Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention
Phase: NA
Conditions: Substance Use Disorders, Overdose
Sponsor: Indiana University

 
 
 
 
 
 
Project POINT:  
Effectiveness and Scalability of an  
Overdose Survivor Intervention 
 
Protocol Number: 1706859955 
 
Principal Investigators:  
Alan McGuire, PhD, Indiana University, Richard M. Fairbanks School of Public Health; Indianapolis, IN 
Dennis Watson, PhD, Chestnut Health Systems, Lighthouse Institute; Chicago, IL 
 
Funded By: National Institute on Drug Abuse (NIDA) 
NIH Grant/Contract Award Number: R33DA045850 
 
 
V7 
02/03/2020 
[V1 approved 09/12/2017]

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
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recipient that no unpublished information contained herein will be published or disclosed without prior 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 Investigator or other participating study leadership and as consistent with the 
NIH terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 4 
1.3 
Schedule of Activities .......................................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................................................ 5 
2.1 
Study Rationale .................................................................................................................................... 5 
2.2 
Background........................................................................................................................................... 5 
2.3 
Risk/Benefit Assessment .................................................................................................................... 6 
2.3.1 
Known Potential Risks ..................................................................................................... 6 
2.3.2 
Known Potential Benefits ................................................................................................ 6 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 6 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 7 
4 
STUDY DESIGN ............................................................................................................................................. 8 
4.1 
Overall Design ...................................................................................................................................... 8 
4.2 
Scientific Rationale for Study Design................................................................................................ 8 
4.3 
Justification for Intervention ............................................................................................................... 8 
4.4 
End-of-Study Definition ....................................................................................................................... 8 
5 
STUDY POPULATION .................................................................................................................................. 9 
5.1 
Inclusion Criteria .................................................................................................................................. 9 
5.2 
Exclusion Criteria ................................................................................................................................. 9 
5.3 
Lifestyle Considerations ...................................................................................................................... 9 
5.4 
Screen Failures .................................................................................................................................... 9 
5.5 
Strategies for Recruitment and Retention ........................................................................................ 9 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 10 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 10 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 10 
6.1.2 
Administration and/or Dosing ....................................................................................... 10 
6.2 
Fidelity ................................................................................................................................................. 12 
6.2.1 
Interventionist Training and Tracking .......................................................................... 12 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 12 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 13 
6.5 
Concomitant Therapy ........................................................................................................................ 13 
6.5.1 
Rescue Therapy ............................................................................................................. 13 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 13 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 13 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 13 
7.3 
Lost to Follow-Up ............................................................................................................................... 14 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 14 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 14 
8.2 
Safety Assessments .......................................................................................................................... 15 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 15 
8.3.1 
Definition of Adverse Events ........................................................................................ 15 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 15 

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8.3.3 
Classification of an Adverse Event .............................................................................. 16 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 17 
8.3.5 
Adverse Event Reporting .............................................................................................. 17 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 18 
8.3.7 
Reporting Events to Participants ................................................................................. 18 
8.3.8 
Events of Special Interest ............................................................................................. 18 
8.3.9 
Reporting of Pregnancy ................................................................................................ 18 
8.4 
Unanticipated Problems .................................................................................................................... 18 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 18 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 18 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 18 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 18 
9.1 
Statistical Hypotheses ....................................................................................................................... 19 
9.2 
Sample Size Determination .............................................................................................................. 19 
9.3 
Populations for Analyses .................................................................................................................. 20 
9.4 
Statistical Analyses............................................................................................................................ 20 
9.4.1 
General Approach .......................................................................................................... 20 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 21 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 22 
9.4.4 
Safety Analyses .............................................................................................................. 24 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 24 
9.4.6 
Planned Interim Analyses ............................................................................................. 24 
9.4.7 
Sub-Group Analyses ..................................................................................................... 24 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 24 
9.4.9 
Exploratory Analyses ..................................................................................................... 24 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 25 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 25 
10.1.1 
Informed Consent Process ........................................................................................... 25 
10.1.2 
Study Discontinuation and Closure ............................................................................. 25 
10.1.3 
Confidentiality and Privacy ........................................................................................... 26 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 27 
10.1.5 
Key Roles and Study Governance .............................................................................. 27 
10.1.6 
Safety Oversight ............................................................................................................. 27 
10.1.7 
Clinical Monitoring .......................................................................................................... 28 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 28 
10.1.9 
Data Handling and Record Keeping ............................................................................ 28 
10.1.10 
Protocol Deviations ........................................................................................................ 29 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 29 
10.1.12 
Conflict of Interest Policy .............................................................................................. 30 
10.2 
Additional Considerations ................................................................................................................. 30 
10.3 
Abbreviations and Special Terms ................................................................................................... 30 
10.4 
Protocol Amendment History ........................................................................................................... 32 
11 
REFERENCES ................................................................................................ Error! Bookmark not defined. 
 

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STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the National 
Institute on Drug Abuse Terms and Conditions of Award. The Principal Investigator will assure that no 
deviation from, or changes to the protocol will take place without prior agreement from the funding 
agency and documented approval from the Institutional Review Board (IRB). All personnel involved in the 
conduct of this study 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 IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
02/03/2020 
 
Name*:  Dennis P. Watson 
 
Title*: Principal Investigator  
 
Investigator Contact Information 
Affiliation*: Chestnut Health System, Senior Research Scientist  
Address: 221 W Walton St. Chicago, IL 60610 
Telephone: 312-274-5316 
Email: dpwatson@chestnut.org  
 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Following Opioid Overdose Survivors to Improve Emergency 
Department-Based Services: A Pilot Study 
Grant Number: 
R33DA045850 
Study Description: 
The investigators seek to conduct a pragmatic trial to assess the 
effectiveness of Project POINT (Planned Outreach, Intervention, 
Naloxone, and Treatment), an emergency department (ED)-based peer 
recovery coach intervention for people with opioid use disorder who 
present to the ED. 
Objectives*: 
 
The primary goal of this project is the establishment of POINT as an 
effective and scalable intervention for connecting patients to 
medications for opioid use disorder (MOUD). This study employs a 
Hybrid Type 1 effectiveness implementation design to take full 
advantage of current POINT expansion efforts currently happening in 
Indiana, with the goal of the effectiveness component described in this 
protocol to be testing the effectiveness of POINT under real-world 
conditions. 
Endpoints*: 
Primary Outcome Measure:  
1. Overdose Admissions  
Secondary Outcomes Measures:  
2. Medication for opioid use disorder (MOUD) engagement 
3. Duration of MOUD Engagement 
4. ED Admissions 
5. Inpatient Hospital Admissions 
6. Time to Relapse 
7. Medicaid Enrollment for Participants Without Insurance 
8. Child Welfare Involvement 
9. Incarceration 
Study Population: 
Inclusion Criteria: (a) Revived from a drug overdose or admitted to the 
ED for an opioid-related health issue, including opioid withdrawal, 
abscess (from intravenous (IV) opioid use), endocarditis (from IV opioid 
use), or active opioid intoxication; (b) Score at least “1” on the 
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 for 
Opioid Use Disorder screening tool; (c) Eligible for discharge from a 
participating ED and deemed able to speak to research staff by ED staff; 
(d) Be 18 or older; (e) Be medically stable (i.e., cleared to leave the ED 
by a physician) and capable of providing consent. 
Phase* or Stage: 
N/A 
Description of 
Sites/Facilities Enrolling 
Participants: 
Indiana University (IU) Health Ball Memorial Hospital; IU Health 
Methodist Hospital 

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Description of Study 
Intervention/Experimental 
Manipulation: 
POINT is a quality improvement initiative that connects trained 
outreach workers with ED patients who experienced a non-fatal 
overdose. A member of the POINT team (a peer recovery coach) meets 
patients after they have experienced an opioid overdose and, following 
a model of patient-centered care, offers them a range of evidence-
based services including a brief assessment of high-risk behaviors, 
Hepatitis C and HIV testing, harm reduction counseling informed by 
motivational interviewing, and treatment referrals with follow-up to 
either MOUD provider, detoxification services, or an inpatient 
treatment setting. 
Study Duration*: 
58 months (February 2018-December 2022) 
Participant Duration: 
Original data collection occurs only at enrollment and includes a single 
30–60-minute structured interview. Administrative data is accessed for 
a 5-year period (i.e., 3 years prior to enrollment- 2 years post 
enrollment).  
1.2 
SCHEMA  
 
Figure 1: Flow Diagram including original planned enrollment* 
 
 
 
 
Note: Planned enrollment was not met after enrollment activities were 
temporarily stopped for several months at the busiest enrollment site due 
to the COVID-19 pandemic. An alternative plan using a retrospective case 
control design was approved by the study funder.  

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1.3 
SCHEDULE OF ACTIVITIES  
 
Table 1: Schedule of Activities  
 
Procedures 
Enrollment 
24 months post-enrollment 
Informed Consent 
x 
 
Intake Information 
x 
 
Patient Questionnaire 
x 
 
Adverse Childhood Experiences 
(ACEs) Questionnaire  
x 
 
Secondary Data Pull  
 
x* 
*Secondary data are pulled at a coordinated time point at which data reflecting 24 months post-
enrollment was provided for each study participant. 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Opioid misuse and addiction are at historic heights in the United States. Despite significant need, 
substantial treatment and design barriers prevent many opioid users from accessing medications for 
opioid use disorder (MOUD), the gold standard treatment for opioid use disorder (OUD).  
 
Planned Outreach, Intervention, Naloxone, and Treatment (POINT) is an emergency department (ED)-
based intervention for engaging opioid overdose survivors into MOUD. POINT was conceptualized (and 
implemented at its originating site) as a critical time intervention in that it seeks to quickly mobilize 
support for members of a highly vulnerable population at a juncture in their lives when they are likely to 
be receptive to assistance (i.e., after an overdose). It accomplishes this through use of peer recovery 
coaches (i.e., individuals with lived experience of recovery who are trained to assist those struggling with 
addiction) who assist patients to navigate barriers to MOUD access after ED discharge. The use of recovery 
coaches in substance use disorder services is based in the premise that patients will be more receptive to 
sharing their personal struggles with someone who has had similar experiences. The primary goal of this 
project is the establishment of POINT as an effective and scalable intervention for engaging patients in 
MOUD through a Hybrid Type I effectiveness-implementation study. The component of this study 
described in this protocol is a pragmatic trial that seeks to understand the effectiveness of POINT under 
real-world conditions. 
 
2.2 
BACKGROUND  
 
Despite its demonstrated effectiveness, the availability of providers offering MOUD is in short supply. 
Even where MOUD is available, a significant portion of opioid users encounter treatment and design 
barriers. Moreover, stigma associated with OUD and ubiquitous abstinence-only views have resulted in 
political roadblocks to MOUD expansion and reluctance among opioid users to seek and accept treatment. 
Previous studies indicate high motivation for change among opioid users, suggesting treatment avoidance 
is not the primary issue. As such, an increase in MOUD availability must be accompanied by innovative 

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approaches to help opioid users navigate obstacles blocking both access to and continued engagement in 
MOUD. Furthermore, people who use opioids and injection drugs inconsistently utilize health care 
services and are heavier users of emergency and inpatient hospital care than the general population. 
Therefore, the ED is in a unique position to identify, develop, and implement solutions to improve 
outcomes in this population. There is indeed burgeoning evidence supporting ED-based interventions for 
substance misuse.  
 
At the time of this study’s conceptualization, POINT was developed and operating in Indianapolis’s 
Eskenazi Hospital. Initial results of a quality improvement study supported the intervention’s potential for 
improving patient outcomes. The proposed project aimed to extend this work  
 
Using settings and protocols more reflective of “real-world” conditions to study POINT will help ensure 
relevance of resulting findings to practice. This is particularly important considering the need for fast 
translation of evidence in light of the significant toll the opioid crisis is taking on the nation. The fact that 
POINT was already undergoing scaling activities at the time of the study’s conceptualization was an 
important opportunity to take advantage of considering key stakeholder decisions to promote or adopt 
interventions are often made without regard to the scientific evidence.  
 
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
 
Immediate risks to participants include: the potential that individuals may feel uncomfortable due to the 
sensitive nature of some of the questions that will be asked at intake or that they may become fatigued 
answering questions. There is also a risk of loss of confidentiality related to data collection, including the 
secondary data collection, should there be a breach during the collection or data transfer process (prior 
to the deidentification of data). In particular, individuals may be identified as a substance user. This may 
result in stigma for the individual. However, it is important to note that individuals will not suffer risk of 
criminal prosecution for drug use should their opioid overdose become known by the police, as 
possession, not use, is a criminally prosecutable risk in Indiana. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Immediate benefits that subjects may likely gain include: the opportunity to discuss and reflect on their 
recent opioid use and/or overdose, a list of resources that may benefit them as someone who uses 
opioids (these resources will be provided even if they do not choose to participate in the study), and the 
opportunity to inform research that may lead to the development of stronger interventions to assist 
people at risk of future opioid use or overdose. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
Sensitive data collected for this study (e.g., data pertaining to illicit drug use) are necessary to assess the 
proposed outcomes and examine the implementation of POINT. Study procedures aim to minimize risks 
associated with the collection of these data through the following ways: (a) all original data collection 

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will occur in a private area where others cannot overhear what is shared or see the interaction between 
research staff and participant; (b) all data collected during these interviews will be entered directly into 
Research Electronic Data Capture (REDCap to ensure secure data storage is HIPAA compliant and that 
only relevant research team members will have access to these data; (c) research staff will assure all 
participants throughout the interview that they may choose to skip any questions they do not want to 
answer and will also end the interview or skip the question if the participant seems distressed about 
sharing the information requested; (d) secondary data will be accessed through the assistance of 
Regenstrief Institute, an honest broker who can act as a firewall between personally identifiable health 
data and the researchers. Regenstrief will mask and merge the data and ensure all data are stripped of 
personally identifying information before delivering them to the research team. Specifically, Regenstrief 
will link hospital, government, substance abuse treatment, and data collected by the research staff and 
will keep the identification key and not share it with the research team so that information remains 
confidential.  
3 
OBJECTIVES AND ENDPOINTS  
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
PUTATIVE 
MECHANISMS OF 
ACTION 
Primary  
 
 
 
Assess POINT’s effectiveness 
at reducing overdose 
presentations to the 
emergency department.  
 
Overdose 
Admissions 
The primary goal of the 
intervention as it is designed is 
to reduce overdoses by linking 
clients to MOUD treatment.   
Engagement in 
MOUD treatment 
is demonstrated to 
reduce overdose.    
Secondary  
 
 
 
Assess POINT’s effectiveness 
at improving treatment-
related outcomes. 
MOUD Engagement 
These outcomes should improve 
following linkage to MOUD.  
MOUD treatment 
is associated with 
better treatment 
outcomes 
compared to 
alternative 
treatments for 
OUD. 
Duration of MOUD 
Engagement 
Time to Relapse 
ED Admissions 
Hospital Admissions 
Overdose Mortality 
Medicaid Enrollment 
Exploratory 
 
 
 
Assess POINT’s effectiveness 
at improving recovery-
related outcomes. 
Child Welfare 
System Involvement 
These outcomes should improve 
as a function of treatment 
engagement. 
MOUD treatment 
should result in 
greater abstinence 
from illicit opioids 
that will improve 
other areas of a 
patient’s life.  
Incarceration 
 
 
 
 

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4 
STUDY DESIGN 
 
4.1 
OVERALL DESIGN 
The primary objective of this pragmatic clinical trial is to replicate POINT at two new hospitals and 
establish POINT’s effectiveness compared to standard care. In doing so, we aim to understand POINT’s 
effect on the recovery process, including treatment and recovery outcomes and overdose. We 
hypothesize that POINT patients will engage in MOUD at higher rates, remain in treatment longer, and 
have significantly improved outcomes in comparison to the standard care group.  
Hospital patients meeting the eligibility criteria at one of the two participating EDs are approached by a 
recovery coach or research assistant and invited to enroll in the study. Participants of the study are 
randomly enrolled into one of two study arms: (1) the POINT intervention arm, in which they receive 
ongoing recovery support services from a recovery coach or (2) the control arm, in which they receive a 
list of available local resources for substance use disorder from the research assistant. The study utilizes 
shift-level randomization, and each day of enrollment is separated into three enrollment shifts which 
are randomly assigned to one of the two study arms. Thus, participants’ arm assignment is pre-
determined by the shift in which they are discharged from the ED and enrolled into the study.  
Participants are asked to complete a single structured interview at the time of their enrollment and are 
followed longitudinally only through administrative data, which is collected for participants from three 
years prior to their enrollment through two years following their enrollment.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
The rational for a pragmatic trial is based on the fact that POINT was already demonstrating success and 
implemented as standard care at its originating hospital site and was under consideration to be 
implemented as regular care at the current study’s participating hospital system at the time of study 
design. Given this, a standard explanatory trial was considered unfeasible. Furthermore, the funding 
mechanism supporting the project was designed to support research aimed at taking advantage of 
opioid use disorder-related initiatives that were already underway as part of Opioid State Targeted 
Response funding, which required researchers to design a study around already developing state plans 
and efforts.   
4.3 
JUSTIFICATION FOR INTERVENTION 
The rational for providing recovery coach support at the patient ED bedside is because an emergency 
room encounter is considered a critical point in time when a person might be more motivated toward 
and accepting of treatment linkage. The minimal acceptable participation is engagement with the 
recovery coach at one time point while in the emergency department.   
4.4 
END-OF-STUDY DEFINITION 
 

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A participant is considered to have completed the study if he or she has completed the baseline 
assessment. The end of the study is defined as completion of this assessment.  
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
To be eligible for the study, a patient must:  
 
1. Be revived from a drug overdose or admitted to the ED for an opioid-related health issue, 
including opioid withdrawal, abscess (from IV opioid use), endocarditis (from IV opioid use), or 
active opioid intoxication. 
2. Score at least “1” on the opioid use disorder screening tool. 
3. Be eligible for discharge from one of the two participating EDs and deemed able to speak to 
research staff by ED staff. 
4. Be age 18 or older.  
5.  Be medically stable (i.e., cleared to leave the ED by a physician) and capable of providing consent.  
5.2 
EXCLUSION CRITERIA 
 
A patient will be excluded from the study if:  
 
1. They are unable to answer the 3 study competency questions that indicate capability of providing 
consent.  
5.3 
LIFESTYLE CONSIDERATIONS 
 
Not applicable.  
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not entered 
into the study because they do not meet the inclusion or exclusion criteria (i.e., failure of screening). If 
research staff or recovery coaches learn that the clinical information provided for someone previously 
consented to the study was inaccurate (for example, if a research staff member learns from a participant 
during their baseline assessment that their admission to the ED was non-opioid related and that the 
participant does not use opioids), data collection will be discontinued, and the participant will be 
excluded from the study. The patient will still be provided with the related study compensation for their 
time.  
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 

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Individuals who are admitted to the ED for either an opioid overdose OR an opioid-related health issue 
will be deemed initially eligible, and the research personnel will be alerted of their presence in the ED. 
Research staff will also verify that the patient is at least 18 years of age. Once the initial eligibility is 
determined per the medical staff (reason for admission and at least age 18), either the recovery coach 
or the research assistant will approach the patient to inform them of study. This interaction will occur in 
the room in which they are receiving care in the ED, which is confidential area of the ED. They will use 
this initial meeting to explain the study and to ask the patient the questions from the opioid use 
disorder screening tool. If the patient scores at least a "1" on the opioid use disorder screening tool, 
they will be initially eligible for the study. They will then provide a brief overview of who they are and 
what the POINT study involves.   
 
Because this initial interaction will occur prior to their discharge clearance, the research staff or recovery 
coach will reiterate to the patient that the research study is not a part of the treatment plan, and the 
patient may decline the study without impacting their treatment. Further, this "pre-discharge clearance" 
interaction will not hinder the discharge process; rather, we will utilize the "down time" the patient 
experiences while waiting in the ED. Once this initial discussion is complete, and if the patient chooses 
to take part, the research staff will return to the patient once he or she has received medical clearance 
for discharge from the ED and will move forward with the consent process. 
 
Participants receive a $30 gift card for their participation in the study. Research staff or recovery 
coaches will inform patients of this while explaining the study to the patient. The incentive is received at 
the end of their study visit.  
 
Retention strategies are not applicable to the study, as participant will only be followed longitudinally 
through secondary administrative data.  
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
This study includes both an intervention and control condition.  
 
The POINT intervention utilizes the services of a recovery coach (i.e., someone certified by the Indiana 
Counselors' Association on Alcohol and Drug Abuse to deliver recovery supports who has lived 
experience with addiction). The 
recovery coach meets patients in 
the ED after they have been revived 
from an overdose or are admitted to 
the ED for an opioid-related health 
issue, including opioid withdrawal, 
abscess (from IV opioid use), 
endocarditis (from IV opioid use), or 
active opioid intoxication. The 
Conceptual Model for Project POINT 

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recovery coach offers the patient a range of evidence-based services including a brief assessment of 
high-risk behaviors, Hepatitis C and HIV testing, harm reduction counseling informed by motivational 
interviewing, and treatment referrals with follow-up to either a MOUD provider, detoxification services, 
or an inpatient treatment setting—with most patients choosing MOUD referral. Patients are also offered 
a take-home naloxone kit (i.e., the overdose reversing drug, which is offered as part care delivered by 
the recovery coach) and assistance with Medicaid enrollment, if applicable. Close collaboration with the 
local community mental health provider ensures POINT patients have their first assessment for MOUD 
within 1-2 business days of ED discharge.  
 
Grounded in the concept of critical time intervention, recovery coaches provide over the phone or in 
person support to navigate barriers to care throughout the recovery process. Recovery coaches also 
offer to accompany patients to intake appointments or criminal justice and child welfare meetings as 
part of the standard care they deliver. Recovery coaches reach out to the client every 2-3 days, initially, 
until the patient is successfully engaged in recovery services. The entire care transition process takes 
between 2 weeks and several months, and POINT leaves the door open so patients can re-engage at any 
point they require help overcoming recovery barriers. Recovery coaches do not collect data for study 
purposes during this time; rather, any information they collect will be solely for the purposes of 
providing professional care as a recovery coach.  
 
The control condition refers to standard care within the ED, in which patients receive a list of available 
local treatment options for opioid use disorder.   
 
6.1.2 ADMINISTRATION AND/OR DOSING 
The POINT intervention begins immediately following enrollment, at which point the recovery coach 
begins speaking with the participant about recovery support services. Depending on the needs and 
desires of the client, the recovery coach customizes the delivery of his or her services to aid the 
participant in getting the resources they need to support recovery. Once the participant leaves the 
hospital, the recovery coaches attempt to remain in contact and reaches out to the participant every 2-3 
days initially or until the patient is successfully engaged in recovery services. The process will depend on 
the client’s interest and engagement, but the recovery coach often works with them for a period of 
weeks or months. POINT recovery coaches intentionally make room for open communication and re-
engagement so patients can ask for help overcoming recovery barriers.  
Following the patient’s exit from the hospital, the recovery coach attempts to make additional contact. 
If recovery coaches are unable to immediately reach the patient, they complete the following steps.  
• 
They continue to attempt follow-up calls, emails, texts for 2 weeks. The number provided could 
belong to another individual or be temporarily or permanently out-of-service or disconnected. 
The recovery coach will continue to follow-up, as the phone status might change, and make an 
attempt to call each person at least once a day during the 2-week time period. 
• 
After two weeks, the recovery coach will stop trying to engage the patient. If the recovery coach 
has the opportunity to send an email or text or leave a voice mail, they will inform them the 
participant they are going to stop trying to call them but give them their contact information if 
they decide they need assistance with anything. 
• 
If they reach an individual aside from the patient (e.g., mom, dad, spouse), the recovery coach 
will state that they are calling from IU Health and that they are attempting to reach the patient’s 
name. No details of the study or the context of call will be provided to the individual.  

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If the recovery coach is able to reach the patient, and the patient indicates they want services, the 
recovery coach will provide individualized services while considering the following.  
• 
The recovery coach will make sure all recovery avenues are open to the client such as 
medication for opioid use disorder (MOUD) (e.g., ensuring they are aware of methadone, 
Suboxone, and Vivitrol availability) and abstinence-based treatment.  
• 
The recovery coach will discuss the evidence, benefits, and drawback of each type of treatment 
with the patient.  
• 
The recovery coach will make sure the right resources are in place when connecting the patient 
to care, including payment source, insurance, and transportation.  
• 
The recovery coach should continue to provide personalized support based on the needs of the 
patient.  
 
POINT uses a warm handoff model, which means that recovery coaches:  
• 
work to link patients to appropriate substance use disorder treatment and recovery supports, 
• 
should obtain a health information release from the provider to which the patient is referred, 
and it should cover 12 months, 
• 
continue to follow-up with the patient after they are connected to other supports for anywhere 
from 2 weeks to 3 months, depending on the patients’ level of need and comfort with the 
services they were linked to, and 
• 
allow patients to reengage with POINT services at any time for any reason if they need support 
in their recovery. 
6.2 
FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
Fidelity assessments with the recovery coaches and hospital sites will ensure compliance with the POINT 
intervention design. A checklist of putative critical intervention components will guide the fidelity audit 
and feedback activities. We will conduct site visits at pre-implementation, early implementation (1 
month following kick-off), mid-implementation (approximately 3 months), and late implementation (6 
months). The day-long site visits will include interviews with clinicians and administrators, observation 
of POINT intervention, and review of records.  
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
The study is randomized at the enrollment shift level. Each day of study enrollment is broken into three 
shifts (8am-3:59pm, 4pm-11:59pm, 12am-7:59am). In advance, each shift is randomly assigned to one of 
the two enrollments arms (i.e., POINT or control) to determine whether patients discharged during 
these times will enroll into the POINT arm or the standard care arm. Any individual who is cleared for 
discharge from the ED for an overdose or for an opioid-related health issue, including opioid withdrawal, 
abscess (from IV drug use) or active opioid intoxication will be eligible for the study. As determined by 
the preset randomization, recovery coaches (RC) will engage with patients cleared for discharged from 
the ED during the POINT shifts and research assistants (RA) will engage with patients cleared for 
discharged from the ED during control shifts.  
 
Additional note: The study sites plan to implement Project POINT regardless of the research study. We 
are not modifying any aspect of POINT for the study purposes. Therefore, all recovery coach duties 

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(baseline administrative data collection, provision of naloxone, patient follow-up) are part of POINT 
prescribed services that would be carried out regardless of the research. We are randomizing the shift 
POINT is delivered on to take advantage of the fact that they are not able to fully staff all hospital shifts 
with a recovery coach--thus allowing us to test the intervention's effectiveness. Only those patients in 
the standard care arm will be asked to complete data collection activities that would not be completed 
outside of the research study. 
 
Sample randomization for week of services 
Week 
Shift 
Day 
Mon 
Tue 
Wed 
Thu 
Fri 
Sat 
Sun 
1 
8am-
3:59pm 
RC 
RA 
RA 
RC 
RC 
RC 
RA 
4pm-
11:59am 
RA 
RC 
RC 
RA 
RA 
RA 
RC 
12am-
7:59am 
RC 
RA 
RA 
RC 
RA 
RA 
RC 
 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
Not applicable; participants of the POINT intervention or not required to adhere to any protocol.  
6.5 
CONCOMITANT THERAPY 
 
Not applicable.  
6.5.1 RESCUE THERAPY 
 
Not applicable.  
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
If a participant wishes to withdraw from the study, they can notify the Principal Investigators, Research 
Assistants, or Peer Recovery Coaches at any time. While there are no follow-up data collection activities 
with participants, participants are provided with the contact information for a Principal Investigator and 
the IRB and informed that they can make contact at any time to withdraw. Withdrawal from the study 
will not adversely affect the participant. If the participant is receiving POINT services, they will have the 
option to continue receiving them if they withdraw from the study. Should a participant withdraw, we 
will remove their data from the sample. 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 

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Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study if the participant is later determined to not 
have originally met the inclusion criteria (e.g., admitted for an opioid-related reason). Subjects who have 
signed the informed consent form, and are randomized and receive the study intervention, and 
subsequently withdraw, or are discontinued from the study, will remain eligible to continue receiving 
recovery coach services.  
7.3 
LOST TO FOLLOW-UP 
 
Study participants are involved in data collection activities at a single time (i.e., enrollment) and do not 
participate in any follow-up data collection. Participants of the intervention arm are not required to 
engage in further interactions with the recovery coach; thus, participants can disengage whenever they 
prefer.  
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
The study will utilize the following procedures, measures, and assessments during the eligibility 
screening and data collection processes.  
Prior to recruitment, a research assistant or recovery coach will (a) verify that patients are at least 18 
years of age and (b) have been admitted to the ED for an opioid-related reason. Additionally, prior to 
screening the patient for eligibility, it must be confirmed that (c) a patient is cleared for discharge from 
the ED by a healthcare provider; this may include patients who are discharged from the ED but admitted 
to inpatient care and those returning home. To do so, the research assistant or recovery coach will first 
approach the ED staff and ask if the patient is medically cleared for discharge. If so, the patient may be 
approached by the study team member.  
Subsequently, the research assistant or recovery coach will utilize a recruitment script to introduce 
themselves and the study and (d) assess the patient for an opioid use disorder by reading the questions 
from the DSM-5 Criteria for Diagnosis of Opioid Use Disorder to the patient. A score of at least “1” is 
required for eligibility. Lastly, they will read the statement of informed consent to the participant if they 
are interested in the study and will confirm the final component of eligibility by (e) reading three 
questions to the patient to confirm the patient’s competency: (1) Can you repeat to me the purpose of 
the study? [Response: The patient must say something indicating they know we are interested in 
studying opioid use and/or overdose.] (2) Do you remember some of the types of data we will be 
collecting about you or the agencies we will be getting them from? [Response: The patient must name 
at least two data sources.] (3) Do you remember what you should do if you decided you no longer wish 
to take part in the study after leaving here? [Response: The patient must indicate that they can call the 
research team or IRB and let them know.] If the patient does not answer correctly, the research team 
member will attempt to re-explain the consent form and ask the questions a second time. If the patient 
still does not answer correctly, the patient is not eligible for the study. 
If the patient meets all criteria and consents to enrollment, the patient will be asked to immediately 
complete a structured interview that asks questions regarding the patient’s: 
1. Demographics 

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2. Social support 
3. Living arrangements 
4. Drug use 
5. Context of current overdose or ED admission 
6. Treatment history 
7. Interest in recovery services 
8. Use of strategies to reduce risks related to drug use 
9. HIV and Hepatitis C 
10. Physical and mental health 
The patient will also be asked to complete the Adverse Childhood Experiences questionnaire.  
In addition to the original data collection, administrative data will be collected for each participant to 
assess long-term impacts regarding health, treatment, criminal justice, and child welfare involvement, as 
well as death records. Secondary data collection for the study will be assessed accessed from the following 
sources for three years prior to a participant’s enrollment through two years following:  
1. Indiana Network for Patient Care (hospital and overdose admissions data)  
2. Indiana Scheduled Prescription Electronic Collection & Tracking Program (INSPECT) (prescription 
information for controlled substances)  
3. Division of Mental Health and Addiction (methadone treatment information) 
4. Indiana Office of Medicaid Planning and Policy (Medicaid enrollment information) 
5. Indiana Department of Child Services (child welfare involvement information) 
6. Publicly available arrest and incarceration data via (a) Indiana Department of Correction’s prison 
incarceration search portal and (b) Marion County’s inmate database search portal   
7. Indiana Department of Public Health Vital Records Data (state health/vital records)  
 
8.2 
SAFETY ASSESSMENTS 
Not applicable.  
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered 
intervention related. 
 
These will include the following as pertains to the study: violation of confidentiality; discomfort due to 
interview procedures (including embarrassment in disclosing sensitive information); and disclosure of 
information about current or intended physical harm to self or others. 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 

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An adverse event (AE) or suspected adverse reaction is considered "serious" if it results in any of the 
following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not 
result in death, be life-threatening, or require hospitalization may be considered serious when, based 
upon appropriate medical judgment, they may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 
 
These will include the following: death; subsequent hospitalizations; and any other conditions or 
situations members of the DSMB believe represent serious adverse events that can be measured with 
the available data. 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.] 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below.  
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
 
OR 
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 

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explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
8.3.3.3 EXPECTEDNESS  
 
As defined in 8.3.4, assessment of adverse events from study data will not occur until after the 
participant is finished participating in the intervention. This is because all outcome data will come from 
secondary datasets collected at the end of the study. All adverse events that will be measured using 
these data (e.g., ED encounters, hospital admissions, overdose, and overdose and all-cause mortality) 
are expected due to the nature of opioid use disorder. Should an adverse event be reported to the 
researchers outside of secondary data sources, a clinician with appropriate expertise in opioid use 
disorder will be responsible for determining whether an adverse event (AE) is expected or unexpected. 
An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the study procedures. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) for participants receiving the 
POINT intervention may come to the attention of recovery coaches while performing follow-up 
engagement. However, the study relies on administrative data to follow participants longitudinally and 
does not allow study personnel to assess for adverse events in real-time.  
8.3.5 ADVERSE EVENT REPORTING  
 
Adverse events will be reported to the IRB and the NIDA Program Officer in regular annual reporting.  
 

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8.3.6 SERIOUS ADVERSE EVENT REPORTING  
Serious adverse events will be reported to the IRB and NIDA Program Officer within 24 hours, and a 
written follow-up (including information on the date of the event, what occurred, actions taken by 
project staff, any planned follow up, the intervention group/study arm of the affected participant, 
whether the event appears to be related to the intervention) will be provided within 72 hours of the 
event. Confidentiality will be breached in any circumstance where mandatory reporting is required. We 
have put procedures in place with the social work staff at the hospital and will inform them when there 
are concerns of self-harm or child abuse/neglect. As this is a long-term follow-up study, we have no way 
of tracking a number of events that could happen.  
 
If any adverse event is noted, we will immediately contact the IRB and inform the ED. Additionally, 
participant withdrawals or complaints will be monitored by Dr. Watson to ensure that study procedures 
have not resulted in unanticipated outcomes to participants. Results of all data safety and monitoring 
activities will be reported to NIDA annually. Subject withdrawals and complaints will be monitored by 
the PIs with assistance from the Project Manager to ensure study procedures designed to protect the 
privacy and confidentiality of participants are adequate and no unanticipated distress or unintended 
outcomes have resulted from any of the study procedures.  
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
Not applicable.  
8.3.8 EVENTS OF SPECIAL INTEREST  
 
Not applicable.  
8.3.9 REPORTING OF PREGNANCY  
 
Not applicable.  
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
Not applicable.  
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
Not applicable.  
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
Not applicable. 
9 
STATISTICAL CONSIDERATIONS  
 

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9.1 
STATISTICAL HYPOTHESES 
Primary Endpoint:  
 
• 
Overdose Admissions  
o [Measured: 1 year pre-enrollment through 1 year post-enrollment] 
We hypothesize that, compared to patients in the control condition, patients receiving the POINT 
intervention will experience fewer subsequent admissions to the ED for overdose.  
Secondary Endpoints:  
• 
MOUD Engagement 
o [Measured: 1 year pre-enrollment through 1 year post-enrollment] 
• 
Duration of MOUD Engagement 
 
o [Measured: 1 year pre-enrollment through 1 year post-enrollment] 
• 
ED Admissions 
 
o [Measured: 1 year pre-enrollment through 1 year post-enrollment] 
• 
Inpatient Hospital Admissions 
 
o [Measured: 1 year pre-enrollment through 1 year post-enrollment] 
• 
Time to Relapse 
 
o [Measured: Enrollment through 1 year post-enrollment] 
• 
Medicaid Enrollment for Participants Without Insurance 
 
o [Measured: Enrollment through 1 year post-enrollment] 
• 
Child Welfare Involvement  
o [Measured: 3 years pre-enrollment through 1 year post-enrollment] 
• 
Incarceration 
 
o [Measured: 3 years pre-enrollment through 1 year post-enrollment] 
We hypothesize that, compared to patients in the control condition, patients receiving the POINT 
intervention will experience better recovery outcomes (i.e., higher MOUD engagement and longer 
duration of engagement, lower ED and inpatient admissions, longer times between relapse, higher 
Medicaid enrollment for those without insurance, lower child welfare involvement, and lower 
incarceration). 
9.2 
SAMPLE SIZE DETERMINATION 
 
Our goal is to obtain a total of 356 patients in each study arm (n = 712) by Month 32, which will provide 
us with enough patients to obtain a full year of follow-up data to detect a minimum 6% reduction in our 
primary outcome (subsequent overdose) at 80% power, assuming a 12% rate of subsequent overdose 
for the standard care arm at the 5% significance level (this is a conservative calculation based on 
observed subsequent overdose rates at Eskenazi and Indianapolis Emergency Medical Services).  

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(Note: This goal was not ultimately reached due research activities needed to stop because of the 
COVID-19 pandemic. Researchers developed an alternative plan to assess outcomes using a 
retrospective case control design that was approved by the funder. However, all planned analyses were 
conducted using collected from patients who were enrolled in the trial.) 
 
9.3 
POPULATIONS FOR ANALYSES 
 
All participants consented to the trial will be included in the analyses.  
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
We will summarize patient characteristics using means and standard deviations for continuous variables 
and counts and proportions for categorical variables. Initial analysis of outcomes (using data pulled at 9 
months) will focus on MOUD engagement one-month post overdose, as all other outcomes will be too 
distal to observe any meaningful change. This time period is based on our prior POINT experience 
demonstrating initial engagement tends to happen within 1-2 weeks of overdose. We will focus on 
immediate outcomes (e.g., treatment engagement, length, dropout). While observed change in more 
distal outcomes (e.g., subsequent overdose and mortality) is unlikely to be seen in such a short pilot 
period, we will look at them and, if needed, adjust the benchmark (established based on our experiment 
at Eskenazi) for the power analysis. Summary of outcome measures will be computed similarly. The 95% 
confidence intervals of outcome measures for the POINT and standard care arms will be used to estimate 
the rate of binary outcomes and mean of continuous outcomes.  
 
The primary analysis involves comparison of outcome measures post ED discharge between the POINT 
and standard care arms. Binary outcome measures (e.g., MOUD engagement and dropout, subsequent 
overdose, overdose mortality, and all-cause mortality) will be compared between the POINT and standard 
care arms using the Fisher’s exact test. Length of MOUD treatment will be compared using the Wilcoxon 
rank sum test. Comparison of the length of time to relapse will be conducted using the survival analysis. 
Time to relapse will be plotted using the Kaplan Meier curve and comparison between the POINT and 
standard care arms will be performed using the log rank test.  
 
The secondary analysis involves comparing outcome measures pre- and post-ED discharge for POINT 
patients. Binary outcomes including child welfare involvement will be compared using the McNemar’s test 
and the continuous outcome including the days of incarceration will be compared using the Wilcoxon 
signed rank test due to the skewness of the data. Additional analyses will be conducted to account for 
patient characteristics in the comparison between the POINT and standard care arms using logistic 
regression for binary outcomes, Poisson regression for length of MOUD treatment, and Cox proportional 
hazards model for time to relapse. For the comparison pre- and post-ED discharge in the POINT arm, 
generalize estimating equations approach will be performed using logistic regression for Medicaid 
enrollment and child welfare involvement and Poisson regression for days of incarceration. Hospitals will 
be included in the models as a fixed effect to account for the potential differences in patient population 
across hospitals 

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9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
Questions 
Defined/explained 
Primary endpoint 
 
 
Describe how the primary endpoint is calculated, if not 
readily apparent 
Change in Overdose Admissions: Using electronic 
health records, it is calculated as the total 
combined number of overdoses resulting in an 
emergency department presentation within the 
specified time period.  
Describe the scale (nominal/binary/categorical, 
ordinal, interval); state if it is measured as a single 
endpoint/summary measure or repeated measure 
binary 
Describe the statistical procedure(s) that will be used 
to analyze the primary endpoint (e.g., multiple 
regression, repeated measures mixed models, logistic 
regression, Analysis of Covariance (ANCOVA)). 
Describe the covariates and factors in the model. 
Provide a rationale for covariates and how they will be 
selected to achieve a parsimonious model. If the 
decision to specify covariates is deferred for the SAP, 
indicate here.  
Summarized using frequencies and percentages 
and then compare arms using the Fisher’s exact 
test. 
Describe how results of statistical procedure(s) will be 
presented (e.g., adjusted means (Least-squares means 
(LSMEANS)) with standard errors, odds ratios with 95% 
confidence intervals, prevalence rates, number-
needed-to-treat) 
Presented using frequencies and percentages 
Describe details to check assumptions required for 
certain types of analyses (e.g., proportional hazards, 
transformations or, when appropriate, nonparametric 
tests) 
The nonparametric Fisher’s exact test is used to 
compare the primary endpoint. 
Describe the Populations for which the analysis will be 
conducted, as discussed in Section 9.3, Populations for 
Analyses 
All study participants  
Describe how missing data will be handled (e.g., type 
of imputation technique, if any, and provide 
justification), and approach to handling outliers, non-
adherence and lost to follow-up  
We do not expect there to be a large amount of 
missing data due to the use of administrative 
datasets. However, missing values may occur 
when subjects die during the specified time 
period. Sensitivity analysis is performed by 
excluding subjects who die during the specified 
time period.  
 
 
 
 

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9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
Secondary endpoints 
 
Note if analysis of secondary endpoint(s) are 
dependent on findings of primary endpoint  
Analysis of secondary endpoints are not 
dependent on the findings of primary endpoint. 
Describe how each secondary endpoint is calculated, if 
not readily apparent 
Change in MOUD Engagement: Using state 
methadone treatment data, Medicaid claims 
data, state prescription drug monitoring data, 
and electronic health records data to  
identify whether or not the person engaged in at 
least one episode of MOUD treatment 
(methadone, buprenorphine, or naltrexone) 
within the specified time period. 
 
Change in MOUD Engagement Duration: Using 
state methadone treatment data, Medicaid 
claims data, state prescription drug monitoring 
data, and electronic health records data to 
calculate the number of days MOUD treatment 
was received during the specified time period.  
 
 
Change in ED Admissions: Using electronic health 
records, it is calculated as the total combined 
number of all-cause ED presentation within the 
specified time period. 
 
 
Change in Inpatient Hospital Admissions: Using 
electronic health records, it is calculated as the 
total combined number of all-cause hospital 
admissions within the specified time period. 
 
Time to Relapse: Using electronic health records 
data, it is calculated as number of days to the first 
overdose ED visit or overdose death since the 
index ED. Subjects who did not experience 
overdose ED or overdose death are censored at 
the end of the specified time period or the time 
of death due to other reasons, whichever 
occurred first 
 
Change in Medicaid Enrollment for Participants 
Without Insurance: Using Medicaid claims data 
to identify Medicaid coverage among participants 
within the specific time period.  

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Change in Child Welfare Involvement: Using 
child welfare data to identify the number of new 
cases and children removed from the home 
within the specified time period.  
 
Change in Incarceration: Using public 
incarceration data to identify the number of days 
of incarceration within the specific time period.  
Describe the scale (nominal/binary/categorical, 
ordinal, and interval); state if it is measured as a single 
endpoint/summary measure or repeated measure 
Change in MOUD Engagement: binary  
 
Change in MOUD Engagement Duration: 
Interval/Ratio 
 
 
Change in ED Admissions: binary  
 
 
Change in Inpatient Hospital Admissions: binary  
 
Time to Relapse: Interval 
 
Change in Medicaid Enrollment for Participants 
Without Insurance: Binary  
 
 
Change in Child Welfare Involvement: binary 
 
Change in Incarceration: Interval  
Describe the statistical procedure(s) that will be used 
to analyze the secondary endpoint (e.g., multiple 
regression, mediation or moderation analyses, 
multilevel modeling, MANOVA). Describe the 
covariates and factors in the model. Provide rationale 
for covariates and how they will be selected to achieve 
a parsimonious model. If decision to specify covariates 
is deferred for the SAP, indicate here.  
We will summarize patient characteristics using 
means and standard deviations for continuous 
variables and counts and proportions for 
categorical variables. The primary analysis 
involves comparison of outcome measures post 
ED discharge between the POINT and standard 
care arms. Binary outcome measures (e.g., 
MOUD engagement, subsequent overdose, 
overdose mortality, and all-cause mortality) will 
be compared between the POINT and standard 
care arms using the Fisher’s exact test. Length of 
MOUD treatment will be compared using the 
Wilcoxon rank sum test. Comparison of the 
length of time to relapse will be conducted using 
the survival analysis. Time to relapse will be 
plotted using the Kaplan Meier curve and 
comparison between the POINT and standard 
care arms will be performed using the log rank 
test. 
Describe how results of statistical procedure(s) will be 
presented (e.g., adjusted means (Least- squares means 
(LSMEANS)) with standard errors or effect size 
For continuous endpoints, we will present the 
mean and standard deviation or median and 
interquartile range for each treatment arm. 

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Frequency and percentages are presented for 
binary endpoints. Time to event endpoints are 
presented using estimated survival probability at 
the end of the specified time period. 
Describe details to check assumptions required for 
certain types of analyses (e.g., checks on assumptions 
of normality, transformations or, when appropriate, 
nonparametric tests) 
Nonparametric tests are used to compare 
endpoints between treatment arms. Fisher’s 
exact test is used for binary variables, Wilcoxon 
rank sum test is used for continuous variables, 
and log-rank test is used for time to event 
variables. 
Describe the Populations for which the analysis will be 
conducted as discussed in Section 9.3, Populations for 
Analyses 
All study participants 
Describe how missing data will be handled (e.g., type 
of imputation technique, if any, and provide 
justification), and approach to handling outliers, non-
adherence and lost to follow-up  
We do not expect there to be missing data due to 
the use of administrative datasets. 
If there is more than one primary endpoint or more 
than one analysis of a particular endpoint, state the 
statistical adjustment used for Type I error criteria or 
give reasons why it was considered unnecessary 
Not relevant as there is only one primary 
endpoint and each endpoint is analyzed once. 
 
9.4.4 SAFETY ANALYSES 
 
Not applicable.  
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
Baseline characteristics will be calculated and competed to assess if there are any significant differences 
between groups.  
 
9.4.6 PLANNED INTERIM ANALYSES  
 
Because the availability of data from administrative sources is outside the control of the research team, 
interim analyses could not be planned for. 
9.4.7 SUB-GROUP ANALYSES 
 
No sub-group analyses are planned for this study. 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data by measure and time point will not be listed. 
9.4.9 EXPLORATORY ANALYSES 

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No exploratory analyses are planned for this study. 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to 
the participant and written documentation of informed consent will be completed prior to starting the 
study intervention.  The following consent materials are submitted with this protocol: (1) consent form, 
(2) list of competency questions, (3) health information release form.  
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Once the patient is determined to meet all the initial eligibility criteria, the research team member will 
begin informed consent. Informed consent is a process that is initiated prior to the individual’s agreeing 
to participate in the study and continues throughout the individual’s study participation. Consent forms 
will be Institutional Review Board (IRB)-approved and the participant will be read the document by a 
recovery coach or research assistant and review the document. The study team member will explain the 
research study to the participant and answer any questions that may arise. A verbal explanation will be 
provided in terms suited to the participant’s comprehension of the purposes, procedures, and potential 
risks of the study and of their rights as research participants.   
 
We will not fully disclose the purposes of the research to the standard care arm because (1) Methodist 
Hospital and Ball Memorial were planning on implementing POINT outside of the context of this study 
and because their ability to staff recovery coaches is limited anyway, we are not creating any disparity in 
patients ability to access point that would not naturally exist and (2) we are concerned that full 
disclosure of the purposes would unnecessarily upset the control arm patients who might desire the 
services after learning of them. 
 
Participants will have the opportunity to carefully review the written consent form and ask questions 
prior to signing. The participant will sign the informed consent document prior to data collection 
beginning. Participants must be informed that participation is voluntary and that they may withdraw 
from the study at any time, without prejudice. A copy of the informed consent document will be given 
to the participants for their records. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they decline 
to participate in this study. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 

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This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to investigator, funding agency, and/or regulatory 
authorities. If the study is prematurely terminated or suspended, the principal investigators will 
promptly inform the Institutional Review Board (IRB) and sponsor/funding agency and will provide the 
reason(s) for the termination or suspension. If the risks are not associated with POINT intervention 
recovery coaching services, participants may continue to receive them.  
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies 
(DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Responses to the structured interview questions will be entered by the recovery coach or research 
assistant into a form housed in REDCap. Only necessary research team members will have access to 
these data, and all accounts are password protected.  
 
To protect the confidentiality of patients related to the secondary data, we will work with Regenstrief 
Institute (an honest broker who can act as a firewall between personally identifiable health data and the 
researchers) to develop a process for masking and merging the data that will ensure all data is stripped 
of personally identifying information before being delivered to the research team. Regenstrief will link 
hospital, government, substance abuse treatment, and structured interview data. We will only be asking 
for data to be delivered at a single time point, so there will be no need to link data longitudinally. 
Regenstrief will keep a key that will allow them to identify subjects; however, this key will not be shared 
with the researchers and will be destroyed at conclusion of the study; thus, researchers will never obtain 
an identifiable data set. The researchers will keep all data on a HIPPA compliant network/server behind 
a university firewall, and only those individuals who need access to the data will be able to obtain it 
using their login ID.  
  
To protect confidentiality of all participants, we will assign each participant a subject identification 
number that will only be connected to the participants’ names on a separate REDCap form, which will 
only be accessible by necessary research team members. We will store all complete informed consent 
documents in a locked file cabinet in a locked office. When REDCap data are extracted from the system 
to be sent to Regenstrief, they will be temporarily stored on a secure server behind a university firewall. 
They will be sent via a secure online sharing system that requires a password for download. Once 
accessed and downloaded by Regenstrief, these data will be deleted from the secure server. All grant 
personnel who are involved in the design or conduct of this research will have demonstrated successful 
completion of human subjects training, specifically Collaborative Institutional Training Initiative (CITI) 
Program. 
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued by the 
National Institutes of Health (NIH). This certificate protects identifiable research information from 

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forced disclosure. It allows the investigator and others who have access to research records to refuse to 
disclose identifying information on research participation in any civil, criminal, administrative, legislative, 
or other proceeding, whether at the federal, state, or local level. By protecting researchers and 
institutions from being compelled to disclose information that would identify research participants, 
Certificates of Confidentiality help achieve the research objectives and promote participation in studies 
by helping assure confidentiality and privacy to participants. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Original data collected for this study will be stored in REDCap; secondary data will be stored on 
Regenstrief Institute’s secure server until it is de-identified and shared with the research team, at which 
point it will be stored in a secure Box Health folder. After the study is completed, the de-identified, 
archived data will be available to other researchers upon request.  
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Principal Investigator  
Alan McGuire, PhD 
Dennis Watson, PhD 
Indiana University  
Chestnut Health Systems  
1481 W. 10th St. (11H) 
221 W Walton St. Chicago, IL 60610 
317-988-5366 
312-274-5316 
abmcguir@iu.edu 
dpwatson@chestnut.org 
 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB), which 
includes representation from a person in recovery and a clinician, will carry out the following activities: 
(1) Review all research protocols and plans for data safety and monitoring. (2) Review clinical trial 
progress, including data analysis quality and timeliness, subject recruitment, subject risk versus benefit, 
and other factors that may influence outcomes. (3) Review serious adverse event reports and provide 
feedback and oversight they are reported properly to the appropriate Institutional Review Boards (IRB) 
and the Office of Human Research Protections (OHRP). (4) Review outcome analyses and reports of 
related studies to determine whether the study needs to be changed or terminated. (5) Make 
determinations as to whether the study should be continued, changed, or terminated based on the 
data. (6) Review proposed study modifications prior to any changes being implemented by the research 
team. (7) Protect data confidentiality and review results of monitoring. (8) Determine whether and to 
whom outcomes should be reported prior to final reporting of study results. (9) Provide reports 
summarizing findings of DSMB meetings, which will be sent to the appropriate IRBs and NIH staff (if 
warranted). An analysis of key variables at each of our administrative data pulls will be reviewed for any 
significant negative outcomes that might result from participation in the POINT arm. 
 
Data Safety Monitoring Board Members:  
 
• Danielle McCarthy, MD, Assistant Professor, Department of Emergency Medicine, Northwestern 
University; expertise in emergency medicine 

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• Ross Silverman, JD, MPH, Professor, Department of Health Policy and Management, Indiana 
University-Purdue University Indianapolis; expertise in public health law and ethics 
 
• Antonio (Dave) Jimenez, PhD., Director, Community Intervention Projects, University of Illinois at 
Chicago; expertise in recovery support services for people with opioid use disorder, experience with 
clinical trials in opioid using population 
 
• Gina Fears, Certified Peer Recovery Coach, Public Advocates for Community Re-Entry; person with 
lived experience 
 
10.1.7 CLINICAL MONITORING 
Not applicable.  
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
In addition to required CITI trainings, to ensure adherence to research protocols, the principal 
investigator and project manager will conduct a required training for all study personnel involved in the 
enrollment and data collection processes. During this training, the PI and project manager will provide a 
detailed overview of the study purpose and the enrollment procedures, including the eligibility criteria, 
screening process, enrollment script, and informed consent procedures. They will also discuss the data 
collection procedures in detail, during which they will read through the data collection questionnaire 
and complete mock interviews with study personnel. Subsequently, during the first two weeks of study 
enrollment, the PI, project manager, or senior research staff will shadow all study personnel during 
consent and data collection activities to ensure protocol adherence.  
 
Throughout the course of the study, the project manager will monitor enrollment adherence using the 
Emergency Medical Services (EMS) Patient Tracker system. The system will send daily automated 
reports to the project manager to indicate which EMS runs involving naloxone administration were 
taken to the hospitals involved in the study. The project manager will then look up the names of the 
patients who received naloxone and compare these names with the enrollment records; any missed 
patients will be noted in our tracking records and, if necessary, the project manager will follow-up with 
study personnel. To ensure consent and data collection procedures are properly followed and potential 
issues are promptly addressed, the PI and project manager will conduct monthly teleconference calls 
with all study personnel. They will discuss current enrollment and potential concerns regarding 
enrollment, consent documents, or data collection procedures and tools. Further, the project manager 
will touch base one-on-one with all study personnel at least once every month to address any specific 
issues.  
 
Lastly, we will review all data collection packets, including consent documents and health information 
releases, to ensure proper completion. All data collection records in REDCap will be reviewed by the 
project manager to check for accuracy and completion. Revisions to the data collection forms will be 
completed as necessary. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  

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10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection will be the responsibility of the recovery coaches and research assistants at the site 
under the supervision of the project manager and principal investigator. The recovery coaches and 
research assistants will be responsible for ensuring the accuracy, completeness, legibility, and timeliness 
of the data reported, and the project manager will review each record.  
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data.  Hardcopies of the enrollment documents (consent form, competency questions, and health 
information release forms) will be kept for each participant consented/enrolled in the study. Original 
data will be entered directly into the REDCap data collection system, which is accessible by team 
members only and can be immediately reviewed by the project manager.  
10.1.9.2 STUDY RECORDS RETENTION  
 
Study documents will be retained for 3 years after the final patient is enrolled.  
10.1.10 
PROTOCOL DEVIATIONS   
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol or 
International Council on Harmonisation Good Clinical Practice (ICH GCP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions will be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the principal investigator to use continuous vigilance to identify and report 
deviations. All major deviations will be reported to NIDA and the IRB promptly, within 5 business days.  
Minor protocol deviations will be reported at the time of the subsequent IRB renewal or closure.  
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 

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such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals. Due to agreements with the agencies providing de-identified data for this study, we 
are unable to make the dataset public. However, we will share a limited dataset with interested parties 
who are willing to sign a specific data-sharing agreement. The limited dataset will not include any 
information from the INSPECT prescription drug monitoring database due to concerns of the board 
members overseeing it. The data-sharing agreement will stipulate the interested party must: (1) commit 
to using the data for research purposes only; (2) secure the data using appropriate precautions and 
technology; (3) commit to returning or destroying the data after analyses are completed. 
 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial. The study leadership 
in conjunction with the NIDA has established policies and procedures for all study group members to 
disclose all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest. 
10.2 ADDITIONAL CONSIDERATIONS 
 
Not applicable.  
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
ACEs 
Adverse Childhood Experiences  
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CITI 
Collaborative Institutional Training Initiative 
COC 
Certificate of Confidentiality 
DSM 
Diagnostic and Statistical Manual of Mental Disorders 
DSMB 
Data Safety Monitoring Board 
ED 
Emergency Department 
EMS 
Emergency Medical Services 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Council on Harmonisation  
INSPECT 
Indiana Scheduled Prescription Electronic Collection & Tracking Program 
IRB 
Institutional Review Board 
IU 
Indiana University 
IV 
Intravenous 
MOUD 
Medication for Opioid Use Disorder 
NIH  
National Institutes of Health 

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NIDA 
National Institute on Drug Abuse  
OHRP 
Office for Human Research Protections 
OUD 
Opioid Use Disorder 
PI 
Principal Investigator 
POINT 
Planned Outreach, Intervention, Naloxone, and Treatment 
RA 
Research Assistant 
RC 
Recovery Coach 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
2 
2/14/18 
Amended the eligibility criteria to 
include the time of discharge (rather 
than the time of admission). 
 
Amended the interview criteria so 
that interviews can be conducted in 
any private area (rather than be 
restricted to the patient’s ED area). 
We learned that patients can 
stay in the ED for long durations 
that might extend beyond an 
enrollment shift. Thus, a 
research staff person or 
recovery coach might have 
completed their shift by the 
time the patient is ready to be 
enrolled. The discharge time 
aligned more closely with the 
time of enrollment.  
 
Due to limited space, patients 
might need to complete 
interviews in another private 
area to make room for new 
hospital patients.  
3 
3/30/18 
Expanded the eligibility criteria from 
only opioid overdoses to opioid-
related issue (including withdrawal, 
abscess, intoxication).  
 
Amended the enrollment shifts to 24 
hours, rather than excluding 12am-
7:59am. 
Hospital staff informed us that 
a large volume of patients with 
opioid addiction enter the ED 
for non-overdose related 
issues. 
 
Hospital staff informed us that 
patients can be discharged from 
the ED overnight and admitted 
to inpatient care (i.e., still able 
to be enrolled onsite by staff).  
4 
4/18/18 
Amended eligibility criteria so that 
patients may be eligible if deemed 
“cleared for discharge by a provider” 
(rather than "discharged from the 
ED”).  
 
Expanded the eligibility criteria to 
include endocarditis. 
 
We learned that patients often 
want to exit the ED as soon as 
they are officially discharged 
and do not want to spend extra 
time enrolling in a study. 
Changing the timing allowed us 
to utilize the time in between 
clearance and official discharge, 
while administrative tasks are 
completed.  
 

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Hospital staff informed us that 
a high volume of patients enter 
the ED for endocarditis, related 
to opioid addiction.  
5 
10/16/18 
Added IU Health Ball Memorial as a 
study site.  
Initial enrollment occurred at IU 
Health Methodist and then 
expanded to IU Health Ball 
Memorial.  
6 
4/11/19 
Amended the recruitment and 
eligibility process to include the 
DSM-5 for Opioid Use Disorder as a 
screening tool for eligibility. 
Participants must score at least “1” 
on this screening tool to be eligible.  
 
Amended the REDCap questionnaire 
to include the 16-item Subjective 
Opioid Withdrawal Scale (SOWS).  
We identified that some 
individuals were coming 
through the ED whose overdose 
was the result of occasional 
recreational use of opioids or 
adulteration of another drug 
with fentanyl; therefore, these 
individuals would not have an 
opioid use disorder and be 
inappropriate for MOUD 
treatment linkage.  
7 
2/6/20 
Amended protocols so that RAs & 
RCs may enter the room and 
introduce the study prior to their 
discharge clearance. They must still 
wait for discharge clearance before 
consenting/collecting data. 
We identified that this would 
have less of an impact on the 
ED workflow and result in less 
delays to patient discharge as a 
result of data collection.