-April, 2020, Wave 1 and 2 communities (baseline) 
(2) CEQ2: September-October, 2020, Wave 1 only (post-Campaign 1) 
(3) CEQ3: January-February, 2021, Wave 1 only (post Campaigns 2 and 3) 
(4) CEQ4: May-June, 2021, Wave 1 and Wave 2 (pre-Campaign 4 and beginning of CTH 
evaluation phase, secular trends comparison in Wave 2) 
(5) CEQ5: November-December, 2021, Wave 1 only (post-Campaign 4) 
(6) CEQ6: May-June, 2022, Wave 1 and Wave 2 (post Campaign 5, CTH evaluation phase 
comparison) 
(7) CEQ7: May-June, 2023, Wave 1 and Wave 2 (Campaign effects in Wave 2, sustainability 
comparison in Wave 1) 

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51 
Community Survey Participants  
The study population for the HCS-CES community surveys will include any community member 
older than age 18 who resides in one of the 67 HCS communities. These individuals will be 
recruited for the campaign evaluation surveys via a series of Facebook/Instagram 
advertisements targeted to people aged 18 or older who reside within the ZIP Codes of the 67 
communities. Data from the Health Information National Trends Survey demonstrates that social 
media is an effective tool for health communication research.52 Specifically, researchers have 
found Facebook to be a viable platform for recruiting participants from lower socio-economic 
backgrounds,53 recruiting representative samples,53 and contacting hard-to-reach populations.54 
Using Facebook is also a cost-effective recruitment strategy.53,55 Additionally, Healthy People 
202056 has demonstrated the reach and penetration of mobile device data plans and found no 
significant difference in accessing Internet via cellular networks on the basis of rural versus 
urban communities, gender, Hispanic and non-Hispanic populations, and educational 
attainment.57 Recruiting via social media has become an increasingly popular method for 
conducting surveys, because recruitment for telephone surveys has become increasingly 
challenging.  
Prior to completing the pre-test survey (more details below in the HCS-CES procedures 
section), participants from Facebook/Instagram samples will be asked to complete a brief two-
minute screening survey. Respondents will be routed to a screening survey that RTI has 
programmed in the Qualtrics survey system. RTI’s license includes the premium data isolation 
feature, meaning the data are encrypted at rest. As a part of the screener, participants will be 
asked to provide their email address. For this question, the participant will be directed to a 
separate instrument so that the email address is stored within the Qualtrics system but 
separately from the other screener questions. Responses to screening questions will also be 
kept separate from the pre-test, intermediate, and post-test survey data since these data will be 
hosted on REDCap (more details below). This screening survey will be completed by each new 
sample obtained for subsequent campaigns.  
The Qualtrics survey system has advanced capabilities to monitor the screening success rates, 
and to prevent fraudulent activity that is pervasive during social media survey recruitment. Using 
Qualtrics allows the study to implement best practices for social media survey respondent 
recruitment.  
Respondents deemed eligible for the survey based on responses to the screener will be routed 
to a REDCap survey. Upon completion of the pre-test, intermediate, or post-test surveys, 
participants will be offered the opportunity to enter a drawing to win a $100 Amazon electronic 
gift card. One electronic gift card will be distributed to one winner in each of the 67 communities 
per data collection period. Those individuals wishing to enter the drawing will be offered the 
opportunity to voluntarily enter their name and email address at the end of the survey, so they 
can be contacted if they win the gift card.  
The primary analysis is to assess the average stigma change in communities with the 
campaign.  We expect to see a mean change score of at least 0.05.  Furthermore, based on 
pilot data from Maulik, Siddhardha, Sudha, Abha, Shailaja, Miria, and Thornicroft (2017), we 
assume a SD of 0.09 for paired changes.  However, our data are collected cross-sectionally, 
and therefore the SD corresponding to changes from pre to post will be larger.  To be 
conservative with our sample size calculations, we assume a very large correlation of 0.95 for 

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52 
pairs, which maps the 0.09 SD to a conservative SD of 0.40 for our cross-sectional 
study. Furthermore, we calculate required numbers of surveys per community corresponding to 
intra-cluster correlation coeﬃcient (ICC) values ranging from 0.01 to 0.05, which statistically 
account for differences in mean changes across the communities.  Based on these conservative 
assumptions, we will need approximately 20 to 80 surveys per community, on average, to be 
completed at each time point for each of the 33 Wave 1 communities in order to have at least 
80% power for a two-sided test at the 0.05 significance level.  With respect to baseline data for 
Wave 2, if we collect the same number of surveys across these 33 other communities, then 
these assumptions imply we will be able to estimate the true mean stigma score within +/- 
0.024, based on a 95% confidence interval.  
Data collection for each time point in the REDCap survey will be programmed to continue until 
this number of desired completions has been achieved. If a participant elects to not volunteer for 
future surveys or enter the raffle, all surveys will be anonymous. We will not be collecting any 
PII other than basic demographics (age, gender, race/ethnicity, educational attainment, and 
whether they self-identify as a health care provider or community leader). If participants elect to 
volunteer for future surveys, the raffle, or both, their information (name and email address) will 
remain confidential and will be used only for purposes of contacting for future surveys or 
informing them that they won a raffle.  
HCS-CES Procedure 
As discussed previously, data will be collected across the five campaigns in Wave 1 
communities with annual inclusion of Wave 2 communities for comparison purposes. Wave 1 
communities will also be included in a follow-up CEQ to measure sustainability of knowledge, 
attitudes and behaviors and Wave 2 communities will receive a CEQ to measure the overall 
impact of the campaigns across the year of implementation. These data collection points 
represent our cross-sectional study design. The following sections describe the data collection 
process for the first campaign for Wave 1 communities; these procedures will then be repeated 
for the second campaign for Wave 1, as well as for campaigns 3, 4, and 5.  
Details of proposed survey of attitudes regarding stigma, naloxone availability, and MOUD for each discrete 
campaign 
Campaign Evaluation Questionnaire: For the proposed community survey, the Facebook 
advertisements will target individuals living in the geographic regions of all 67 HCS 
communities. The survey will be programmed to continue until the number of desired 
completions has been achieved. Each discrete CEQ will be staggered to serve as both pretest 
for the beginning campaign and posttest for each previous campaign as test messages from all 
previous campaigns will be iteratively added to each subsequent CEQ. This will provide an 
overall impression of message recognition from each previous campaign (via cued recall of 
messages used in each previous campaign) as well as the current campaign. 
The CEQ includes measures of stigma toward individuals with OUD and EBPs to prevent or 
treat OUD, as well as awareness and intentions to seek MOUD and OEND. Using a cued-recall 
survey methodology (discussed as follows), respondents will also be asked questions about 
recognition and attitudes toward other competing campaign messages being disseminated in 
their community. They will not be shown HCS messages at baseline. Survey completion is 
estimated to require approximately 20 minutes. Individuals will be asked if they are willing to be 

The HEALing Communities Study 
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53 
re-contacted for the second and third time points of the campaign currently running in their 
community, and if willing, to provide an email address to help construct the cohort panel 
discussed previously. This process will be duplicated for all subsequent Campaign Evaluation 
Questionnaires. 
The basic procedure for the cued-recall survey methodology involves two steps. Participants will 
first answer a set of demographic questions and items that assess their beliefs about evidence-
based treatments for OUD, stigma surrounding OUD and treatments for it, and attitudes toward 
individuals with OUD. After completing these sections. each participant will be shown the 
current HCS messages being disseminated in their community, an additional message from 
non-HCS campaigns currently running in their state (e.g., sponsored by a federal, state, or non-
profit organization), and a foil (or fabricated) message that will aid with calculating alternative 
explanations for message exposure effects.58 After each message, the participants will complete 
brief measures using the Message Impact Framework (MIF)59 to assess the perceived 
effectiveness of the messages, recognition of the messages, and frequency of self-reported 
exposure to the messages. We intend to submit these test messages to the sIRB as they are 
finalized and produced. 
The data will be aggregated to the community level and aggregated for all individuals recruited 
in a given community. RSs have the option to conduct site-specific analyses so that they can 
share and give back non-identifying CEQ data to their HCS communities.  
Measures 
The measures for the proposed surveys (see Table 7) cover 10 areas related to the specific 
aims and hypotheses of the CES. 
Table 7: Measures by data collection point 
Measure 
Baseline Surveys and 
Initial CEQ 
All Subsequent 
CEQs 
Campaign 
CEQ Post-
Tests 
HCS Study and Campaign 
Awareness 
X 
X 
X 
Barriers and Knowledge 
X 
X 
X 
Personal Stigma 
X 
X 
X 
Provider Stigma 
X 
X 
X 
Self-Efficacy 
X 
X 
X 
Social Distance/Community Stigma 
X 
X 
X 
HCS Message Impact 
 
X 
X 
Behavior 
X 
X 
X 
Personal Experience 
X 
X 
X 
Demographics 
X 
X 
X 

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54 
 
To meet the aims of the CES and test the proposed hypotheses, the following measures are 
included: (1) initial measures of recognition of the HCS and HCS campaign (adaptation60), as 
well as of other major communication campaigns that may be circulating in the treatment and 
control communities; (2) measures of barriers to uptake of MOUD and OEND and knowledge 
about MOUD/OEND (developed and refined by the Communications Workgroup); (3) measures 
of personal stigma (adaptation from work on predictors of depression stigma61,62); (4) measures 
of stigma toward MOUD providers (adaptation62); (5) measures of self-efficacy;62,63 (6) measures 
of social distance (community stigma) as currently approved for the HCS Coalition Baseline 
Survey, (7) a message impact scale that tests perceived message effectiveness (adaptation59), 
(8) measures of behavior surrounding OUD, naloxone, and treatment (adaptation60) and from 
the Communications Workgroup, (9) items measuring personal experience with OUD 
(adaptation60), and (10) a series of demographic questions that directly align with those from the 
HCS Coalition Baseline Survey. See Figure 9 for a graph of measures by data collection point 
and instrument.  
Overview of Health Economics Plan for Intervention Protocol 
We will conduct health economics research to determine the incremental costs of startup and 
ongoing implementation of the CTH. We will combine these cost estimates with data on the 
reduced number of opioid overdose deaths attributable to the CTH intervention to estimate the 
cost effectiveness of reducing opioid overdose deaths, yielding an estimate of the additional 
cost per averted opioid overdose death. We will also develop a microsimulation model that 
simulates the natural history of OUD and the effects of prevention and treatment methods, and 
the CTH intervention. Using the inputs and outcomes of the microsimulation model, we will 
develop an interactive online tool for policy makers and the scientific community that will allow 
users to select a geographic area and to evaluate the costs and effectiveness of alternative 
interventions for that particular area. 
The initial phase of the project is focused on estimating the costs of the CTH intervention. To 
estimate these costs, we use an activity-based costing approach that captures the time spent by 
staff, space and material resources associated with implementing the CTH intervention 
components, and other direct costs such as medication, transportation, and staff training. 
We will estimate the cost of the core components of the CTH intervention: the CE process, the 
communication campaign, and the ORCCA EBPs. Health economics measures include 
instruments that estimate the CE costs of the CAB meetings and activities performed by CAB 
members; the cost of the community coalition meetings; the cost of activities performed by 
project staff to facilitate the CTH intervention in communities; and the cost of the preparation, 
planning, and implementation phases of the communication campaign.  
The simulation model will draw on cost, outcome, and transition probability data from the 
literature and the HCS; no additional primary data collection is anticipated for the simulation 
model. 

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6.2 
Fidelity 
6.2.1 
Fidelity Measures for CTH Community Engagement Intervention 
We will use several indicators and sources of data to assess the fidelity of how we deliver the 
CTH intervention and implementation strategies across the Wave 1 communities and Wave 2 
communications when they start implementing the CTH. Fidelity broadly defined is “the extent to 
which an intervention is implemented as intended”. Fidelity constructs include (1) dosage or 
exposure to CTH using attendance data (2) adherence using the CTH fidelity checklist and 
meeting minutes (3) quality of delivery using meeting minutes and ethnographic observation 
(MA only); (4) output of coalitions as measured by production of such activities as a community 
profile, community action plan, community dashboard and implementing ORCCA-related 
trainings (5) participant responsiveness to CTH as measured by feedback from coalition 
members in annual surveys and qualitative interviews and participant feedback forms and (6) 
any adaptations or modifications to CTH intervention that communities make. Collectively these 
different measures will help us assess the extent to which CTH intervention was implemented 
as intended, the quality of implementation and what adaptations/modifications were made to 
inform the refinement and dissemination of the intervention if it is found to be effective on study 
outcomes. If the CTH intervention is for some reason not found to be effective, the fidelity 
measures will help us understand to what extent the lack of fidelity to CTH may have 
contributed to the failure to detect significant effects. 
The primary source of data will be the CTH Milestone and Benchmark Checklist, which asks the 
level to which each activity of CTH CE is completed successfully. Responses are coded on a 
five-point Likert scale: 4=completed, 3=mostly achieved, 2=somewhat achieved, 1=just began, 
and 0=not started yet. The checklist also asks participants to indicate whether they completed 
the activity before the CTH CE intervention or during the CTH intervention, what barriers and 
facilitators hindered or helped their ability to complete the activity, and whether they made 
adaptations or modifications to the activity. During qualitative interviews, community coalition 
members will also be asked about challenges they are experiencing adhering to certain CTH CE 
activities and whether they have made adaptations to certain activities. Another key source of 
data includes regular review by the study team of coalition meeting minutes and documents of 
key outputs from CTH CE activities to identify the level to which certain activities are completed; 
barriers and facilitators to completing certain activities and the extent to which different 
members of the coalition attend meetings and contribute to the completion of activities; and 
whether participation in certain activities varies by gender, race, age, educational attainment, or 
geographic status. The study team will review qualitative interviews, meeting minutes, 
attendance records of meetings, and anonymous coalition participant evaluation forms to 
examine the extent to which all members are engaged in decision making, share common goals 
and objectives, engage in mutually reinforcing activities, and can identify and prioritize activities 
of the coalition that align with the CTH CE intervention. Table 8 specifies the fidelity measures 
that will be used to assess adherence to the specific activities of the seven phases of CTH and 
the implementation strategies that will be used to implement CTH. 

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Table 8: Fidelity measures and implementation strategies 
Processes and Activities Within 
Each Phase 
Fidelity Measures 
Type/Sources 
of Data 
Time Points for 
Data Collection  
Phase 0: Pre-Intervention 
Formation of Study CAB, Share 
information with communities 
regarding randomization; Landscape 
Analysis Phase 1 and 2 and Reporting, 
Training HCS staff on community 
engagement; Formation of Coalitions  
 
Phase 1: Getting Started 
Establish a structure for working with 
coalitions (charter); Recruit 
Champions, Train Community 
Coalitions, Plan Communication 
Campaign; Select Priority groups for 
Campaign; Introduce ORCCA Menu: 
Discuss Guidebook and Maps with 
Coalition, Coalition Review of LA 
Community Assets Data 
 
Phase 2: Getting Organized 
Discuss ORCCA Menu Options 
Develop a shared vision; Commence 
and Evaluate Communications 
Campaign 
 
Phase 3: Community Profiles and 
Dashboards 
Creation of Community Profile 1.0; 
Creation of Data Dashboard Template; 
Map existing services to ORCCA Menu  
 
Phase 4: Community Action Plan 
Develop Implementation plan and 
Implement ORCCA EBP Strategies; 
Start Implementing EBPs 
 
Phase 5: Implement and Monitor EBPs 
Continue to implement and evaluate 
ORCCA EBPs, troubleshoot and 
provide technical assistance 
 
 
 
 
CTH milestone and 
benchmark checklist for all 
Phase 1–6 activities 
 
 
Meeting minutes and 
attendance records for all 
Phase 1–6 activities 
 
Qualitative interviews to 
identify barriers and facilitators 
of completing Phase 1–6 
activities 
 
Repeated partner tool survey 
 
Document review and upload:  
Landscape reporting from 
Phases 1 and 2; 
Charter;  
Communication campaign 
plan and list of priority groups; 
Community profile, Dashboard 
template; Mapping of existing 
sources to ORCCA menu: 
ORCCA EBP strategy 
selection; Evaluation of 1st 
and 2nd communication 
campaigns: Implementation 
Plan for ORCCA EBPs 
 
Coalition member participant 
evaluation forms 
 
 
 
 
HCS CE 
facilitators 
 
HCS staff 
 
Coalition 
participants 
and key 
stakeholders 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Monthly 
 
 
 
 
Continuous 
After every Meeting 
 
 
Annually 
 
 
 
 
Annually 
 
 
 
 
 
Continuous after 
document 
completion 
 

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Phase 6: Sustainability Planning 
Build capacity and align resources, 
training of coalitions through Learning 
Health Collaborative 
Implementation Strategies 
Fidelity Measures 
Type/Sources 
of Data 
Time Points for 
Data Collection  
CTH CE implementation strategies 
 
• 
CTH training of coalition members 
on CE strategies 
 
• 
CTH technical assistance and 
supervision on CE strategies  
 
• 
Utilization of Dashboard for 
planning and implementing CTH 
CE activities 
 
• 
Group Model Building 
Implementation Strategy (NY Site 
Specific) 
 
• 
Use of dashboard and portal data 
to guide CTH and ORCCA 
activities 
Number and type of CE and 
ORCCA training and TA 
activities completed using 
training and TA forms, 
including CE supervision via 
learning health collaborative 
meetings  
 
Number and type of CTH 
supervision meetings held  
 
Attendance records of 
community coalition members 
and organizations at CTH 
supervision meetings 
 
Designated 
community 
coalition chair 
or 
representative 
 
Monthly 
 
Annual 
 
Continuous 
Qualitative interviews and 
repeated surveys 
Coalition 
members 
Annual 
Participant evaluation forms 
on training, education (site 
optional) 
 
Participant evaluations of 
group model building (GMB) 
Implementation Strategy (NY 
site specific) 
 
GMB Field Notes (NY site 
specific) 
CTH/CE 
training, 
technical 
assistance and 
supervision 
coordinators 
 
Training and 
TA participants 
 
GMB 
participants 
 
HCS research 
staff 
Continuous 
Dashboard and/or portal 
Dashboard or 
community 
portal search 
and utilization 
logs 
Continuous 
 

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Following is a description of the administration of the fidelity measures listed in Table 8. 
CTH milestone and benchmark checklist: HCS CE staff hired by the study will be asked to 
complete the checklist using a REDCap computerized survey on a monthly basis throughout the 
CTH intervention period (Phase 0 through Phase 6). Staff will log into REDCap every month to 
report on intervention fidelity. Each RS will send checklist data for their communities that are in 
the active intervention phase. 
Attendance records: HCS staff will take attendance at every regular HCS designated coalition 
meeting or conference call in each community implementing the CTH intervention. The 
attendance sheet will list names of participants, their organizations, and their contact 
information. The project director (PD) or other designated HCS research staff in each 
community will enter the participant into the REDCap program and report the total number of 
participants who attended the meeting, the total number invited to the meeting, the total number 
of organizations represented at the meeting, and the total number of organizations invited to the 
meeting. After the PD or designated HCS research staff member finishes entering this 
attendance information into REDCap, they will store the attendance sheet in a folder in a 
separate locked file cabinet without any research data in their office, or they will scan a PDF of 
this sheet and save it in a password-protected, encrypted file on their computer. Hard copies 
and electronic files of attendance sheets with identifying information will be destroyed at the end 
of the study after quality assurance is completed. Attendance information will also be collected 
from subcommittee and work group meetings or conference calls that occur outside the regular 
HCS designated HCS coalition meeting that will include (1) date of meeting/conference; (2) 
number of attendees at the meeting/conference call; (3) topics covered in the meeting; and (4) 
length of meeting in minutes. 
Meeting minutes: HCS staff will take minutes of every coalition meeting using a template or an 
existing meeting minute form. Meeting minutes are critical to HCS study outcomes; thus, the 
research sites have the option to audio and/or video-record coalition meetings held either in-
person, web-based/remotely, or via a hybrid approach where some members are in-person and 
some join remotely. At the beginning of every meeting, HCS staff will apprise coalition members 
and attendees that they will be taking meeting minutes that will be used for research purposes 
to better understand how the coalitions are implementing the CTH intervention, to identify 
barriers and facilitators of implementing CTH, and to identify any adaptation. If applicable, 
coalition members will also be informed that the meeting will be audio and/or videorecorded for 
the sole purpose of creating detailed meeting minutes. At the coalition’s request, meeting 
recording(s) can be shared with coalition members. Coalitions may also choose to take their 
own meeting minutes and/or record their own meetings for internal purposes. HCS staff will let 
coalition members know that they can ask to have any comments off the record, and those 
discussions will not be included in the minutes. The coalition will receive a copy of the minutes 
by email, and coalition members may ask to remove or edit any portion of the minutes. 
Coalitions have the final say in what type of information is included in their meeting minutes 
(some do not want members’ names associated comments and questions made during the 
meeting, while other coalitions do).  HCS staff will upload meeting minutes into a REDCap 
program or a similar secure, electronic environment along with information on the community 
and the date of the meeting. If the meeting is audio and/or video-recorded, recorded files will be 
transcribed, and audio and/or video files will be destroyed within 6 months of being transcribed. 

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The procedures of taking meeting minutes and using them for research purposes will also be 
described in coalition charters.   
CTH document upload and review: Coalitions will be asked to provide electronic copies of 
selected documents they produce during CTH activities, including community-specific LA and 
reporting beyond standard format, the coalition charter, the communication campaign plan and 
list of priority groups, community profile, data dashboard template, mapping of existing sources 
to the ORCCA menu, ORCCA EBP strategy selection, evaluation of the first and second 
communication campaigns, and the implementation plan for ORCCA EBPs. HCS research staff 
will upload documents into the REDCap program or a similar secure, electronic environment. 
For document upload, HCS research staff will be asked to indicate what type of document, the 
community coalition, and the date of upload. HCS research staff may later review and evaluate 
documents to better understand how CTH activities were implemented and to monitor progress 
of coalitions and provide feedback for quality improvement. The procedures of collecting and 
using CTH documents for research purposes will also be described in coalition charters.   
Coalition member participant evaluation forms: HCS research staff may administer paper copies 
(or electronic copies if the meeting is held remotely/web-based) of anonymous brief participant 
evaluation forms to coalition members after meetings to elicit feedback on their level of 
satisfaction with different aspects of the CTH intervention and conduct of the meeting, as well as 
their suggestions for improving the meetings in the future. If the meeting is held in-person, 
participants will be asked to complete forms and place them in a large envelope when they are 
done. No identifying information or participant ID numbers will be included on the forms. Data 
from the forms will be entered into a secure REDCap program. After quality assurance is 
conducted, paper forms will be destroyed. 
Training and TA tracking: RSs will be asked to fill out training or TA service forms for CE or 
ORCCA training and TA activity in Wave 1 communities on a monthly basis. Data from the 
forms will be entered into a secure REDCap program. After quality assurance is conducted, 
paper forms will be destroyed. The collected information will support analyses of ORCCA 
implementation and costing activities. 
Coalition dashboard and portal website logs: HCS RSs may download and review logs or 
archives of data searches and visualizations conducted by coalition members or key community 
stakeholders to better understand what type of data coalitions are requesting and how they are 
using data to guide their planning of CTH and ORCCA activities. These logs will be coded by 
community site ID number and date. Coalition members will be apprised that their data logs and 
searches will be saved and used for research purposes on search pages of dashboards and 
website portals. The procedures of collecting and using these logs for research purposes will 
also be described to dashboard and portal users when they request access.   
Portal Functionality Group Interviews: HCS RSs will conduct group interviews with community 
members and research staff who actively utilize the community portals and dashboards as part 
of the HCS. These group interviews will inform the RSs about whether and how dashboards 
have been useful in CTH decision making, whether they are easy to use and understand, 
whether they will continue to be used and for what purpose(s), and whether and in what 
capacity the landscape data will continue to be used to populate the HCS dashboards. A short 
questionnaire will also be administered electronically via REDCap to gather basic 

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sociodemographic information and assess the respondent’s satisfaction with using the CTH 
portal and dashboard.  
The Group Model Building (GMB) participant feedback form: This is a brief, semi-structured 
instrument intended to evaluate GMB participants’ ratings of the quality of the workshop’s 
facilitation, content, clarity, and perceived utility. The instrument includes 13 six-point Likert-type 
items (6=excellent, 5=very good, 4=good, 3=fair, 2=poor, and 1=very poor) and three short-
answer items (to capture specific comments about their experience as a participant). The form 
was adapted from its original version, which was developed by Zimmerman and 
colleagues.64 GMB participants will be asked to complete this form by hand after a workshop 
session. Completed forms will be placed in a large envelope. Forms will be completed 
anonymously. No identifying information or participant ID numbers will be used. After quality 
assurance is conducted, paper forms will be destroyed. 
Applying lessons learned from group discussions: HCS research sites may hold group 
discussions with members from the HCS research cores, community coordinators, fiscal agent 
representatives and others involved in the CTH intervention to gather feedback and lessons 
learned for process improvement. These discussions may help inform approaches used with 
HCS communities and will ensure an intentional and inclusive approach. Lessons learned and 
process improvement strategies may be shared in presentation and publications and may be 
shared with community organizations for their own program improvement.  
6.3 
Implementation Science Measures for Communities That HEAL 
Although the primary aim of the HCS is to evaluate the effectiveness of a community-engaged 
intervention on reducing opioid overdose fatalities, the HCS provides a unique opportunity to 
extend knowledge regarding the factors that mediate or moderate the impact of the intervention 
on this critically important public health outcome in 67 communities in four states. To conduct a 
scientifically rigorous study of the implementation process, the HCS is informed by an adaption 
of the RE-AIM/PRISM model.65 Similar to other frameworks in implementation science,66-71 RE-
AIM/PRISM emphasizes the inter-relationships between inner and outer context, the 
interventions to be implemented, implementation strategies, and implementation outcomes. The 
adapted RE-AIM/PRISM model guiding the HCS is presented in Figure 10. The primary 
adaptation is represented in the circle, where the generic “evidence-based intervention 
(components)” and “implementation strategies” have been replaced by the CTH intervention 
(i.e., the CE strategy focused on community coalitions, the communication campaigns, and the 
ORCCA), which emphasizes the scaling up of EBPs across a range of organizational settings 
that serve individuals who are at elevated risk of opioid-related overdose (e.g., criminal justice, 
behavioral health, medical organizations).  

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Figure 9: RE-AIM/PRISM model adapted for HCS 
 
Source: Glasgow and colleagues.65 
The purpose of the implementation science data collection is to measure coalition members’ 
and key stakeholders’ perspectives on the opioid epidemic in their communities, current 
responses to the opioid epidemic, and factors in the internal context (i.e., coalition perspectives 
and characteristics) and external context (i.e., community perspectives and characteristics) that 
may facilitate or impede the reduction in overdose deaths in these 67 communities when the 
CTH intervention is deployed. The implementation science assessments will rely on 
observational research methods, including qualitative semi-structured interviews and 
quantitative surveys to measure key components relevant to the RE-AIM/PRISM model. In 
addition to baseline data collection, similar data will be collected annually in all 67 communities 
at three additional time points during implementation of the CTH.  
6.3.1 
Study Participants 
Study participants will be (1) members of community coalitions or (2) key stakeholders (e.g., 
representatives from treatment organizations, criminal justice organizations, medical and public 
health organizations, emergency services, faith-based organizations) in the 67 HCS 
communities. All participants will be at least 18 years of age. The number of participants per 
community will vary based on the size of the community, the size of the community coalition, 
and the plans of each RS, but a total of up to 2,010 participants across the 67 communities 
(approximately 30 per community) are anticipated to participate in baseline and three follow-up 
timepoints of data collection activities (approximately 15 months, 30 months, and 48 months). In 
Massachusetts and New York, human subjects will also include members of a statewide CAB 
that represents all communities and key state stakeholders.  
Participants will be excluded if they 

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● show evidence of significant psychiatric or cognitive impairment as confirmed during 
written informed consent, or  
● are not fluent in English as determined during written informed consent (we estimate 
that fewer than 5% of potential participants will be excluded for lack of fluency in 
English). 
6.3.2 
Recruitment Procedures 
Subject recruitment for baseline data collection will vary among RSs because in some 
communities, a community coalition exists, whereas in other communities, a coalition will be 
formed in the early phases of the HCS. Hence, key stakeholders will be recruited for data 
collection through existing relationships, snowball sampling, or purposive sampling. Regardless 
of whether recruitment begins via email, telephone, or in person, the study procedures will be 
explained, and potential participants will be given an opportunity to ask questions. Research 
staff from each RS will then obtain informed consent from all interested people; consent 
procedures will be based on the mode of data collection (e.g., in person, REDCap web survey, 
telephone, videoconference such as Zoom). For self-administered surveys where participants 
directly input their responses into REDCap, consent will be obtained via an introductory screen 
that provides relevant information for consent. For telephone interviews, verbal consent will be 
obtained. When data are collected via hard copy surveys (self-administered by the participant or 
via an in-person interview), written informed consent will be obtained. Each potential participant 
will be assigned an ID number by the local RS so that rates of participation can be calculated. 
All raw data files will be transferred from the research sites to the Data Coordinating Center 
(DCC). All research participants recruited into the study must be able to read and understand 
the English language. 
6.3.2.1 
Recruitment Procedures for the Qualitative Interviews With Coalition Members/Key 
Stakeholders 
The following recruitment procedures will be used for the qualitative interviews with coalition 
members/key stakeholders: 
● RSs will use purposive sampling to select coalition members or key stakeholders for 
a given community (if no coalition exists) from those identified for the Baseline 
Coalition/Stakeholder Survey. When selecting potential participants for the qualitative 
semi-structured interviews, RSs will consider the role of the individual (e.g., coalition 
chair, community coordinator, health commissioner, “champion” if the HCS 
intervention is active at the time of the interview), sector (e.g., MOUD, harm 
reduction, criminal justice, person with lived experience), and geographic diversity 
(e.g., if county includes more than one town, if more than one town is in the 
coalition). At follow-up, sites will use purposive sampling from recent coalition rosters 
or recommendations from key stakeholders (if no coalition exists in a given Wave 2 
community).  
● Initial contact with selected individuals may be made in person or via video/web 
conferencing (e.g., at a regularly scheduled meeting), by email, or by telephone to 
describe the purpose of the study, to describe compensation associated with 
participating, and to gauge potential interest in participating. Selected individuals 
may be sent an email invitation (see Coalition Survey & Qualitative Recruitment 

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Subject Facing Materials), which will describe the purpose of the interview and any 
compensation associated with participating in the interview. If there is no response to 
the initial email invitation in 2 days, the email invitation will be re-sent. Repeating the 
invitation will occur once more if the potential participant does not reply to the second 
invitation. If the participant’s telephone number is available, the [RS staff role] may 
also follow up with those who do not respond to the initial email invitation by 
telephone (see Coalition Survey & Qualitative Recruitment Subject Facing Materials). 
● Informed consent, including consent for audio-recording, will be obtained from 
participants before any interview data are collected. Individuals who do not consent 
to audio-recording may not participate in the interview because verbatim transcripts 
are needed for data analysis.  
These recruitment procedures for the qualitative interviews with coalition members/key 
stakeholders will be repeated at three additional time points.  
6.3.2.2 
Recruitment Procedures for the Surveys With Coalition Members/Key Stakeholders 
The following recruitment procedures will be used for the surveys with coalition members/key 
stakeholders: 
● RSs will invite all coalition members (if coalitions exist) or will work with key contacts 
to identify key stakeholders (if no coalition already exists) for the survey. At baseline, 
in communities without coalitions, RSs may work to quickly analyze the initial 
responses to the social network section of the survey (which also identifies key 
stakeholders in a given community) to determine whether additional individuals 
should be invited to participate in the survey. 
● RSs may work to identify Survey Champions who can introduce the baseline survey 
to coalition members/key stakeholders. The Survey Champion may be the key 
government official for an RS, a local or state government official, a member of the 
research team who is well known to the communities, and/or the chairperson of the 
community coalition if a community coalition already exists. Ideally, no less than 3 
business days before individuals are invited to participate in the baseline survey (via 
an email invitation or during an in-person Phase 0 orientation meeting), the Survey 
Champion(s) will engage the community about the survey via email. The purpose of 
the Survey Champion email is to grant legitimacy to the HCS survey and to inform 
individuals that data collection may occur at the in-person HCS community coalition 
orientation session and/or they may be sent an email invitation with a link to the HCS 
survey, which will be sent from the RS’s account (i.e., University of Kentucky, Ohio 
State University, Columbia University, or Boston Medical Center email account; e.g., 
HCS_KY@uky.edu) on a specified date. The email will also provide a brief 
introduction to the study’s purpose and describe the target respondent’s importance 
to the study and may be co-signed by multiple Survey Champions (see Coalition 
Survey & Qualitative Recruitment Subject Facing Materials). 
● A 4-week recruitment process will be used for the survey at baseline: 
− 
In week 1, an email invitation (see Coalition Survey & Qualitative Recruitment 
Subject Facing Materials) will be sent, which will describe the purpose of the 
study and any compensation associated with participating in the study. This 

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64 
email invitation will include information about how to access the survey via 
REDCap and may include information about completing the survey after the 
Phase 0 orientation meeting via computer/tablet or hard copy. This email may 
also include a PDF of the survey, so the participant can download the survey to 
print, complete, and mail or fax back to the HCS RS along with a hard copy 
version of the consent form.   
− 
In weeks 2–4, if there has been no response to the previous invitation, an email 
reminder will be sent as well as instructions about how to contact the RS if the 
individual prefers to complete the survey by telephone or in person (see Coalition 
Survey & Qualitative Recruitment Subject Facing Materials). This email may also 
include a PDF of the survey, so the participant can download the survey to print, 
complete, and mail or fax back to the HCS RS along with a hard copy version of 
the consent form. In addition, at week 2, the Survey Champion may send a 
separate reminder email (see Coalition Survey & Qualitative Recruitment Subject 
Facing Materials). During weeks 2–4, the RS may follow up with non-
respondents with a telephone call, text, letter, or fax to ensure that the email has 
been received and to answer any questions. At week 4, non-respondents will 
also be mailed a packet that includes a letter on the RS’s institutional letterhead 
requesting participation, a paper version of the survey, and a prepaid addressed 
envelope (see Coalition Survey & Qualitative Recruitment Subject Facing 
Materials).   
These recruitment procedures for the surveys with coalition members/key stakeholders, as 
relevant, will be repeated at three additional time points. It is anticipated that by the time of 
these future time points, coalitions will be established, so all coalition members at the time of the 
follow-up will be invited to participate. For the three additional follow-up surveys, an eight-week 
recruitment process will be used. Sites may choose to contact non-respondents using the 
methods described for the baseline survey (e.g., telephone call, text, letter, or fax) for up to 8 
weeks. At week 8, sites may mail a hard copy survey to non-respondents, but this is a site-
optional data collection strategy. Sites may also choose to announce the survey data collection 
at coalition meetings.  
6.3.3 
Compensation 
Kentucky, Massachusetts, and New York propose to compensate all participants $50 (cash/gift 
card) for the community coalition and key stakeholder survey and $50 (cash/gift card) for the 
coalition and key stakeholder semi-structured qualitative interview, consistent with agreements 
in place with their community partners. Ohio will not compensate participants.  
6.3.4 
Instruments 
Semi-Structured Qualitative Interviews With Coalition Members/Key Stakeholders (Core) 
Semi-structured qualitative interviews are planned to be conducted at baseline in the 67 HCS 
communities with (1) community coalition members or (2) key stakeholders who may be 
considered for future coalitions in communities where there are no existing community coalitions 
addressing the opioid epidemic. For communities with existing coalitions at baseline that are 
partnering in the HCS, at least one member of the coalition will be interviewed; the leader for the 

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coalition will be prioritized if such a position exists. RSs may choose to interview additional 
members of the coalition, using site-specific processes to identify additional interviewees. For 
communities that do not have existing coalitions at baseline, the RS will identify at least one key 
community stakeholder to be interviewed. Additional interviews with stakeholders may be 
conducted, using site-specific processes to identify these interviewees. Although we anticipate 
that sites will conduct an average of 4–12 interviews per community, it is important to note that 
interviewees will be drawn from the same population as the survey, so most of these 
participants are included in the estimated survey sample (n=2,010). 
Baseline interviews will be conducted in person to observe and record non-verbal cues when 
feasible; if this is not possible, they will be conducted via videoconference or telephone. Due to 
the COVID-19 pandemic, interviews at the follow-up time points will be conducted via 
videoconference or telephone. With participants’ consent, interviews will be audio-recorded; in 
the event that an individual consents to be interviewed but not audio-recorded, the interview will 
be terminated, because notes would be insufficient for qualitative analysis. Interviews will 
explore key components of the implementation science conceptual framework and will be 
conducted ideally with the selected community coalition member at baseline, which is defined 
as before the start of the intervention phase, and again at three additional time points. For 
baseline data collection, respondents will follow one of two paths through the interview (see 
Coalition and Key Stakeholder Semi-Structured Qualitative Interview Guide). The attachment 
contains a version of the guide for coalition members and another version for those without an 
existing opioid coalition. The guide contains items measuring the community context (i.e., outer 
context regarding other efforts to address the opioid epidemic, support to expand EBPs) and 
measures of coalition history and current activities (i.e., the inner context of the coalition). For 
follow-up data collection, respondents will follow one of two paths through the interview based 
on whether they represent a Wave 1 or Wave 2 community (see Follow-Up Coalition Member 
and Key Stakeholder Semi-Structured Interview Guide).  If the individual has not already 
completed the Community Coalition and Key Stakeholder Survey at baseline (see next section) 
or has not previously participated (i.e., person is a new participant recruited at follow-up time-
point), demographic information (using the same questions from the survey) will be collected at 
the end of the interview. The Locator Form may be collected at the end of the interview but is 
not required.  
Qualitative interview data collection will occur via a similar process at three additional time 
points after the baseline data collection. A future amendment will be submitted if there are 
changes to the specific items included in the interview guide at follow-up.  
For HCS-related qualitative interviews (core interviews), the following procedures regarding 
transcription, data sharing, and analysis will be used. With participant consent, recordings of the 
qualitative interviews will be transcribed verbatim. Transcription will happen locally, using 
professional transcription services or a combination of transcription software with review by 
research staff for accuracy. Participants will be given a unique participant ID number that will 
link their data across sites and time points; if the participant has already completed the 
Community Coalition and Key Stakeholder Survey, the ID number issued for the survey will be 
used for the qualitative interview. A linking log connecting the ID number with the name will be 
stored in a locked file on a secure system available to only researchers at the RS. 
In line with current IRB and National Institutes of Health ethical standards, recordings will be 
destroyed after transcription validation. Transcripts will be manipulated and analyzed using 

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qualitative software (e.g., NVivo, ATLAS.ti). To code the data, we will analyze each interview 
transcript in two ways: initially, we will code the data using factors in the study conceptual 
framework, identifying and creating codes in each of the core constructs. In coding, passages 
referring to the different conceptual categories of the framework and other areas will be marked 
and identified by cover terms that reflect the conceptual category. The marked passages will be 
compared to enable the identification of similarities and differences across the sites and the 
program models. Second, using the general procedures of inductive coding, we will also be able 
to identify additional themes that emerge organically from the data. The initial sets of transcripts 
will be coded by two researchers from each site skilled in qualitative analysis in order to create a 
codebook. After consensus coding, the remaining transcripts will be coded by two individuals. 
Constant comparative coding will be employed, so all transcripts are coded with the full set of 
codes that emerges. According to this method, the initial conceptual categories are then applied 
to new data, and the categories are revised to reflect the addition of the new data. 
Surveys With Coalition Members/Key Stakeholders (Core) 
Surveys will be conducted with community coalition members or key stakeholders who have 
been identified for future community coalitions before the start of the intervention, with the goal 
of collecting data from all coalition members or key stakeholders who consent to provide these 
data. The preferred method for distributing surveys is via REDCap’s web-based electronic data 
capture survey module software. REDCap is housed in the Data Coordinating Center’s (DCC’s) 
and the RSs’ secure, web-based services, and all appropriate measures will be taken to ensure 
the security of the system and the data collected. To ensure high rates of participation, RS staff 
may also distribute paper copies of the survey to coalition members in a group setting (e.g., the 
Phase 0 orientation meeting), may distribute laptops/computers in a group setting so that 
participants can directly input their responses into REDCap, may distribute a PDF of the survey 
via email, and may collect the survey data via telephone/videoconference. If coalition members 
complete the survey in a group setting, research study staff will ensure sufficient space between 
participants to ensure privacy (i.e., that participants cannot see each other’s responses). In 
instances where data are collected on paper forms, PDFs, or by telephone, it is the 
responsibility of the RS to enter the data into REDCap. 
Surveys will measure key components of the implementation science framework (see Figure 
10). Survey measures include (1) the inner context of the coalition, such as coalition 
characteristics (e.g., trust and communication quality in the coalition, coalition leadership) and 
coalition perspectives (e.g., coalition readiness to change related to EBPs); (2) the outer context 
of the community (e.g., perceptions regarding the community’s needs for addressing the opioid 
epidemic, perceptions of the community climate for expanding OEND and MOUD); (3) 
perceived characteristics of EBPs; and (4) coalition member/key stakeholder characteristics 
(e.g., demographics, the community sector they represent).  
Surveys will be conducted with coalition members and key stakeholders from the 67 
communities before the start of the intervention. Survey data collection will occur via a similar 
process at three additional time points after the baseline data collection. A future amendment 
will be submitted if there are changes to the specific items included in the survey at follow-up. 
At the end of the Community Coalition and Key Stakeholder Survey, the Locator Form will be 
administered at baseline. If the participant is self-administering the survey via REDCap, the 
participant will directly input the Locator Form information. For all other modes of survey 

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administration, the Locator Form will be completed on hard copy, then entered into REDCap by 
RS staff. At follow-up data collection, the Locator Form is optional.  
All survey participants will be asked to provide informed consent before beginning the survey. 
The consent process will emphasize the voluntary nature of participation, the rights of 
interviewees to decline to answer any question and to stop the interview at any time, and that 
de-identified data may be used by researchers in the future, because all HCS data will be 
archived for secondary analysis by non-HCS researchers once the primary study has been 
completed.  
Statistical analyses will be performed on these implementation science survey data. Descriptive 
statistics (e.g., frequencies, means, standard deviations) will be calculated for all variables, and 
regression analyses may be performed. Individual responses will also be aggregated to 
community-level measures. 
Community Advisory Board Member Survey 
Members of the implementation science team in Massachusetts and New York will conduct a 
survey (see the HEALing Communities CAB Member Survey) with all CAB members to 
understand CAB structures and processes and their feelings about the work of the CAB. They 
will also collect basic demographic information on the CAB members. The conduct of this 
survey will use the same procedures as described for the other surveys described for core 
measures mentioned earlier. This tool will be used with each CAB—the estimated number is up 
to 30 participants in Massachusetts and 50 participants in New York. In addition to baseline data 
collection, we will conduct surveys annually with Massachusetts and New York CABs. At 
baseline, the HEALing Communities CAB Member Survey will include a tool that addresses 
trust in the research team conducting the intervention called the Partnership Trust Tool. The 
goal of this tool is to understand their relationship and level of trust with each other. This tool will 
be used with all CAB members in Massachusetts and New York. 
Document Review 
Members of the implementation science teams will review documents to better understand the 
communities. Examples of the types of documents to be reviewed include needs assessments, 
community profiles, meeting agendas/notes, TA logs, community information regarding different 
programs, department of health/public health initiatives, and other community resources. The 
Document Review Guide will be used to structure and standardize data collection. After data 
collection, the guides will be stored using the same procedures for security as described earlier 
for all survey tools. Data will be analyzed qualitatively using the concepts from the conceptual 
framework to guide analysis. 
Ethnographic Analysis 
Members of the implementation science team in Massachusetts will attend coalition and CAB 
meetings as ethnographic observers. The Ethnographic Guide for Field Notes template will be 
used to structure observations collected during these meetings. Data collection will focus on 
understanding interactions between participants, the interactions with the facilitation (CE team), 
and the meeting process. After data collection, the guides will be stored using the same 
procedures for security as described earlier for all survey tools. Data will be analyzed 

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qualitatively using the principles from the conceptual framework to guide analysis with a focus 
on understanding the role of the facilitation process. 
Community Advisory Board Member Interview Guide 
Members of the implementation science team in Massachusetts and New York will conduct 
semi-structured qualitative interviews with members of the statewide CAB. All members of the 
CAB (up to 30 in Massachusetts and 50 in New York) will be interviewed. Interviews will be 
conducted in person to observe and record non-verbal cues; if this is not possible, interviews 
will be conducted via videoconference or telephone. Interviews will explore key components of 
the implementation science conceptual framework. Interviews will be conducted at baseline, 
before the intervention begins (see the Community Advisory Board (CAB) Member Interview 
Guide). Procedures for CAB qualitative interviews will be identical to those described earlier for 
community coalition interviews but will occur only once.  
6.4 
Toxicology Survey 
Toxicologists in Kentucky, Massachusetts, New York, and Ohio will be administered a survey 
(see Toxicology Survey for Labs) to gather data on the characteristics of postmortem toxicology 
testing for suspect drug overdose deaths and other characteristics of the medicolegal death 
investigation and certification of drug overdose deaths. The toxicology survey will be 
administered to all four states using REDCap. REDCap is housed in the DCC’s secure, web-
based services, and all appropriate measures will be taken to ensure the security of the system 
and the data collected. Descriptive statistics will be performed on the resulting data, including 
tabular frequencies, means, minimum, and maximum by overall data and by state and 
community. Listings and graphical displays will also be used as appropriate.  
In addition, a brief REDCap survey (see Medical Examiner Survey [NY site-specific] and 
Toxicology Survey for Medical Examiners & Coroners [KY, MA, and OH site-specific]) will be 
distributed to one respondent per county to obtain an understanding of the procedures in each 
county related to investigating and determining opioid overdose-related deaths. Depending on 
the county or community, this respondent may be the county health or mental health 
commissioner themselves, a key staff member they identify, or a medical examiner or coroner. 
These surveys will be programmed and administered remotely by the site-specific research 
teams. The research teams will share the survey link via email with county-level partners and 
follow-up to ensure completion. Findings will be analyzed by the research teams. 
6.5 
Measures to Minimize Bias: Randomization and Blinding 
HCS communities will be the unit of randomization and the unit of analysis. Randomization will 
be stratified by RS (i.e., Kentucky, Massachusetts, New York, and Ohio). In each RS, we will 
use a technique referred to as covariate-constrained randomization21,22 in order to ensure 
balance between intervention and control arms on three key community characteristics: 
baseline opioid overdose death rate, population size, and urban/rural status. This technique will 
remove these variables as potential confounders and improve the power to detect the effect of 
the CTH intervention on the opioid overdose death rate. For the continuous covariates, opioid 
overdose death rate and population size, balance constraints will be set at <0.2 standardized 
difference between arms. For the dichotomous variable, urban/rural status, randomization will 
be constrained to require equal numbers between arms among RSs with even numbers of 

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urban/rural communities (i.e., Kentucky, Massachusetts, and New York), and a difference of no 
more than 1 among RSs with odd numbers (i.e., Ohio). In each RS, one allocation will be 
selected at random among all possible allocations that meet the aforementioned criteria. 
The HCS will not be blinded. The communities will know which are in Wave 1 of the CTH 
intervention because they will start to receive the CTH process 2 years and 6 months before the 
wait-listed Wave 2 communities. Also, the RS members, including the Principal Investigators, 
will know the assignments of communities to Waves 1 and 2 because they will be working with 
the communities to implement the CTH. However, it is not expected that this will cause a 
significant chance for bias in the study. The HCS research staff will be at arm’s length from the 
service venues, and the professionals working in therein, where OUD patients are seen and 
receive services. Although the HCS will not be blinded to communities or the HCS team, the 
statisticians performing the analysis will be blinded. Once the analyses are completed, the wave 
assignments will be associated with the analytic results. 
7. 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
Discontinuation of Study Intervention 
The HEALing Communities Study (HCS) could be discontinued for several reasons. Examples 
include the following: 
● The National Institutes of Health (NIH) decides to withdraw funding and cancel the 
study. 
● The Data and Safety Monitoring Board recommends, and NIH agrees, that the study 
is unsafe to continue due to adverse events or futile to continue due to lack of 
participation. 
● A state decides to withdraw critical support for the conduct of the study and the study 
is discontinued in that state. 
● A community coalition decides to withdraw critical support for the conduct of the 
study or decides to no longer participate and the study is discontinued in the 
associated community. 
● A key political leader determines, however unlikely, that they do not want their 
community participating because they perceive that it could stigmatize their 
community or have some other negative impact on their community. 
The study team will work closely with all HCS communities to ensure that issues, such as the 
aforementioned examples, are promptly addressed with the aim of achieving mutually beneficial 
outcomes. Additionally, the HCS Steering Committee (SC) will discuss any community-specific 
issues that arise that may adversely affect the study outcomes. 
A specific evidence-based practice (EBP) strategy could be discontinued or eliminated from the 
package for a variety of reasons. For example, a practice could be discontinued if: 
● its legal status changes in a state or local community, or 
● it is determined to be unsafe (e.g., a medication presently approved for the treatment 
of opioid use disorder is withdrawn by the Food and Drug Administration). 

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7.2 
Participant Discontinuation/Withdrawal From the Study 
Individuals are not being enrolled into care by the HCS. Rather, the HCS is facilitating 
communities to enroll individuals into treatment, retention in treatment, enhancing provision of 
overdose prevention education and naloxone distribution, and other prevention strategies. If a 
community coalition or service venue chooses to cease participation in the HCS, they can do 
so. Efforts will be made to maximize retention in the study. 
Community coalitions and participating service venues could be discontinued from participation 
if the SC determines that they are not delivering the EBPs as part of their agreement (e.g., an 
opioid treatment program closes). The study team will work with community coalitions and 
venues to problem solve and help facilitate improvement before discontinuation. 
Individuals recruited for surveys and interviews could decide to discontinue. 
7.3 
Lost to Follow-Up 
It is unlikely that a community coalition or community service venue will cease operation without 
notice. Efforts will be made to retain community coalitions and service venues throughout the 
intervention. Some professionals working in service venues will participate in data collection 
through surveys, interviews, and so on concerning the opioid-related services currently being 
offered, their ability to offer new services, attitudes that might affect the success of service 
offerings, and the cost of offering services. If a participating professional decides to no longer 
participate or is no longer working at the venue, efforts will be made to understand and 
document the reasons for discontinuation. Most of the desired information is not about the 
specific participant but about the venue where he or she works. In such situations, a 
replacement respondent will be sought. 
8. 
INSTRUMENTS AND PROCEDURES 
8.1 
Instruments 
This section describes the instruments and approaches that will be used to collect data for the 
HEALing Communities Study (HCS). Data collection will include surveys and interviews with 
coalition and Community Advisory Board (CAB) members, key stakeholders, and organizational 
representatives (e.g., in jails, emergency departments, and recovery support programs) to 
measure outcomes. Research staff will conduct focus groups, individual interviews, and 
workshops to test and refine messages for the communication campaign. Coalition and CAB 
members will provide cost information on the implementation of the Communities That HEAL 
(CTH) to estimate cost-effectiveness. Finally, we will collect secondary data via a Landscape 
Analysis to characterize the communities and contextualize the study findings. See Table 9 for a 
list of instruments linked to informed consent. 
Table 9 provides a list of the instruments, guides, and templates that will be used to collect 
quantitative and qualitative data. The table links the instruments to their associated informed 
consent forms (ICFs). For coalition and CAB members, who will be interviewed more than once, 
we will use a general written consent form that seeks consent for all survey activities (from 
baseline through study end). Data collections that are conducted in multiple modes (e.g., web 
and telephone) have multiple ICFs tailored to the mode of administration.  

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Table 10 consists of one table for each data collection instrument. Each table provides detailed 
instrument summaries that describe how each data collection will be conducted. Among other 
items, these tables indicate the data collection’s purpose, respondent, mode, use of incentives, 
and frequency.  
Table 9: Instrument name and associated informed consent form name 
Instrument Name 
Informed Consent Form Name 
Brandeis Payer Pre-Interview 
Survey & Interview Guide 
HCS_ICF_MA_Brandeis Payer Pre-Interview Survey & 
Interview Guide (In-Person) 
HCS_ICF_MA_Brandeis Payer Pre-Interview Survey & 
Interview Guide (Verbal) 
HCS_ICF_MA_Brandeis Payer Pre-Interview Survey & 
Interview Guide (Web) 
Campaign Evaluation 
Questionnaire 
HCS_ICF_Master_Campaign Evaluation Questionnaire (Web) 
Coalition Meeting Minute 
Template 
N/A 
Communication Design Workshop 
Guide 
HCS_ICF_Master_Communication Design Workshop (In 
Person) 
Communications Campaign 
Costing 
HCS_ICF_Master_Cost Template Information (Verbal) 
HCS_ICF_Master_Cost Template Information (Web) 
HCS_ICF_MA NY & KY_General Consent for Coalitions (In 
Person) 
HCS_ICF_OH_General Consent for CAB and Coalitions (In 
Person) 
Community Advisory Board (CAB) 
Demographics Survey 
N/A 
Community Advisory Board (CAB) 
Member Interview Guide  
HCS_ICF_NY&MA_CAB Member Interview Guide (Verbal) 
Community Coalition Member and 
Key Stakeholder Semi-Structured 
Qualitative Interview Guide 
(Baseline and Follow-Up) 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Semi-Structured Qualitative Interview Guide (In 
Person) – used from Nov. 2019 – Jan. 2020 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Semi-Structured Qualitative Interview Guide 
(Verbal) – used from Nov. 2019 – Jan. 2020 
HCS_ICF_MA NY & KY_General Consent for Coalitions (In 
Person) 
HCS_ICF_OH_General Consent for CAB and Coalitions (In 
Person) 
HCS_ICF_Master_Follow-Up Community Coalition Member 
and Key Stakeholder Semi-Structured Qualitative Interview 
Guide (Verbal) 

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Instrument Name 
Informed Consent Form Name 
Community Coalition and Key 
Stakeholder Survey (Baseline and 
Follow-Up) 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Survey (In Person) – used from Nov. 2019 – Jan. 
2020 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Survey (Verbal) – used from Nov. 2019 – Jan. 
2020 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Survey (Web) – used from Nov. 2019 – Jan. 2020 
HCS_ICF_MA NY & KY_General Consent for Coalitions (In 
Person) 
HCS_ICF_OH_General Consent for CAB and Coalitions (In 
Person) 
HCS_ICF_Master_KY MA OH_Follow-Up Community 
Coalition Member and Key Stakeholder Survey (In-Person) 
HCS_ICF_Master_NY_Follow-Up Community Coalition 
Member and Key Stakeholder Survey (In-Person) 
HCS_ICF_Master_KY MA OH_Follow-Up Community 
Coalition Member and Key Stakeholder Survey (Verbal) 
HCS_ICF_Master_NY_Follow-Up Community Coalition 
Member and Key Stakeholder Survey (Verbal) 
HCS_ICF_Master_KY MA OH_Follow-Up Community 
Coalition Member and Key Stakeholder Survey (Web) 
HCS_ICF_Master_NY_Follow-Up Community Coalition 
Member and Key Stakeholder Survey (Web) 
Community Engagement Costing 
(Coalition Meetings) 
HCS_ICF_Master_Cost Template Information (Verbal) 
HCS_ICF_Master_Cost Template Information (Web) 
HCS_ICF_MA NY & KY_General Consent for Coalitions (In 
Person) 
HCS_ICF_OH_General Consent for CAB and Coalitions (In 
Person) 
Community Engagement 
Facilitator – Community 
Assessment Tool (CAT) 
N/A 
Costing the Evidence Based 
Practices Interview Guide 
HCS_ICF_Master_KY MA NY_Template for Costing the 
Evidence Based Practices (Verbal) 
CTH Milestone and Benchmark 
Checklist 
N/A 
Demographic Form 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Semi-Structured Qualitative Interview Guide (In 
Person) 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Semi-Structured Qualitative Interview Guide 
(Verbal) 

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Instrument Name 
Informed Consent Form Name 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Survey (In-Person) 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Survey (Web) 
HCS_ICF_Master_Community Coalition Member and Key 
Stakeholder Survey (Verbal) 
Document Review Guide 
N/A 
Ethnographic Guide for Field 
Notes 
N/A 
Focus Group CAB, Coalition, and 
Partner Organizations Guide 
HCS_ICF_Master_Focus Group with CAB, Coalition and 
Partner Organization (In Person) 
HCS_ICF_Master_Focus Group with CAB, Coalition and 
Partner Organization (Verbal) 
Focus Group for Persons with 
OUD 
HCS_ICF_Master Focus Group Person with OUD (In Person) 
Focus Group Testing of Launch 
Messages 
HCS_ICF_Master_Focus Group Testing of Launch Messages 
(In Person) 
HCS_ICF_Master_Focus Group Testing of Launch Messages 
(Verbal) 
General Template Costing the 
Community Engagement Process 
(CAB Members) 
HCS_ICF_Master_Cost Template Information (Verbal) 
HCS_ICF_Master_Cost Template Information (Web) 
HCS_ICF_OH_General Consent for CAB and Coalitions (In 
Person) 
HCS_ICF_MA NY & KY General Consent for CABs (In 
Person) 
Grant Writing Needs Assessment 
N/A 
Group Model Building 
HCS_ICF_MA NY & KY_General Consent for Coalitions (In 
Person) 
HCS_ICF_MA NY & KY General Consent for CABs (In 
Person) 
Group Model Building (GMB) 
Session Feedback Form 
N/A 
HEALing Communities CAB 
Member Survey  
HCS_ICF_NY&MA_HEALing Communities CAB Survey (In 
Person) 
HCS_ICF_NY&MA_HEALing Communities CAB Survey 
(Verbal) 
HCS_ICF_NY&MA_HEALing Communities CAB Survey 
(Web) 
HCS Annual Jail Survey 
HCS_ICF_Master_Annual Jail Survey (In-Person) 
HCS_ICF_Master_Annual Jail Survey (Verbal) 

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Instrument Name 
Informed Consent Form Name 
HCS_ICF_Master_Annual Jail Survey (Web) 
HCS Community Data Dashboards 
Survey & Portal Group Interview 
Guide 
HCS_ICF_Master_HCS Community Data Dashboards Survey 
& Portal Group Interview Guide (Verbal) 
HCS Community Grant 
Documentation 
N/A 
HCS Staff Activity Costing 
Instrument 
N/A 
HCS Staff Tracker 
N/A 
Interview Guide Message Testing 
HCS_ICF_Master_Interview Guide Message Testing Hcare 
Providers Comm Leaders Persons wOUD and Family Mbrs 
(Verbal) 
Interview Guide Message Testing 
Persons with OUD 
HCS_ICF_Master_Interview Guide Message Testing Hcare 
Providers Comm Leaders Persons wOUD and Family Mbrs 
(Verbal) 
Landscape Analysis 1 (Wave 
1)/Landscape Analysis (Wave 2) 
N/A 
Landscape Analysis 2 (Wave 
1)/Landscape Analysis 
Organizational Questionnaire 
(Wave 2) 
HCS_ICF_KY&OH_Landscape Analysis 2 for Data Collection 
(Verbal) 
HCS_ICF_KY&OH_Landscape Analysis 2 for Data Collection 
(Web) 
HCS_ICF_KY&OH_Landscape Analysis 2 for Data Collection 
(In Person) 
HCS_ICF_KY_Landscape Analysis 2 for Data Collection-
Pharmacy Module (Verbal) 
Learning Collaborative Evaluation 
Survey 
N/A 
Medical Examiner Survey 
HCS_ICF_Master_NY Medical Examiner Survey (Web) 
Medication Disposal Drop Box 
Sustainability Interview Guide 
HCS_ICF_Master_KY Medication Disposal Program 
Pharmacy Interviews (Verbal) 
Mobile MOUD Interview Guide 
HCS_ICF_Master_Mobile MOUD Interview Guide for MA, NY 
& OH (Verbal) 
Monthly Coalition Work Group or 
Subcommittee Meeting Log 
N/A 
MOUD Organization Interview 
Guide 
HCS_ICF_Master_KY MOUD Organization Interview Guide 
(Verbal) 
Municipal Drug Policies Interview 
Guide 
HCS-ICF_Master_MA Municipal Policies Interview Guide 
(Verbal) 
ORCCA Tracker (ORCCAT) 
N/A 
PARTNER Tool 
HCS_ICF_Master_OH Partner Tool for Wave 2 (Verbal) 

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Instrument Name 
Informed Consent Form Name 
HCS_ICF_Master_OH Partner Tool for Wave 2 (Web) 
Pharmacy Study Interview Guide 
HCS_ICF_Master_NY Pharmacy Study Interview Guide for 
Community Member (Verbal) 
HCS_ICF_Master_NY Pharmacy Study Interview Guide for 
Pharmacist (Verbal) 
Pharmacy Study Survey 
HCS_ICF_Master_NY Pharmacy Study Survey 
PHARMACIST ONLY (Verbal) 
HCS_ICF_Master_NY Pharmacy Study Survey 
PHARMACIST ONLY (Web) 
HCS_ICF_Master_NY Pharmacy Study Survey PHARMACY 
ONLY (Verbal) 
HCS_ICF_Master_NY Pharmacy Study Survey PHARMACY 
ONLY (Web) 
Photovoice Focus Group 
Interview Guide & Demographics 
Survey 
HCS_ICF_Master_Photovoice Focus Group for KY, MA & OH 
(In-Person) 
HCS_ICF_Master_Photovoice Focus Group for KY, MA & OH 
(Verbal) 
Policy Community Report 
N/A 
Policy Environmental Scan 
N/A 
Post Coalition Meeting Feedback 
Form 
N/A 
Qualitative Assessment Form for 
Campaign 4 
N/A 
Race and Ethnicity Data 
Collection Readiness Survey 
HCS_ICF_Master_NY Race and Ethnicity Data Collection 
Readiness Survey (In-Person) 
HCS_ICF_Master_NY Race and Ethnicity Data Collection 
Readiness Survey (Verbal) 
HCS_ICF_Master_NY Race and Ethnicity Data Collection 
Readiness Survey (Web) 
Reach Tracker 
N/A 
State Grant Funding 
HCS_ICF_Master_State Grant Funding (Verbal) 
Sustainability Partner 
Organization Interview Guide 
HCS_ICF_Master_Sustainability Partner Organization 
Interview Guide (Verbal) 
Toxicology Survey for Labs  
HCS_ICF_Master_Toxicology Survey for Labs (Verbal) 
HCS_ICF_Master_Toxicology Survey for Labs (Web) 
Toxicology Survey for Medical 
Examiners & Coroners 
HCS_ICF_Master_KY MA OH Toxicology Survey for Medical 
Examiners & Coroners (Verbal) 
HCS_ICF_Master_KY MA OH Toxicology Survey for Medical 
Examiners & Coroners (Web) 

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Instrument Name 
Informed Consent Form Name 
Training and Technical 
Assistance Tracking (TTAT) Form 
N/A 
 
Table 10: Instrument Summaries 
Brandeis Payer Pre-Interview Survey & Interview Guide 
Main Study Data Collection 
1 
Purpose 
To gather information about the extent to which 
payers currently fund or otherwise encourage 
activities that communities may adopt as part of the 
HCS intervention, such as medications for opioid 
use disorder (MOUD), distribution of naloxone, or 
initiatives in schools, pharmacies and law 
enforcement settings. 
2 
Respondent 
Officials at MassHealth (the state Medicaid 
Program) and at commercial insurers that serve 
Massachusetts customers. 
3 
How will respondents be selected? 
Respondents will include officials from 13 
commercial insurers that were identified by the 
Massachusetts Division of Insurance. Respondents 
may also include officials from other organizations 
that manage substance use disorder treatment 
under subcontracts with these insurers. 
4 
Sample size 
Up to 20 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Annually 
6 
Mode (telephone, web, in person) 
The Brandeis Payer Pre-Interview Survey will be 
collected via the web. The Brandeis Payer 
Interview Guide will be administered either over the 
telephone or in-person. 
7 
Self-administered or interviewer 
administered 
The Brandeis Payer Pre-Interview Survey will be 
self-administered, and the Brandeis Payer 
Interview Guide will be interviewer-administered. 
8 
Informed consent (verbal, written, 
digital) 
Verbal, written, or digital  
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify site)  Site specific (Massachusetts) 

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12 
Data collection platform (e.g., paper, 
REDCap, video) 
The Brandeis Payer Pre-Interview Survey will be 
administered via REDCap. The Brandeis Payer 
Interview Guide will be audio recorded. All 
recordings will be password protected and archived 
on a secure server. All transcripts will be de-
identified. 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
Email invitation to participate 
 
Campaign Evaluation Questionnaire 
Main Study Data Collection 
1 
Purpose 
Survey data for evaluation of the health 
communication campaigns within and across all 
four HCS sites 
2 
Respondent 
Community members 
3 
How will respondents be selected? 
Via targeted Facebook advertisements seeking 
respondents in their respective communities to 
take the survey evaluating the campaign 
4 
Sample size 
In total, across all 4 sites and all campaigns of the 
HCS, approximately 30,000 surveys will be 
completed 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
3 times for each campaign (as a pre-test, 
intermediate, and post-test) for 6 campaigns (Wave 
1 and Wave 2) plus additional baseline and post-
tests * 4 sites = 84 times repeated 
6 
Mode (telephone, web, in person) 
Web 
7 
Self-administered or interviewer 
administered 
Self-administered. Interested respondents will click 
a Facebook advertisement that will take them to 
the REDCap survey where they will read and 
consent to participate, then they will begin the 
survey and complete it online via REDCap  
8 
Informed consent (verbal, written, 
digital) 
Digital 
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
A raffle of a $100 Amazon e-gift card for each 
survey time point for each county or community 
participating in the survey at that time 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify site)  Cross-site 

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12 
Data collection platform (e.g., paper, 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
N/A 
 
Coalition Meeting Minute Template 
Main Study Data Collection 
1 
Purpose 
To assess adherence and quality of implementing 
the CTH intervention 
2 
Respondent 
HCS research staff 
3 
How will respondents be selected? 
HCS research staff hired by the study 
4 
Sample size 
67  
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Will vary; dependent on how often the coalition 
meets 
6 
Mode (telephone, web, in person) 
In person or web 
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify site) 
Cross-site 
12 
Data collection platform (e.g., REDCap, 
video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
N/A 
 
Communication Design Workshop Guide 
Main Study Data Collection 
1 
Purpose 
To understand how people in the community 
perceive the opioid problem and potential solutions 
and to test messages about naloxone, OUD, 
MOUD, and stigma 

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2 
Respondent 
Respondents will be members of the community 
and people who work in organizations that offer 
services that address the opioid crisis in that 
community 
3 
How will respondents be selected? 
Potential participants will be solicited at coalition 
meetings and through public notices on social 
media and print outlets. Coalition members will help 
identify respondents from partner or implementation 
agencies in the community. 
4 
Sample size 
Total up to 1,000 across 33 Wave 1 communities 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
These workshops may be repeated for subsequent 
communication campaigns 
6 
Mode (telephone, web, in person) 
In person 
7 
Self-administered or interviewer 
administered 
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Written 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Observers’ notes, participant-generated content to 
exercises 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email invitation, confirmation, and meeting logistics 
information 
 
Communications Campaign Costing 
Main Study Data Collection 
1 
Purpose 
To estimate the cost of the communication 
campaign in the preparation and planning phases 
for health economic analysis 
2 
Respondent 
RS staff and community members assigned to work 
on the communication campaign 
3 
How will respondents be selected? 
RSs and the DCC will identify respondents who are 
involved with the communication campaign 

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Communications Campaign Costing 
4 
Sample size 
N=221−489 
(3–7 coalition members per community) × (67 
communities) + 20 DCC and RS staff 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Monthly 
6 
Mode (telephone, web, in person)  
In person or by telephone  
7 
Self-administered or interviewer 
administered  
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
General written consent or verbal consent for 
community members 
No consent for study staff 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site  
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
There will be an email or telephone-based invitation 
to participate  
 
Community Advisory Board (CAB) Demographics Survey 
Main Study Data Collection 
1 
Purpose 
To capture demographic characteristics of the 
Community Advisory Board (CAB) for Wave 1 and 
Wave 2 communities.  
2 
Respondent 
Community Advisory Board (CAB) members 
3 
How will respondents be selected? 
Respondents are members of the state-specific 
Community Advisory Boards. Survey responses will be 
anonymous.  
4 
Sample size 
Up to 175 per data collection period 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Annually 

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Community Advisory Board (CAB) Demographics Survey 
6 
Mode (telephone, web, in person) 
Web 
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) 
(specify) 
N/A 
 
Community Advisory Board (CAB) Member Interview Guide 
Main Study Data Collection 
1 
Purpose 
To measure CAB members’ perspectives on the 
role of the CAB in the study and the structure and 
processes of the CAB 
2 
Respondent 
CAB members 
3 
How will respondents be selected? 
Potential participants will be identified based on 
CAB membership 
4 
Sample size 
80 (up to 30 in Massachusetts; up to 50 in New 
York) 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Annually 
6 
Mode (telephone, web, in person) 
Telephone 
7 
Self-administered or interviewer 
administered 
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal  
9 
Incentives (Y/N) 
Yes 

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Community Advisory Board (CAB) Member Interview Guide 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
The participant will receive $75 cash, check, or gift 
card after completing the interview.  
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify site) 
Site specific (Massachusetts and New York) 
12 
Data collection platform (e.g., REDCap, 
video) 
Audio-recording. All recordings will be password 
protected and archived on a secure server. All 
transcripts will be de-identified.  
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
See HCS Email Invitation and Follow Up Reminders 
for CAB Survey & Interview 
 
 
 
 
 
Community Coalition Member and Key Stakeholder Semi-Structured Qualitative Interview Guide 
(for Baseline and Follow-Up Interview) 
Main Study Data Collection 
1 
Purpose 
To qualitatively measure coalition members’ and 
key stakeholders’ perspectives on the opioid 
epidemic in their communities, current community 
responses to the opioid epidemic, and factors in the 
internal context (i.e., coalition perspectives and 
characteristics) and external context (i.e., 
community perspectives and characteristics) that 
may facilitate or impede the successful 
implementation of HCS efforts to reduce opioid-
related mortality by 40% 
2 
Respondent 
Coalition members and key stakeholders in Wave 1 
and Wave 2 HCS communities 
3 
How will respondents be selected? 
Potential participants will be identified based on 
membership of a given community coalition or key 
stakeholders for a given community (if no coalition 
exists). A purposive sampling strategy will be used, 
with the goals of including coalition leadership and 
maximizing variability and diversity. Initial contact 
with potential participants may be made in person 
(e.g., at a regularly scheduled meeting), by email, or 
by telephone to describe the purpose of the study, 
to describe compensation associated with 
participating, and to gauge potential interest in 
participating. 

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Community Coalition Member and Key Stakeholder Semi-Structured Qualitative Interview Guide 
(for Baseline and Follow-Up Interview) 
4 
Sample size 
4–12 interviews per community 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Three additional follow-up time points 
(approximately 15 months, 30 months, and 42 
months) 
6 
Mode (telephone, web, in person) 
Telephone/video conference or in-person for 
baseline interview; telephone/video conference for 
follow-up interview 
7 
Self-administered or interviewer 
administered 
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal or written for baseline interview; verbal for 
follow-up interview 
9 
Incentives (Y/N) 
Yes (for KY, MA, NY); OH will not offer an incentive. 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
$50 cash, check, or gift card 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify site) 
Cross-site 
12 
Data collection platform (e.g., REDCap, 
video) 
Telephone or video conferencing  
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
See HCS Follow-Up Community Coalition Member 
and Key Stakeholder Interview Guide Subject 
Facing Materials 
 
Community Coalition and Key Stakeholder Survey  
(for Baseline and Follow-Up Interview) 
Main Study Data Collection 
1 
Purpose 
To measure coalition members’ and key 
stakeholders’ perspectives on factors in the internal 
context (e.g., coalition characteristics, coalition 
functioning, coalition readiness to promote 
expansion of MOUD and OEND) and external 
context (e.g., community need and stigma) that may 
facilitate or impede the successful implementation of 
HCS efforts to reduce opioid-related mortality by 
40% 
2 
Respondent 
Coalition members and key stakeholders 
3 
How will respondents be selected? 
Potential participants will be identified based on 
coalition membership and rosters (if a coalition 
exists). If a coalition does not exist, potential 

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Community Coalition and Key Stakeholder Survey  
(for Baseline and Follow-Up Interview) 
participants will also be identified through the state 
department of health, appropriate county official, or 
other key contacts in the state or county. 
Participants will be selected to ensure diversity of 
stakeholder types. Additional participants may be 
identified using a snowball sampling strategy based 
on the PARTNER section of the survey. 
4 
Sample size 
Approximately 2,010 coalition members and key 
stakeholders across communities (30 per 
community) 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Three additional follow-up time points 
(approximately 15 months, 30 months, and 42 
months 
6 
Mode (telephone, web, in person) 
Web, telephone, in person 
7 
Self-administered or interviewer 
administered 
Self-administered or interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Digital, verbal, or written  
9 
Incentives (Y/N) 
Yes (for KY, MA, NY); OH will not offer an incentive. 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
$50 cash, check, or gift card 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap or hard copy/paper version of the survey 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
See HCS Follow-Up Community Coalition Member 
and Key Stakeholder Survey Subject Facing 
Materials 
 
Community Engagement Costing (Coalition Meetings) 
Main Study Data Collection 
1 
Purpose 
To estimate the cost of community coalition 
meetings and the cost of community coalition 
member activities in support of the CE process  
2 
Respondent 
Community coalition members  

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Community Engagement Costing (Coalition Meetings) 
3 
How will respondents be selected? 
All coalition members attending coalition meetings 
will be surveyed 
4 
Sample size 
1,005–1,340 coalition members 
(15–20 coalition members per community) * (67 
communities) 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Monthly (or when coalition meetings are held) 
6 
Mode (telephone, web, in person)  
In person, web, or by telephone 
7 
Self-administered or interviewer 
administered  
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
General written, verbal, or digital consent for 
coalition members 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email invitation and follow-up reminders 
 
Community Engagement Facilitator - Community Assessment Tool (CAT) 
Main Study Data Collection 
1 
Purpose 
The Ohio research site will develop a community 
genogram model to track connections among 
organizations, agencies, and providers involved in 
relevant HCS work. As part of this process, the 
Community Engagement (CE) Facilitators will use the 
CE Facilitator - Community Assessment Tool (CAT) to 
detail their process and work in Ohio’s participating 
HCS communities. 
2 
Respondent 
Ohio HCS research staff (Community Engagement 
Facilitators) 
3 
How will respondents be selected? 
HCS research staff hired by the study 

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Community Engagement Facilitator - Community Assessment Tool (CAT) 
4 
Sample size 
18 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
As needed 
6 
Mode (telephone, web, in person) 
The CE Facilitator’s interactions with coalition 
leaders/community members can occur face-to-face, 
by telephone or email.  
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Site specific (Ohio) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) 
(specify) 
N/A 
 
 
 
 
Costing the Evidence Based Practices Interview Guide 
Main Study Data Collection 
1 
Purpose 
To understand the costs of implementing the Evidence-Based 
Practice (EBP) Strategies. Specifically, the interviews will 
gather information about start-up and operational costs, such 
as time spent on activities required to stand up the EBP 
strategies and provide ongoing services, as well as additional 
resources that are required to implement and sustain each 
strategy. 
2 
Respondent 
Key Informants at implementing organizations in the HCS 
communities. 

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3 
How will respondents be 
selected? 
The HCS research teams will identify the key informant(s) at 
each institution most likely to have knowledge about start-up 
and operational costs.  
4 
Sample size 
Up to 90 (up to 30 at each research site) 
5 
Repeated (Y/N) 
Yes 
  
If yes: frequency (e.g., 
annually, monthly) 
Annually 
6 
Mode (telephone, web, in 
person) 
Telephone or Videoconference 
7 
Self-administered or 
interviewer administered 
Interviewer Administered 
8 
Informed consent (verbal, 
written, digital) 
Verbal 
9 
Incentives (Y/N) 
No 
  
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Site Specific (Kentucky, Massachusetts, New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Yes, see HCS Template for Costing the Evidence Based 
Practices Subject Facing Materials (KY, MA, NY) 
 
 
CTH Milestone and Benchmark Checklist 
Main Study Data Collection 
1 
Purpose 
To assess adherence to the CTH CE SOP 
2 
Respondent 
HCS research staff 
3 
How will respondents be selected? 
HCS CE staff hired by the study  
4 
Sample size 
67  
5 
Repeated (Y/N) 
Yes 

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CTH Milestone and Benchmark Checklist 
 
If yes: frequency (e.g., annually, 
monthly) 
Monthly basis for the first 6 months, then quarterly 
until all six phase activities are completed  
6 
Mode (telephone, web, in-person) 
Web 
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify site) 
Cross-site 
12 
Data collection platform (e.g., REDCap, 
video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
N/A 
 
Document Review Guide 
Main Study Data Collection 
1 
Purpose 
To assess adherence to the CTH CE SOP and the 
quality of implementing the CTH intervention 
2 
Respondent 
HCS research staff 
3 
How will respondents be selected? 
HCS research staff hired by the study 
4 
Sample size 
67  
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
As needed 
6 
Mode (telephone, web, in person) 
Web 
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 

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Document Review Guide 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Site specific (Massachusetts and New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
N/A 
 
Ethnographic Guide for Field Notes 
Main Study Data Collection 
1 
Purpose 
To observe coalition meetings for quality and 
adherence of delivering the CTH intervention  
2 
Respondent 
HCS research staff 
3 
How will respondents be selected? 
HCS research staff from the implementation science 
team 
4 
Sample size 
To be determined 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Will vary; dependent on how often the coalition meets 
6 
Mode (telephone, web, in person) 
In person 
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify site) 
Site specific (Massachusetts and New York) 
12 
Data collection platform (e.g., REDCap, 
video) 
Data from paper forms will be entered into REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
N/A 

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Focus Group CAB, Coalition, and Partner Organizations Guide 
Main Study Data Collection 
1 
Purpose 
To understand how people who are involved in 
addressing various aspects of the local community 
response to the opioid crisis respond to messages 
about naloxone, OUD, MOUD, and stigma 
2 
Respondent 
Coalition members, CAB members, and senior staff 
from local agencies implementing programs and 
services related to naloxone, OUD, MOUD, and 
stigma reduction 
3 
How will respondents be selected? 
Potential participants will be solicited at coalition and 
CAB meetings. These coalition and CAB members 
will help identify respondents from partner or 
implementation agencies in the community.  
4 
Sample size 
Total up to 400 across 33 Wave 1 communities  
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
These focus groups may be repeated for subsequent 
campaigns 
6 
Mode (telephone, web, in person)  
In person or telephone 
7 
Self-administered or interviewer 
administered  
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal or written   
9 
Incentives (Y/N) 
Yes  
 
If yes: incentive type (e.g., gift card, 
cash, check) 
$50–$75 gift card to be determined by the RS 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Audio-recording. Records will be maintained in a 
locked file cabinet and destroyed after analysis is 
complete. 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email invitation, confirmation, and meeting logistics 
 
 
 
 

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Focus Group for Persons with OUD 
Main Study Data Collection 
1 
Purpose 
Message testing to ensure relevance and lower risk 
of unintended effects of the communication 
campaign 
2 
Respondent 
People who self-identify as having OUD or using 
injection opioids 
3 
How will respondents be selected? 
Potential participants will be recruited through print 
and social media advertisements. We anticipate that 
some recruitment will also occur through word of 
mouth in the social and professional networks of 
coalition members. Participants will be screened to 
be (1) between ages 18 and 75, (2) a resident of the 
town or county where the groups will take place, and 
(3) having a self-reported opioid use disorder or self-
reporting use of injection opioids (i.e., heroin, 
fentanyl) or had an opioid overdose in the past year. 
4 
Sample size 
N=300 across 33 communities; groups will have 
between 3 and 8 participants each 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Yes, may be repeated for formative research in 
subsequent communication campaigns 
6 
Mode (telephone, web, in person) 
In-person or web conferencing, to be determined by 
each RS 
7 
Self-administered or interviewer 
administered 
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Written  
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
$50–$75 gift card to be determined by the RS 
10 
Seeking Waiver of Documentation 
of Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Audio-recording 
13 
Audio-recording (Y/N) 
Yes. Recordings will be saved on secure project 
servers and deleted after analysis is complete. 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email invitation, confirmation, and meeting logistics 

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Focus Group Testing of Launch Messages 
Main Study Data Collection 
1 
Purpose 
To understand how people who are aware of the 
opioid crisis in the community respond to messages 
about naloxone, OUD, MOUD, and stigma 
2 
Respondent 
Residents in each community 
3 
How will respondents be selected? 
Potential participants may be approached by a 
coalition member or will respond to an open 
solicitation via social media and newspaper items. 
They will be screened for (1) being between ages 18 
and 75 and (2) being a resident of the town or county 
where the groups will take place. The RSs will 
attempt to have a broad mix of demographic 
backgrounds and people from different occupation 
groups in each group (e.g., not all working in the 
health sector but also representing connections to 
public safety, law enforcement, business/retail, 
farming, and other sectors). 
4 
Sample size 
Total up to 400 across 33 Wave 1 communities 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
These focus groups may be repeated for subsequent 
communication campaigns but will not include the 
same participants 
6 
Mode (telephone, web, in person) 
In person or telephone, to be determined by each RS 
7 
Self-administered or interviewer 
administered 
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal or written  
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
$50–$75 gift card to be determined by the RS 
10 
Seeking Waiver of Documentation 
of Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Audio-recording. These recordings will be saved on 
secure project servers and deleted after analysis is 
complete. 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email invitation, confirmation, and meeting logistics 
information 

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General Template Costing the Community Engagement Process (CAB Members) 
Main Study Data Collection 
1 
Purpose 
To collect the resources (e.g., labor, time, space, 
equipment) spent on CE activities by CAB members 
2 
Respondent 
CAB members and other key informants 
3 
How will respondents be selected? 
All CAB members attending the CAB meetings will 
be invited to participate 
4 
Sample size 
60–80 CAB members (15–20 members per state * 4) 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Monthly (or when CAB meetings are held) 
6 
Mode (telephone, web, in person) 
In person, web, or telephone 
7 
Self-administered or interviewer 
administered 
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
General written, verbal, or digital consent for CAB 
members 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) 
(specify) 
Email invitation and follow-up reminders 
 
 
 
 
 
 

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Grant Writing Learning Collaborative Needs Assessment 
Main Study Data Collection 
Purpose 
For HCS community members to provide input and 
feedback regarding their grant writing training needs. 
Respondent 
HCS community members planning to attend the grant 
writing Learning Collaborative 
How will respondents be selected? 
Respondents self-select to participate after being asked to 
provide input and feedback regarding their grant writing 
training needs. 
Sample size 
70  
Repeated (Y/N) 
No 
If yes: frequency (e.g., annually, 
monthly) 
N/A 
Mode (telephone, web, in person) 
Web 
Self-administered or interviewer 
administered 
Self-administered 
Informed consent (verbal, written, 
digital) 
N/A 
Incentives (Y/N) 
No 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
N/A 
Cross-site or site specific (specify 
site) 
Site-specific (Ohio) 
Data collection platform (e.g., 
REDCap, video) 
Qualtrics 
Audio-recording (Y/N) 
No 
Other respondent-facing material (e.g., 
email invitation to participate) 
(specify) 
N/A 
 
 
 
 
 

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Group Model Building 
Main Study Data Collection 
1 
Purpose 
To develop causal loop diagrams (CLDs) that 
elucidate the implementation challenges of opioid-
related prevention and treatment strategies in each 
county. CLDs are learning and CE tools used for 
subsequent simulation modeling efforts and the 
development/adaptation of community actions. 
2 
Respondent 
Key stakeholders drawn from community coalitions 
3 
How will respondents be selected? 
Participants should be leaders or influencers from 
different sectors in each community. In small 
communities, key stakeholders could be the entire 
coalition if its membership is small. In communities 
with larger or multiple coalitions, key stakeholders 
will be selected based on their leadership role in 
different sectors. 
4 
Sample size 
12–20 participants per community 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., annually, 
monthly) 
N/A 
6 
Mode (telephone, web, in person) 
In person 
7 
Self-administered or interviewer 
administered 
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
General written consent for coalition members 
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
$50 gift card for key stakeholders in New York 
10 
Seeking Waiver of Documentation 
of Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Site specific (New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
Stella for visualizing the CLDs. Handwritten notes of 
discussion. 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email or telephone invitation and a brief describing 
the session  
 

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Group Model Building (GMB) Session Feedback Form 
Main Study Data Collection 
1 
Purpose 
To elicit anonymous feedback from Group Model 
Building Workshop participants to evaluate the 
quality of the workshop’s facilitation, content, clarity, 
and perceived utility   
2 
Respondent 
Workshop participants 
3 
How will respondents be selected? 
Respondents will be participants from the Group 
Model Building Workshop 
4 
Sample size 
To be determined 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
As needed 
6 
Mode (telephone, web, in person) 
In person  
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Site specific (New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
Will be completed on paper, then data from forms will 
be entered into REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) 
(specify) 
N/A 
 
 
 
 
 

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HEALing Communities CAB Member Survey 
Main Study Data Collection 
1 
Purpose 
To understand CAB member structures and 
processes and CAB members’ opinions about the 
CAB’s work 
2 
Respondent 
CAB members 
3 
How will respondents be selected? 
Potential participants will be identified based on CAB 
membership 
4 
Sample size 
80 (up to 30 in Massachusetts; up to 50 in New York) 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Annually 
6 
Mode (telephone, web, in person) 
In-person, web, or telephone 
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
Written, verbal, or digital  
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
Massachusetts will not provide an incentive; New 
York will provide $50 after the participant completes 
the survey. 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Site specific (Massachusetts and New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) 
(specify) 
Email invitation and follow-up reminders 
 
 
 
 

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HCS Annual Jail Survey 
Main Study Data Collection 
1 
Purpose 
To assess the provision of opioid-related services 
by jails associated with communities participating in 
the HCS 
2 
Respondent 
Key informants 
3 
How will respondents be selected? 
Key employees who are knowledgeable about 
opioid-related services provided by jails in 
communities participating in the HCS 
4 
Sample size 
67–200 jails 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Annually 
6 
Mode (telephone, web, in person) 
Telephone, web, or in person 
7 
Self-administered or interviewer 
administered 
Self-administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal, written, or digital  
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify site) 
Cross-site 
12 
Data collection platform (e.g., REDCap, 
video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
Email/letter invitation and follow-up reminders via 
email/letter/phone scripts 
 
 
 
 
 
 

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HCS Community Data Dashboards Survey & Portal Group Interview Guide 
Main Study Data Collection 
1 
Purpose 
To gather information on how the HCS dashboards 
have been useful in CTH decision making, whether 
they are easy to use and understand, whether the 
HCS dashboards will continue to be used and for 
what purpose, and whether and in what capacity 
landscape data will continue to be used to populate 
the HCS dashboards. 
2 
Respondent 
HCS community members and research staff 
3 
How will respondents be selected? 
Respondents will have actively utilized the 
community portals and data dashboards as part of 
the HCS. 
4 
Sample size 
Up to 130 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., annually, 
monthly) 
N/A 
6 
Mode (telephone, web, in person) 
The HCS Community Data Dashboards Survey will 
be collected via the web. The Portal Group 
Interview Guide will be collected via video 
conference. 
7 
Self-administered or interviewer 
administered 
The HCS Community Data Dashboards Survey will 
be self-administered, and the Portal Group 
Interview Guide will be interviewer-administered. 
8 
Informed consent (verbal, written, 
digital) 
Verbal 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify site)  Cross-Site 
12 
Data collection platform (e.g., paper, 
REDCap, video) 
The HCS Community Data Dashboards Survey will 
be administered via REDCap. The Portal Group 
Interview Guide will be conducted via video 
conference. 
13 
Audio-recording (Y/N) 
Yes (Portal Group Interview Guide) 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
Yes, see Subject Facing Materials for the HCS 
Portal Group Interview Guide 
 
 
 

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HCS Community Grant Documentation 
  
Main Study Data Collection 
1 
Purpose 
To document grants or similarly funded projects in HCS 
communities related to the CTH implementation or EBPs. 
2 
Respondent 
HCS staff will document information after receiving 
information from key informants/coalition members in HCS 
communities. 
3 
How will respondents be 
selected? 
Additional grants and/or similarly funded projects will be 
discussed and identified during coalitions meetings or other 
meetings where coalition members are present. Key 
informants/coalition members will be asked to clarify basic 
details about the addition grant/funded project. HCS staff will 
document these details. 
4 
Sample size 
Unknown; it is unknown how many grants and/or similarly 
funded projects are occurring in the HCS communities. This 
information will be collected for each HCS community. 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Ongoing. These discussions will be a set agenda item during 
coalition meetings in three of the research sites (KY, MA, 
NY). The fourth research site (OH) will train the community 
engagement facilitators to stay up to date on grants and/or 
similarly funded projects in their HCS communities. 
6 
Mode (telephone, web, in 
person) 
Interactions with key informants/coalition members can occur 
face-to-face, by telephone or email. 
7 
Self-administered or 
interviewer administered 
Self-administered  
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
No 
11 
Cross-site or site specific 
(specify site) 
Cross-Site 
12 
Data collection platform (e.g., 
REDCap, video) 
Word document 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 

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HCS Staff Activity Costing Instrument 
Main Study Data Collection 
1 
Purpose 
Collect the time spent by project staff facilitating the 
CTH intervention   
2 
Respondent 
HCS project staff 
3 
How will respondents be selected? 
Any staff funded in part by the HCS grants and who 
perform intervention activities that are not for the 
purposes of research   
4 
Sample size 
40 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency, (e.g., annually, 
monthly) 
Monthly, with an option to decrease to quarterly 
6 
Mode (telephone, web, in person) 
Telephone, web, and in person  
7 
Self-administered or interviewer 
administered 
Can be self-administered after the initial interview 
8 
Informed consent (verbal, written, 
digital) 
N/A  
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of Documentation 
of Informed Consent (Y/N) 
No 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
N/A 
 
 
 
 
 
 
 
 

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HCS Staff Tracker 
  
Main Study Data Collection 
1 
Purpose 
To document the labor resources of HCS staff hired to 
support the CTH implementation in HCS communities. 
2 
Respondent 
Health economists and collaborating staff from the research 
sites.  
3 
How will respondents be 
selected? 
Data will be collected on all HCS staff hired to support the 
CTH implementation. 
4 
Sample size 
Up to 205 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
The data will be updated quarterly to reflect changes in 
staffing over the course of the project. 
6 
Mode (telephone, web, in 
person) 
An excel spreadsheet template will be completed by a 
responsible person(s) (RPs) at each research site. The KY 
research site has the option of completing the information via 
REDCap (see KY-Staff Research Effort Survey).  RPs may 
use email, phone, and/or face-to-face interactions when 
completing the excel spreadsheet/REDCap survey. 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
No 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
An excel spreadsheet template will be provided to research 
site RPs. The KY research site has the option to use 
REDCap to facilitate data entry. All data will ultimately be 
complied in spreadsheets for systematic analysis.  
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 
 
 

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Interview Guide Message Testing 
Main Study Data Collection  
1 
Purpose 
To understand how people who are aware of the 
opioid crisis in the community respond to messages 
about naloxone, OUD, MOUD stigma  
2 
Respondent 
Community leaders and health care providers in 
each community 
3 
How will respondents be selected? 
Potential participants may be approached by a 
coalition member or will respond to an open 
solicitation via social media and newspaper items. 
They will be screened for (1) being between ages 18 
and 75 and (2) being a resident of the town or county 
where the groups will take place. The RSs will 
attempt to have a broad mix of demographic 
backgrounds and people from different occupation 
groups in each group (e.g., not all working in the 
health sector but also representing connections to 
public safety, law enforcement, business/retail, 
farming, and other sectors). 
4 
Sample size 
Total up to 400 across 33 Wave 1 communities  
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
These focus groups may be repeated for subsequent 
communication campaigns but will not include the 
same participants 
6 
Mode (telephone, web, in person)  
Telephone  
7 
Self-administered or interviewer 
administered  
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal  
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
$50 or $200 gift card (dependent on respondent 
type) 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Audio-recording. These recordings will be saved on 
secure project servers and deleted after analysis is 
complete. 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email invitation, confirmation, and meeting logistics 
information  

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Interview Guide Message Testing Persons with OUD 
Main Study Data Collection 
1 
Purpose 
Message testing to ensure relevance and lower risk 
of unintended effects of the communication 
campaign 
2 
Respondent 
People who self-identify as having OUD or using 
injection opioids 
3 
How will respondents be selected? 
Potential participants will be recruited through print 
and social media advertisements. We anticipate that 
some recruitment will also occur through word of 
mouth in the social and professional networks of 
coalition members. Participants will be screened to 
be (1) between ages 18 and 75, (2) a resident of the 
town or county where the groups will take place, 
and (3) having a self-reported OUD or self-reporting 
use of injection opioids (i.e., heroin, fentanyl) or had 
an opioid overdose in the past year. 
4 
Sample size 
N=300 across 33 communities; groups will have 
between 3 and 8 participants each 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Yes, may be repeated for formative research in 
subsequent communication campaigns 
6 
Mode (telephone, web, in person)  
In-person or web conferencing, to be determined by 
each RS 
7 
Self-administered or interviewer 
administered  
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal  
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
$50–$75 gift card to be determined by the RS 
10 
Seeking Waiver of Documentation 
of Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Audio-recording 
13 
Audio-recording (Y/N) 
Yes. Recordings will be saved on secure project 
servers and deleted after analysis is complete.  
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Email invitation, confirmation, and meeting logistics 
information to be developed 

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Landscape Analysis 1 (Wave 1)/Landscape Analysis (Wave 2) 
Main Study Data Collection 
1 
Purpose 
The Landscape Analysis is a collection of 
secondary data to describe the external setting in 
which the HCS will occur. 
2 
Respondent 
HCS researchers (i.e., study staff), community 
informants 
3 
How will respondents be selected? 
N/A 
4 
Sample size 
One Landscape Analysis will be performed for each 
community. 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Data collected at baseline (Phase 0 through Phase 
1 of the intervention) and updated as needed 
throughout the intervention 
6 
Mode (telephone, web, in person)  
Information will be collected via web searches (i.e., 
publicly available data), administrative reports, and 
via conversations with community informants 
7 
Self-administered or interviewer 
administered  
N/A 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
N/A 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
N/A 
11 
Cross-site or site specific (specify site) 
Cross-site  
12 
Data collection platform (e.g., REDCap, 
video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
No 
 

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Landscape Analysis 2 (Wave 1)/Landscape Analysis Organizational Questionnaire (Wave 2) 
Main Study Data Collection 
1 
Purpose 
Wave 1: The Asset Classification (AC) is Phase 2 of the 
Landscape Analysis. The AC will be conducted to capture 
prevention, treatment, recovery support services, and 
infrastructure in health care, behavioral health, and criminal 
justice organizations, along with other key community 
features. Results of the AC will provide community context 
and directly inform CE efforts of the HCS. The roster of 
community-based organizations (assets) for the AC is 
generated from publicly available data sources gathered 
during Landscape Analysis Phase 1. The AC will be 
conducted via telephone, online, or in person with key facility 
contacts, or those best able to answer questions about opioid 
use treatment and opioid overdose prevention services at the 
facility.  
Wave 2: The Organizational questionnaires will be conducted 
to capture prevention, treatment, recovery support services, 
and infrastructure in health care, behavioral health, and 
criminal justice organizations, along with other key 
community features. Results of the questionnaires will 
provide community context and directly inform CE efforts of 
the HCS. The roster of community-based organizations 
(assets) is generated from publicly available data sources 
gathered during Landscape Analysis process (web 
searching, use of extant data sources and conversations with 
community informants). The questionnaires will be conducted 
via telephone, online, or in person with key facility contacts, 
or those best able to answer questions about opioid use 
treatment and opioid overdose prevention services at the 
facility. 
2 
Respondent 
Organization employees 
3 
How will respondents be 
selected? 
A roster of organizations will be generated by LA. The 
primary respondents for the survey will be employees of the 
organization/agency that provides opioid-use disorder related 
services as identified by LA. 
4 
Sample size 
Sample size is dependent on the number of assets identified 
by the LA process and difficult to estimate a priori. 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Data collected at baseline (Phase 0 through 1 of the 
intervention) and updated as needed throughout the 
intervention period 
6 
Mode (telephone, web, in 
person)  
Agency/organization employee—web based, in person, 
telephone 
7 
Self-administered or 
interviewer administered  
Agency employee—self-administered (if web based) and 
interviewer administered (if by telephone or in person) 

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Landscape Analysis 2 (Wave 1)/Landscape Analysis Organizational Questionnaire (Wave 2) 
8 
Informed consent (verbal, 
written, digital) 
Verbal, written, or digital  
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Site Specific (Kentucky and Ohio) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
There will be an email invitation to participate with a follow-up 
reminder from a data collector, if necessary 
 
Learning Collaborative Evaluation Survey 
Main Study Data Collection 
1 
Purpose 
For Learning Collaborative training attendees to rate 
how well the training session(s) met learning 
objectives, as well as satisfaction with the training.   
2 
Respondent 
Community members from HCS communities 
3 
How will respondents be selected? 
Each learning collaborative training attendee will be 
asked to complete a post-event evaluation survey 
immediately following the completion of the learning 
collaborative training. 
4 
Sample size 
To be determined. 
5 
Repeated (Y/N) 
No. An attendee will complete the evaluation survey 
for each unique Learning Collaborative training they 
attend. 
 
If yes: frequency (e.g., annually, 
monthly) 
N/A 
6 
Mode (telephone, web, in person)  
Web 
7 
Self-administered or interviewer 
administered  
Self-Administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 

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Learning Collaborative Evaluation Survey 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
N/A 
11 
Cross-site or site specific (specify site) 
Site-specific (Ohio) 
12 
Data collection platform (e.g., REDCap, 
video) 
Qualtrics 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material (e.g., 
email invitation to participate) (specify) 
N/A 
 
Medical Examiner Survey 
Main Study Data Collection 
1 
Purpose 
To understand the procedures in each New York county 
related to determining opioid overdose-related deaths 
2 
Respondent 
Medical examiners in New York State 
3 
How will respondents be 
selected? 
Medical examiners in New York’s communities 
4 
Sample size 
16 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Web 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
Digital  
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
Participants will receive $50 after completing the survey. 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Site specific (New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 

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Medical Examiner Survey 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Email invitation 
 
Medication Disposal Drop Box Sustainability Interview Guide 
Main Study Data Collection 
1 
Purpose 
To gather information about satisfaction with the 
experience, barriers to implementation and 
maintenance, readiness for sustainment of drop 
boxes, training or technical needs related to drop 
box maintenance, and the inner construct of the 
pharmacy.   
2 
Respondent 
Pharmacies who participated in the HCS medication 
disposal program.   
3 
How will respondents be selected? 
Potential participants will be identified based on 
participation in the HCS medication disposal 
program.   
4 
Sample size 
64  
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., annually, 
monthly) 
N/A 
6 
Mode (telephone, web, in person)  
Telephone or Videoconferencing 
7 
Self-administered or interviewer 
administered  
Interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Site specific (Kentucky) 
12 
Data collection platform (e.g., 
REDCap, video) 
Video conference (Zoom) 
13 
Audio-recording (Y/N) 
Yes  
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
See HCS_Medication Disposal Program Pharmacy 
Interview Guide Subject Facing Materials (KY Site-
Specific)  
 

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Mobile MOUD Interview Guide 
Main Study Data Collection 
1 
Purpose 
To understand the facilitators of and barriers to 
implementing mobile MOUD interventions (e.g., 
interventions that provide mobile access to 
clinicians who prescribe buprenorphine, naltrexone, 
or methadone). The interviews will gather 
information about services offered, barriers and 
facilitators to standing up such programs, as well as 
additional factors that are required to implement and 
sustain each strategy.  
2 
Respondent 
Key informants from organizations in HCS Wave 1 
communities implementing mobile MOUD 
interventions. 
3 
How will respondents be selected? 
The HCS research teams will identify the key 
informant(s) at each organization most likely to have 
knowledge about implementation planning and 
operations of the mobile MOUD programs. 
4 
Sample size 
Up to 33 (1-2 key informants per organization) 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., annually, 
monthly) 
N/A 
6 
Mode (telephone, web, in person)  
Telephone or videoconference 
7 
Self-administered or interviewer 
administered  
Interview administered 
8 
Informed consent (verbal, written, 
digital) 
Verbal 
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
$50 gift card or pre-paid debit card (ClinCard) 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
Yes 
11 
Cross-site or site specific (specify 
site) 
Site-specific (MA, NY, and OH) 
12 
Data collection platform (e.g., 
REDCap, video) 
Telephone or videoconference (Zoom) 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
Yes, see HCS Mobile MOUD Interview Guide 
Subject Facing Materials. 
 
 

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Monthly Coalition Work Group or Subcommittee Meeting Log 
Main Study Data Collection 
1 
Purpose 
To assess number, length and type of different CTH 
subcommittee/workgroup committees that occur in 
wave 1 communities on a monthly basis 
2 
Respondent 
HCS research staff will collect data from CE 
facilitators 
3 
How will respondents be selected? 
HCS research sites will identify HCS staff in each 
community to complete the form 
4 
Sample size 
67  
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., annually, 
monthly) 
Monthly 
6 
Mode (telephone, web, in person)  
Telephone, Web, In Person 
7 
Self-administered or interviewer 
administered  
Self-administered and interviewer administered 
8 
Informed consent (verbal, written, 
digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift card, 
cash, check) 
N/A 
10 
Seeking Waiver of Documentation of 
Informed Consent (Y/N) 
N/A 
11 
Cross-site or site specific (specify 
site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing material 
(e.g., email invitation to participate) 
(specify) 
N/A 
 
 
 
 
 

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MOUD Organization Interview Guide 
Main Study Data Collection 
1 
Purpose 
To gather information about the barriers to access and 
retention in MOUD, as well as the impacts of COVID on the 
delivery of MOUD within the Kentucky HCS communities. 
2 
Respondent 
Staff working in organizations providing MOUD, which 
includes, but is not limited to, opioid treatment programs 
(OTPs), non-OPT specialty substance use disorder 
programs, and office-based medical practices. 
3 
How will respondents be 
selected? 
To select potential respondents, the team will draw upon 
information provided by the community’s HCS coalition, 
individuals in MOUD organizations that have already 
implemented fast-track overdose education and naloxone 
distribution, and the team’s professional networks, the Drug 
Enforcement Agency’s list of waivered providers, and MOUD 
organizations’ websites. Approximately 2-3 staff members 
from a given organization will be asked to participate in the 
interview. 
4 
Sample size 
Up to 160 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Telephone or Videoconferencing  
7 
Self-administered or 
interviewer administered 
Interviewer administered 
8 
Informed consent (verbal, 
written, digital) 
Verbal 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Site specific (Kentucky) 
12 
Data collection platform (e.g., 
REDCap, video) 
Video conference (Zoom) 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
See HCS_KY_Subject Facing Materials for MOUD 
Organization Interview 
 

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Municipal Drug Policies Interview Guide 
Main Study Data Collection 
1 
Purpose 
To identify and develop an understanding of municipal 
policies that may impact the implementation of evidence-
based practice (EBP) strategies to prevent opioid overdose in 
HCS communities. 
2 
Respondent 
HCS MA community facing staff, HCS MA Community 
Advisory Board members, HCS MA coalition members, HCS 
community municipal leadership and staff 
3 
How will respondents be 
selected? 
MA research staff will develop a list of potential participants 
based on HCS staff lists, participant recommendations made 
by HCS MA staff/CAB members/coalition members, and 
public facing contact information for municipal leadership and 
staff 
4 
Sample size 
50 
5 
Repeated (Y/N) 
Yes 
  
If yes: frequency (e.g., 
annually, monthly) 
Annually 
6 
Mode (telephone, web, in 
person) 
Telephone or Videoconference 
7 
Self-administered or 
interviewer administered 
Interviewer administered 
8 
Informed consent (verbal, 
written, digital) 
Verbal  
9 
Incentives (Y/N) 
Yes 
  
If yes: incentive type (e.g., gift 
card, cash, check) 
Gift Card ($25) 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
MA Site-Specific 
12 
Data collection platform (e.g., 
REDCap, video) 
Telephone or Videoconference  
13 
Audio-recording (Y/N) 
Yes 

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14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Yes, see HCS Municipal Drug Policies Interview Guide 
Subject Facing Materials 
 
ORCCA Tracker (ORCCAT) 
Main Study Data Collection 
1 
Purpose 
To track the ORCCA EBP strategies participating HCS 
communities are selecting and implementing.  
2 
Respondent 
Community Coordinators, Program Managers, Others familiar 
with HCS communities’ day-to-day practices. 
3 
How will respondents be 
selected? 
Research site leads will select the appropriate respondents 
4 
Sample size 
1 per community 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Monthly 
6 
Mode (telephone, web, in 
person) 
Web  
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
No 
11 
Cross-site or site specific 
(specify site) 
Cross site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 

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PARTNER Tool 
Main Study Data Collection 
1 
Purpose 
The purpose of the analysis is to better understand the role 
coalition members (i.e., agencies) play within the coalition, 
what resources each agency brings to the table, identify 
activity levels of agencies in the coalition and determine how 
these agencies interact to address the opioid epidemic in 
their community(ies).  
2 
Respondent 
Respondents will be coalition members from Wave 2 HCS 
communities. 
3 
How will respondents be 
selected? 
Respondents will be selected from coalition rosters with help 
from coalition leaders for proper network selection. 
4 
Sample size 
The sample size will depend on the size of community 
coalitions (which vary); there are 9 Wave 2 community 
coalitions, for a total of 9 networks. 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Once more at the end of the study period. 
6 
Mode (telephone, web, in 
person) 
Web or telephone 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
Digital or verbal 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
OH Site-Specific 
12 
Data collection platform (e.g., 
REDCap, video) 
Visible Network Labs online instrument website 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
See HCS PARTNER Tool for Wave 2 Subject Facing 
Materials (OH Site-Specific) 
 
 

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Pharmacy Study Interview Guide 
  
Main Study Data Collection 
1 
Purpose 
To assess racial/ethnic disparities in Medication for Opioid 
Use Disorder (MOUD) and Naloxone availability at 
pharmacies in HCS communities, and to examine the 
perspectives of People With Opioid Use Disorder (PWOUD) 
with respect to barriers to accessing MOUD and Naloxone 
services in pharmacies.  
2 
Respondent 
There are two types of respondents: 1) Pharmacists who 
work for pharmacies in New York’s HCS communities and 2) 
People With Opioid Use Disorder (PWOUD). 
3 
How will respondents be 
selected? 
Pharmacists will be selected because they work for 
pharmacies in New York’s HCS communities. The NYS 
Pharmacy Association will provide recruitment assistance to 
the NY research team.  
 
People With Opioid Use Disorder (PWOUD) will be 
selected/recruited from three types of programs serving 
PWOUD at sites in NY’s HCS counties, with diverse 
communities: a) Methadone Maintenance treatment 
programs; b) primary care clinics; c) syringe exchange 
programs. Recruitment will ensure that the sample includes 
minority representation across non-Hispanic Blacks and 
Hispanics. 
4 
Sample size 
20 Pharmacists; 20 People With Opioid Use Disorder 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Annually 
6 
Mode (telephone, web, in 
person) 
Telephone/Video Conference 
7 
Self-administered or 
interviewer administered 
Interviewer administered 
8 
Informed consent (verbal, 
written, digital) 
Verbal 
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
$50 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Site Specific (New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
Video Conference 

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Pharmacy Study Interview Guide 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
See NY Pharmacy Study Survey & Interview Guide Subject 
Facing Materials.  
 
Pharmacy Study Survey 
  
Main Study Data Collection 
1 
Purpose 
To assess racial/ethnic disparities in Medication for Opioid 
Use Disorder (MOUD) and Naloxone availability at 
pharmacies in HCS communities., The surveys (one for 
pharmacy staff or pharmacists and one specifically for 
licensed pharmacists) will include questions about access to 
Narcan/Naloxone, Buprenorphine, Naltrexone, Methadone 
and COVID-19 services in pharmacies located within NY’s 
HCS Communities. 
2 
Respondent 
Pharmacists, pharmacy technicians and/or other pharmacy 
staff who work for a pharmacy in one of NY’s HCS 
communities. 
3 
How will respondents be 
selected? 
The NYS Pharmacy Association will provide recruitment 
assistance to the NY research team that will also conduct an 
online search for pharmacy contact information. The 
pharmacist, pharmacy technician and/or other pharmacy 
staff will work for pharmacies in NY’s HCS communities.  
4 
Sample size 
Up to 700 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Annually 
6 
Mode (telephone, web, in 
person) 
Telephone and Web 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
Verbal and digital 
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
$15 for Pharmacy Only Survey and $50 for Pharmacist Only 
Survey 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Site Specific (New York) 

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Pharmacy Study Survey 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
See NY Pharmacy Study Survey & Interview Guide Subject 
Facing Materials. 
 
Photovoice Focus Group Interview Guide 
Main Study Data Collection 
1 
Purpose 
To gather community members’ perspectives (via shared 
photographs and focus group discussions) regarding barriers 
and facilitators that impact efforts to prevent opioid-related 
overdose deaths in their HCS community and to identify ways 
to address the challenges; HCS communities will be able to 
hone the focus of their inquiry to the local context. 
2 
Respondent 
Community member or key stakeholder that can provide 
insight about the state of the opioid epidemic in their HCS 
community, as well as information about local community 
resources and responses.  
3 
How will respondents be 
selected? 
Purposeful Selection 
4 
Sample size 
Up to 16 individuals per HCS community 
5 
Repeated (Y/N) 
No, though one Photovoice project may involve up to 6 
sessions 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
In person or by video conference 
7 
Self-administered or 
interviewer administered 
Focus group is interviewer administered. Brief (5-minute) 
demographic survey is self-administered. 
8 
Informed consent (verbal, 
written, digital) 
Written or verbal consent 
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
Gift cards (MA will compensate $25 per session, up to $150 
per participant; KY and OH will compensate $50 per session, 
up to $300 per participant) 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes, for verbal consent 
11 
Cross-site or site specific 
(specify site) 
Site-Specific (KY, MA and OH) 

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Photovoice Focus Group Interview Guide 
12 
Data collection platform (e.g., 
REDCap, video) 
Interviews will be audio-recorded and transcribed. Transcripts 
coded and saved in Box.com folder. Communities may 
choose to enter/share some photos via EpiCollect5. 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
See HCS Photovoice Focus Group Subject Facing Materials 
(MA & OH), HCS Abbreviated Subject Facing Materials for 
Photovoice Focus Group (KY, MA & OH) and HCS 
Permission to Use Image(s) from Photovoice Process. 
 
Policy Community Report 
Main Study Data Collection 
1 
Purpose 
To document policies reported by the coalition members and 
research team staff that may facilitate or impede the CTH 
intervention and track the HCS responses to them. 
2 
Respondent 
Research staff 
3 
How will respondents be 
selected? 
Policies that HCS communities encounter or become aware 
of will be recorded when the research team is notified. 
4 
Sample size 
To be determined 
5 
Repeated (Y/N) 
No but individual records will be updated as needed 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Direct entry into REDCap by research team member 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
N/A 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 

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Policy Community Report 
Main Study Data Collection 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 
Policy Environmental Scan 
Main Study Data Collection 
1 
Purpose 
To document policies that may facilitate or impede the CTH 
intervention. 
2 
Respondent 
Research staff 
3 
How will respondents be 
selected? 
An environmental scan will be conducted to identify federal 
and state level policies. 
4 
Sample size 
To be determined 
5 
Repeated (Y/N) 
No but individual records will be updated as needed 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Direct entry into REDCap by research team member 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
N/A 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 
 
 

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Post Coalition Meeting Feedback Form 
Main Study Data Collection 
1 
Purpose 
To elicit anonymous feedback from coalition members on 
CTH coalition meeting minutes  
2 
Respondent 
Coalition members 
3 
How will respondents be 
selected? 
Will be an active member of the coalition; evaluation form to 
be completed after coalition meetings 
4 
Sample size 
To be determined 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
As needed 
6 
Mode (telephone, web, in 
person) 
In person  
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
No 
11 
Cross-site or site specific 
(specify site) 
Site specific (New York) 
12 
Data collection platform (e.g., 
REDCap, video) 
Will be completed on paper, then data from forms will be 
entered into REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 
 
 
 
 

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Qualitative Assessment Form for Campaign 4 
Main Study Data Collection 
1 
Purpose 
To learn what HCS communication campaign materials and 
distribution methods worked well and what could be 
improved. 
2 
Respondent 
Community staff or Coalition members 
3 
How will respondents be 
selected? 
Person(s) in each community primarily responsible for 
campaign implementation 
4 
Sample size 
Will vary, 1-3 per community site 
5 
Repeated (Y/N) 
N 
 
If yes: frequency (e.g., 
annually, monthly) 
 
6 
Mode (telephone, web, in 
person) 
Web 
7 
Self-administered or 
interviewer administered 
Self-Administered; HCS staff will follow-up if there are 
questions about the respondent’s answers. 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
N/A 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
N/A 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
N/A 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Yes, see HCS Campaign 4 Qualitative Assessment Subject 
Facing Materials 
 
 
 
 
 

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Race and Ethnicity Data Collection Readiness Survey 
Main Study Data Collection 
1 
Purpose 
To identify the process that organizations are using to collect 
and monitor demographic data in NY’s HCS communities.  
2 
Respondent 
Key informants working at NY’s HCS partner organizations.   
3 
How will respondents be 
selected? 
The NY HCS research team will develop a list of potential 
survey participants from internal study records. To gauge 
interest, potential participants will be contacted by the 
research team via email.  
4 
Sample size 
Between 60 and 70 Wave 1 organizations will be recruited to 
participate in the survey. 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Mail, Web or via video conference/phone. 
7 
Self-administered or 
interviewer administered 
Self-administered if conducted by mail or web and interviewer 
administered if conducted by video conference/phone. 
8 
Informed consent (verbal, 
written, digital) 
In-Person, Verbal or web consent 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes, for verbal and web consent 
11 
Cross-site or site specific 
(specify site) 
Site-Specific (NY) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap Survey 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
See HCS Subject Facing Materials for NY Race and Ethnicity 
Data Collection Readiness Survey 
 
 

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Reach Tracker 
Main Study Data Collection 
1 
Purpose 
To track aggregate reach data for the Overdose Reduction 
Continuum of Care Approach (ORCCA) evidence-based 
practices (EBP) strategies HCS communities are 
implementing.   
2 
Respondent 
HCS program or research staff  
3 
How will respondents be 
selected? 
RSs will identify HCS program or research staff from each 
community who will be responsible for filling out the tracker 
for each community. 
4 
Sample size 
Variable, up to 264 across all 4 sites (8 per community for 33 
communities across 4 sites) 
5 
Repeated (Y/N) 
Y 
 
If yes: frequency (e.g., 
annually, monthly) 
Once data collection begins (estimated start date: December 
2021), the Reach Tracker will be administered 45 days after 
close of the month, and data are submitted on the 15th of the 
month. For example, January 2022 data are due March 15. 
6 
Mode (telephone, web, in 
person) 
Web (REDCap instrument) 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
N/A 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 
 

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State Grant Funding 
Main Study Data Collection 
1 
Purpose 
Collect information on federal resources going to 
communities in the HCS states 
2 
Respondent 
State employee key informant working in the relevant state 
agency  
3 
How will respondents be 
selected? 
Research staff will reach out to a contact at each state who 
will help us identify the individual who can best extract data 
for our tool 
4 
Sample size 
4 (one from each state) 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Annually 
6 
Mode (telephone, web, in 
person)  
Telephone introduction followed by emailed spreadsheet for 
data entry 
7 
Self-administered or 
interviewer administered  
This is a collection of secondary (administrative) data. The 
key informant will work with the state’s administrative records 
to enter data on programs into the spreadsheet.  
8 
Informed consent (verbal, 
written, digital) 
Verbal 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Emailed spreadsheet along with telephone support as 
necessary 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Telephone introduction  
 
 
 
 
 
 

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Sustainability Partner Organization Interview Guide 
Main Study Data Collection 
1 
Purpose 
To expand knowledge regarding experiences of Wave 1 
partner organizations in implementing ORCCA Menus 1 and 
2 and to learn about the period of early sustainment.  
2 
Respondent 
Staff from Wave 1 organizations that partnered with the HCS 
across all four HCS research sites.  
3 
How will respondents be 
selected? 
Purposive sample that includes a range of organizations, 
including those located in rural and urban communities, those 
that are or are not represented on the coalition, and those in 
the three primary sectors of HCS (health care, behavioral 
health, and criminal justice).  
4 
Sample size 
Approximately 450 participants 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Videoconference or telephone 
7 
Self-administered or 
interviewer administered 
Interviewer administered 
8 
Informed consent (verbal, 
written, digital) 
Verbal 
9 
Incentives (Y/N) 
Yes 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
$50 (check, cash, gift card) 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Videoconference or telephone 
13 
Audio-recording (Y/N) 
Yes 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Yes, see Subject Facing Materials for Sustainability Partner 
Organization Interview Guide 
 
 

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Toxicology Survey for Labs 
Main Study Data Collection 
1 
Purpose 
To gather data on the characteristics of post-mortem 
toxicology testing for suspected drug overdose deaths. 
Information will also be collected on the processes and 
barriers related to toxicology testing. 
2 
Respondent 
Toxicology laboratory staff 
3 
How will respondents be 
selected? 
Staff who work at a lab providing post-mortem toxicology 
testing in HCS study communities.  
4 
Sample size 
Up to 200 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Web or telephone 
7 
Self-administered or 
interviewer administered 
Both; Self-administered (web) or interviewer-administered 
(telephone) 
8 
Informed consent (verbal, 
written, digital) 
Digital and verbal 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Yes, see Toxicology Survey for Labs Subject Facing 
Materials 
 
 
 
 

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Toxicology Survey for Medical Examiners & Coroners 
Main Study Data Collection 
1 
Purpose 
To gather information about the processes and barriers 
affecting the completion of death certificates for suspected 
drug overdose deaths.  
2 
Respondent 
Medical examiners and coroners 
3 
How will respondents be 
selected? 
Medical Examiners or coroners in one of the HCS 
communities.  
4 
Sample size 
Up to 200 
5 
Repeated (Y/N) 
No 
 
If yes: frequency (e.g., 
annually, monthly) 
N/A 
6 
Mode (telephone, web, in 
person) 
Web or telephone 
7 
Self-administered or 
interviewer administered 
Both; Self-administered (web) or interviewer-administered 
(telephone) 
8 
Informed consent (verbal, 
written, digital) 
Digital and verbal 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
Yes 
11 
Cross-site or site specific 
(specify site) 
Site Specific (Kentucky, Massachusetts, and Ohio) 
12 
Data collection platform (e.g., 
REDCap, video) 
REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
Yes, see Toxicology Survey for Medical Examiners Subject 
Facing Materials for KY MA OH 
 
 
 
 

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Training and Technical Assistance Tracking (TTAT) Form 
Main Study Data Collection 
1 
Purpose 
To assess cost, dosage, and adherence of training or 
technical assistance service for CE or ORCCA activity as an 
implementation strategy 
2 
Respondent 
HCS project staff 
3 
How will respondents be 
selected? 
HCS project staff from each RS 
4 
Sample size 
To be determined 
5 
Repeated (Y/N) 
Yes 
 
If yes: frequency (e.g., 
annually, monthly) 
Monthly 
6 
Mode (telephone, web, in 
person) 
In person 
7 
Self-administered or 
interviewer administered 
Self-administered 
8 
Informed consent (verbal, 
written, digital) 
N/A 
9 
Incentives (Y/N) 
No 
 
If yes: incentive type (e.g., gift 
card, cash, check) 
N/A 
10 
Seeking Waiver of 
Documentation of Informed 
Consent (Y/N) 
No 
11 
Cross-site or site specific 
(specify site) 
Cross-site 
12 
Data collection platform (e.g., 
REDCap, video) 
Completed on paper, then data will be entered into REDCap 
13 
Audio-recording (Y/N) 
No 
14 
Other respondent-facing 
material (e.g., email invitation 
to participate) (specify) 
N/A 
 
8.2 
Safety Assessments 
As described in Section 2.3, the risks associated with the CTH intervention are minimal. The 
CTH intervention does not directly treat members of the communities. Rather, it assists the 
communities and their service venues in selecting evidence-based practices (EBPs) that the 
communities will implement, and which were previously demonstrated as safe and effective. 
Thus, safety outcomes are not the driving issue for our monitoring assessments, and we do not 
expect to find adverse impacts of the HCS intervention. However, recognizing that the study will 

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collect data on opioid-related mortality and morbidity, the HCS will monitor adverse events 
(AEs) and serious adverse events (SAEs). It is very unlikely that opioid-related overdose events 
will be directly associated with the study; nevertheless, Wave 1 and Wave 2 communities will be 
monitored, and monthly reports of AEs and SAEs will be prepared and reviewed as described 
below. 
The primary outcome for the HCS is opioid-related overdose fatalities; however, accurate fatality 
data are not available in a timely manner (i.e., the data lag is 6 months or more). Therefore, 
monitoring of opioid-related overdose fatalities is not a feasible measure that is available rapidly 
and reliably. For the HCS, we will monitor emergency medical services (EMS) runs for 
suspected opioid-related overdoses where naloxone was administered. The four HCS Research 
Sites (RSs) already have access to EMS runs that could be requested monthly, with a 30–90-
day lag after the end of each month. The HCS will estimate the rate of suspected opioid-related 
overdose events by month in a community with the rate being the number of events per 1,000 
community members.72 In this manner, EMS runs provide the HCS with an early warning sign of 
an increase in opioid-related overdose events in HCS communities. 
To determine if there is a situation where AEs or SAEs might be related to the HCS, we will 
employ a two-step AE/SAE review process (Figure 10). Step one involves distinguishing 
whether the observed AE or SAE from monthly monitoring reports is a “safety signal”. If it is, 
then we will proceed with step two which involves assessing if the AE or SAE is related to the 
HCS. 
Figure 10: Two-Step AE/SAE Review Process 
 
 
We consider the following criteria when assessing if an AE or SAE is a safety signal:  
1) Has the community had a previous AE/SAE? This would depict some repeatable pattern 
within a community rather than one isolated event. 
2) Do AEs/SAEs repeat across adjacent months in a community? Two or more continuous 
months with an AE/SAE are more indicative of a building concern. 
3) Is the observed increase in the number of EMS runs for a month meaningful? In small 
communities with low counts of EMS runs per month (often with zero or one EMS run in 
a month), an increase of a few runs could result in an AE or SAE due to a small 12-

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131 
month running standard deviation. Therefore, we only want to flag instances with 
meaningfully large observed increases.  
4) Do several communities have AEs/SAEs in the same month? We are interested in 
whether there is a widely prevalent occurrence of AEs/SAEs.  
If one or more of these criteria are met for an AE or SAE, and it is thus deemed a safety signal, 
we will conduct a relatedness analysis which might include examining if there are non-HCS 
events within a community that might increase opioid related events, if there are state/national 
events or trends related to increased opioid related events, if HCS and non-HCS populations 
within each state differ in opioid related events, and if Wave 1 and Wave 2 communities within 
each state differ in opioid related events. This AE/SAE review process will allow the HCS to use 
a managed process to determine safety signals and relatedness to the HCS.  
8.3 
Adverse Events 
8.3.1 
Definition of Adverse Events and Serious Adverse Events 
The HCS will use EMS opioid-related overdose runs to monitor opioid-related overdose events 
as an AE and an SAE. These events provide important knowledge about the opioid crisis that 
the HCS should ethically investigate and report to the community coalitions involved, the 
National Institute on Drug Abuse (NIDA), the Substance Abuse and Mental Health Services 
Administration SAMHSA, the Institutional Review Board (IRB), and the Data and Safety 
Monitoring Board (DSMB). The HCS does not collect any data attributable to specific individuals 
who received services from the HCS intervention. Only aggregate date for an entire community 
will be available.  
● AEs will be identified by the following criterion: 
− 
The opioid-related overdose rate for a single month increases more than three 
standard deviations above the moving average of the previous 3 months. For 
example, the rate in a community for April 2020 is more than three standard 
deviations greater than the average rate for January, February, and March 2020. 
● SAEs will be identified by the following criterion: 
− 
The opioid-related overdose rate for a single month increases more than four 
standard deviations above the moving average of the previous 3 months. For 
example, the rate in a community for April 2020 is more than four standard 
deviations greater than the average rate for January, February, and March 2020. 
The standard deviation will be determined as the rolling standard deviation calculated from the 
12 months prior to the target month.  
Opioid-related overdoses are expected events in the HCS communities because, to be eligible 
for being selected into the HCS, NIDA required communities to being highly affected by the 
opioid epidemic with minimum numbers and rates per 100,000 of opioid-related overdose 
fatalities in 2016. 
We will follow a metric-based approach to help identify safety signals and evaluate relatedness 
to the HCS. Table 11 describes both the monthly and cross-month metrics that serve as triggers 

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for further analyses. If one of these events occurs, we will consider it a safety signal and will 
proceed with conducting a relatedness analysis. This analysis will help determine whether 
observed AE/SAEs are directly related to the HCS intervention and inform further action if 
necessary.  
Table 11: Metrics Used to Declare a Safety Signal in AE/SAE Review Process 
 
Monthly Metrics 
Cross-Month Metrics 
• 
5 Adverse Events 
• 
2 Serious Adverse Events 
• 
1 Serious Adverse Event + 3 
Adverse Events 
• 
Steering Committee Direction 
• 
DSMB Direction 
• 
3 Consecutive Adverse Events 
within the Same Community  
• 
Consecutive Adverse Event and 
Serious Adverse Event 
• 
Steering Committee Direction 
• 
DSMB Direction  
 
8.3.2 
Time Period and Frequency for Event Assessment and Follow-Up 
The RSs will provide monthly reports of the estimated number of opioid-related overdoses from 
the EMS runs in each of their communities to the Data Coordinating Center (DCC). These data 
will be available approximately by the end of the month after a target month for the Kentucky 
and Ohio sites, two months after a target month for the Massachusetts site, and on a quarterly 
schedule from the New York site. As part of the DCC’s regular processing of the data, AEs and 
SAEs will be determined within 9 days of the receipt of the monthly data from all communities to 
allow for data cleaning and validation to minimize erroneous AEs or SAEs. 
8.3.2.1 
Adverse Event Reports to the Steering Committee 
A monthly report of AEs will be sent to the Steering Committee (SC). This report will include all 
AEs that have occurred since the last report. The SC will review the report and determine what 
actions should be taken, including ongoing AE monitoring. 
8.3.2.2 
Adverse Event Reports to the DSMB, NIDA, and SAMHSA 
A monthly and semi-annual report of AEs will be sent to the DSMB, NIDA, and SAMHSA. This 
report will include all AEs that have occurred since the last report. The DSMB will recommend 
any additional actions it deems appropriate to the NIDA Director. 
8.3.2.3 
Serious Adverse Event Reports and Follow-Up 
Once an SAE is identified, the DCC will email a report to the SC, NIDA, and SAMHSA within 24 
hours. The SC will meet within 24 hours of notification to determine whether the SAE is related 
to the CTH intervention and assign it to one of three categories: 
1. 
Definitely related to the CTH intervention 

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3. 
Possibly related to the CTH intervention 
5. 
Unrelated to the CTH intervention 
Because the CTH intervention is directed toward community coalitions, it is unlikely that SAEs 
will be related to the CTH intervention. The DSMB will be notified within 24 hours of the SC 
determination. If the SC determines the SAE is related to the CTH intervention, the IRB will be 
notified within 24 hours. The IRB or the DSMB may request additional information or 
recommend actions for the SC to take. 
If the SC determines that follow-up action is needed, then the course of action will depend on 
whether the affected community is in Wave 1 or Wave 2. When a community is participating in 
the CTH intervention, it will incorporate this new information into the implementation of the CTH 
intervention (e.g., coalition members will be notified). When a community is not participating in 
the CTH intervention, it will be informed of the SAE and may elect to address the event without 
facilitation from the HCS team. 
8.4 
Unanticipated Problems 
8.4.1 
Definition of Unanticipated Problems 
This protocol uses the definition of unanticipated problems (UPs) as defined by the U.S. 
Department of Health and Human Services Office for Human Research Protections (OHRP). 
OHRP considers UPs involving risks to participants or others to include, in general, any incident, 
experience, or outcome that meets all the following criteria: 
● Unexpected in terms of nature, severity, or frequency given (1) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (2) the 
characteristics of the participant population being studied 
● Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the CTH intervention) 
● Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized 
8.4.2 
Unanticipated Problem Reporting 
The following steps will be used to review and report an UP: 
● The contact Principal Investigators at the RSs and the DCC will be responsible for 
identifying any event, incident, experience, or outcome that is a potential UP. 
● A potential UP will be discussed by the SC within 1 workday to determine whether it 
meets the criteria in Section 8.4.1, and it will be reported to the IRB (as needed), 
NIDA, SAMHSA, and the DSMB by the next workday. 
● The procedures in Section 8.4.1 will be followed to assess a potential UP and 
recommend any corrective actions that might be appropriate. 

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134 
● The SC will make the final determination of whether the event, incident, experience, 
or outcome is a UP or not. 
● The findings of the SC and the associated report will be submitted to NIDA, 
SAMHSA, the DSMB, and the IRB (if determined to be a UP). The report will include 
the following: 
− 
A detailed description of the event, incident, experience, or outcome 
− 
An explanation of the basis for determining that the event, incident, experience, 
or outcome represents an UP or not 
− 
A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP 
8.4.3 
Reporting Unanticipated Problems to HCS Communities 
The HCS Communications team, in conjunction with the HCS SC and the NIDA Office of 
Science Policy and Communications, will be responsible for reporting UPs or AEs. The steps 
will include the following: 
● Monitoring emerging issues 
● Assessing the potential for a situation to develop into a crisis 
● Identifying appropriate communications strategies and actions 
● Briefing spokespeople 
● Developing materials to respond to the situation 
● Engaging media and community channels as necessary and appropriate 
● Keeping partners and stakeholders informed of the situation 
● Evaluating responses and adjusting strategies as needed 
9. 
STATISTICAL CONSIDERATIONS 
9.1 
Statistical Hypotheses 
The HEALing Communities Study (HCS) has one primary hypothesis (H1) and three secondary 
hypotheses (H2, H3, H4). Compared with Wave 2 communities, we hypothesize the following: 
H1: Wave 1 communities will reduce opioid overdose deaths. 
H2: Wave 1 communities will increase naloxone distribution. 
H3: Wave 1 communities will expand utilization of buprenorphine for opioid use disorder. 
H4: Wave 1 communities will reduce high-risk opioid prescribing. 
9.2 
Sample Size Determination 
A total of 67 clusters or communities will be randomized and analyzed in an intention-to-treat 
(ITT) approach based on a negative binomial regression model, as described in Section 9.4.2. 
Detailed as follows, this study is designed to have >99% power to detect a 40% (i.e., relative 

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135 
risk 0.60) reduction in opioid overdose deaths between Wave 1 and Wave 2 communities during 
the 12-month period of the HCS multi-site, parallel arm, cluster randomized, wait-list controlled 
trial. Our calculations are based on a simulation study driven by pilot data from all 67 
communities, including actual community sizes and corresponding numbers of opioid overdose 
deaths. 
Our simulation study was conducted using 20,000 replications to ensure very small error in 
estimated powers (i.e., 95% confidence intervals corresponding to our calculated power are no 
wider than 0.011 for power ≥0.80). This simulation study is advantageous relative to a basic 
power calculation approach due to the ability to account for the high variation in community 
sizes, as well as its ability to adapt to the analytical approach (negative binomial regression 
model) that will be used. To conduct our study, actual data from these 67 communities were 
used to empirically drive our population assumptions. 
For each community, we took the average reported number of individuals in the given 
community and the average number of opioid overdose deaths. A negative binomial regression 
model was then fit to these data to extract estimates for the marginal parameters in the 
regression model, as well as the dispersion parameter, k, corresponding to between-community 
variation as expected in cluster trials. We note that this model did not include an intervention 
effect, because the pilot data are reflective of control conditions, and the desired intervention 
effect is dictated by the assumed risk reduction for which we calculate power. Furthermore, due 
to the unknown influence observed community-specific baseline opioid overdose death rates 
have on future rates, and more importantly, in order to provide conservative power calculations 
(greater power will potentially be achieved in our actual analysis via a reduction in unexplained 
variability due to the use of the observed baseline opioid overdose death rate as a covariate in 
the regression model), this variable was not included as a covariate in the regression model for 
the simulation study. In short, we obtained a value of 0.0431 for k, and with the resulting 
regression parameter estimates, marginal probabilities ranged from 0.000255 to 0.000436. 
To conduct our simulation study, we assume that these population parameters just described 
will be reflective of the true parameters for the wait-list comparison population at the time of the 
12-month parallel-arm trial period. The analyses were conducted as described in Section 9.4.2, 
with the exception that observed baseline opioid overdose death rate for the community was not 
incorporated into the model as a covariate, thus providing conservative power estimates. 
Table 12 provides power estimates for a variety of reductions in opioid overdose deaths for the 
Wave 1 and Wave 2 communities. As can be seen, we have greater than 99% power to detect a 
40% (i.e., relative risk 0.60) reduction and at least 83% power for any reduction of 20% or more. 
Table 12: Power calculation for underlying reduction in risk of opioid overdose fatalities between 
Wave 1 and Wave 2 communities 
Intervention Effect 
Relative Risk (Opioid 
Overdose Fatality) 
Power 
40% 
0.60 
0.999 
25% 
0.75 
0.961 
24% 
0.76 
0.943 
23% 
0.77 
0.925 

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Intervention Effect 
Relative Risk (Opioid 
Overdose Fatality) 
Power 
22% 
0.78 
0.899 
21% 
0.79 
0.866 
20% 
0.80 
0.832 
19% 
0.81 
0.792 
18% 
0.82 
0.748 
0% 
1.00 
0.075 
9.3 
Populations for Analyses 
Analyses of efficacy outcome measures and safety measures will be conducted using the ITT 
approach (i.e., including all randomized HCS communities according to their assigned group). 
9.4 
Statistical Analyses 
9.4.1 
General Approach 
The HCS is a multi-site, parallel arm, cluster randomized, wait-list controlled trial of 
Communities That HEAL (CTH). All statistical computations will be performed by HCS 
biostatisticians. For summaries of study data, categorical measures will be summarized in 
tables listing the frequency and the percentage of participating communities; continuous data 
will be summarized by presenting mean, standard deviation, median, 95% confidence intervals, 
and range; and ordinal data will be summarized by only presenting median and range. The 
balance or imbalance of these characteristics will be studied and reported, particularly for 
analyses comparing the two study groups. Graphical displays will be used to show distributions 
(box plots, density curves). The reported p-values will be based on two-sided tests at an α=0.05 
unless otherwise specified and statistical models will generally be adjusted for the covariates in 
the randomization. No adjustment will be made for multiple testing for the primary analyses 
given there is a single primary outcome being compared between two arms. For the analysis 
and modeling of the data, general methodological standards will be followed throughout, 
including proper handling of missing data, assessing model assumptions, incorporating 
appropriate covariates, and conducting sensitivity analysis to assess robustness of findings. For 
continuous outcomes, checks of normality will be performed and if required, transformations or 
non-parametric tests will be employed. Additional details for potential covariate adjustments in 
secondary analyses or handling violations of analytic method assumptions will be detailed in the 
statistical analysis plan. 
The analyses will be done using an ITT approach, including all randomized HCS communities 
according to assigned group. For the primary and secondary outcomes, every effort will be 
made to minimize missing data; however, in the event that missing data do exist, we will 
document the process that resulted in the missing data and consider model-based imputation 
methods to account for the missing data if needed.73 In short, guidelines for missing data in 
clinical trials prescribed by a National Research Council report,74 and guidelines for handling 

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missing data in cluster trials, will be followed. Additional details will be supplied in the statistical 
analysis plan. 
Baseline counts and rates of opioid overdose deaths in HCS communities, and other outcome 
measures needed for the statistical analysis, will be collected based on the 24 months 
preceding the study initiation, where available. Additionally, baseline counts and rates will be 
used for dashboard visualization measures, where available. Baseline data may be used in 
additional state-specific analyses, including geospatial analyses using address information (e.g., 
from death certificate data, including address of death and address of residence) where 
permitted by site’s state-specific data use agreements. 
9.4.2 
Analysis of the Primary Outcome 
The primary outcome is the number of opioid overdose deaths that occur in the 12-month 
evaluation period of the HCS multi-site, parallel arm, cluster randomized, wait-list controlled trial. 
The evaluation period is defined as the last year of the waiting period for Wave 2 communities. 
The number of opioid overdose deaths is an aggregate outcome assessed at the community 
level. The primary comparison of interest is between Wave 1 communities compared with the 
Wave 2 communities during the 12-month evaluation period. The analysis will assess the 
primary hypothesis (H1 in Section 9.1) that CTH intervention will reduce opioid overdose 
deaths. The primary analysis will use an ITT approach as described above. 
A marginal negative binomial regression model will be utilized to analyze the count outcomes. 
The model will include trial arm as the main independent variable. In addition, the model will 
control for the following covariates: the Research Site (RS) (i.e., Kentucky, Massachusetts, New 
York, or Ohio), the rural/urban status of the community, and the observed baseline opioid 
overdose death rate for the community. The reported natural log of the population size for each 
community will be utilized to offset the model, such that our proposed model is a model for the 
probability of an opioid overdose death in the population. The interpretation from the proposed 
model will therefore be with respect to changes in the population probabilities (i.e., risk ratios for 
opioid overdose death for Wave 1 vs. Wave 2 communities). We note that alternatively, the 
analysis can also be interpreted as a model for opioid overdose death rate per individual, 
evaluating changes in rates (i.e., rate ratios). RS, rural/urban status, baseline opioid overdose 
death rate, and population size are accounted for in the model in order to increase statistical 
power because each of these factors was included in the constrained randomization scheme. 
The previously described marginal negative binomial regression model will be fit utilizing PROC 
GLIMMIX in SAS (version 9.4 or higher). We note that GLIMMIX will utilize maximum likelihood 
theory to estimate parameters. However, in general, this procedure utilizes unbiased estimating 
equations for regression parameter estimation; therefore, quasi-likelihood theory or generalized 
estimating equation (GEE) theory applies. Specifically, we will utilize small-sample adjusted 
empirical standard error estimates and degrees of freedom equal to the number of communities 
minus the number of regression parameters. Furthermore, as a sensitivity analysis, a 
permutation test at the 0.05 significance level will be conducted with respect to the impact of the 
intervention. This test will be based on our implementation of constrained randomization. 

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9.4.3 
Analysis of the Secondary Outcomes 
As with the primary outcome, secondary and structural outcomes will be modeled using an ITT 
approach as described above. The models will include trial arm as the main independent 
variable and will control for the following covariates: the RS (i.e., Kentucky, Massachusetts, New 
York, or Ohio), the rural/urban status of the community, baseline opioid overdose death rate, 
and the observed baseline level of the particular secondary outcome for the community. The 
secondary outcomes related to H2–H4 in Section 9.1 are counts or rates; therefore, a marginal 
negative binomial regression model estimated using GEE will be utilized to analyze the count 
outcomes, as with the primary analysis. For those outcomes that involve a rate, the implied 
denominator in the county during the 12-month parallel-arm trial period will be utilized to offset 
the model, such that the outcome is interpreted as a rate, and differences between treatment 
assignments would be rate ratios. A model-based approach will be used for hypothesis testing, 
as described in the primary analysis. 
9.4.4 
Baseline Descriptive Statistics 
We will collect and describe the following baseline characteristics overall and by randomized 
group: demographics, community socio-economic characteristics, policy/behavioral 
characteristics, and baseline values of structural variables. As recommended in the CONSORT 
guideline,75 these characteristics will not be statistically tested for differences by randomized 
group. 
9.4.5 
Subgroup Analyses 
There are two planned subgroup analyses based on the categorical stratification factors in the 
covariate-constrained randomization: urban/rural and RS (i.e., Kentucky, Massachusetts, New 
York, or Ohio). Subgroup analyses will follow the same analysis plan as the primary and 
secondary analyses. However, to test for the subgroup effect, an interaction effect (e.g., 
subgroup identifier * trial arm condition) will be included. If this statistical test is not significant at 
the α=0.05 level, then there will be no further examination of the subgroup. If the statistical test 
is significant at α=0.05, then tests of significance of trial arm condition in each subgroup level 
will be examined, using an adjusted alpha level that accounts for the number of tests.75 Analytic 
approaches for additional subgroups or subgroups involving subsets of populations in 
communities will be conducted as described in Section 9.4.6. 
9.4.6 
Exploratory Analyses 
Subgroup analyses are planned (Section 9.4.5), but additional subgroup analyses by sex and 
race will also be conducted. This type of subgroup analysis subsets the population in 
communities and partitions the outcome into separate aggregate counts for each subgroup in a 
community. The statistical model will use GEE as described in primary and secondary analyses 
but will account for the additional nesting of subgroups in a community. Grouping or redefining 
subgroup identifiers may be necessary with small community-level counts. Therefore, these 
analyses will be considered exploratory. The statistical model will utilize the same general GEE 
approach as the primary and secondary analyses, utilizing a negative binomial distribution, 
including a population offset to estimate a rate, rather than a count. The initial test of subgroup 

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effect will examine the significance of the interaction of the subgroup indicator with the trial arm 
condition (see Section 9.4.5 for the conduct of subgroup analyses). 
For Steering Committee approved non-hypothesis driven analyses, the comparison group may 
either be Wave 2 communities and/or the rest-of-the-state (non-Wave 1 communities) 
dependent upon aims and the statistical analysis plan. The RSs have access to the rest-of-the-
state administrative data given approved security procedures, restricted access, and DUAs. In 
addition, the HCS has a full Health Insurance Portability and Accountability Act (HIPAA) waiver 
for use of secondary administrative data. The risk-benefits of using Wave 2 or the rest-of-the 
state administrative data as the comparison group is not changed.  
RSs and/or the DCC will conduct Steering Committee approved adjacent analyses. These 
analyses will utilize state-specific data and/or additional data collected from site-specific 
research activities (approved by the sIRB). These analyses will adhere to the same rigorous 
data security processes as those used for hypothesis driven analyses.  
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 Regulatory, Ethical, and Study Oversight Considerations 
10.1.1 
Informed Consent 
The cluster randomized trial design of the HEALing Communities Study (HCS) has structured 
the overall consent process in ways that significantly differ from a standard randomized 
controlled trial. It is important to note that the HCS is a study of the Communities That HEAL 
(CTH) intervention, the primary targets of which are 67 communities as a whole and their 
members. Data collected in the process of implementing the CTH intervention will involve 
surveys and qualitative interviews with state Community Advisory Board (CAB) and community 
coalition members and service venue staff. Data on community social and health outcomes will 
be gathered through administrative data rather than through direct interactions with members of 
the public. The study will not be collecting data directly from individuals receiving services. 
10.1.1.1 
Waiver of Consent for Secondary Data Review 
The HCS requested a waiver of informed consent and a full Health Insurance Portability and 
Accountability Act (HIPAA) waiver for use of secondary administrative data. Primary and 
secondary outcomes will primarily be measured using a retrospective review of secondary 
administrative data. Individuals whose health care data are included in the secondary 
administrative data sets will not be contacted at any time during the project. Given the time 
frame of the study and estimated population sizes of the HCS communities, secondary data will 
likely include millions of individual health records. The Institutional Review Board (IRB) granted 
a waiver of consent and a full waiver of HIPAA authorization for secondary data analysis. 
10.1.1.2 
Informed Consent Process 
Researchers will obtain consent from research participants before data collection. When 
collecting data during in-person interviews or focus groups, researchers will provide eligible 
subjects with a hard copy of the informed consent form and describe the study objectives and 

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what will be asked of them if they choose to participate. Enough time will be scheduled to allow 
them to read the informed consent form and to answer all questions. Participants will be given a 
copy of the consent form to keep that includes contact information for the local Principal 
Investigator (PI). Hard copy consent forms will be stored in a secured location. When data 
collection occurs via web interfaces (REDCap), researchers will contact individuals by email and 
direct them to an online form that explains the research, the consent process, and steps taken 
to ensure confidentiality. Individuals will then provide consent as instructed by the online 
process. Research will not begin until the participant completes the electronic informed consent 
form. If the participant is contacted by telephone or videoconference to complete an interview, 
researchers will administer a verbal consent using an approved script that provides all the key 
information about the study. When administering the verbal consent, study staff will record the 
respondent name, interviewer name, and interviewer signature on the consent form. Because 
study staff are working remotely due to the COVID pandemic and may not have access to a 
hard copy of the verbal consent, research sites have the option of programming these fields 
(respondent name, interviewer name, and interviewer signature) into REDCap. The data will be 
stored securely on the site-specific REDCap server, in the same manner as all REDCap data. 
The study staff’s signature is stored as an image file on the same server. The IRB also 
approved a waiver of documentation of consent; therefore, participant signatures will not be 
required for verbal or online consent. 
10.1.2 
Certificate of Confidentiality 
This research will be covered by a Certificate of Confidentiality from the National Institutes of 
Health (NIH). Researchers covered under this Certificate may not disclose personally 
identifiable information (PII) of any research participant in any federal, state, or local civil, 
criminal, administrative, legislative, or other action suit. Disclosure of this information is 
permitted only when: 
● required by federal, state, or local laws (e.g., as required by the Federal Food, Drug, 
and Cosmetic Act, or state laws requiring the reporting of communicable diseases to 
state and local health departments), excluding instances of disclosure in any federal, 
state, or local civil, criminal, administrative, legislative, or other proceeding; 
● necessary for the medical treatment of the individual to whom the information, 
document, or biospecimen pertains and made with the consent of such individual; 
● made with the consent of the individual to whom the information, document, or 
biospecimen pertains; or 
● made for the purposes of other scientific research that is compliant with applicable 
federal regulations governing the protection of human subjects in research. 
The Certificate does not cover requests for information from personnel of the U.S. federal or 
state government agency sponsoring the project that is needed for auditing or program 
evaluation by the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental 
Health Services Administration (SAMHSA). A Certificate of Confidentiality does not prevent an 
individual from voluntarily releasing information about himself or herself or his or her 
involvement in the research. 

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10.1.3 
Confidentiality and Privacy 
No data that contain identifiers will be shared with anyone outside of approved key personnel 
affiliated with the HCS. Research sites will assign a subject identification number to each 
participant and will securely transfer all raw data to the Data Coordinating Center (DCC). Every 
effort will be made to keep all research records confidential. Information will be combined with 
information from all study participants. Participants will not be identified in any study materials or 
reports. The results of this study may be published; however, results will be presented only in 
aggregate and will not allow for the identification of any individual participant. 
The research teams will make every effort to prevent anyone who is not on the research team 
from accessing any PII. For example, participants’ names will be kept separate from the 
information provided, and these two items will be stored in different places under lock and key. 
All hard copy research data will be kept in locked file cabinets; electronic data will be password 
protected and stored on secure servers. The RSs will assign a participant ID number to 
individual records and maintain the key linking PII with participant ID numbers in an encrypted 
and password-protected electronic file. Research data will be identified only by participant ID 
number. 
10.1.4 
Future Use of Stored Specimens and Data 
This study intends to store, use, and share data from surveys and interviews for future research. 
Having information collected from many people helps researchers identify trends and discover 
better ways to implement interventions to reduce opioid overdoses. Researchers will use the 
stored information to research additional scientific questions. The study will prepare a data 
sharing plan that is described in Section 10.1.10. 
10.1.5 
Key Roles and Study Governance 
The HCS Steering Committee (SC) comprises the PI, a state government official, and one CAB 
member from each of the four RSs, as well as project scientists from NIDA and SAMHSA, and a 
chairperson (Table 13). The responsibility of the SC is to give guidance and direction to the 
overall study design and execution. 
Table 13: Key roles and study governance 
DCC PIs 
Charles Knott, MPA 
RTI International 
3040 East Cornwallis Road 
Research Triangle Park, NC 27713 
919-541-6294 
cknott@rti.org  
 
Gary Zarkin, PhD 
RTI International 

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3040 East Cornwallis Road 
Research Triangle Park, NC 27713 
919-541-5858 
gaz@rti.org 
 
LaShawn Glasgow, DrPH, MPH 
RTI International 
2987 Clairmont Road NE 
Atlanta, GA 30329 
770-407-4913 
lglasgow@rti.org  
 
Kentucky PI 
Sharon Walsh, PhD 
University of Kentucky 
845 Angliana Avenue 
Lexington, KY 40508 
859-257-6485 
sharon.walsh@uky.edu  
Massachusetts PI 
Jeffrey H. Samet, MD, MA, MPH 
Boston Medical Center 
801 Massachusetts Avenue, 2nd Floor 
Boston, MA 02118 
617-414-7288 
jsamet@bu.edu  
 
New York PI 
Nabila El-Bassel, PhD 
Columbia University School of Social Work 
1255 Amsterdam Avenue 
New York, NY 10027 
212-851-2391 
ne5@columbia.edu  
 

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Ohio PI 
Bridget Freisthler, PhD 
The Ohio State University 
530 W. Spring Street, Suite 275 
Columbus, OH 43215 
614-292-2856 
freisthler.19@osu.edu  
NIDA Project Scientist 
Redonna Chandler, PhD 
National Institute on Drug Abuse 
6001 Executive Boulevard, Room 5265 
Rockville, MD 20892 
301-402-1919 
redonna.chandler@nih.gov 
 
SAMHSA Project Scientist 
Yngvild K. Olsen, MD, MPH  
Substance Abuse and Mental Health Services Administration 
5600 Fishers Lane 
Rockville, MD 20857 
240-276-0493 
yngvild.olsen@samhsa.hhs.gov 
Chairperson 
Scott Walters, PhD 
University of North Texas Health Science Center 
3500 Camp Bowie Boulevard, EAD 709K 
Fort Worth, TX 76107 
817-735-2365 
scott.walters@unthsc.edu  
 
10.1.6 
Safety Oversight 
Safety oversight will be monitored by the Data and Safety Monitoring Board (DSMB), which is 
composed of individuals with the appropriate expertise, including community-based research, 
implementation science, epidemiology, biostatistics, bioethics, and opioid use disorder. 
Members of the DSMB will be independent from the study conduct and free of conflicts of 

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interest. The DSMB will meet at least semi-annually to assess safety and efficacy data from 
each arm of the study. The DSMB will operate under an approved Data and Safety Monitoring 
Plan. The DSMB will provide its recommendations about trial safety to the NIDA Director, who 
will determine any actions to be taken on the recommendations. The DSMB members are as 
follows (see Table 14): 
Table 14: Data and Safety Monitoring Board members 
Name/Title/Organization 
Expertise 
DSMB 
Role 
Christine Grella, PhD 
Professor, Department of 
Psychiatry and Biobehavioral 
Sciences, David Geffen School 
of Medicine at University of 
California, Los Angeles 
Substance use disorder (SUD) treatment 
services, health services research, and 
longitudinal research on treatment utilization 
and outcomes 
Chair 
Celia Fisher, PhD 
Professor and Director, 
Fordham University Center for 
Ethics Education  
Ethical principles, racial/ethnic identity, 
cultural competence, and community-based 
participatory research 
Member 
Monica Taljaard, PhD 
Senior Scientist, Clinical 
Epidemiology Program, Ottawa 
Hospital Research Institute  
Biostatistics and epidemiology 
Member 
Vivian Go, PhD 
Associate Professor, University 
of North Carolina at Chapel Hill 
SUD treatment, implementation science, and 
opioid/human immunodeficiency virus 
(HIV)/hepatitis C virus research in rural 
communities 
Member 
Margarita Alegría, PhD 
Chief, Disparities Research Unit, 
Massachusetts General Hospital 
Implementation science, clinical trials, large 
multi-site studies, community-based 
participatory research, and qualitative 
methods 
Member 
 
10.1.7 
Quality Assurance and Quality Control 
Quality assurance (QA) and quality control (QC) are critical to ensure that data are generated, 
documented, and reported in compliance with the protocol, Good Clinical Practice (GCP), and 
all other regulatory requirements. QA is process oriented and includes planned, systematic 
reviews of procedures and standards used to manage and complete project deliverables. QA is 
prospective and intended to prevent mistakes and avoid problems. QC is product oriented and 
includes activities to ensure adherence to the protocol, GCP guidelines, and other regulatory 
requirements. QC occurs in real time and includes standards followed during the completion of 
project deliverables to ensure that work products are accurate and complete. 

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QA processes, QC standards, and the related roles and responsibilities of staff will be 
documented in the DCC and site-specific data management plans (DMPs) and standard 
operating procedures (SOPs). Specific QA procedures will include the following: 
● Reviewing training and certification of staff in GCP and use of data systems 
● Tracking study performance metrics 
● Conducting internal audits for compliance with DMPs and SOPs 
QC standards will be implemented and maintained according to SOPs that cover the following 
activities: 
● Development of the data collection forms and data dictionaries 
● Development of an electronic data capture system for measures collected by all sites 
that includes automated reporting and programmatic edit checks (range checks, 
logical inconsistencies, missing data) to identify potential errors at the point of entry 
● Thorough testing of the data capture system capabilities and functioning, and 
establishment of change control processes, issue tracking, and load testing 
● Development of the data management system following an approved software 
development life cycle in which requirements are specified, changes to code are 
controlled, defects are reported and resolved, and systems are tested throughout the 
life cycle 
● Review of secondary data (e.g., from state databases) to ensure accuracy and 
completeness 
10.1.8 
Data Handling and Record Keeping 
10.1.8.1 
Data Collection and Management Responsibilities 
Data Collection 
Data used for the HCS are derived from primary (de novo) and secondary data collection 
efforts. The RSs and the DCC will collect the study data. The DCC will establish an electronic 
data capture system (e.g., REDCap) that all RSs will use for primary data collection activities. 
The sites will also collect secondary administrative data from various state agencies (e.g., 
Medicaid, vital records). These data (both primary and secondary administrative data) may 
include identifiable and protected health information. The RSs will work with one another and 
the DCC to ensure that data collection procedures, QA, and QC are harmonized across the 
HCS. 
Data for the primary and most secondary study outcomes rely on administrative data, which will 
be requested directly from various state agencies in each of the RSs. Each RS will develop a 
study-specific data use agreement with state agencies, which will (1) ensure access to fully 
identified or limited-use data sets for site-specific analysis and development of a limited and de-
identified data set, and (2) allow sites to submit this limited data set to the DCC for the purpose 
of statistical analysis and dashboard visualization. Brief descriptions of the variables and 
operational definitions for the calculations of the study outcome measures are included in 
Appendix A. The data sets required for the calculation of each measure are listed in Table 1 and 
in Appendix A. The RS research teams will develop data security protocols that will ensure the 

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collection, storage, and transfer of fully identified and/or limited-use data sets. The DCC will 
develop a protocol for secure data collection, storage, and transfer for limited data sets that will 
be received from the sites. 
Data Management 
The DCC is responsible for developing and maintaining an informatics environment to host and 
control access to data sets collected by the sites and the DCC. This environment will include a 
secure SQL-based server with a web interface and technologies (e.g., secure file transfer 
protocol [SFTP], application programming interfaces, Secure Sockets Layer [SSL] encryption) 
supporting data ingestion from REDCap and the sites. The development of this environment will 
be guided by in-house SOPs and follow an applicable software development life cycle 
framework. 
The DCC will be responsible for performing active data management in the informatics 
environment to ensure the collection of high-quality data and support downstream activities 
including dashboard display, provision of quality metrics related to the quality management plan, 
and data analysis and sharing. The data management techniques, detailed in the DMP, will 
include automated and semi-automated programmatic data checks and production of data 
reports. As discrepancies are identified, the DCC will notify the sites of the need for corrective 
action. Audit trails will be retained for documentation purposes. 
The sites will be responsible for establishing local, secure, and approved informatics 
environments to store site-specific primary and secondary data, and for performing relevant 
data management activities and processes. Each site will work with the DCC to establish a 
secure method for transmission of data sets to the DCC. State-specific plans are as follows: 
● Kentucky: The Kentucky HCS team will provide a robust, secure, and user-friendly 
informatics platform to manage the data source flow and integration, data modeling 
and validation, data warehousing, and multiple reporting tools. These tools allow 
investigators to monitor and interact with project data, including generation of 
dashboards, reports, and query tools. We use enterprise class data warehousing 
software and tools including SQL Server, DataStage, and Tableau. The entire 
system will be housed in the University of Kentucky HealthCare Information 
Technology secure data center, which includes enterprise network firewalls, Dell 
SecureWorks Advanced Malware Protection and Detection service, and an annual 
risk assessment and security audit. Access to protected health information is 
supported through an encrypted access solution (e.g., virtual private network [VPN]) 
by qualified investigators with protected virtual machines to manage all sensitive 
data. (1) Data import. Data will be extracted, transformed, and imported into the 
Kentucky Health Data Trust staging area using validated SQL scripts and procedures 
to standardize the imports. (2) Data staging. Scripts will be developed to load the 
data files into the operational data store SQL Server database. A complete series of 
data validation and quality checks will be completed to finalize the production data 
and provide data quality monitoring and feedback. (3) Data repositories. Each 
specific intervention team will help develop implementation-specific use-case data 
marts to support implementation monitoring, evaluation, and analysis including the 
dissemination and sharing of results and data (in standardized formats) with 
community partners, NIDA, the DCC, the public, and the research community using a 

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suite of business analytics tools. The Kentucky HCS team will release to the DCC 
small counts normally subject to suppression rules for analysis purposes only, under 
the condition that they never be released publicly, including public-use versions of 
data. The release of Kentucky counts beyond the purpose of HCS statistical analysis 
(e.g., for publications, reports, dashboards) will follow the Kentucky data reporting 
policy and small count suppression rules as listed in the Kentucky HCS data use 
agreements with agencies’ data owners. 
● Massachusetts: The Massachusetts Department of Public Health has built 
substantial protections to prevent identification of individuals in the public health data 
set. Specifically, access to secondary individual-level data is restricted to only death 
information. For all other secondary state data, only summary statistics are provided, 
and information is suppressed if there is an insufficient number of individuals for a 
given query (between 1 and 10 individuals, variable dependent). Massachusetts 
study staff will obtain secondary state data, working in the virtual environment 
provided by the Massachusetts Department of Public Health. Primary data containing 
PII will be stored on virtual machines located in the premium secure environment of 
the Boston University Medical Campus Information Technology group. A 
Massachusetts informatics lead will provide usernames and passwords for 
authorized users to access the study data based on role. All PII will be encrypted on 
transfer using SSL encryption technology. 
● New York: Only de-identified aggregate-level data will be transferred to servers 
under control of Columbia University Information Technology from partners at the 
New York State Department of Health. Small counts normally subject to suppression 
rules will be released for analysis purposes only, under the condition that they never 
be released publicly, including public-use versions of data. De novo data collection 
will be stored in REDCap. Both of these types of data will be stored in Columbia 
Universities’ accounts using Google Cloud Platform and BigQuery, Google's 
serverless enterprise data warehouse. All data and metadata are stored in a multi-
redundant, AES256-encrypted data store and leverage Google Cloud Platform 
infrastructure to manage encryption keys. All data access is logged, and Google 
Cloud Platform uses industry-leading electronic and physical security controls. 
Permissions and access to data and metadata will be managed by the front-end 
discovery platform, Redivis.  
● Ohio: All data and analysis of protected health information from state agency sources 
will reside on and occur on the InnovateOhio Platform (IOP). The IOP is a secure 
government data environment administered and maintained by the Ohio Department 
of Administrative Services (DAS), the organization that provides all IT services for 
the state of Ohio. DAS will be responsible for obtaining and uploading data from all 
state agencies listed in the data use agreement, automating monthly refreshes, 
linking records across data sets, and de-identifying resulting records. Ohio state 
agencies will transfer raw identifiable data to the IOP through SFTP or a direct 
connection. DAS will link data across agencies and use a token system to generate 
unique ID numbers for each individual record. These individual-level de-identified 
data will be placed in a secured workspace on the IOP, behind a secured 
government firewall. HCS researchers will have access to this workspace through a 
secured virtual machine. Select study personnel will be issued government ID 

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numbers and passwords and be allowed to log in to the IOP workspace. No 
individual-level data will be hosted on Ohio State University servers. County 
aggregate, de-identified data will be transferred from the IOP to Ohio State University 
through SFTP. Small numbers, typically subject to suppression, will be released to 
Ohio State University and transferred to the DCC, but will not be released in public-
use data sets. Primary data collected through the REDCap system, and any de-
identified data transferred from the IOP, will be housed on the Ohio State University 
Wexner Medical Center internal network and protected by its enterprise firewall. 
Application servers and databases are kept physically separate to enhance security. 
All in-flight communication is secured by transport layer security under the SSL 
protocol. The databases will also be encrypted at rest to protect them from external 
attacks. Data accessibility will be controlled by an identity and access management 
service allowing only authorized users to view or process data. 
Secondary data received from state partners consist of de-identified or limited data sets. 
Secondary data will be transferred from each RS to the DCC and will be stripped of protected 
health information (PHI). Primary data collection will include PII of coalition members and 
associated surveys, qualitative interviews, and study documentation (e.g., meeting minutes). 
Data will be collected by each RS, and data sets containing primary data will be encrypted and 
transferred from each RS to the DCC. 
Each RS and the DCC has a data center that has physical security and enterprise class network 
firewalls, secure servers, encryption protocols, malware protection and detection services, role-
based security protocols, hardware redundancy, data backup policies, and user logging and 
auditing. Each data center undergoes an annual risk assessment and security audit to ensure 
compliance. Access to PHI is supported through an encrypted access solution (VPN) by 
qualified investigators with protected virtual machines to manage all sensitive data. 
The DCC has developed a secure environment and a data warehouse to store primary and 
secondary data that comply with FAIR (Findable, Accessible, Interoperable, Reusable) Guiding 
Principles and HIPAA. Specifically, collection of metadata will ensure that data and 
documentation are findable and that metadata, data, and documentation are accessible through 
the dashboard with links to data sources, documentation, and information of interest. Data will 
be stored in SQL format, and standard practice for assignment of common geographic 
identifiers (e.g., nested census-based geographies) and data model will be followed to facilitate 
interoperability. Metadata, data, and documentation will be reusable because data will be stored 
in native or raw format, and extract, transform, load logic and variable definitions for derived and 
analytic data sets will be available. 
All HCS investigators and staff who are involved in the design, conduct, oversight, or 
management of this clinical trial have been or will be trained in GCP. 
10.1.8.2 
Study Records Retention 
Data collected or transmitted to the DCC under this protocol will be maintained at the DCC for at 
least 3 years from the date of the last annual Federal Financial Report submission. 

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10.1.9 
Protocol Deviations 
This protocol defines a protocol deviation as any non-compliance with the clinical trial protocol 
or SOP requirements. The non-compliance may be on the part of the research participant, the 
PI, or the study site staff. As a result of deviations, corrective actions will be developed by the 
RSs and the DCC and implemented promptly. 
It will be RS investigator’s responsibility to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation. All deviations will be 
addressed in study source documents and reported to the NIDA Program Official and the SC. 
The DCC will send protocol deviations to the single IRB, Advarra, per its policies. The DCC is 
responsible for knowing and adhering to the IRB’s reporting requirements. Further details about 
the handling of protocol deviations will be included in the SOP. 
10.1.10 
Publication and Data Sharing Policy 
We plan to make study methods, data, and results available to scientists, health policy experts, 
and members of the public who are interested in reducing the burden of the opioid crisis. We will 
develop a data sharing plan that describes the process by which study publications and the 
underlying primary data will be made broadly available to the public. The data sharing plan will 
comply with the NIH HEAL InitiativeSM Public Access and Data Sharing Policy, the NIH Data 
Sharing Policy, and the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, 
and the NIH Clinical Trial Registration and Results Information Submission rule. As such, this 
trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. 
The data sharing plan will be implemented through five key steps. First, a data management 
plan will be developed to describe the final data documentation and archival considerations for 
study data. Second, best practices will be followed for creating, maintaining, and documenting 
study data to ensure preservation of accurate and usable data and metadata while protecting 
the privacy of study participants. Third, de-identified data (as specified in the data use 
agreements) and accompanying documentation will be made readily available to researchers for 
secondary analysis through a repository selected by NIDA, such as the NIDA-funded National 
Addiction & HIV Data Archive Program (NAHDAP). NAHDAP is hosted by the Inter-university 
Consortium for Political and Social Research, the largest social science data archive in the 
world and part of the University of Michigan's Institute for Social Research. Fourth, NIDA and 
SAMHSA will be given access to all data generated under this award, subject to rules specified 
in any Certificates of Confidentiality obtained by the RSs. Fifth, the DCC and the SC will develop 
a publication policy consistent with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH-funded research and is consistent with the following 
criteria: 
1. 
Within 4 weeks of acceptance by a journal, electronic copies of publications will be 
deposited to the digital archive PubMed Central with no embargo period and with 
proper tagging of metadata to ensure online discoverability and accessibility. 
2. 
Publications will be published under the Creative Commons Attribution 4.0 
International generic license (CC BY 4.0) or an equivalent license. 

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3. 
To the extent feasible, de-identified data will be made accessible simultaneously with 
the publication and through NAHDAP. 
The data sharing plan will follow NIH requirements for sharing data via the creation of public-use 
data sets and will apply established procedures to ensure that publicly released data satisfy all 
necessary requirements. A structured process will be followed to determine the risk of re-
identification of people included in public-use data sets based on guidance documents from the 
U.S. Department of Health and Human Services75 and HIPAA or related requirements for 
protecting participant identity. The risk of re-identification will also be quantitatively evaluated 
using accepted statistical methods.76,77 Study data deposited into a repository will be de-
identified or masked to minimize risks to study participant privacy. The following are examples 
of procedures typically followed to de-identify and mask the data: 
● Replacing site numbers with randomly generated site ID numbers 
● Replacing study ID numbers with randomly generated study ID numbers 
● Removing or recoding distinguishing parameters, such as dates or specific locations 
● Removing verbatim responses or sensitive variables 
● Combining subgroups with low frequencies or truncating distributions to ensure a 
minimum number of observations per category or variation within cells 
● Dropping categorical variables, combining levels, or otherwise modifying response 
categories with less than 5% prevalence or fewer than 10 observations 
● Dropping continuous variables with fewer than 10 observations 
We plan to share a variety of dissemination products that will emerge from this study including 
scientific manuscripts and conference presentations describing study methods, findings, content 
within and utility of supporting materials, and best practices. We plan to present results at 
national scientific meetings that focus on drug use, public health, and modeling methods (e.g., 
the Rx Drug Abuse & Heroin Summit, the College on Problems of Drug Dependence, and the 
Society for Medical Decision Making). Given the national attention and urgency of mitigating the 
opioid crisis, we aim to publish results in high-impact peer-reviewed medical (e.g., New England 
Journal of Medicine) and specialty (e.g., Drug and Alcohol Dependence, Health Affairs) journals. 
Publications resulting from this study will have authorship decided based on contribution to 
study design, conduct, analysis, and writing per HCS policy and journal guidelines. The HCS 
publication policy will follow the published policies of the International Committee of Medical 
Journal Editors and the appropriate use of federal disclaimer and acknowledgment of funding 
and disclosure statements. 
In addition to sharing study data and publications, the HCS modeling tool will be made freely 
available to the scientific community and policy makers through the Internet (e.g., 
www.opioidpolicysimulator.org). Per the guidelines from the Second Panel on Cost-
Effectiveness Analysis and the report on model transparency and validation by the Society for 
Medical Decision Making and the International Society for Pharmacoeconomics and Outcomes 
Research, we will present all modeling elements including technical details in future 
publications. Transparency will also be maintained, so key stakeholders can see how the model 
is built. 

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10.2 Abbreviations and Special Terms 
 
AE 
adverse event 
API 
application programming interface 
CAB 
Community Advisory Board 
CBPR 
community-based participatory research 
CDC 
Centers for Disease Control and Prevention 
CE 
community engagement 
CTC 
Communities That Care 
CTH 
Communities That HEAL 
DAS 
Department of Administrative Services (Ohio) 
DCC 
Data Coordinating Center 
DEA 
Drug Enforcement Administration 
DMP 
data management plan 
DSMB 
Data and Safety Monitoring Board 
DSMP 
data and safety monitoring plan 
DUA 
data use agreement 
EBP 
evidence-based practice 
ED 
emergency department 
EMS 
emergency medical services 
FDA 
U.S. Food and Drug Administration 
GCP 
Good Clinical Practice 
GEE 
general estimating equation 
GMB 
Group Model Building 
HCS 
HEALing Communities Study 
HCV 
hepatitis C virus 
HHS 
U.S. Department of Health and Human Services 
HIPAA 
Health Insurance Portability and Accountability Act of 1996  
HIV 
human immunodeficiency virus 

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ICD-10-CM  
International Statistical Classification of Diseases and Related 
Health Problems, 10th Revision, Clinical Modification 
ICF 
informed consent form 
ID 
Identification 
IOP 
InnovateOhio Platform 
IRB 
Institutional Review Board 
IS 
Information Systems 
ITT 
intention-to-treat 
KY-ASAP 
Kentucky Agency for Substance Abuse Policy  
LDS 
limited data set 
MME 
morphine milligram equivalent 
MOUD 
medication for opioid use disorder 
NAHDAP 
National Addiction & HIV Data Archive Program 
NEMSIS 
National Emergency Medical Services Information System 
NIDA 
National Institute on Drug Abuse 
NIH  
National Institutes of Health 
NSDUH 
National Survey on Drug Use and Health 
OBAT 
office-based addiction treatment 
OD 
Overdose 
OEND  
overdose education and naloxone distribution 
OHRP 
Office for Human Research Protections 
ORCCA 
Opioid-Overdose Reduction Continuum of Care Approach 
OTP 
opioid treatment program 
OUD 
opioid use disorder 
PI 
Principal Investigator 
PII 
personally identifiable information 
QA 
quality assurance 
QC 
quality control 
REDCap 
Research Electronic Data Capture 

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RS 
Research Site 
SAE 
serious adverse event 
SAMHSA 
Substance Abuse and Mental Health Services Administration 
SAP 
statistical analysis plan 
SC 
Steering Committee 
SFTP 
secure file transfer protocol 
SOP 
standard operating procedure 
SSL 
Secure Sockets Layer 
UP 
unanticipated problem 
 
10.3 Protocol Amendment History 
Protocol amendments will be recorded in Table 15, which is maintained by the DCC. 
Table 15: Protocol Amendment History 
Version 
Date 
Description of Change 
Brief Rationale 
1.1 
10-28-2019 
Landscape Analysis 
(LA) 1 revision 
Updated the LA 1 instrument 
1.2 
11-1-2019 
Protocol, informed 
consent form (ICF), 
instrument, and subject-
facing material updates 
Updated the protocol, the majority of the 
ICFs, and most of the instruments 
Submitted new instruments, associated 
ICFs, and subject-facing materials 
Moved and updated prior approved 
documents from Pro00037850 to 
Pro00038088 
1.3 
11-27-2019 
Protocol, ICF, 
instrument, and subject-
facing material updates 
Updated the protocol, ICFs, and 
instruments related to the HCS data 
collection in jails  
Updated the protocol and instruments 
related to the HCS fidelity measures 
1.4 
12-12-2019 
Protocol, ICF, and 
instrument updates 
Updated the protocol to reflect changes 
made to the health economics 
instruments and the LA 2 instrument 
revision 
Made minor revisions to related ICFs 
and created a new online ICF for the 
health economics instruments 

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Version 
Date 
Description of Change 
Brief Rationale 
Added information in Appendix D of the 
protocol about GetNaloxoneNow  
1.5 
1-10-2020 
Protocol, ICF, 
instrument, and subject-
facing material updates 
Updated the protocol: Appendices A and 
C 
Added information on new and revised 
instruments/ICFs and outcome 
measures 
Added information about the evaluation 
of the communication campaign 
Made minor revisions to the health 
economics section 
1.6 
3-6-2020 
Protocol, ICF, 
instrument, and subject 
facing material updates 
Light edits made throughout the protocol 
to fix formatting and grammatical errors 
Updates made to Section 6.1.1 (study 
intervention) 
Updates made to Section 6.2 (fidelity) 
Submitted new subject facing materials 
for the communications campaign 
Revisions made to the CEQ instrument 
and its associated ICFs 
1.7 
4-7-2020 
Protocol, ICF and 
instrument updates 
Edits made throughout the protocol to 
allow the DCC to receive PII/PHI from 
the research sites for de novo data 
Protocol updates made related to the 
HCS Jail Survey, changing data 
collection from every six months to 
annually 
Protocol updates made to remove 
information around Dynata, as the 
Consortium is no longer using Dynata to 
recruit participants for Campaign 
Evaluation Questionnaire 
Protocol updates made to remove the 
TA and Training Participant Evaluation 
Form as this instrument is not being 
used at this time 
Revisions made to the TTAT instrument 
Revisions made to 5 web modality ICFs 
1.8 
5-15-2020 
Protocol and subject 
facing material updates 
Protocol updates made to revise 
hypothesis 3; revisions made to section 

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Version 
Date 
Description of Change 
Brief Rationale 
3 (objectives and outcomes), section 9.3 
(statistical hypotheses), and Appendix A 
Protocol updates made to section 8.1 
(instruments), 8.2 (safety assessments), 
8.3 (adverse events), 8.4 (unanticipated 
problems) 
Submission of two new generic phone 
scripts 
Minor edits made to existing email 
templates/scripts 
1.9 
8-26-2020 
Protocol updates 
Protocol revisions made to section 3 
(objectives and outcomes), section 6 
(study interventions), section 9 
(statistical considerations) and Appendix 
A 
Added the MA Site-Specific Brandeis 
Payer Pre-Interview Survey & Interview 
Guide research activity to Appendix D 
Added the KY Site-Specific Academic 
Detailing and CECentral Online Modules 
research activity to Appendix D 
1.10 
10-20-2020 
Protocol updates 
Protocol revisions made to section 6 
(study interventions), section 8 
(instruments and procedures) and 
Appendix D. 
Added the KY Site-Specific MOUD 
Organization Interview Guide research 
activity to Appendix D. 
Added the NY Site-Specific Pharmacy 
Study Interview Guide & Survey 
research activity to Appendix D.  
1.11 
11-23-2020 
Protocol, instrument, 
and subject facing 
materials updates 
Protocol revisions made to section 6.3.2 
(recruitment procedures), section 8 
(instruments) and section 10.1.1.2 
(informed consent process). 
Revisions made to the Campaign 
Evaluation Questionnaire 
Submission of a MA site-specific 
recruitment flyer. 

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Version 
Date 
Description of Change 
Brief Rationale 
1.11 
01-14-2021 
Protocol updates 
Protocol revisions made throughout the 
protocol to capture study timeline 
changes.  
1.12 
04-05-2021 
Protocol, ICF, 
instrument, and subject 
facing material updates 
Protocol revisions made to section 6 
(study interventions), section 8 
(instruments and procedures), and 
Appendix D.  
Added the OH Site-Specific CE 
Facilitator Community Genogram Model 
research activity to Appendix D. 
Revisions made to the NY Site-Specific 
Pharmacy Study research activity in 
Appendix D. 
Submission of the OH Site-Specific 
Community Engagement Facilitator 
Community Assessment Tool. 
Submission of the HCS Community Data 
Dashboards Survey & Portal Group 
Interview Guide, and their associated 
verbal ICF and subject facing materials. 
1.13 
06-17-2021 
Protocol and instrument 
updates 
Protocol revisions made to section 6 
(study interventions), section 8 
(instruments and procedures), and 
Appendix D. 
Added the Policy Barriers and 
Facilitators research activity to Appendix 
D. 
Submission of the Policy Community 
Report and Policy Environmental Scan 
instruments. 
1.14 
11-08-2021 
Protocol updates 
Protocol revisions made throughout the 
protocol to capture Wave 2 study 
timeline changes, section 8 (instruments 
and procedures), and Appendix D. 
Added Costing the Evidence Based 
Practices to Appendix D. 
Added Identifying the Municipal Policies 
that Impact the Implementation of the 
EBP Strategies to Appendix D. 
1.15 
12-10-2021 
Protocol and instrument 
updates 
Protocol revisions made to section 6 
(study interventions), section 8 

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Version 
Date 
Description of Change 
Brief Rationale 
(instruments and procedures), and 
Appendix D. 
Added Photovoice Participatory 
Research Technique to Appendix D. 
Added Race and Ethnicity Data 
Collection Readiness Survey to 
Appendix D. 
Submission of new and revised data 
collection instruments. 
1.16 
4-14-2022 
Protocol and instrument 
updates 
Protocol revisions made throughout the 
protocol to capture Wave 2 research 
activities, section 6 (study interventions), 
section 8 (instruments and procedures), 
section 9 (statistical considerations), and 
Appendix D.  
Added PARTNER Tool research activity 
to Appendix D. 
Added Medication Disposal Program 
Pharmacy Interviews to Appendix D. 
Added Mobile Interventions for 
Increasing Access to Medications for 
Opioid Use Disorder to Appendix D.  
1.17 
11-7-2022 
Protocol and instrument 
updates 
Protocol revisions made to section 2 
(introduction), section 3 (objections and 
outcomes), section 6 (study 
interventions), section 8 (instruments 
and procedures), section 10 (supporting 
documentation and operational 
considerations), Appendix A and 
Appendix D.  
Added Cost Analysis of Peer Recovery 
Support Services research activity to 
Appendix D. 
Added Wave 1 Partner Organization 
Sustainability Interview research activity 
to Appendix D.  
1.18 
3-30-2023 
Protocol updates 
Protocol revisions made to the cover 
page and section 10 (supporting 
documentation and operational 
considerations).  

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Version 
Date 
Description of Change 
Brief Rationale 
1.19 
8-17-2023 
Protocol updates 
Protocol revisions were made to add 
secondary outcome 3.4 and update the 
OSU research site address in Table 13.   
1.20 
10-9-2023 
Protocol Updates 
Minor revisions made to section 6 (study 
interventions). 
1.21 
3-6-2024 
Protocol Updates 
Protocol updates were made to extend 
the study end date through March 2025 
in section 1 (protocol summary) and 
section 4 (study design).  
1.22 
3-12-2025 
Protocol Updates 
Protocol updates were made to extend 
the study end date through September 
2025 in section 1 (protocol summary) 
and section 4 (study design). Updates 
were also made to the DCC PI on the 
cover page and in Table 13 of section 10 
(supporting documentation and 
operational considerations).  
11. 
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12. 
APPENDICES 
12.1 Appendix A: Study Outcomes 
12.1.1 
Primary Outcomes  
1 Definition Number 
1 
2 Definition Name 
Number of opioid overdose deaths 
3 Population 
General population/all residents 
4 Data Sources 
The primary data source will be death certificate records. 
Additional data sources (e.g., medical examiner and/or 
coroner data) may be used to identify opioid involvement in 
certified drug overdose deaths when the death certificates do 
not list any specific drugs involved in the overdose death. 
Because of differences in the medicolegal death investigation 
systems across the jurisdictions, the data sources cannot be 
standardized, but the process for capturing opioid overdose 
deaths developed by each site or jurisdiction will ensure that 
high-quality measures for opioid overdose deaths will be 
captured consistently in each jurisdiction, allowing 
harmonization across the HEALing Communities Study (HCS) 
communities and sites. 
5 Other Available Data 
for Additional or State-
Specific Analyses  
Other data sources (e.g., medical examiner and coroner 
reports, post-mortem toxicology records, law enforcement 
reports) will be used to supplement death certificate records 
for identification of opioid contribution to drug overdose 
deaths when needed 
6 Primary Outcome 
Measure 
Number (count) of HCS community resident overdose deaths 
(i.e., deaths with an underlying cause of drug poisoning) 
where opioids were determined to be contributing (alone or in 
combination with other drugs) to the drug poisoning 
7 Population Size 
Adjustment 
The population size estimate for each HCS community will be 
the mid-year population estimate as of July 1 for the calendar 
year under surveillance. This population size estimate will be 
utilized in the primary analysis as an offset (for details, see 
the study protocol) 
8 Covariates 
The Hypothesis 1 (H1) analysis will control for the following 
community-level covariates: rural/urban classification, HCS 
site, and baseline rates of opioid overdose deaths in HCS 
communities (based on the 12 months preceding the study 
initiation) 

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9 Additional Analyses 
Stratified by intent of the death (unintentional, suicide, 
undetermined), gender (male, female), race (white, black, 
other), and drugs or drug classes contributing to the opioid 
overdose death (at minimum—heroin, fentanyl, 
methamphetamine, cocaine, stimulants, benzodiazepines) 
(drugs or drug classes are not mutually exclusive) 
 
12.1.2 
Secondary Outcomes  
1 Definition Number 
2.1 
2 Definition Name 
Number of drug overdose deaths 
3 Population 
General population/all residents 
4 Data Sources 
Death certificates 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses  
Variety of data sources (including death certificates and 
medical examiner and/or coroner data) allowing accurate and 
timely capturing of overdose deaths for HCS community 
residents and harmonization across the HCS sites 
6 Primary Outcome 
Measure 
Number of overdose deaths 
7 Population Size 
Adjustment 
The denominator would be the mid-year population for the 
county or local community 
8 Subgroups 
In addition to the count of all drug overdose deaths, we would 
like to examine the counts of death by various drug subtypes, 
including opioids, heroin, fentanyl, cocaine, psychostimulants, 
benzodiazepines, stimulants, and others, alone or in 
combination  
 
1 Definition Number 
2.2 
2 Definition Name 
Number of non-fatal drug overdose events 
3 Population 
General population/all residents 
4 Data Sources 
A combination of state hospital inpatient billing claims and 
emergency department (ED) billing claims  
5 Other Available Data 
for Additional or 
State-Specific 
Analyses  
Syndromic surveillance, emergency medical services (EMS), 
and Medicaid data may be a common source across states; 
Massachusetts and New York have all-payer claims data  
6 Primary Outcome 
Measure 
Hospital or ED discharge records for HCS residents with a 
discharge status different from death and codes in the 
International Statistical Classification of Diseases and Related 

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Health Problems, 10th Revision, Clinical Modification (ICD-10-
CM) for drug overdose in any discharge diagnosis field 
7 Population Size 
Adjustment 
Mid-year population estimate 
 
1 Definition Number 
2.3 
2 Definition Name 
Number of non-fatal opioid overdose events 
3 Population 
General population/all residents 
4 Data Sources 
A combination of state hospital inpatient billing claims and ED 
billing claims 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses  
Syndromic surveillance, EMS, and Medicaid data may be a 
common source across states; Massachusetts and New York 
have all-payer claims data  
6 Primary Outcome 
Measure 
Hospital or ED discharge records for HCS residents with a 
discharge status different from death and any ICD-10-CM 
codes for opioid-related overdose in any discharge diagnosis 
field   
7 Population Size 
Adjustment 
Mid-year population estimate 
 
1 Definition Number 
2.4 
2 Definition Name 
Number of individuals with OUD (prevalence) 
3 Population 
Medicaid beneficiaries  
4 Data Sources 
Medicaid claims 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses  
Massachusetts and New York have all-payer claims 
databases; Ohio will combine Medicaid claims with claims from 
the Ohio Department of Mental Health and Addiction Services 
(OhioMHAS), the New York Office of Alcoholism and 
Substance Abuse Services (OASAS), and the Massachusetts 
Bureau of Substance Addiction Services (BSAS) 
6 Primary Outcome 
Measure 
Individuals with a claim during the 12-month period coded with 
an ICD-10-CM diagnosis code of opioid use disorder  
7 Population Size 
Adjustment 
Number of Medicaid beneficiaries enrolled during the 12-month 
study period for full benefit  
 
1 Definition Number 
2.5.1 

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2 Definition Name 
Number of individuals receiving buprenorphine products that 
are approved by the Food and Drug Administration (FDA) for 
treatment of OUD 
3 Population 
General 
4 Data Sources 
Prescription drug monitoring program 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses  
Claims (Medicaid in Kentucky; all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York) 
6 Primary Outcome 
Measure 
Count of number of unique individuals receiving buprenorphine 
MOUD during the measurement period 
7 Population Size 
Adjustment 
Mid-year population in the county or local community 
8 Covariates  
The H3 analysis will control for the following community-level 
covariates: rural/urban classification, HCS site, and baseline 
rates  
 
1 Definition Number 
2.5.2 
2 Definition Name 
Number of individuals receiving methadone 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts 
6 Primary Outcome 
Measure 
Count of individuals receiving methadone as MOUD during the 
measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64, with OUD receiving MOUD during the measurement period 
 
1 Definition Number 
2.5.3 
2 Definition Name 
Number of individuals receiving naltrexone 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
All-payer claims (Massachusetts) 

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State-Specific 
Analyses 
6 Primary Outcome 
Measure 
Count of individuals receiving naltrexone as MOUD during the 
measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64, with OUD receiving MOUD during the measurement period 
 
1 Definition Number 
2.5.4 
2 Definition Name 
Number of individuals with OUD receiving MOUD 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
All-payer claims (Massachusetts and New York); Ohio can 
combine claims from Medicaid and OhioMHAS; OASAS in 
New York; BSAS in Massachusetts 
6 Primary Outcome 
Measure 
Count of HCS residents who are Medicaid enrollees aged 18–
64, with OUD receiving MOUD during the measurement period 
7 Population Size 
Adjustment 
Number of member-months enrolled during the 12-month study 
period for full-benefit Medicaid enrollees, aged 18–64, who 
were identified as individuals with OUD  
 
1 Definition Number 
2.6 
2 Definition Name 
Number of individuals with OUD receiving behavioral health 
treatment  
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or State-
Specific Analyses  
All-payer claims (Massachusetts and New York); Ohio can 
combine claims from Medicaid and OhioMHAS; OASAS in 
New York; BSAS in Massachusetts 
6 Primary Outcome 
Measure 
2.6.1: Number of individuals with OUD receiving behavioral 
health treatment (inpatient, ASAM levels 3,4) 
2.6.2: Number of individuals with OUD receiving behavioral 
health treatment (IOP, ASAM level 2) 
2.6.3: Number of individuals with OUD receiving behavioral 
health treatment (outpatient, ASAM level 1) 
2.6.4: Number of individuals with OUD receiving behavioral 
health treatment (any of ASAM levels 1–4) 

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2:6:5 Number of individuals with OUD receiving behavioral 
health treatment (any of ASAM levels 1–4) 
2.6.6: Number of individuals with OUD receiving behavioral 
health treatment (peer support) 
2.6.7: Number of individuals with OUD receiving behavioral 
health treatment (any of case management, peer support) 
2.6.8: Number of individuals with OUD receiving behavioral 
health treatment (screening) 
7 Population Size 
Adjustment 
Medicaid enrollees with a diagnosis of OUD and a claim for 
MOUD during the measurement period, recorded during any 
health service encounter (inpatient, outpatient, office visit, ED, 
etc.)  
 
1 Definition Number 
2.7.1 
2 Definition Name 
Number of individuals receiving buprenorphine/naloxone 
retained beyond 6 months 
3 Population 
General 
4 Data Sources 
Prescription drug monitoring programs 
5 Other Available Data 
for Additional or State-
Specific Analyses  
Claims (Medicaid in Kentucky; all-payer in Massachusetts and 
New York, Medicaid/OhioMHAS in Ohio; OASAS in New 
York) 
6 Primary Outcome 
Measure 
Individuals who maintained continual MOUD for 6 months in 
the measurement period. Continuous treatment is calculated 
based on days’ supply and dosage, and an individual can 
have a gap of no more than 7 days’ treatment to be 
considered in continual treatment.  
7 Population Size 
Adjustment 
Mid-year population in the county or local community 
 
1 Definition Number 
2.7.2 
2 Definition Name 
Number of individuals receiving methadone retained beyond 6 
months 
3 Population 
Medicaid beneficiaries  
4 Data Sources 
Medicaid beneficiaries  
5 Other Available Data 
for Additional or State-
Specific Analyses  
All-payer claims in Massachusetts and New York; Ohio can 
combine claims from Medicaid and OhioMHAS; BSAS in 
Massachusetts 

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6 Primary Outcome 
Measure 
Individuals who maintained continual methadone MOUD for 6 
months in the measurement period. Continuous treatment is 
calculated based on days’ supply and dosage, and an 
individual can have a gap of no more than 7 days’ treatment 
to be considered in continual treatment.  
7 Population Size 
Adjustment 
Medicaid enrollees with a diagnosis of OUD and a methadone 
claim during the first half of the measurement period—
allowing for a full 6 months of measurement to occur after the 
initial claim 
 
1 Definition Number 
2.7.3 
2 Definition Name 
Number of individuals receiving naltrexone retained beyond 6 
months 
3 Population 
Medicaid beneficiaries  
4 Data Sources 
Medicaid beneficiaries  
5 Other Available Data 
for Additional or State-
Specific Analyses 
All-payer data in Massachusetts 
6 Primary Outcome 
Measure 
Individuals who maintained continual naltrexone MOUD for 6 
months in the measurement period. Continuous treatment is 
calculated based on days’ supply and dosage, and an 
individual can have a gap of no more than 7 days’ treatment 
to be considered in continual treatment.  
7 Population Size 
Adjustment 
Medicaid enrollees with a diagnosis of OUD and a naltrexone 
claim during the first half of the measurement period—
allowing for a full 6 months of measurement to occur after the 
initial claim 
 
1 Definition Number 
2.7.4 
2 Definition Name 
Number of individuals with MOUD retained in treatment 
beyond 6 months 
3 Population 
Medicaid 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or State-
Specific Analyses 
All-payer claims in Massachusetts; BSAS in Massachusetts 
6 Primary Outcome 
Measure 
Individuals who, by (1) prescription MOUD, (2) office-
administered MOUD, or (3) a combination of both, maintained 
continual MOUD for 6 months in the measurement period. 

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Continuous treatment is calculated based on days’ supply and 
dosage, and an individual can have a gap of no more than 7 
days’ treatment to be considered in continual treatment.  
 
7 Population Size 
Adjustment 
Medicaid enrollees with an OUD diagnosis, an MOUD claim 
during the measurement period, and continuous eligibility for 
6 months after the first MOUD, concluding before the end of 
the measurement period 
 
1 Definition Number 
2.7.5  
2 Definition Name 
Person-months in MOUD  
3 Population 
Medicaid  
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or State-
Specific Analyses 
All-payer claims in Massachusetts; OASAS in New York, Ohio 
can combine claims from Medicaid and OhioMHAS; BSAS in 
Massachusetts 
6 Primary Outcome 
Measure 
Identify all individuals with an OUD diagnosis who received 
MOUD during the measurement period. 
For each individual, calculate the number of person-months 
during the measurement period that the individual maintained 
continuous MOUD by (1) prescription MOUD, (2) office-
administered MOUD, or (3) a combination of both. Continuous 
treatment is calculated based on days’ supply and dosage, 
and an individual can have a gap of no more than 7 days’ 
treatment to be considered in continual treatment. 
Outcome measure at the HCS community level is the total 
number of person-months in continuous MOUD. 
7 Population Size 
Adjustment 
Number of member-months enrolled during the 12-month 
study period for full-benefit Medicaid enrollees, aged 18–64, 
who were identified as individuals with OUD  
 
1 
Definition Number 
2.8.1 
2 
Definition Name 
Number of emergency medical services (EMS) naloxone 
administration events 
3 
Population 
An emergency-response patient-EMS encounter 
4 
Data Sources 
EMS run data, typically collected by the state’s board of EMS 
as part of national reporting to NEMSIS 
(https://nemsis.org/technical-resources/) 

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5 
Other Available Data 
for Additional or State-
Specific Analyses 
N/A 
6 
Primary Outcome 
Measure 
Number of EMS runs that involve naloxone administration 
7 
Population Size 
Adjustment 
Mid-year population estimate 
 
1 
Definition Number 
2.8.2 
2 
Definition Name 
Number of EMS runs for opioid-related incidents/overdoses 
3 
Population 
Any emergency-response patient-EMS encounter  
4 
Data Sources 
EMS run data, typically collected by the state’s board of EMS 
as part of national reporting to NEMSIS 
(https://nemsis.org/technical-resources/) 
5 
Other Available Data 
for Additional or State-
Specific Analyses 
N/A 
6 
Primary Outcome 
Measure 
Number of EMS runs for opioid-related incidents or overdoses 
 
7 
Population Size 
Adjustment 
Mid-year population estimate 
 
1 
Definition Number 
2.9 
2 
Definition Name 
Number of individuals linked to MOUD after opioid overdose 
3 
Population 
Medicaid beneficiaries 
4 
Data Sources 
Medicaid claims 
5 
Other Available Data 
for Additional or 
State-Specific 
Analyses 
All-payer claims in Massachusetts and New York; Ohio can 
combine claims from Medicaid and OhioMHAS; BSAS in 
Massachusetts; prescription drug monitoring programs; EMS 
and hospital discharge data for Massachusetts 
6 
Primary Outcome 
Measure 
2.9.1.: Count of individuals with ≥1 claim for naltrexone, 
methadone maintenance treatment, or buprenorphine within 
30 days of ED or inpatient discharge 
2.9.2: Count of overdose events with ≥1 claim for naltrexone, 
methadone maintenance treatment, or buprenorphine within 
30 days of ED or inpatient discharge 

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7 
Population Size 
Adjustment 
2.9.1: Number of full-benefit Medicaid enrollees with an opioid 
overdose 
2.9.2: Total number of opioid overdose events among full-
benefit Medicaid enrollees 
 
1 
Definition Number 
2.10 
2 
Definition Name 
Number of individuals linked to MOUD after release from 
prison 
3 
Population 
Imprisoned inmates released to HCS communities 
4 
Data Sources 
State departments of corrections linked to Medicaid claims 
5 
Other Available Data 
for Additional or State-
Specific Analyses 
Departments of corrections data linked to all-payer claims, 
where available; OASAS in New York; BSAS in 
Massachusetts; prescription drug monitoring program in 
Massachusetts 
6 
Primary Outcome 
Measure 
Number of individuals who reside in HCS communities who 
receive a first dose of MOUD within 2 and 4 weeks of release 
from prison as identified by Medicaid claims 
7 
Population Size 
Adjustment 
Imprisoned inmates released to HCS communities 
 
1 
Definition Number 
2.11 
2 
Definition Name 
Number of individuals provided MOUD while in jail  
3 
Population 
Jailed (pre-trial and sentenced) inmates at jails associated 
with each HCS community (if more than one, limit to top three 
jails)  
4 
Data Sources 
Survey of jails associated with each HCS community 
5 
Other Available Data 
for Additional or State-
Specific Analyses 
Linkage of Massachusetts jail releases to the prescription 
drug monitoring program in Massachusetts; all-payer claims 
data and BSAS data 
6 
Primary Outcome 
Measure 
Number of individuals who received MOUD in community jails 
7 
Population Size 
Adjustment 
Number of individuals were offenders in community jails 
 

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1 
Definition Number 
2.12 
2 
Definition Name 
Number of individuals linked to MOUD after an opioid-related 
ED visit 
3 
Population 
Medicaid beneficiaries 
4 
Data Sources 
Medicaid claims 
5 
Other Available Data 
for Additional or 
State-Specific 
Analyses 
All-payer claims in Massachusetts and New York; Ohio can 
combine claims from Medicaid and OhioMHAS; hospital/ED 
discharge data from Massachusetts; prescription drug 
monitoring data from Massachusetts; BSAS data from 
Massachusetts 
6 
Primary Outcome 
Measure 
≥1 claim for naltrexone, methadone maintenance treatment, 
or buprenorphine within 30 days of ED or inpatient discharge 
7 
Population Size 
Adjustment 
Medicaid beneficiaries with an opioid-related ED visit during 
the relevant study period 
 
1 Definition Number 
2.13 
2 Definition Name 
Incidents of high-risk opioid prescribing 
3 Population 
All residents 
4 Data Sources 
Prescription drug monitoring program data  
5 Other Available Data 
for Additional or State-
Specific Analyses 
Claims (Medicaid in Kentucky; all-payer in Massachusetts and 
New York; combined Medicaid/OhioMHAS in Ohio) 
6 Primary Outcome 
Measure 
Count of individuals with one or more of the following during 
the 12-month study period, and not in a prior specified time 
window (3 months): 
Risk of continued opioid use (new opioid episode lasting at 
least 31 days) 
Initiating opioid treatment with an extended-release or long-
acting opioid 
Incident high dosage (average ≥90 mg morphine per day) 
Incident overlapping opioid and benzodiazepine for ≥30 days 
(Measures A–D will be tracked separately and aggregated for 
the H4 analysis to a total count of unique individuals during 
the 12-month measurement period) 
7 Population Size 
Adjustment 
The population size estimate for each HCS community will be 
the mid-year population estimate as of July 1 for the year 
under surveillance  

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8 Covariates 
The H4 analysis will control for the following community-level 
covariates: rural/urban classification, HCS site, and baseline 
rates  
 
1 Definition Number 
2.14.3 
2 Definition Name 
Number of naloxone units distributed in communities 
3 Population 
General residents in HCS communities 
4 Data Sources 
Data sources include state administrative sources, HCS study 
records and pharmacy sales  
1. Data from the office in each state’s department of health or 
contracting agency that distributes naloxone to groups for 
community distribution (exclusive of pharmacies) and data 
from HCS for any naloxone distributed by the study  
2. Naloxone dispensed by pharmacies will be obtained from 
the IQVIA pharmacy database Xponent® for all sites   
5 Other Available Data 
for Additional or State-
Specific Analyses 
Massachusetts can expand the measure by using all-payer 
claims data. Medicaid may be a source in other states. 
6 Primary Outcome 
Measure 
Count of naloxone units distributed in the HCS communities 
during the measurement period as captured by the following 
submeasures:  
2.14.1.: Count of naloxone units distributed by the state health 
agency (secondary data from state health agencies) 
and HCS study logs for naloxone distributed by the 
study. 
2.14.2.: Count of dispensed naloxone units from pharmacies 
(IQVIA Dispensed Prescription Data) 
2.14.3.: This is the sum of 2.14.1 and 2.14.2  
7 Population Size 
Adjustment 
The population size estimate for each HCS community will be 
the mid-year population estimate as of July 1 for the year 
under surveillance  
8 Covariates 
The H2 analysis will control for the following community-level 
covariates: rural/urban classification, HCS site, and baseline 
rates  
 
1 
Definition Number 
2.15 
2 
Definition Name 
Number of individuals with OUD who are screened, 
diagnosed, and treated for hepatitis C 
3 
Population 
Medicaid beneficiaries residing in HCS communities 

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4 
Data Sources 
Medicaid administrative data 
5 
Other Available Data 
for Additional or State-
Specific Analyses 
All-payer claims in Massachusetts 
6 
Primary Outcome 
Measure 
Count of HCS residents who are Medicaid enrollees with OUD 
who are screened, diagnosed, and treated for hepatitis C 
7 
Population Size 
Adjustment 
Medicaid beneficiaries during the time period 
 
 
 
Definition Number 
2.17 
2 
Definition Name 
Number of opioid-related overdoses treated in EDs and 
captured by syndromic surveillance data 
3 
Population 
This is a population measure and would refer to the count in 
the local community; thus, all demographic groups would be 
included 
4 
Data Sources 
Syndromic surveillance records (accessed via CDC’s NSSP-
ESSENCE application or other state-based platforms) 
5 
Other Available Data 
for Additional or State-
Specific Analyses 
N/A 
6 
Primary Outcome 
Measure 
Number of opioid-related overdoses treated in EDs in the 
HCS community  
1 Definition Number 
2.16 
2 Definition Name 
Number of newly diagnosed HIV cases 
3 Population 
All residents 
4 Data Sources 
State-specific registry for HIV/AIDS reporting; funding 
provided by CDC to state health departments for surveillance 
(http://www.cdc.gov/hiv/library/reports/surveillance/) 
5 Other Available Data 
for Additional or State-
Specific Analyses 
Medicaid claims data 
6 Primary Outcome 
Measure 
Count of newly diagnosed cases of HIV 
7 Population Size 
Adjustment 
The population size estimate for each HCS community will be 
the mid-year population estimate as of July 1 for the year 
under surveillance  

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7 
Population Size 
Adjustment 
Mid-year population estimates 
 
1 Definition Number 
2.18 
2 Definition Name 
Number of new acute opioid prescriptions limited to a 7-day 
supply 
3 Population 
All residents 
4 Data Sources 
Prescription drug monitoring program; census data for 
population estimates 
5 Other Available Data 
for Additional or State-
Specific Analyses 
Claims (Medicaid in Kentucky and Ohio; all-payer in 
Massachusetts and New York—these are inferior to 
Prescription Monitoring Program (PMP) because they lack 
cash payments but would allow for removal of patients with 
cancer or on hospice care) 
6 Primary Outcome 
Measure 
Count of individuals with a new opioid prescription (45-day 
washout period preceding opioid prescription with no opioids) 
with a supply for ≤7 days 
7 Population Size 
Adjustment 
The population size estimate for each HCS community will be 
the mid-year population estimate as of July 1 for the year 
under surveillance  
 
12.1.3 
Structural Outcomes  
1 Definition Number 
3.1 
2 Definition Name 
Opioid prescriptions from multiple prescribers or pharmacies 
3 Data Sources 
Prescription drug monitoring program; CDC standards for 
MME; census data for population estimates 
4 Other Available Data 
for Additional or State-
Specific Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, Ohio can combine Medicaid and OhioMHAS 
data)—these are inferior to PMP because they lack cash 
payments) 
5 Primary Outcome 
Measure 
Count of individuals with an opioid prescription from ≥4 
providers or ≥4 pharmacies in a quarter  
6 Population Size 
Adjustment 
Mid-year population estimate 
 
1 Definition Number 
3.2 

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2 Definition Name 
Number of providers with a waiver under the Drug Addiction 
Treatment Act of 2000 (DATA 2000) 
3 Data Sources 
Drug Enforcement Administration’s Active Controlled 
Substances Act (CSA) Registrants Database, which lists all 
provider types that meet the requirements to prescribe 
buprenorphine for the treatment of OUD; requires a 
purchased subscription from the National Technical 
Information Service (NTIS) 
(https://classic.ntis.gov/products/dea/) 
4 Other Available Data 
for Additional or State-
Specific Analyses 
N/A 
5 Primary Outcome 
Measure 
Using information from the DEA’s Active CSA Registrants 
Database, calculate the total number of buprenorphine for 
OUD treatment providers: (1) civilian physicians, (2) civilian 
nurse practitioners, and (3) civilian physician assistants 
6 Population Size 
Adjustment 
Mid-year population estimates 
7 Strata 
Measures will be stratified by level of prescribing 
 
1 Definition Number 
3.3 
2 Definition Name 
Number of providers with a DATA 2000 waiver who actively 
prescribe buprenorphine products that are FDA approved for 
OUD  
3 Data Sources 
The calculation of this measure will require linkage between 
the DEA Active CSA Registrants Database and the state 
prescription drug monitoring program records to identify 
waivered prescribers from the HCS communities and their 
volume of prescriptions for buprenorphine products approved 
by FDA for the treatment of OUD. 
Drug Enforcement Administration’s Active Controlled 
Substances Act (CSA) Registrants Database, which lists all 
physicians who meet the requirements to prescribe 
buprenorphine for the treatment of OUD; requires a 
purchased subscription from NTIS 
(https://classic.ntis.gov/products/dea/) state prescription drug 
monitoring program records  
4 Other Available Data 
for Additional or State-
Specific Analyses 
N/A 

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5 Primary Outcome 
Measure 
Using information from the DEA’s Active CSA Registrants 
Database, identify waivered prescribers (see measure 3.2) 
from the HCS communities and their allowed capacity 
(number of patients that they can treat at a given point) 
Using the state prescription drug monitoring program records, 
for each prescriber in step 1, identify the unique patients who 
had at least one dispensed prescription issued by this 
prescriber for an FDA-approved buprenorphine product for 
treatment of OUD during the period under surveillance. 
Calculate the total number of prescribers who prescribed 
buprenorphine to at least one patient 
6 Population Size 
Adjustment 
The denominator would be the “number of providers with a 
DATA 2000 waiver” (measure 3.2) 
7 Strata 
Measures will be stratified by level of prescribing 
 
1 Definition Number 
3.4 
2 Definition Name 
Number of providers who actively prescribe buprenorphine 
products that are FDA approved for OUD  
3 Data Sources 
Prescription Drug Monitoring Program (PDMP) data 
4 Other Available Data 
for Additional or State-
Specific Analyses 
None  
5 Primary Outcome 
Measure 
Number of dispensed prescriptions with National Drug Code 
(NDC) for buprenorphine products that are approved by the 
FDA for the treatment of OUD.  
  
 
1 Definition Number 
3.5 
2 Definition Name 
Number of jails initiating and linking people to MOUD  
3 Data Sources 
De novo 
4 Other Available Data 
for Additional or State-
Specific Analyses 
None  
5 Primary Outcome 
Measure 
1. Number of jails associated with HCS communities that 
initiate buprenorphine/methadone/Vivitrol for inmates 
before release 
2. Number of jails associated with HCS communities that link 
people to MOUD treatment after release 
3. Number of jails that provide naloxone to people upon 
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1 Definition Number 
3.8 
2 Definition Name 
Number of take-back drug drop boxes  
3 Data Sources 
All states will use DEA records to get the number of current 
drop boxes.  
4 Other Available Data 
for Additional State-
Specific Analyses 
None 
5 Primary Outcome 
Measure 
Count of drug take-back boxes in HCS Communities 
 
1 Definition Number 
4.1.1 
2 Definition Name 
Number of ED visits for BH (count visits) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of unique emergency department (ED) visits 
with a behavioral health (BH) diagnosis code in the 
measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.1.2 
2 Definition Name 
Number of ED visits for non-BH (count visits) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of unique emergency department visits that 
do not have a behavioral health diagnosis code in the 
measurement period 

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7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.2.1 
2 Definition Name 
Number of hospital/inpatient nights for non-detox BH (count 
nights) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of inpatient nights with a behavioral health 
diagnosis code, excluding inpatient stays with a detox revenue 
or procedure code, in the measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.2.2 
2 Definition Name 
Number of hospital/inpatient nights for detox (count nights) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of detox inpatient nights in the measurement 
period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.2.3 
2 Definition Name 
Number of hospital/inpatient nights for non-BH (count nights) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 

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5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of inpatient nights that are NOT behavioral 
health in nature in the measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.3.1 
2 Definition Name 
Number of non-detox BH residential nights (count nights) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of residential non-detox nights, excluding 
the number of detox nights, in the measurement period; 
residential services by nature are assumed to be behavioral 
health related 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.3.2 
2 Definition Name 
Number of BH detox residential nights (count nights) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of residential detox nights in the 
measurement period; residential services by nature are 
assumed to be behavioral health related 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 

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1 Definition Number 
4.4.1  
2 Definition Name 
Number of intensive BH outpatient visits (count nights) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of intensive outpatient visits in the 
measurement period; intensive outpatient visits by nature are 
assumed to be behavioral health related 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.5.1 
2 Definition Name 
Number of outpatient visits BH (count visits) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of outpatient visits with a behavioral health 
diagnosis code in the measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.5.2 
2 Definition Name 
Number of outpatient visits non-BH (count visits) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 

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6 Primary Outcome 
Measure 
Count the number of outpatient visits that do NOT have a 
behavioral health diagnosis code in the measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.6.1 
2 Definition Name 
Number of non-pain buprenorphine days supplied (count days   
supply) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of days supplied of non-pain oral 
buprenorphine in the measurement period; this will come from 
two datasets: prescription drug claims and outpatient claims 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.6.2 
2 Definition Name 
Number of non-pain buprenorphine injections (count injections) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of non-pain buprenorphine injections in the 
measurement period; this will come from two datasets: 
outpatient claims and prescription drug claims. 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.6.3 

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2 Definition Name 
Number of opioid-related oral naltrexone days supplied (count 
days supply) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of prescription days supplied that are opioid 
related oral naltrexone fills in the measurement period; the 
population in the denominator for this measure requires 
evidence (i.e., a diagnosis) of an OUD in the measurement 
period or in the past 12 months 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.6.4 
2 Definition Name 
Number of opioid-related naltrexone injections (count 
injections) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of opioid related naltrexone injections in the 
measurement period; this will come from two datasets: 
outpatient claims and prescription drug claims. The population 
in the denominator for this measure requires evidence (i.e., a 
diagnosis) of an OUD in the measurement period or in the past 
12 months. 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.6.5 
2 Definition Name 
Number of methadone days supplied (count calculated days 
supply) 
3 Population 
Medicaid beneficiaries 

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4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts 
6 Primary Outcome 
Measure 
Count the number of days that methadone has been supplied 
in the measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.7.1 
2 Definition Name 
Number of opioid pain medication days supplied (count days 
supply) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts 
6 Primary Outcome 
Measure 
Count the number of prescription days supplied that are opioid 
pain medication fills in the measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 
 
1 Definition Number 
4.7.2 
2 Definition Name 
Number of non-opioid pain medication days supplied (count 
days supply) 
3 Population 
Medicaid beneficiaries 
4 Data Sources 
Medicaid administrative data 
5 Other Available Data 
for Additional or 
State-Specific 
Analyses 
Claims (Medicaid in Kentucky, all-payer in Massachusetts and 
New York, combined Medicaid and OhioMHAS in Ohio; 
OASAS in New York; BSAS in Massachusetts) 
6 Primary Outcome 
Measure 
Count the number of prescription days supplied that are non-
opioid pain medication fills in the measurement period 
7 Population Size 
Adjustment 
Count of HCS residents who are Medicaid enrollees aged 18–
64 who are non-dual eligible during the measurement period 

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12.2 Appendix B: Health Message Testing Service Questions—Centers for 
Disease Control and Prevention  
 
Core Questions 
(Questions can be used for Central Location Intercept Interviews, Telephone Interviews, 
Individual In-depth Interviews [Cognitive Interviews], Focus Group Screeners, and Focus 
Groups. 
Comprehension 
1d. 
What is the main idea that this message is trying to get across, in your own 
words? 
 
2d. 
How well do you think the main ideas come across?  
 
3d. 
Is it trying to get people to do something? 
• 
What action would the message prompt you to take? 
 
4d. 
Were there any words that were unusual or unfamiliar? 
 
5d. 
What other words can be used in their place? What would you say is the main 
idea or ideas they are trying to convey here? 
 
6d. 
Is there anything confusing, unclear, or hard to understand? 
Impressions 
7d. 
How would you sum up in just a few words your first impression of this 
message? Do you like it? Not like it? What makes you say that? 
 
8d. 
What feelings do you have in reaction to this message? Anything positive? 
Anything negative? 
 
9d. 
Was your reaction to this positive or negative? 
• 
What positive images do you associate with “[INSERT 
message/phrase]?” 

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• 
What negative images do you associate with “[INSERT 
message/phrase]”? 
 
10d. 
Is this an appealing message?  
• 
What makes the message appealing or unappealing? 
 
11d. 
How does it make you feel? 
 
12d. 
Was this a new idea or something that you’ve heard before? 
 
13d. 
Do you strongly agree with any part of this message? If so, what?  
 
14d. 
Do you strongly disagree with anything in this message? If so, what? 
 
15d. 
Is this message believable or not? Why or why not?  
 
16d. 
Is this message believable? GRID FORMAT, ROTATE LIST AS RELEVANT. 
(MESSAGES TO BE INSERTED BASED ON SPOTS. 
• 
Yes 
• 
No 
 
A. 
INSERT message 1 from Ad 
B. 
INSERT message 2 from Ad 
C. 
INSERT message 3 from Ad 
D. 
INSERT message 4 from Ad 
 
17d. 
What additional information would you need in order to more strongly believe 
this message? 
 
18d. 
Are any of the five advertisements memorable?  
• 
Yes 

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• 
No 
 
19d. 
Please rank these five advertisements by placing a 1 by the ad you felt was 
the most memorable, a 2 by your second-most memorable, etc. RANKING 
QUESTION UP TO TOP 5, FORCE EXACTLY ONE RESPONSE FOR EACH 
OF 1 THROUGH 5. ROTATE 1-5. 
 
1. 
PICTURE/DESCRIPTION OF FIRST SPOT VIEWED 
2. 
PICTURE/DESCRIPTION OF SECOND SPOT VIEWED 
3. 
PICTURE/DESCRIPTION OF THIRD SPOT VIEWED 
4. 
PICTURE/DESCRIPTION OF FOURTH SPOT VIEWED 
5. 
PICTURE/DESCRIPTION OF FIFTH SPOT VIEWED 
 
20d. 
Do you think you will talk about any of these ads with others? 
• 
Yes 
• 
No 
 
21d. 
Please rank these five advertisements by placing a 1 by the ad you felt you 
are more likely to talk about with others, a 2 by your second-most likely to talk 
about, etc. RANKING QUESTION UP TO TOP 5, FORCE EXACTLY ONE 
RESPONSE FOR EACH OF 1 THROUGH 5. ROTATE 1-5. 
 
1. PICTURE/DESCRIPTION OF FIRST SPOT VIEWED 
2. PICTURE/DESCRIPTION OF SECOND SPOT VIEWED 
3. PICTURE/DESCRIPTION OF THIRD SPOT VIEWED 
4. PICTURE/DESCRIPTION OF FOURTH SPOT VIEWED 
5. PICTURE/DESCRIPTION OF FIFTH SPOT VIEWED 
 
22d. 
Did you think any of these ads was effective to motivate you or someone else 
to [INSERT health behavior/message/phrase]? 
• 
Yes 
• 
No 

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23d. 
Please rank these five advertisements by placing a 1 by the ad you felt was 
the most effective in motivating you or someone else to [INSERT health 
behavior/message/phrase], a 2 by the second-most effective in motivating you 
to [INSERT health behavior/message/phrase], etc. RANKING QUESTION UP 
TO TOP 5, FORCE EXACTLY ONE RESPONSE FOR EACH OF 1 
THROUGH 5. ROTATE 1-5. 
1. PICTURE/DESCRIPTION OF FIRST SPOT VIEWED 
2. PICTURE/DESCRIPTION OF SECOND SPOT VIEWED 
3. PICTURE/DESCRIPTION OF THIRD SPOT VIEWED 
4. PICTURE/DESCRIPTION OF FOURTH SPOT VIEWED 
5. PICTURE/DESCRIPTION OF FIFTH SPOT VIEWED 
Audience and Personal Relevance 
24d. 
Who would you say they are trying to reach? 
• 
Does it seem like this message is talking to you, and people like you? Or 
someone else?  
• 
What in the message suggested it was talking to you and people like you 
or someone else? 
 
25d. 
Who would you say they are trying to reach? Please check all that apply.  
1. You 
2. People like you 
3. Someone else 
4. None of these 
 
26d. 
Do you see yourself doing this? Or something like it? Why/why not? 
 
27d. 
Who do you believe would benefit most from [INSERT health behavior]? 
Content and Wording 
28d. 
Do you like the way it is written? [Probe: tone, language/style, etc.] Is it easy 
to read? 
 
29d. 
Is there anything you want to know that this item does not tell you? 

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30d. 
If you saw or heard this message, would it get your attention? Why or why 
not? 
 
31d. 
Are there any words or phrases here that you think are especially attention-
getting or appealing? 
 
32d. 
Are there any words or phrases that bother you or that you think should be 
said differently? 
 
33d. 
How could this message be improved? 
 
34d. 
Is there a way to say this differently that would make you personally more 
likely to notice and think about the message?  
 
35d. 
Thinking back to the information they are trying to convey, is there anything 
else you would add? 
 
36d. 
[Underline/circle/highlight/cross out] phrases, sentences or images that you 
think are [important/confusing/unclear/inappropriate/offensive/should be 
deleted]. 
 
What did you indicate as 
[important/confusing/unclear/inappropriate/offensive/to be deleted]? 
 
37d. 
How much of the [INSERT item] would you read? Please choose all that 
apply. 
[Screen shows the responses below] 
 
• 
I would only read the headline 
• 
I would only look at the image/s 
• 
I would only read the headline and look at the image/s 
• 
I would read the whole thing 

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• 
I wouldn’t read any of it 
Efficacy 
38d. 
Which actions, if any, sound doable to you? Why? 
 
39d. 
How feasible is it that you would try to do this? Please explain. 
 
40d. 
Would you consider doing this behavior? 
 
41d. 
What makes it hard to do this? 
 
42d. 
Who in your household would be against trying this? Why? 
 
43d. 
Which descriptions, if any, sound do-able? Why? Why not? 
 
44d. 
Which of these options would be the easiest to incorporate into your life? 
What makes that option the easiest? 
 
45d. 
What do you think of this idea? 
 
46d. 
How appealing is it to you as a way to control [INSERT health topic or 
behavior]? 
 
47d. 
Do you think it could work in your home? Why or why not? 
 
48d. 
Would you consider doing this at home? 
 
49d. 
How would you try it out in your home? 
 
50d. 
How feasible would this be to try at home? Explain. 
 
51d. 
What would make this easier for you to do? 

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52d. 
How would you try this at work or when out of your home? 
 
53d. 
Which of these would be most effective in your workplace? 
 
54d. 
How easy are these guidelines for you to follow and understand? 
 
55d. 
What, if anything, makes it difficult to follow? How might this be presented in 
an easier way? 
 
56d. 
What are the good things about trying this tactic? 
 
57d. 
What makes it hard to do this? 
 
58d. 
Who in your household would be against trying this? Why? 
 
59d. 
I’m going to pass around a sheet that gives you some descriptions for [INSERT 
health topic or behavior]. Please review these descriptions silently, and circle 
those that seem most doable. Cross out any that don’t seem do-able. 
 
• 
After all tactics have been discussed, the moderator asks participants to 
identify the two or three tactics that they think are most important and 
that they have the greatest likelihood of doing. (Moderator takes hand 
count.) 
 
• 
From the two or three top tactics, the participants are asked to choose 
the single tactic that they think is most important and that they have the 
greatest likelihood of implementing. The moderator explores some of the 
participants’ choices and their reasons for choosing. 
 
• 
As you look at these strategies, does any one of the three stand out as 
the one that you would try first? Which one? Why? 
 
• 
What are the one or two things we have discussed today ─ if any ─ that 

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seem most feasible to implement in your household? 
 
• 
Is there any more information or tools that you would need that would 
help you implement some of these strategies? 
 
• 
What are some of the things that would make it difficult for people in your 
area to [INSERT health topic or behavior]? 
 
• 
What could, or has, been done in the local area to make it easier—to 
overcome some of the barriers you described? 
Placement 
60d. 
Do you like the idea of having material to take with you into a doctor's 
appointment or to take home? 
 
61d. 
Do you think you would take information with you, or leave it in the waiting 
room? Why? 
 
62d. 
Does this affect your likelihood to read the information? How? 
 
63d. 
Does it affect your likelihood to ask your doctor? How? 
 
64d. 
Where would you expect to see it? 
 
65d. 
Where would it need to be so that you would pay attention to it? 
 
66d. 
How do you prefer to see health information presented? 
 
67d. 
In what form (probe: posters, brochures, fliers)? 
 
68d. 
What kinds of promotional items would you use? 
 
Channels 

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69d. 
Where do you get your information about [INSERT health topic or behavior]? 
• 
Probe for sources such as media, family, friends, church 
 
70d. 
Has your doctor talked with you about [INSERT health topic or behavior]? 
• 
What did he/she tell you? 
 
71d. 
What are some of the ways you have gotten information about [INSERT 
health topic or behavior] prior to today? [Probe: role of media, word-of-mouth, 
other.] 
 
72d. 
Is [INSERT health topic or behavior] a topic on which you seek out 
information? If so, how? 
• 
What type of information are you seeking? 
• 
Where might you seek out information? 
• 
Where would you turn first for information? 
 
73d. 
How often, if at all, do you pick up information about [INSERT health topic or 
behavior]? 
• 
What are the sources of this information? 
 
74d. 
When it comes to [INSERT health topic or behavior], are there any 
organizations that you would really trust as a reliable source of information? 
 
75d. 
What makes them a trusted source of [INSERT health topic or behavior] 
information? 
 
76d. 
What do you think [INSERT organization name] needs to know about your 
community? How would you want them to be involved in your community? Do 
you see ways of partnering with them? How would you like to receive the 
information? 
77d. 
How do you usually learn about environmental issues? Who or what is your 
main source of trusted information about community issues? Is there 
adequate information out there? How do these sources compare to [INSERT 
organization name]? 

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78d. 
How would you rank your level of knowledge and understanding of information 
you have received from [INSERT organization name]? 
• 
5: knowledge is extensive 
• 
4: above average 
• 
3: average 
• 
2: have some knowledge 
• 
1: no knowledge 
 
79d. 
How could this information be conveyed more effectively? 
 
80d. 
What types of information would you like to receive regarding environmental 
issues? What would be the most effective way or format to provide this 
information [INSERT health topic or behavior]? (Probes: Video? Educational 
pamphlets? Community/public meetings? Internet?) 
 
81d. 
What are some places where you might notice messages like these? 
 
82d. 
Are there some places in particular that you would be most likely to notice and 
pay attention to these messages? 
Sources of Information 
83d. 
If you are trying to put together a group of people in your community to deal 
with [INSERT health topic or behavior] in a comprehensive fashion, who are 
the people you want at the table? 
• 
Probe: Community based organizations, health care practitioners, and 
policy makers 
• 
Probe: Religious leaders/faith-based organizations 
• 
Probe: What is it about these people that make you want them there? 
• 
Probe: Once you get these people in the room, what is the conversation 
going to sound like? 
84d. 
What topics do you want to cover? What will be the outcome of this 
conversation, what kinds of things are going to happen as a result? 
 
85d. 
Who wrote or produced this item?  

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86d. 
Have you heard of them before?  
 
87d. 
Are they a good source of information? 
 
88d. 
Are they believable? 
 
89d. 
Do they seem trustworthy? 
 
90d. 
How do you feel about CDC as the source of this information? 
Spokespeople/Sponsor 
91d. 
Who do you think would be a good spokesperson to use to convince you and 
your friends to [INSERT health topic or behavior]? 
 
92d. 
Who would have the ability to influence you? 
• 
Would it be a physician, celebrity, religious or spiritual leader, or 
someone like you? 
 
93d. 
If you were trying to make up your mind about [INSERT health topic or 
behavior], who would influence you? 
 
94d. 
If you were trying to influence a friend to [INSERT health topic or behavior], 
what would you say? 
• 
Probe for benefits and ways to overcome barriers 
 
95d. 
Have you ever heard of [INSERT organization name]? 
 
96d. 
What is [INSERT organization name]? Where did you learn about [INSERT 
organization name]? 
 
97d. 
What could [INSERT organization name] do to make you feel better about the 
health risks in your community? 

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98d. 
Do any companies or organizations say something like this now? Which 
ones? 
 
99d. 
What impact does [INSERT organization name] have on your community? On 
you and your friends and family’s lives? What kind of impact should it have? 
 
100d. 
What do you think about the work of [INSERT organization name]? Why? 
 
101d. 
Have you ever heard of an organization called the Centers for Disease Control 
and Prevention or CDC? 
 
102d. 
What if the CDC was to say something like this? Would that change the way 
you look at these statements? Would it make any of them more or less 
believable? More or less appealing? Motivating? 
 
103d. 
What if the CDC and [INSERT partner name] said something like this? Would 
that change the way you look at these statements? Would it make any of them 
more or less believable? More or less appealing? Motivating? 
Comparison of Concepts/Messages/Materials 
104d. 
Do you think one is more appealing than the others? Which? Why/why not? 
 
105d. 
Is one more likely than another to get your attention? 
• 
To make you think about it afterwards?  
• 
If yes, what is it about that one that “works” for you (or someone else you 
care for or take care of, such as a spouse/partner, child, parent, relative, 
or friend)? 
 
106d. 
Now that you’ve seen all of these concepts, which one catches your attention 
the most? 
 
107d. 
Now that you’ve seen all of these ads, rank which one catches your attention 
the most by placing a 1 by the ad you liked the most, a 2 by your (NEXT) 
favorite, etc. SINGLE RESPONSE. SCREEN CAPTURES FROM THE ADS 
WILL BE INSERTED FOR VISUAL RECALL OF THE ADS. 

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1. 
PICTURE/DESCRIPTION OF FIRST SPOT VIEWED 
2. 
PICTURE/DESCRIPTION OF SECOND SPOT VIEWED 
3. 
PICTURE/DESCRIPTION OF THIRD SPOT VIEWED 
4. 
PICTURE/DESCRIPTION OF FOURTH SPOT VIEWED 
5. 
PICTURE/DESCRIPTION OF FIFTH SPOT VIEWED 
 
108d. 
Looking over all of the different messages we have discussed, which two or 
three are the most effective?  
• 
Probe: 
What makes it most effective? 
 
109d. 
Looking over all of the different messages, which two or three are the most 
effective? INSERT LIST OF MESSAGES VIEWED IN THE 5 SPOTS. 
MULTIPLE MENTION. Please check up to three. 
 
110d. 
Which one was most inspiring or motivating for you personally? 
 
111d. 
Which one is most believable? 
 
112d. 
Now, looking at just the top two or three messages, which one message is the 
most important to you to help you [INSERT health topic or behavior] and that 
you have the greatest likelihood of doing?  
 
113d. 
What makes this message most effective? 
 
114d. 
What about this particular one is most engaging? 
 
115d. 
What item is least effective? 
 
116d. 
Which of these is the worst? Why? What, specifically, do you dislike about it? 
What do you mean by “worst?” What criteria did you use? 
• 
Least likely to attract attention? 

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• 
Least likely to read? 
• 
Least likely to act upon? 
 
117d. 
Did any of the concepts not motivate you at all? Why not? 
 
118d. 
Did any of the concepts turn you off? What was it about the statement/s that 
turned you off? 
 
119d. 
Would any of the statements make you feel opposed [INSERT health topic or 
behavior]? 
 
120d. 
What could be changed to make it more effective? 
 
121d. 
What information would most motivate you to ask your doctor about [INSERT 
health topic or behavior]? 
 
122d. 
What is the most motivational format for this information? 
Campaign Awareness 
123d. 
In the past month, do you remember seeing, hearing, or reading any TV, 
radio, newspaper, or online advertising about a [INSERT program, campaign, 
or web site description]? 
• 
Yes 
• 
No 
• 
Don’t Know/Not Sure 
• 
Refused 
 
124d. 
What can you tell me about this/these [INSERT format]? Please describe for 
me anything specific you saw, heard, or read in the [INSERT format]. 
• 
What was the [INSERT format] about? 
• 
What was the name of the program mentioned in the [INSERT format]? 
Is there anything else you can recall? 
[Probe for specifics/details they remember, for example who, if anyone, 
appeared in the message.] 

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125d. 
In general, are you aware of [INSERT description of program, campaign, or 
web site]? 
• 
Yes 
• 
No 
• 
Don’t Know/Not Sure 
• 
Refused 
 
126d. 
What is the name of the [INSERT description of program, campaign, or web 
site] (Probe: Any others?) 
 
127d. 
Now, I am going to describe an ad you may or may not have seen on TV. You 
may or may not have seen the following ad because it is NOT running in all 
parts of the country. But in the past month, have you happened to have seen 
an ad that shows [INSERT ad description]. 
• 
Yes 
• 
No 
• 
Don’t Know/Not Sure 
• 
Refused 
128d. 
n a scale from 1 to 10 where 1 is not at all appealing and 10 is extremely 
appealing, how would you rate this [INSERT type of communication, e.g., ad]? 
 
Not at All 
Appealing 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Extremely 
Appealing 
10 
DK 
88 
RF 
99 
How would you 
rate this 
[INSERT type 
of 
communication, 
e.g., ad]? 
 
 
 
 
 
 
 
 
 
 
 
 
 
129d. 
Now I’m going to read a list of a few [INSERT type of communication, e.g., 
website, slogan, or program] names you may or may not have heard about. 
Which of the following [INSERT type of communication, e.g., website, slogan, 
or program] have you heard about? [REPEAT as necessary for other types of 
communication] 

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• 
Yes 
• 
No 
• 
Don’t Know/Not Sure 
• 
Refused 
 
 
 

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12.3 Appendix C: Justice Community Opioid Innovation Network (JCOIN) and 
HCS Annual Jail Survey   
 
As part of a separate federally funded (NIDA) grant, unrelated to the HCS, Dr. Chris Scott of the 
Lighthouse Institute of Chestnut Health Systems is conducting interviews with jail 
administrators. The survey (the Justice Community Opioid Innovation Network Jail Interview 
[JCOIN]) is designed to collect administrative data about the availability, accessibility, and 
utilization of interventions to treat opioid use disorder (OUD) in jails. Dr. Scott works with each 
sampled jail to determine who at the jail is best able to provide the institutional data she 
requires, and all the questions are about the facility and its procedures (i.e., no individual-level 
data are collected).  
The data Dr. Scott is collecting are relevant for the HCS, and she will share data with the HCS 
team once the appropriate data sharing agreements are in place. Once she completes the 
JCOIN data collection, she will alert the HCS team in that state, and the HCS team can then 
reach out to specific jails in the JCOIN sample to request their involvement with the HCS. The 
HCS team will not know whether the jail participated, only that the jail was included in the 
sample for Dr. Scott’s study. If a jail is willing to have its JCOIN data shared with the HCS team, 
it will be asked to complete an Authorization to Disclose form and will provide completed forms 
to Dr. Scott. The informed consent for the jail interview contains a statement regarding other 
NIDA projects. The statement says that if the jail or county is participating in other NIDA projects 
and would like for JCOIN to share the data obtained in the JCOIN to please provide a release of 
information that explicitly states with whom they would like to share their data. 
Dr. Scott has expanded the JCOIN sample to include an additional 33 counties representing 
HCS communities. Principal Investigators from the HCS will be responsible for obtaining 
Authorization to Disclose forms from the facilities to share the interview data with the HCS. The 
form makes it clear that the identity of the facility will be linked to the disclosed data for the 
purpose of re-contacting the jail in the future to request permission to update a portion of the 
data collected. The revised JCOIN protocol, JCOIN survey, JCOIN ICF, and Authorization to 
Disclose have all been approved by the local IRB for JCOIN. 
For those jails that authorize the release of their (baseline) data to the HCS, the HCS will utilize 
the jail names to re-contact the jails for two additional follow-up surveys over the course of the 
HCS study. A standardized email message will be sent by the PIs to the jails to serve as an 
introduction to the project, and informed consent will be obtained for each HCS follow-up survey 
completed.   
 
 
 

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Justice Community Opioid Innovation Network (JCOIN) 
in collaboration with the HEALing Communities Study (HCS) 
 
AUTHORIZATION TO DISCLOSE 
 
IDENTIFYING INFORMATION 
 
Name of Jail: 
___________________________________________________ 
Name of Authorized Representative:  
___________________________________________________ 
(preferably, the same Authorized Representative who signed the previous consent to participant in JCOIN. If not available, the 
current authorized designee may sign.) 
 
Jail Address: 
 
 
By signing this Authorization to Disclose, the above-named individual, on behalf of the above-named jail (“Jail”), acting with sufficient 
authority to legally bind Jail, hereby authorizes Chestnut Health Systems, Inc. (“Chestnut”) to release to the individuals or entities 
named below the Jail information described below.   
WHAT MAY BE DISCLOSED: 
Chestnut may disclose data duly collected from Jail’s responses to the Justice Community Opioid Innovation Network (JCOIN) Jail 
Interview (“Jail Interview”) under a grant from the National Institute on Drug Abuse (“NIDA”). The identity of Jail will be linked to the 
disclosed data for the purpose of re-contacting Jail in the future to update a portion of the data collected. This completes your 
participation in the JCOIN survey. However, as part of their on-going monitoring of the HEALing Communities Study (HCS), HCS 
staff may follow-up with additional data-collection requests over the next two years.  
WHO MAY RECEIVE: 
Chestnut may disclose the above-described data to the following entities that have received funding from NIDA for the HCS to learn 
more about the availability, accessibility, and utilization of interventions to treat opioid use disorder (OUD):  
[Name HSC research site to received data] - will receive data linked to Jail’s identity only for the purpose described above. This 
Research Site will in-turn provide a copy of the data, with Jail identifying information removed, to RTI International, the HCS Data 
Coordinating Center, for the purpose of statistical analysis and summary reports.  
Chestnut is in no way responsible for the use or sharing of Jail Interview data by the above entities.    
GENERAL: 
Jail understands and agrees that Chestnut will in no way be liable to it or any third party for disclosing Jail Interview data in accordance 
with this Authorization to Disclose and that Chestnut is in no way responsible for the use or sharing of Jail Interview data by the entities 
listed above. Further, Jail understands that it may revoke this Authorization to Disclose at any time by providing written notification to 
Chestnut. However, any revocation will not cover disclosures that Chestnut has already made pursuant to the authority granted by 
Jail in this Authorization to Disclose prior to the date of such revocation. 
____________________________________________    ______________________________________ 
Signature of Authorized Representative  
 
Date 
____________________________________________    ______________________________________ 
Name and Title of Authorized Representative 
 
Email Address of Authorized Representative 
 
 

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Procedures for Recruitment and Improving the Response Rates for the HCS Annual Jail Survey  
To improve recruitment and survey response rates, the following procedures will be used. 
These procedures include jails that do not complete the JCOIN Baseline Survey but who 
consent to the HCS Annual Jail Survey at baseline. Jail Administrative Directors (i.e., jailers) will 
receive a pre-recruitment letter or email from a Jail Survey Champion(s) no less than 10 
business days before the survey invitation is sent. The Jail Survey Champion may be the key 
government official for an RS, a local or state government official, and/or a local or state 
influencer (e.g., from the state’s jailer’s association or sheriff’s association). The Jail Survey 
Champion letter or email may be co-signed by multiple stakeholders. The purpose of the Jail 
Survey Champion letter or email is to grant legitimacy to the HCS Jail Annual Survey and 
provide a brief introduction to the study’s purpose. In addition, the goal is to request that the Jail 
Administrative Director identify a key jail employee who is knowledgeable about opioid-related 
services in his or her jail and describe this person’s importance to the study (see Attachment: 
Jail Survey Champion). It is requested that the Jail Administrative Director send the name, title, 
telephone number, and email of the key jail employee to the RS’s account (i.e., University of 
Kentucky, Ohio State University, Columbia University, or Boston Medical Center email account, 
e.g., HCS_KY@uky.edu). The RS may also reach out directly to the jail via telephone, email, or 
in person to request a key jail employee or alternate and not go through the Jail Survey 
Champion. 
All key jail employees will be sent an email invitation with a link to the Jail Annual Survey, which 
will be sent from the RS’s account (i.e., University of Kentucky, Ohio State University, Columbia 
University, or Boston Medical Center email account, e.g., HCS_KY@uky.edu) on a specified 
date. The email will also provide a brief introduction to the study’s purpose and describe the 
target respondent’s importance to the study (see Attachments: Jail Survey Invitation and the 
Alternate Version for Ohio, Sheriff Email and Phone Script). This email will contain the HCS 
graphic icon to establish rapport and verify authenticity. If target participants have questions, 
they will be able to respond to this email address, and additional contact information for the 
research team will be provided in the email. The email notifications include a unique URL link 
assigned to each participant, which allows for duplicated submissions to be automatically 
eliminated. Only the first completed submission from a URL link will be included in the data set; 
however, it should be noted that participants do not have to complete the survey in one sitting. 
The REDCap survey can be completed at the individuals’ convenience, on various platforms 
(smartphone, laptop, desktop, tablet), and in multiple sittings (e.g., it can be started one day and 
finished at a later date). Targeted participants will be given the option to complete the survey 
online via REDCap, in person, or over the telephone. No compensation is offered for 
participation. 
Following established procedures based on Dillman and colleagues’ Tailored Design Method,78 
a weekly email reminder will be sent to non-responding target participants for up to 4 weeks at 
optimal times (e.g., not on a Friday afternoon). This email will include a link to provide consent 
and complete the REDCap survey as well as instructions on how to complete the survey by 
telephone or in person (see Attachment: Weekly Reminder). This email reminder will also 
include an attached PDF of the informed consent and survey for participants to fax or mail in. If 
telephone numbers are available, target participants may also be contacted by telephone to 
highlight the importance of the study for the specific RS’s state and for reducing opioid related 

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overdose deaths, as well as to reiterate that all responses are confidential (see Attachment: 
Phone Script).   
At 4 weeks after the initial contact, non-respondents may be sent a packet that includes a letter 
on the RS’s institutional letterhead requesting participation, a paper version of the consent form 
and survey, and a pre-paid addressed envelope (see Attachment: 4-Week Follow-Up). The 
packet will also provide instructions for completing the survey via REDCap or in person. During 
these contacts, participants may be given the choice of completing the survey online via 
REDCap, over the telephone, or in person with research staff. In addition, research staff also 
have the option of conducting in-person visits with non-respondents in their respective jails. 
Research staff will bring a hard copy of the consent form and survey as well as information on 
how to complete the survey online. HCS research staff will have up to nine months to collect 
data from the HCS Annual Jail Survey.   
 
 

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12.4 Appendix D: Additional Site-Led HCS Research Activities   
HCS RSs may seek approval from the Steering Committee and NIDA for site-led research 
activities. Steering Committee and NIDA approved protocols, once approved by the IRB, may 
be implemented by a single site, two to three sites, or as many as all sites, based on local 
preference. 
12.4.1 
Group Model Building Workshop 
The New York RS will conduct a group model building (GMB) workshop (see Group Model 
Building Workshop Facilitation Manual) that aims to advance the site’s understanding of how 
community coalitions conceptualize the organizational dynamics that affect OUD and how the 
CTH is implemented in their communities. GMB is a qualitative method used to develop a 
causal loop diagram or systems dynamic model, which are constructions of explicit models, or 
representations, of a system’s behavior, considering multiple actors, factors, levels, and the 
interconnections and feedbacks among them. Systems models can help test the potential effect 
of interventions and identify the points of maximum leverage in the system. 
Community coalition members and other local stakeholders will be asked to participate in the 
GMB workshop. During the GMB workshop, participants will present their understanding of the 
driving factors and etiology of OUD in the context of their community’s organizational dynamics. 
Based on this information, a causal loop diagram or systems dynamic model will be developed. 
Participants will not be forced to disclose or discuss any information they do not feel comfortable 
sharing, and the confidentiality of study participants’ information will be protected throughout the 
general study protocols. The GMB process focuses on documenting participants’ perceptions 
and ideas about the opioid crisis and potential solutions at the community level. No individual 
health information will be collected. In addition, participant names or identifying information will 
not be used in research reports or presentations. 
12.4.2 
GetNaloxoneNow 
Overdose education is part of the ORCCA EBP selection for communities. All four RSs will 
provide HCS communities with the option of using www.GetNaloxoneNow.org. 
GetNaloxoneNow is an online resource to train people to respond effectively to an opioid 
overdose emergency. The content of the GetNaloxoneNow module draws on years of 
scholarship and contributions of many experts in overdose prevention including public health 
researchers, harm-reduction specialists, physicians, nurses, police officers, firefighters, 
emergency medical technicians, case managers, outreach workers, graphic designers, 
professional actors, and educators. Funding to develop the training module was provided by 
NIH/NIDA, Grant #1R43D033746-01 and Grant #1R43DA029358-01A1 (PI: Dr. Janie 
Simmons). This online overdose education is an evidence-based practice that includes a 
bystander (i.e., general public) module and a first responder module. The GetNaloxoneNow 
bystander training module is about 20 minutes, and the first responder training module is 
approximately 45 minutes.   
The four HCS RSs will obtain monthly data analytics on the number of individuals who start and 
complete the bystander and the first responder training module by county and state through Co-
Investigator Dr. Simmons. As part of the registration process for this existing training, 
demographics are collected, including race/ethnicity, preferred language, gender, age range, 

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self-report of overdose, or witnessed overdose, as well as other questions related to how they 
heard about the training. There are also post-training questions to assess the ability to intervene 
in the case of overdose.  
HCS sites will receive only de-identified aggregate data describing participants; therefore, 
informed consent is not required. 
De-identified data will include the following:   
● Demographics including race/ethnicity, preferred language, gender, age range, self-
report of overdose, or witnessed overdose  
● County, state of residence, and ZIP Code  
● Questions related to how they heard about the training  
● Post-training module questions to assess ability to intervene in case of overdose  
 
Data transfers will occur monthly during the period from January 1, 2020, through March 31, 
2023. Data will be stored in local, approved informatics environments for at least 3 years.   
12.4.3 
Brandeis University Collaboration to Conduct Interviews with Health Care Payers 
Brandeis University is collaborating with the Massachusetts RS, and Brandeis University staff 
will conduct semi-structured interviews with health care payers in Massachusetts, as part of the 
HEALing Communities Study (HCS). This activity is site specific to Massachusetts and is 
supervised by the HCS’s Implementation Science Core at Boston Medical Center. 
The interviews are intended to gather information about the extent to which payers currently 
fund or otherwise encourage activities that communities may adopt as part of the HCS 
intervention, such as medications for opioid use disorder (MOUD), distribution of naloxone, or 
initiatives in schools, pharmacies and law enforcement settings. There is also interest in the 
extent to which payers would be willing to fund those activities in the future, and how they make 
decisions about which activities to fund or otherwise support. The resulting information may be 
helpful to determine the long-term sustainability of the system interventions that are being tested 
in the HCS communities. 
The Brandeis University team will seek to interview officials at MassHealth (the state Medicaid 
program) and at commercial insurers that serve Massachusetts customers. In 2018, the 
Massachusetts Division of Insurance identified 13 commercial insurers serving Massachusetts. 
The team will identify the official at each institution most likely to have knowledge about policies 
toward opioid use, MOUD, and other topics of interest. For insurers that contract out the 
management of substance use disorder treatment to an external vendor, the team will also seek 
to interview that vendor (e.g., for MassHealth: Beacon Health Options, and the Medicaid 
managed care plans). A total of up to 20 interviews will be conducted. In some cases, these 
persons are already known to the team from prior research with local health plans. In other 
cases, the team will use other information to identify the best respondent, using contacts from 
professional networks and information from company websites and elsewhere.  

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The team will contact potential participants by email, to explain the HCS study and ask if they 
are willing to participate in an interview. If an official agrees to an interview, the team will 
schedule the interview. The team will ask the respondent to complete a survey (via REDCap) 
that includes a few pre-interview questions on factual issues, such as whether their plan covers 
certain specific opioid use disorder-related services, whether it provides incentive payments to 
providers, etc.  
The interview will last up to one hour and will be an open-ended discussion. Each respondent 
will be asked a series of open-ended questions about their institutional policies and activities in 
relation to MOUD or naloxone, including both use of reimbursement/incentives and other forms 
of encouragement to providers. The interview will not ask respondents about their own beliefs or 
their own experience with health care. The interviews will be conducted annually for the duration 
of the study. After baseline, the team will ask about changes since baseline, and what effect, if 
any, the HCS initiative played in any resulting policy changes.  
Neither the pre-interview survey nor the interview will collect PHI/PII from the respondent. 
The interview will be audio recorded. The recording is for the use of the Brandeis University 
research team in transcribing the interviews and will not be shared with anyone outside of the 
research team. The recording may include the respondent’s name, but it will be removed from 
the transcribed interview form and a study ID number substituted in its place. The audio files 
and transcription will be saved on a secure server at Brandeis University. Audio files will be 
destroyed within 6 months following transcription; transcription files will be kept for 3 years 
following project completion and then destroyed.  
Brandeis University will analyze the interview transcripts using qualitative data techniques. The 
team will summarize the results in annual reports to the Boston Medical Center’s HCS 
leadership team and may use the results in future publications.  
12.4.4 
Academic Detailing and CECentral Online Modules 
To facilitate and operationalize ORCCA EBP Requirement 3: Safer Opioid Prescribing and 
Dispensing at the service provider level, and address barriers for rural healthcare providers, the 
Kentucky RS has developed Academic Detailing and On-Demand Online Continuing Education 
modules through CECentral. Components include Academic Detailing (in-person training) as 
well as online modules for Pain Management for Pharmacy, MOUD for Pharmacy, Safer 
Opioids and Overdose Risk Reduction, and Naloxone Training. Audience will be dentists, nurse 
practitioners (primary care), pharmacist, pharmacy technicians, and physicians (primary care). 
Educational content meet accreditation standards, compliance documentation, and outcomes 
assessment for AMA PRA Category 1 Credits™, ACPE contact hours/CEUs, Dentistry credit, 
and participation certificate, as well as House Bill 1 requirements for dentists, nurse 
practitioners, and physicians. Both Academic Detailing and On-demand Online CE modules will 
be provided free of charge.   
As part of the registration process, CECentral requires pre-activity evaluation questions and 
post-activity evaluation questions. To assess the impact of Academic Detailing and On-Demand 
Online Education on safer opioid prescribing and dispensing, the Kentucky RS will receive de-
identified data describing registrants. Because data received will be de-identified, informed 
consent is not required.   

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De-identified data may include the following: 
● Demographics (profession) 
● Practice Information (county of primary practice) 
● Pre-activity questions to assess knowledge, attitudes, and current practice 
standards/processes 
● Post-activity questions to evaluate knowledge, change in attitudes, and impact on 
practice standards/processes 
● Post-activity questions to assess the delivery and content of educational modules 
and speakers 
Data transfers will occur quarterly (March 31, June 30, September 30, December 31) beginning 
September 30, 2020, through March 31, 2023. Data will be stored in secure, local, approved 
informatics environments for at least 3 years.   
12.4.5 
MOUD Organization Interview Guide 
University of Kentucky research staff will conduct small group semi-structured interviews with 
staff working in organizations that provide medication for opioid use disorder (MOUD) in 
Kentucky, as part of the HEALing Communities Study (HCS). This activity is site-specific to 
Kentucky and is supervised by the HCS’s Implementation Science and Treatment teams at the 
University of Kentucky. 
The interviews are intended to gather information about barriers to access and retention in 
MOUD as well as the impacts of COVID on the delivery of MOUD within the Kentucky HCS 
communities. The resulting information may be helpful in explaining the potential impacts of 
efforts to implement aspects of Menu 2 in the Opioid-overdose Reduction Continuum of Care 
Approach (ORCCA). 
The University of Kentucky team will seek to conduct small group semi-structured interviews 
with staff working in organizations providing MOUD, which include, but are not limited to, opioid 
treatment programs (OTPs), non-OTP specialty substance use disorder programs, and office-
based medical practices. It is anticipated that approximately 2-3 staff from a given organization 
will participate in the interview, but some interviews may be conducted with a single individual. 
To identify potential interviewees, the team will draw upon information provided by the 
community’s HCS coalition, individuals in MOUD organizations that have already implemented 
fast-track overdose education and naloxone distribution, the team’s professional networks, the 
Drug Enforcement Agency’s list of waivered providers, and MOUD organizations’ websites. It is 
anticipated that efforts will be made to conduct interviews with all agencies that have been 
identified for Menu 2 implementation within the eight Wave 1 communities; similar interviews will 
be conducted once HCS moves into Wave 2. Up to 250 individuals will be interviewed.  
The team will contact potential participants by email or telephone to explain the HCS study and 
ask if they are willing to participate in a small group interview. Each small group interview will 
only include individuals from a single organization. If individual(s) from the organization agree to 
an interview, the team will schedule the interview. During the interview, participants will be 
asked open-ended questions about the organization’s MOUD census, resources needed to 
increase the patient census, barriers to MOUD access and retention, differences in barriers 

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between types of MOUD (if the organization offers more than one type of MOUD), the impact of 
the COVID-19 pandemic on MOUD delivery and use of telehealth for MOUD. Because of the 
semi-structured nature of the interview, interviewers may probe for clarity or greater detail. The 
interview guide will not ask individuals about their personal beliefs or their personal experience 
with health care. A brief demographic REDCap survey, using the IRB approved HCS 
Demographic Form will be used to collect information on race, ethnicity, gender, age, and 
education after the interview.  
Neither the interview nor post-interview demographic survey will collect PHI/PII from the 
respondent. 
The interview will be audio-recorded and professionally transcribed. Identifying information will 
not be shared with anyone outside of the research team. The recording may include the names 
of individuals or organizations but identifying information will be removed from the interview 
transcript and a study ID number substituted in its place. The audio files and transcription will be 
saved on a secure server at the University of Kentucky and destroyed 3 years following project 
completion. Demographic data will be stored within REDCap on secure servers.  
The University of Kentucky team will analyze the interview transcripts using qualitative data 
techniques. Findings may be reported in peer-reviewed manuscripts, but confidentiality will be 
maintained by not identifying any individuals or organizations in publications. 
12.4.6 
Pharmacy Study Interview Guide & Survey 
The New York research site will conduct a survey with selected pharmacies and Pharmacists, 
as well as interviews with Pharmacists and community members as part of the HEALing 
Communities Study (HCS). This activity is site-specific to New York and is supervised by 
Columbia University School of Social Work Associate Research Scientist Dawn Goddard-
Eckrich, Ed.D. 
The survey and interviews are intended to assess racial and ethnic disparities in Medication for 
Opioid Use Disorder (MOUD) and Naloxone availability at pharmacies in HCS communities, and 
to examine the perspectives of People with Opioid Use Disorder (PWOUD) with respect to 
barriers to accessing MOUD and Naloxone services in pharmacies. There is also interest in 
using these findings to inform the use of pharmacies to promote MOUD and Naloxone as part of 
the HCS intervention and to increase engagement, participation, and leadership of more ethnic 
minorities in the community coalitions and overall HCS study. 
Members of the New York research team will seek to survey (via two different surveys [one for 
pharmacy staff or pharmacists and one specifically for licensed pharmacists]) a sample of 
Pharmacists, pharmacy technicians and/or other pharmacy staff who work for pharmacies in 
New York’s HCS communities. The NYS Pharmacy Association will provide recruitment 
assistance to the research team that will also conduct an online search for pharmacy contact 
information. The surveys will be programmed in REDCap and will include questions about 
access to Narcan/Naloxone, Buprenorphine, Naltrexone, Methadone and COVID-19 testing in 
pharmacies in the HCS communities. The surveys will take between 20 and 30 minutes to 
complete. Respondents can choose to participate via a REDCap link sent to their email or to 
complete the survey by phone with a NY research site staff member. 

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Members of the New York research team will also conduct semi-structured one-on-one 
interviews with a sample of community members (including African Americans and Hispanics) 
with a goal of interviewing 20 People with Opioid Use Disorder (PWOUD) and 20 pharmacists in 
HCS communities.  
Through the assistance of its community coalitions, the New York team will recruit individuals 
and receive referrals from three types of programs serving PWOUD at sites in NY’s HCS 
counties with diverse communities: (a) one methadone maintenance treatment program 
(MMTP); (b) one primary care clinic; and (c) one syringe exchange program (SEP). Recruitment 
will ensure that the sample includes minority representation across non-Hispanic Blacks and 
Hispanics. 
New York research staff will explain the study to potential PWOUD participants and verify their 
age and drug use experience. To be eligible, PWOUD study participants must be: 18 years of 
age or older, have used heroin, cocaine, and/or methamphetamine within the past 12 months, 
and/or received, or currently receive services from an opioid treatment, HIV primary care, or a 
syringe exchange program. 
The research team will contact potential participants by email to explain the HCS study and ask 
if they are willing to participate in an interview. If the potential participant agrees to participate, 
the team will schedule the interview. The interview will last approximately 45 minutes and will be 
an open-ended discussion. Each respondent will be asked a series of questions about key 
facilitators, barriers to availability and overlap in MOUD services (e.g., Narcan/Naloxone, 
Buprenorphine, and Naltrexone) and COVID services (e.g., testing, vaccine, medication. [e.g., 
Remdesivir], availability, etc.) provided in pharmacies, as well as access to and distribution 
(e.g., mail order, drive thru, in person) of different types of Naloxone, Buprenorphine, Naltrexone 
and other Medications for Opioid use Disorder (MOUD) in pharmacies in NY HCS communities. 
The interview will be audio recorded. The recording is for the use of the New York research 
team in transcribing the interviews and will not be shared with anyone outside of the research 
team. The recording may include the respondent’s name, but it will be removed from the 
transcribed interview form and a study ID number substituted in its place. The audio files and 
transcription will be saved on a secure server at Columbia University. Audio files will be 
destroyed within 6 months following transcription; transcription files will be kept for 3 years 
following project completion and then destroyed.  
The New York research site will analyze the interview transcripts using qualitative data 
techniques. The team will summarize the results in a report to the New York Research Site’s 
HCS leadership team and may also be included in future publications.   
12.4.7 
CE Facilitator Community Genogram Model 
The Ohio research site will use a community genogram model that aims to advance the site’s 
understanding of how community organizations, agencies, and providers are related to and 
connected with one another. The process of completing the genogram and the visualization of 
these relationships will inform the community-facing and research staff in understanding the 
resources and challenges within communities. The genogram is an engagement tool for the field 
staff and assists with understanding the changing landscapes in the HCS counties. 

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Community Engagement Facilitators (CE-Fs) will engage in a listening tour throughout their 
community starting with coalition leadership. This process will allow the CE-F to learn about the 
relevant community members, organizations, and systems.  As a part of the listening tour, CE-
F’s will transcribe information gathered from the listening tour into the Community Engagement 
Facilitator – Community Assessment Tool (CAT).   
Coalition leaders and other community members will not be forced to disclose or discuss any 
information they do not feel comfortable sharing, and the confidentiality of the gathered 
information will be protected. No personal health information will be collected as part of the 
listening tour.  The Ohio research site will use the Community Genogram information to inform 
CTH implementation and assist in strategies to leverage engagement throughout the study. 
Findings may be reported in presentations, reports, and manuscripts, but confidentiality will be 
maintained. 
12.4.8 
Policy Barriers and Facilitators Tracking 
The HEALing Communities Study (HCS) will carry out a policy tracking activity through the 
following 4 aims.  
Aims 
Aim 1) Data collection: Document policy issues (e.g., policy facilitators, barriers or 
misunderstandings) that could impact the implementation or effectiveness of the Communities 
That HEAL (CTH) intervention including identification of which components may be impacted 
(e.g., evidence-based practices known to reduce opioid overdose deaths and strategies to 
implement these evidence-based practices).  
Aim 2) Technical Assistance: Through training and technical assistance, engage key 
stakeholders and community partners to identify, leverage, and address policy issues impacting 
the use of evidence-based practices to reduce opioid overdose deaths.  
Aim 3) Feedback: Provide feedback to policymakers and regulators through our Key 
Government Officials, federal partners (NIDA/SAMHSA), and our state Community Advisory 
Boards about policies that may impact implementation of the CTH intervention. 
Aim 4) Analysis: Anticipate the probable effects of identified policies on study outcomes, and 
whether they are likely to mediate or moderate the impact of the CTH intervention, in order to 
address the policies appropriately in evaluating the effect of CTH. 
While each HCS research site will pursue each aim, the relative emphasis may differ across the 
research sites.  
Methods 
The overall goal of this activity is to collect information on governmental and organizational 
policies relevant to the implementation of the HCS (Aim 1). This includes policies that could 
modify the impact of the Communities That Heal (CTH) intervention, as well as other policies 
that could affect the outcomes being targeted (e.g., opioid overdose deaths; risky prescribing).  
Study team members at the research sites will document and collect information on policies that 
facilitate or impede the CTH intervention in a REDCap tracking system. Research sites may 
also document in the tracking system the support(s) they provide communities on overcoming 
these barriers and/or by sharing information with communities (Aim 2).   

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The HCS research team will pursue two strategies to identify policies that are relevant to the 
implementation of evidence-based practices and evaluation of their outcomes for the CTH 
intervention. Research team members will systematically conduct a contextual analysis of policy 
changes using an environmental scan of publicly available sources (e.g., government websites, 
press releases). In addition, the policy tracking team will seek community reports of policy 
issues from study staff or others, such as community advisory board members or coalition 
members.  
For this research activity, policy is defined as a set of principles intended to guide decisions and 
behavior within an organization or larger system, which includes formal laws, but also the rules, 
guidelines, practices, and protocols guiding organizations and jurisdictions. Examples include 
the following: laws of federal and state legislatures; guidelines, rules, regulations of federal 
agencies and national associations; organizational policies of health insurers; and rules and 
regulations of state and local health departments.  
Information on policies collected by the HCS research team will be shared with communities in 
order to support them in overcoming any barriers or to facilitate implementation of the CTH 
intervention. The research team will also provide feedback to policymakers and regulators 
through our Key Government Officials, federal partners (NIDA/SAMHSA), and our state 
Community Advisory Boards about policies that may impact implementation of the CTH 
intervention (Aim 3). 
We are seeking a waiver of informed consent for these activities as we are not collecting 
identifiable information about an individual’s behavior or health. Data will be collected from 
public websites and documents as well as from research team members. More than one person 
may also be involved in providing information for the community reports.  
This activity will be conducted throughout the study period. 
Analysis 
Data collected as part of this research activity will be available to use in study analyses to 
account for the probable effects of identified policies on study outcomes, and whether they are 
likely to mediate or moderate the impact of the CTH intervention (Aim 4). This will afford 
researchers a better understanding of how the policy landscape may affect the HCS. 
Descriptive reports on policies and data collection activities may also be published to 
disseminate information to broader audiences. 
Risks/benefits 
There are no risks to the community or individual study participants. Benefits for the community 
include receiving support to overcome policy barriers and more easily access information about 
policies.  
12.4.9 
Costing the Evidence Based Practices 
HEALing Communities Study (HCS) staff on the Health Economics Core in Kentucky, 
Massachusetts and New York will conduct semi-structured interviews with key informants from 
implementing organizations to understand the costs of implementing Evidence Based Practice 
(EBP) Strategies. The interviews are intended to gather information about start-up and operational 
costs, such as time spent on activities required to stand up the EBP strategies and provide 

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ongoing services, as well as additional resources (e.g., volunteer time, non-HCS funds, and 
donated items) that are required to implement and sustain each strategy. The resulting 
information will be used to determine costs of the EBP Strategies in the HCS communities in 
Kentucky, Massachusetts, and New York.  
The research teams will seek to interview 1-2 key informants at implementing organizations in 
their Wave 1 HCS Communities. The teams will identify the key informant(s) at each institution 
most likely to have knowledge about start-up and operational costs. A total of up to thirty 
interviews per research site will be conducted. In most cases, these persons are already known 
to the HCS team members who work directly with the implementing organizations. 
Research staff from the Health Economics Core will contact potential participants by email to 
explain the HCS study and ask if they are willing to participate in an interview via phone or video 
conference. The interview may last between 10-45 minutes depending on the role and knowledge 
of the key informant. If a key informant agrees to participate, the team will schedule the interview. 
The research team will document the key informant’s name, role, and contact information in 
REDCap before the interview. During the interview, key informants will be asked a series of 
questions to estimate the start-up and operational costs of the EBP strategy their organization is 
implementing. The research staff member will document the responses on the “Template for 
Costing the Evidence Based Practices” data collection instrument in REDCap. Following the first 
interview, the research team may contact the key informants again to invite them to participate in 
a follow-up interview to ask about changes in operational costs over time.  
The interview will not collect PHI/PII from the respondent. 
12.4.10 
Identifying the Municipal Policies that Impact the Implementation of the EBP Strategies 
At the HEALing Communities Study (HCS) Massachusetts’ research site, community 
implementation has revealed a number of municipal level factors that may have important 
implications for the translation of local Evidence Based Practice (EBP) strategies. For example, 
zoning ordinances and codes have impacted implementation plans involving Opioid Use 
Disorder (OUD) treatment facilities and mobile health services in MA HCS communities. 
Understanding municipal policies that influence implementation as well as effective strategies 
for working with municipal key players may inform local efforts to translate EBP strategies. Just 
as important, engaging with local stakeholders may help to facilitate the sustainability of these 
strategies over time. The HCS MA research site will aim to develop an understanding of local 
policies that may impact the implementation of EBP strategies in their HCS communities. 
To develop an understanding of the local policies, the MA research site will conduct interviews 
with key informants and a document review. Key informants include HCS MA community staff 
supporting Wave 1 communities (e.g., community coordinators), Wave 1 coalition members, 
Community Advisory Board (CAB) members, municipal stakeholders in Massachusetts (for 
example mayors, city council members, public health officials, etc.), and leaders from 
communities with existing drug strategies. For this research activity, drug strategies are defined 
as municipal policies and programs enacted to respond to the opioid epidemic. The interviews 
will last an hour to an hour and a half depending on the role of the key informant (interviews with 
leaders from communities with existing drug strategies will last an hour and a half). 
No more than 50 key informants will be recruited and interviewed. The MA research team will 
develop a list of potential interviewees from internal study records, their knowledge of the 

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communities, and public searches. To gauge interest, potential participants will be contacted by 
the research team through email, no more than three times. If participants do not respond to 
one of the three emails, then they will receive a follow-up phone call or text. HCS MA staff who 
participate in the interview will be asked for their feedback on who in the coalition could be a 
potential interviewee. Over the next two years, participants who participated in the first interview 
may be contacted to participate in a follow-up interview, if needed, or asked to participate in 
community engagement activities around municipal drug policies. Participation in the interviews 
or activities is always voluntary. 
MA HCS study staff will not be compensated as they will complete interviews during their 
working hours. Community members (CAB and Coalition members) and municipal leaders 
within the HCS MA communities and other communities with drug strategies will be offered a 
$25 gift card for their participation in the interviews.  
There are no direct benefits in participating in these interviews. Potential community benefits 
include advancing our understanding of the role municipal policies and practices have in 
supporting the implementation and sustainability of the role of the EBP strategies that were 
introduced as part of the HCS.  
There are no direct risks associated with participation in these interviews beyond potential loss 
of confidentiality for low-risk information related to the implementation of EBP strategies. No 
identifiable information will be disclosed in reports or manuscripts.  
The interview will be audio and/or video recorded. The recording is for the use of the MA 
research site in transcribing the interviews and will not be shared with anyone outside of the 
research team. The recording may include the respondent’s name but identifying information will 
be removed from the recording and transcriptions will be deidentified. The deidentified 
recordings and transcriptions will be saved on a secure server at the Boston University School 
of Social Work. Recordings will be destroyed within 6 months following transcription; 
transcription files will be kept for 3 years following project completion and then destroyed.  
In addition to conducting interviews, the MA research site will qualitatively analyze documents 
including the HCS implementation plans, media and policy scans conducted by the HCS 
communications team and the policy workgroup, documents related to municipal drug policies 
and strategies, and community related news. Documents will be collected through community 
alerts/notifications, implementation plans, and a scan of the municipality website. 
Data will be collected on an ongoing basis between October 2021-July 2022. Interviews and 
documents will be analyzed using both content and thematic analysis to understand what is 
known or being done related to municipal drug policies. They will also be used to identify 
themes that can be translated into recommendations for communities in Massachusetts to 
support community-driven design and enforcement of municipal drug policies. Findings may be 
used in future reports and manuscripts.  
12.4.11 
Photovoice Participatory Research Technique 
The HEALing Communities Study (HCS) Kentucky, Massachusetts and Ohio research sites will 
use the Photovoice participatory research technique to identify community-specific strengths 
and barriers along the continuum of care to prevent opioid overdose deaths in HCS 
communities. Community implementation of the Communities that Heal Intervention (CTH) has 

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revealed a number of both unique and common facilitators and barriers to the continuum of care 
across participating communities (e.g., existence of services, distance to services, stigma, 
cultural beliefs, transportation, homelessness). Understanding the opioid epidemic as 
experienced by community members, including perceptions of existing resources, strengths, 
and barriers, can inform local strategic efforts to prevent overdose deaths.  
Photovoice is a participatory research technique that invites participants to take photos related 
to a chosen challenge in their community. The photos and descriptions are then shared and 
discussed during focus group sessions to explore ways to address the challenge. Over the 
course of the HCS Photovoice sessions in participating communities, participants 1) develop 
photo assignments related to the opioid epidemic, 2) take representative photos to explore 
barriers and strengths related to how their communities are responding to the opioid epidemic, 
3) use photos as a trigger for a focus group discussion, and 4) participate in a focus group 
session focused on each photo assignment. Focus group discussions will be guided by the 
SHOWeD method which uses selected photos as triggers to collectively explore what is 
observed in the photo, reflect on what the photo represents, interpret how it came to be and 
currently affects their lives and the community, and propose actions to address the issue. 
Results will then be disseminated more broadly with community members. At minimum, we will 
encourage sharing results with the community’s HCS coalition to discuss ways to combat the 
opioid epidemic locally. HCS staff, facilitators, and participants will also discuss other means of 
dissemination, potentially including but not limited to presentation(s) at HCS meeting(s), 
presentations to larger community or external forums, community photo displays, and billboards. 
While the overarching goal of the Photovoice projects in HCS communities is to understand 
barriers and facilitators that impact efforts to prevent opioid-related overdose deaths, HCS 
communities will be able to hone the focus of their inquiry to the local context and decide on 
specific photo topics to prepare for each focus group session. For example, a rural community 
with no public transport options may be interested in focusing one session on exploring 
transportation, while an urban community with a geographically distant opioid treatment 
program may be interested in using a session to explore how to expand access to medicines for 
opioid use disorder within their community and surrounding areas.  
The Photovoice projects will be conducted with key community informants, which include 
community members who can provide insight about the state of the opioid epidemic and local 
community resources and responses. Key informants for this effort may include current and 
former opioid users, behavioral health providers, addiction treatment providers, public health 
and social service staff, harm reduction service providers, first responders, members of cultural 
or faith-based institutions, and others with experience, insight, and knowledge of the community.  
The HCS community facing team will develop a list of potential key informants. To gauge 
interest, key informants will be contacted by the research or community teams through email or 
phone no more than three times, or via in person communication during meetings in the 
community. No more than 16 key informants will be recruited from each individual community. 
To keep group size and conversation manageable, individual focus group sessions will be 
limited to 8 participants. Focus groups may be specific to an individual community, or they may 
be cross-community/county and include individuals from Wave 1 and/or Wave 2 
communities/counties.   
 

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The proposed Photovoice projects in the HCS communities will include up to 6 sessions. 
Participants will be offered site-specific compensation up to $50 per session:  
Session 
Activities 
Time 
Commitment 
Incentive 
Orientation 
• 
What is Photovoice? 
• 
Photovoice process 
• 
Ethics of Photography 
• 
Informed consent 
• 
Photo topic development 
1.5 hours 
up to 
$50 
Session 1 
• 
Focus group: Discuss photos 
deemed by participants to be 
most representative of the 
chosen topic; collaboratively 
develop proposed actions  
• 
2nd photo topic development 
1.5-2 hours 
up to 
$50 
OPTIONAL: Session 2 
• 
Focus group 
• 
3rd photo topic development 
1.5-2 hours 
up to 
$50 
OPTIONAL: Session 3 
• 
Focus group 
• 
4th photo topic development 
1.5-2 hours 
up to 
$50 
OPTIONAL: Session 4 
• 
Focus group 
1.5-2 hours 
up to 
$50 
Final session 
Review results and develop 
community dissemination plan 
1.5 hours 
up to 
$50 
Total 
 
4.5 – 11 hours 
Up to $300 
 
Depending on access to smartphones, photos and brief descriptions of photos may be 
submitted via the HIPAA compliant app EpiCollect5. This app also offers a GIS function where 
location of photos could be included if desired by facilitators. Otherwise, photos will be captured 
on digital cameras provided to participants.  
If they agree to participate in the Photovoice project, key informants will be asked to complete a 
brief (5-minute) demographics survey so the study team can gather background characteristics 
of the participants. The survey will ask demographic questions including age, gender, 
race/ethnicity, education, county/community represented, and personal connection to substance 
use disorder. In order to keep the demographic information confidential and de-identified, the 
participant’s responses will not be connected to their name. 
Photovoice sessions may happen in person or via Zoom; they will be audio recorded. The 
recordings will not be shared with anyone outside of the HCS research team. Audio recordings 
will be transcribed. The recording may include the respondent’s name but identifying information 
will be removed from the recording and transcriptions will be de-identified. The de-identified 
recordings and transcriptions will be saved on a secure server at the HCS research site. 

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Recordings will be destroyed within 6 months following transcription; transcription files will be 
kept for 3 years following project completion and then destroyed.  
Data will be analyzed in two stages. Following each session, focus group facilitators will code 
barriers and facilitators impacting the community’s efforts to address the opioid epidemic and 
strengthen the continuum of care in their community. The analysis will be reported back to 
participants at the start of the next session as a form of quality control. A thematic outcome 
analysis will be completed by HCS researchers and interested participants at project conclusion. 
Findings may be used in future reports and manuscripts. 
Each HCS community will have the opportunity to consider whether they are interested in 
implementing a Photovoice project. Participation in the Photovoice project is voluntary, and 
communities and participants may decline or discontinue participation at any time. There is no 
cost to participate, and there are no direct risks associated with participation in this project 
beyond potential loss of confidentiality for low-risk information related to the opioid epidemic in 
their community. No identifiable information will be disclosed in reports or manuscripts. 
Participants will sign an informed consent form, and any individuals depicted in the photos or 
audio recordings will sign a Permission to Use Photographs form and indicate approved use of 
photos in community dissemination or research activities. 
There are no direct benefits for the participant involved in this project. Potential community 
benefits include advancing our understanding of local barriers and strengths in preventing opioid 
overdose deaths to inform strategic decision making, and results can be used in 
communications and dissemination activities.  
Photovoice groups may elect to evaluate efficacy and/or impact of Photovoice and 
dissemination activities as reflected in responses to programmatic surveys.  HCS RS may 
receive deidentified data collected during the course of these Photovoice “administrative” 
activities.  
PROCESS:   
• 
Point person, through their administrative role in Photovoice operations, will 
remove identifying information.   
• 
Point person will then transfer deidentified data to HCS research team. If available, 
deidentified data may include impact of the Photovoice exhibit (i.e., understanding 
community strengths and concerns, community experience with opioid epidemic, 
impact of images, takeaway message, experience with Photovoice, among other 
relevant topics), the individual’s role or connection to Photovoice and/or substance 
use disorder as well as demographics.  County served is a programmatic 
requirement for HCS, and if available, will be retained.   
• 
Point person on HCS research team will store these data on a secure, local, 
approved informatics environment with access limited to delegated members of the 
HCS research team. 
• 
Delegated members of the HCS research team will extract and/or aggregate 
information as necessary to evaluate the efficacy of Photovoice and dissemination 

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research activities.   
The HCS research team will not be able to identify individuals surveyed. Data will be stored in 
secure, local, approved informatics environments for 3 years after the conclusion of the study. 
12.4.12 
Race and Ethnicity Data Collection Readiness Survey 
At the HEALing Communities Study (HCS) New York research site, community implementation 
has revealed a difference in racial and demographic data collection across partner 
organizations. Understanding the process that an organization is using to collect and monitor 
demographic data may inform us on identifying challenges and successes of our community 
partners gathering demographic information. To develop an understanding of demographic data 
collection, the NY HCS research site will conduct a survey with key informants working at our 
HCS partner organizations. From this survey, the team plans to learn about the perceived and 
actual barriers preventing our county partners from obtaining race, ethnicity, gender, sex, 
language and/or age data from the population their organization serves. The aim of this survey 
is to gain a deeper understanding of health inequity in these community settings and address 
them through targeted education and learning collaboratives. Between 60 to 70 Wave 1 
organizations will be recruited to participate in the survey. The NY HCS research team will 
develop a list of potential survey participants from the internal study records. To gauge interest, 
potential participants will be contacted by the research team through email, no more than three 
times. If participants do not respond to one of the three emails, then they will receive a follow-up 
phone call or text. Participants will be asked to complete this survey once; there are no 
additional follow-up surveys.  
Participation in this survey is voluntary. There will be no compensation for participating in the 
survey. There are no direct benefits in participating in these surveys. Potential community 
benefits include advancing our understanding of perceived and physical barriers preventing our 
county partners from obtaining race, ethnicity, gender, sex, language and or age data from their 
patient population. 
There are no direct risks associated with participation in these surveys beyond potential loss of 
confidentiality for low-risk information related to an organizations system of collecting 
demographic data. Participants will be asked to provide their name, email address, name of 
their organization, job title, and their organization’s zip code. This information will be stored 
separately from the information collected about the process their organization uses to collect 
and monitor demographics data. All collected information will be stored in secure, encrypted to 
protect confidentiality. We will not share name and contact information with anyone outside of 
the research team. All data will be assigned a unique, coded participant ID. No identifiable 
information will be disclosed in reports or manuscripts.  
12.4.13 
PARTNER Tool 
The HEALing Communities Study (HCS) Ohio research site’s community engagement team will 
conduct a social network analysis by administering the PARTNER Tool to Wave 2 county 
coalitions. The PARTNER tool is a 24-item survey that will be given to HCS community coalition 
members which asks about 1) their views on the coalition as a whole and 2) their interactions 
with other coalition members. The purpose of this research activity is to better understand the 
role coalition members (i.e., agencies) play within the coalition, what resources each agency 

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brings to the table, identify activity levels of agencies in the coalition, and determine how these 
agencies interact to address the opioid epidemic in their communities/counties.  
HCS Ohio study staff will work with coalition leaders to build a list of potential participants for 
each Wave 2 county/community. Potential participants will be sent an introductory email, 
explaining the PARTNER Tool survey. This email will explain to potential participants that they 
can either complete the survey online or over the phone. If the potential participant wants to 
complete the survey over the phone, the email provides contact information for a study staff 
member. This staff member will verbally consent the participant prior to beginning the survey. If 
the potential participant chooses to complete the survey online, they will review the informed 
consent information (provided in the email) prior to completing the online survey. Participants 
can contact Ohio study staff if they have questions or concerns about the study and are given 
time to decide if they would like to participate. The survey will be repeated once, at the end of 
the study period.  
The survey, data, and analysis tools will be housed online through the Visible Network Labs 
(VNL) group who own the PARTNER Tool.  Participant survey data will be collected and stored 
on VNL’s HTTPS encrypted servers.  The data is only accessible through the VNL web interface 
and requires a login.  Ohio HCS study staff will be given a ‘manager-level’ login where they can 
access participant data and the analysis tool which can generate network maps and scores. 
Study staff will be able to track the number of started and completed surveys which will be used 
to track how many individuals declined to participate (i.e., those that are listed as “Not Started” 
on the VNL website).  Only HCS Ohio staff will communicate directly with participants (e.g., 
reminder emails, phone call, etc.).   
Using the data and analysis tool from the online VNL portal, study staff will generate summary 
reports for each county/community coalition. These reports will only describe network-level 
outcomes such as centralization or density and will not report on specific coalition member 
scores.  The Ohio HCS Community Engagement team will work with coalition leaders to present 
the results to the coalition and discuss implications (e.g., what sectors are underrepresented in 
the coalition, which resources are being contributed or not contributed). Ohio HCS Community 
Engagement Facilitators will also use the results as a tool to better understand coalition 
connections and function. 
12.4.14 
Medication Disposal Program Pharmacy Interviews 
To monitor ORCCA EBP Requirement 3: Safer opioid prescribing and dispensing, the Kentucky 
Research Site (RS) will conduct individual or small group semi-structured interviews with staff at 
community pharmacies who partnered with HCS to increase access to safe medication disposal 
through installation of a medication disposal drop box.  This activity is site-specific to Kentucky. 
The interviews are intended to gather information about satisfaction with the experience, 
barriers to implementation and maintenance, readiness for sustainment of drop boxes, training 
or technical needs related to drop box maintenance, and the inner construct of the pharmacy. 
The resulting information may be helpful in explaining how overcoming previously identified 
barriers to pharmacy-based medication disposal can increase safe medication disposal options 
in a community and potentially decrease the amount of medication, including prescription 
opioids that are available for misuse or accidental poisoning.  The information may also identify 
new barriers and facilitators. 

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HCS Disposal Program Coordinators will seek to conduct one-on-on or small group semi-
structured interviews with staff working in pharmacies who participated in the HCS medication 
disposal program.  It is anticipated that the pharmacy owner or manager will participate in the 
interview, but some interviews may include other pharmacy staff. Efforts will be made to conduct 
interviews with all pharmacies within HCS communities that have installed a medication 
disposal drop box.   
The team will contact potential participants by email no more than 2 times and by telephone no 
more than 3 times to explain the purpose of the interview and ask if they are willing to 
participate. If the pharmacy declines the interview, an offer to discuss only sustainability will be 
made. In the event that the pharmacy is unable to schedule any type of interview, a one-page 
sustainability summary will be sent to the pharmacy for review.  
Each small group interview will typically include individuals from a single pharmacy, but in the 
case of a small pharmacy chain or an individual owning multiple pharmacies, more than one 
pharmacy may be represented. If individual(s) from the organization agree to an interview, they 
will be given a link to schedule the interview, or the research team will schedule the interview. 
During the interview, participants will be asked open-ended questions. Because of the semi-
structured nature of the interview, interviewers may probe for clarity or greater detail. The 
interview guide will not ask individuals about their personal beliefs or their personal experience 
with health care. 
The interview will be audio-recorded and transcribed. Identifying information will not be shared 
with anyone outside of the research team. The recording may include the names of individuals 
but identifying information will be removed from the interview transcript and a pharmacy ID 
number substituted in its place. The audio files and transcription will be saved on a secure 
server at the HCS Kentucky research site. Recordings will be destroyed within 6 months 
following transcription; transcription files will be kept for 3 years following project completion and 
then destroyed.   
12.4.15 
Mobile Interventions for Increasing Access to Medications for Opioid Use Disorder 
(MOUD) 
The HEALing Communities Study (HCS) Massachusetts, New York and Ohio research sites will 
conduct semi-structured interviews with key informants from implementing organizations in HCS 
communities to understand the facilitators of and barriers to implementing mobile MOUD 
interventions (e.g., interventions that provide mobile access to clinicians who prescribe 
buprenorphine, naltrexone, or methadone). The interviews are intended to gather information 
about services offered, barriers and facilitators to standing up such programs, as well as 
additional factors that are required to implement and sustain each strategy. The resulting 
information will be used to develop a set of best practices for other organizations seeking to 
implement mobile MOUD programs.  
The research team will seek to interview 1-2 key informants from implementing organizations in 
Wave 1 HCS communities that have created or are creating mobile MOUD interventions, 
including five communities in Massachusetts, five in New York, and one in Ohio. The team will 
identify the key informant(s) at each organization most likely to have knowledge about 
implementation planning and operations of the mobile MOUD programs. Up to thirty-three 
interviews will be conducted. In most cases, these key informants are people already known to 
the HCS research team.  

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Research staff will contact potential participants by email to explain the HCS study and ask if 
they are willing to participate in an interview via phone or video conference (Zoom). The 
interview may last up to an hour, depending on the role and knowledge of the key informant. If a 
key informant agrees to participate, the team will schedule the interview. The research team will 
document the key informant’s name, role, and contact information in REDCap before the 
interview. During the interview, key informants will be asked a series of questions to explore the 
experiences of standing up mobile MOUD interventions. Key informants will be offered a $50 gift 
card or a pre-paid debit card (ClinCard) for their participation. 
The interviews will be audio recorded. The recordings will not be shared with anyone outside of 
the HCS research team. Audio recordings will be transcribed. The recording may include the 
respondent’s name but identifying information will be removed from the recording and 
transcriptions will be de-identified. The audio files and transcriptions will be saved on a secure 
server at the research site. Audio files will be destroyed within 6 months following transcription; 
transcription files will be kept for up to 3 years following project completion and then destroyed. 
Aside from participants’ names and organizational affiliation, the interview will not collect PHI/PII 
from the respondent. No identifiable information will be included in presentations or publications 
of results. 
12.4.16 
A Cost Analysis of Peer Recovery Support Services 
Opioid Use Disorder (OUD) is a chronic brain disease which has historically been treated 
through a process more appropriate for acute conditions. This short-term care, which has 
largely been focused on stabilizing a patient’s emergent condition, has failed to lead to optimal 
longer-term remission and recovery outcomes. Due to the lack of effective ongoing treatment, 
as many as 3-9% individuals with a prior opioid overdose are readmitted for opioid 
dependence or another overdose within one year. Additionally, beginning a treatment program 
is often just one step in a complex recovery process as substance use disorders (SUDs) are 
often accompanied by additional mental, social, legal, occupational, and other medical needs. 
Peer Recovery Services are growing in popularity throughout the nation as a means of 
assisting individuals with SUDs by providing emotional, informational, and instrument support. 
Numerous studies have proven the effectiveness of these services in improving care and 
recovery outcomes for individuals with SUDs.  However, a common theme among these 
analyses is that services are often not standardized, and the term peer is often applied 
generally and does not specify training or services provided by an individual.  As a result of 
these findings, systematic reviews suggest identifying a clearer description of peer recovery 
support roles and responsibilities.  Additionally, while these reviews mention that the use of 
peer recovery services may result in cost savings through decreased emergency and hospital 
services, none of the studies reported on the cost of peer recovery itself. 
To operationalize and build capacity for ORCCA EBP Requirement 2: Effective delivery of 
MOUD, including agonist/partial agonist medication and outreach and delivery to high-risk 
populations, the Kentucky (KY) HEALing Communities research site (RS) has partnered with a 
nonprofit community recovery organization, Voice of Hope, which trains and manages 
numerous peer recovery specialists to provide MOUD treatment linkage and retention 
services. Because HCS provides funding support for peer recovery specialists, this partnership 
offers a unique opportunity to assess the effectiveness of peer support services in the delivery 

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of MOUD as well as the impact of implementing Evidence Based Practices (EBPs) in 
partnering organizations. Obtaining accurate cost information for peer recovery services is 
critical for evaluating program effectiveness and informing future policy decisions.  Due to the 
current lack of studies in this field, the goals of this HCS research activity are to build a set of 
standard service categories for OUD peer recovery support services which are provided by 
one agency in Kentucky.  Once completed, associated time and resource costs for each 
component will be calculated.  Understanding the costs of this intervention targeting OUD 
within a highly impacted state like Kentucky, and the impact of peer support services in the 
delivery of MOUD in highly impacted HCS communities, will provide greater insight into its 
economic viability and support researchers, practitioners, and policymakers in determining 
future funding allocations for combatting this epidemic.   
The KY HCS Research Site (RS) will answer the following research questions (RQ) through 
this new HCS research activity:  
• 
RQ1: What are the common peer recovery service categories used to provide support 
for OUD recovery? 
• 
RQ2: What roles and resources are needed for operating a peer recovery support 
organization? 
• 
RQ3: What are the unit costs for specific services provided by peer recovery support 
organizations? 
The KY HCS RS will examine peer recovery support services provided by our partners at 
Voices of Hope (VOH).  Data collection will be limited to information on organizational costing.  
Because no human subjects are being studied and no PII or PHI is being collected, informed 
consent is not required, and Waiver of Consent is requested. 
A two-pronged approach will be used to assess organizational costing for peer recovery 
services: 
1. The KY RS will work with VOH to classify a set of standard service categories and the 
types of staffing required to provide these services.  Using these data, the Substance 
Abuse Services Cost Analysis Program (SASCAP) Labor Module has been adapted for 
Peer Recovery Services Agencies and will be administered to staff at VOH. The SASCAP 
Labor Module is a validated instrument that will be used to identify the amount of time 
spent among the different job types on the standard set of peer recovery services.  This 
instrument will be administered by the HCS KY Health Economics team through an 
electronic survey with follow-up conversations with VOH as needed to clarify survey 
responses. The SASCAP Labor Module has been submitted as part of this modification.  
2. The KY RS will use the SASCAP Cost Module to estimate agency-level annual operating 
costs.  The SASCAP Labor Module is designed to do activity-based costing and is 
combined with the SASCAP Cost Module to do program/agency-level costing. Together 
these provide an estimate of total annual operating costs of the agency plus the cost per 
specific service. The SASCAP Cost Module has been submitted as part of this 
modification. 

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Data will be collected with the SASCAP instruments, which are Word or PDF documents that 
can be edited. The KY RS team will work directly with a key informant from VOH agency (CEO 
or similar that has access to financial records and other pertinent information on resources to 
deliver services). These data will be transferred to an Excel spreadsheet.  Once collected, cost 
data will be organized in a statistical software program (e.g., STATA) and will be analyzed 
using algorithms designed by RTI to produce cost analysis results. Results will be reported as 
total annual agency cost, average cost per client served, and average cost per service type. 
Data collection will be limited to organizational costing. All data collected from these research 
activities will be stored in KY’s local, secure, approved informatics environment for 3 years 
after the conclusion of the study.  
12.4.17 
Wave 1 Partner Organization Sustainability Interview 
To expand knowledge regarding the experiences of Wave 1 partner organizations in 
implementing ORCCA (Opioid-overdose Reduction Continuum of Care Approach) Menus 1 and 
2 and to learn about the period of early sustainment (approximately 6 months after the end of 
Wave 1), HCS staff from all four research sites will conduct small group and/or individual semi-
structured interviews with staff working in organizations that partnered with the HEALing 
Communities Study (HCS). The interviews are intended to gather information about internal, 
external, and intervention-related factors that facilitated or impeded implementation as well as 
how these factors are impacting the ability of organizations to sustain these evidence based 
practices (EBPs). The resulting information may be helpful in contextualizing the efforts to 
implement aspects of Menus 1 and 2 as well as broaden our understanding of barriers to and 
facilitators of sustainment. 
Trained HCS Research Site (RS) staff will conduct small group and/or individual semi-structured 
interviews with staff working in Wave 1 partner organizations that implemented EBPs from 
Menu 1 and/or Menu 2. Approximately 50 partner organizations per HCS site will be asked to 
participate in the small group semi-structured interviews (approximately 200 total across all four 
RSs). It is anticipated that 2-3 staff from a given organization will participate in the interview 
(some interviews may be conducted with a single individual depending on interest within the 
organization) for an estimated sample size of about 450 participants.  
To identify potential interviewees, the team will draw upon internal site databases to identify a 
purposive sample that includes a range of organizations, including those located in rural and 
urban communities, those that are or are not represented on the coalition, and those in the three 
primary sectors of HCS (health care, behavioral health, and criminal justice). Efforts will be 
made to conduct interviews with all Wave 1 communities, recognizing that the distribution of 
organizations between communities is likely to vary based on the strategies chosen by the 
respective HCS coalitions. 
Trained HCS RS staff will contact potential participants by email or telephone to explain the 
purpose of this data collection and ask if they are willing to participate in a small group or 
individual interview. Interviews will be conducted by video conference or by telephone. If 
conducted in a small group format, the interview will only include individuals from a single 
organization. If individual(s) from the organization agree to an interview, the team will schedule 
the interview. After providing verbal informed consent, participants will be asked open-ended 
questions (see Wave 1 Partner Organization Sustainability Interview Guide). Because of the 
semi-structured nature of the interview, interviewers may probe for clarity or greater detail. The 

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interview guide will not ask individuals about their personal beliefs or their personal experience 
with health care. At the end of the interview, using the IRB approved HCS Demographic Form, 
information on race, ethnicity, gender, age, and education will be collected. Each individual who 
participates will receive $50 (in the form of check, cash card, or gift card), unless state, 
government, and employer regulations or policies do not permit employees to receive 
compensation for participating in studies. 
The interview will be audio-recorded and transcribed. Identifying information will not be shared 
with anyone outside of the research team. The recording may include the names of individuals 
or organizations but identifying information will be removed prior to inclusion in any study-
related report. The audio files and transcripts will be saved on a secure server at each RS and 
destroyed no later than 3 years following project completion.