Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
Phase: NA
Conditions: Opioid Use Disorder, Opioid Dependence With Current Use (Disorder)
Sponsor: University of Pennsylvania

 
 
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CLINICAL TRIAL PROTOCOL 
 
Randomized Control Trial of the Opioid Use Disorder (OUD) CareConnect Textline 
 
NCT05897788 
 
03/03/2025 
 
 
 

 
 
3.3.25 
 
 
Protocol 
 
This trial protocol has been provided by the authors to give readers additional information 
about their work. 
 
This supplement contains the following items: 
1. Original protocol 
2. Consent 
 
 
 

 
 
3.3.25 
 
 
CLINICAL TRIAL PROTOCOL 
 
Randomized Control Trial of the Opioid Use Disorder (OUD) CareConnect Textline 
Version 2.0. 
03/03/2025 
 
Principal Investigator: 
M. Kit Delgado, MD, MS 
Assistant Professor of Emergency Medicine, University of Pennsylvania 
 
Co-Investigators:  
University of Pennsylvania: 
Margaret Lowenstein, MD 
Jeanmarie Perrone, MD 
James McKay, PhD 
David Mandell, ScD 
Austin Kilaru, MD 
Anna Morgan, MD 
Jeff Ebert, PhD 
 
Staff 
Neda Khan, MBA, MHCI 
Arielle Berk 
Hannah Dart, MS 
Arleen Lopez 
Gavin Lee 
Meryl McLean  
Jonathan Richards, MS 
Dina Abdel-Rahman, BS 
Maya Nelson, BS 
Aria Xiong, MS 
Krishleen Kaur 
Laurel Adams, MBA 
 
Alameda Health System Investigators 
Andrew Herring, MD  
Erik Anderson, MD  
 
Cooper Medicine Investigators  
Matthew Salzman, MD  
 
Rowan University Investigator 
Bethany Raiff, PhD 
 
Contact Address:  
3600 Civic Center Boulevard 
8th floor 
Philadelphia, PA 19104 
 
 
 
 
Email:  
mucio.delgado@pennmedicine.upenn.edu 
Commented [MD1]: Note to add new staff here 

 
 
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Funded By: Patient-Centered Outcomes Research Institute (PCORI)  
Table of Contents  
A. Original Protocol 
1. Background and Significance 
1.1. 
Background 
1.2. 
Significance 
2. TRIAL DESIGN 
2.1. 
Overview 
2.2. 
Setting 
2.3. 
Inclusion Criteria 
2.4. 
Participant Identification 
2.5. 
Consent Procedures 
2.6. 
Contact Information 
2.7. 
Intake Survey 
2.8. 
Follow-up Surveys 
2.9. 
Allocation to Treatment 
2.10. Behavioral Interventions 
2.11. Observation arm 
2.12. Study Procedures 
2.13. Assessment Controls 
2.14. Compensation 
2.15. Regulatory 
2.16. Contingencies and Participant Withdrawal 
2.17. Deception 
3. OUTCOMES 
3.1. 
Definitions 
3.1.1. 
Primary Outcome 
3.1.2. 
Secondary Outcome 1 
3.1.3. 
Secondary Outcome 2 
3.1.4. 
Secondary Outcome 3 
4. SAMPLE SIZE CALCULATION AND STATISTICAL ANALYSIS PLAN 
4.1. 
Analytic Methods 
5. DATA COLLECTION AND MANAGEMENT 
5.1. 
Data Collection Process 
5.2. 
Variables 
5.3. 
Transfer of Data 
5.4. 
Data Storage and Security 
6. HUMAN SUBJECTS 
6.1. 
Risks to Human Subjects 
6.2. 
Protection Against Risk 
6.3. 
Adequacy of Protection Against Risk 
6.4. 
Potential Benefits to Individual Participants 
6.5. 
Clinical Trials 
7. MONITORING 
8. 
FUNDING 
9. 
PUBLICATIONS 
10. DATA SHARING 
11. TASKS AND RESPONSIBILITIES 

 
 
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11.1. 
Principal Investigator 
11.2. 
Co-Investigators 
12. REFERENCES 
Appendices 
1. Table of Measures 

 
 
RCT Protocol v.1.6; 7/08/24 
TRIAL OVERVIEW Title  
Randomized Control Trial of the OUD CareConnect 
Textline 
 
Clinical Trials Number  
853153 
 
Sources of monetary or material support  
 
 
Study Sites  
University of Pennsylvania Hospital System, Cooper 
Heath System Alameda Health System 
 
 
Conditions studied  
Opioid Use Disorder, OUD treatment, OUD engagement, 
Texting interventions, Contingency Management 
 
 
Interventions  
Augmented Usual Care 
Augmented Usual Care + Text Message Check-ins 
Augmented Usual Care + Contingency Management 
(CM) incentives 
Augmented Usual Care +CM incentives + Text Message 
Check-ins 
 
 
Comparator  
 
 
 
Inclusion criteria  
 
 
 
 
 
 
 
 
 
Exclusion 
criteria 
1. 18 years of age or older 
2. Screen positive for OUD 
3. English reading ability 
4. Have a mobile phone capable of receiving text 
messages 
5. Bridge buprenorphine prescription (emergency 
department (ED) enrollment - Buprenorphine 
prescription at ED discharge; Bridge clinic 
enrollment – new buprenorphine prescription 
associated with on-demand or drop-in encounter  
 
 
 
Study type  
Interventional  
• 
14-day bi-directional intervention  
• 
30-day follow-up  
• 
3-month follow-up 
• 
6-month follow-up  
 
 
 
 
Target sample size  
1,808 Participants  
 
 

 
 
RCT Protocol v.1.6; 7/08/24 
 
Primary outcome  
 
 
 
Secondary outcome 
 
 
             
Engagement in any addiction treatment at 30 days of 
randomization 
 
 
Filled buprenorphine prescription within 14 days; 
engagement in addiction treatment within 14 days; 
number of days buprenorphine filled at 30 days; self-
reported 
current 
substance 
use, 
self-care, 
relationships, resources, and outlook on life based on 
Brief Addiction Monitor and Substance Use and 
Recovery Evaluator measured at 15 days, 30 days, 3 
months, and 6 months; ED visits, hospitalizations and 
Hospital Free Days (HFD), and deaths at 15 days, 30 
days, 3 months, and 6 months. 
 
 
 
1. Background and Significance  
1.1 Background 
The U.S. faces a crisis of OUD and overdose driven by fentanyl and other synthetic opioids. Overdoses are now 
the #1 cause of death for people aged 18-44 years old. Drivers of this crisis have only accelerated during the 
COVID-19 pandemic, with overdoses claiming 93,000 lives in 2020 – a 30% increase from the year prior. There 
has been a parallel increase in OUD-related ED visits, with OUD-related ED encounters increasing 100% in the 
last decade and further increases in overdose-related ED encounters during the pandemic. Acute care visits for 
an OUD-related condition strongly predict mortality.  
EDs are critical touchpoints for engaging patients in OUD treatment. Treatment with medications for OUD 
(MOUDs), particularly opioid agonists buprenorphine or methadone, is the standard of care, reducing overdose 
and all-cause mortality by more than half. MOUDs also improve other mental and physical health outcomes, 
reduce illicit drug use, and increase treatment retention and quality of life. With over 1.5 million encounters 
annually for opioid overdose, withdrawal, or complications of substance use, the ED is one of the most important 
places for health systems to engage patients in effective care. Randomized controlled trials (RCT) have 
demonstrated ED-initiated buprenorphine doubles treatment engagement at 30 days compared to referral alone9 
and is cost-effective. 
 
Despite strong evidence supporting ED-initiated buprenorphine, there are substantial implementation gaps in 
linking patients with OUD from the ED to continued treatment, including persistent racial disparities. Because 
ED-initiated buprenorphine increases treatment engagement, it has become a standard practice in our health 
systems and many EDs in recent years. However, initiating treatment for OUD in EDs is insufficient if patients 
do not continue in care. We found that only 17% of US patients with ED visits for opioid overdose received 
buprenorphine or other addiction treatment in the 90 days following ED discharge and that Black patients were 
half as likely as White patients to receive treatment. Even in our health systems, which have well-developed ED 
OUD treatment pathways and standardized referral procedures, treatment engagement rates are 35%. The 
National Academy of Medicine has identified closing this implementation and equity gap as a national public 
health priority. 
There is strong evidence supporting several OUD treatment engagement strategies in other settings, but these 
strategies have not been adapted for or tested in the ED. Text-messaging enhanced telehealth services have 
been shown to overcome barriers and increase patient engagement in outpatient OUD treatment settings. 
Text messages are also feasible and acceptable as part of SUD treatment in addressing multiple dimensions 

 
 
RCT Protocol v.1.6; 7/08/24 
of engagement, including motivation, self-efficacy, social support and appointment attendance.15 Recent 
federal policy changes have loosened regulations for telehealth-based treatment of OUD by allowing initiation 
of buprenorphine via telehealth.16 The result has been a significant increase in telehealth-based treatment 
models, with promising early outcomes in terms of feasibility, acceptability, quality of care, and treatment 
retention.17-24 Telehealth models have enormous potential to overcome barriers to care access – ranging 
from troubleshooting pharmacy barriers, transportation challenges, work or childcare responsibilities, and 
stigma – and to deliver timely, flexible patient-centered addiction care. 
There is also considerable evidence demonstrating effectiveness of financial incentives – also known as 
contingency management – in increasing OUD treatment engagement.  Patients with OUD and other SUDs 
tend to have present bias, a tendency to favor short-term, immediate rewards rather than larger, more distant 
rewards. This tendency may contribute to the SUDs by driving urges to use substances despite the risks. 
Because patients with OUD experience substantial present bias and steeper delay discounting rates than 
other people, they prefer short-term, immediate rewards rather larger rewards in the more distant future. 
Therefore, providing short-term tangible rewards to reinforce treatment engagement and promote decreased 
drug use has been found to be one of the most consistently effective and cost-effective treatments for SUDs, 
including OUD. A recent randomized control trial that enrolled a predominantly low-income, non-white sample 
demonstrated that compared to usual care, patients receiving remotely distributed digital financial incentives 
engaged in buprenorphine treatment at much high-er rates (71% vs. 40%) over 6 months. Our team is the first 
to demonstrate the feasibility of delivering financial incentives for post-ED OUD treatment engagement in a 
pilot RCT indicating that this effective intervention is ready to be applied to the ED setting.  
Despite the strength of the evidence for both text-messaging-enhanced telehealth services in promoting OUD 
treatment engagement in other settings, to our knowledge, there are no studies comparing the effectiveness of 
these interventions either alone or in combination for facilitating treatment engagement from the ED. Our team 
has been a leader in initiating buprenorphine in the ED, text-messaging based data collection and telehealth 
services, and contingency management and mobile phone-based continuing care interventions for SUDs. We 
propose to adapt these evidence-based strategies to the ED context to improve linkage to post-ED care and 
compare the effectiveness of these strategies alone and in combination, filling a critical evidence gap.  
 
Telehealth and in-person “bridge clinics” now provide rapid, low-barrier access to buprenorphine for patients 
who need follow-up care from the ED or as alternative site of care for patients with acute needs. These 
prescriptions “bridge” patients until they can establish a regular source of follow up addiction care. In the fall of 
2022, our emergency departments and addiction medicine care teams launched the Way to Health 
CareConnect text line as a new standard of care for OUD patients with OUD discharged from ED. It provides 
patients with the ability to reach on call substance use navigators (SUNs) 7 days a week from 9a-9p by phone 
or text message for assistance with obtaining buprenorphine, follow up appointments, and addressing barriers 
to engagement in treatment such as transportation and meeting social needs. To date the CareConnect 
textline has already served over 100 patients with OUD discharged from the ED.  
 
 
With funding obtained from the Patient Centered Outcomes Research Institute (PCORI) we are planning to run 
a pragmatic, multi health system randomized trial to test alternative strategies to enhance addiction treatment 
engagement among patients with OUD who receive bridge buprenorphine prescriptions from the ED or via 
low-barrier bridge clinic. The planned launch of the full pragmatic trial is January 2024.  
 
1.2 Significance  
 
There is growing recognition of the need for approaches to initiate treatment wherever patients touch the 
health care system, including the ED and low barrier bridge clinics. Most research has focused on initiation of 

 
 
RCT Protocol v.1.6; 7/08/24 
MOUDs in the ED rather than ensuring continued treatment post-discharge. We propose to adapt evidence-
based interventions to support patients’ complex needs and facilitate continued treatment, rather than 
discharging them and having them navigate outpatient treatment systems with limited support. We will 
randomize participants into 1 of 4 arms to receive varying degrees of augmented usual care, including daily 
check-ins and contingency management. We plan to examine the equity of treatment effects among racial and 
ethnic subgroups and assess important moderators of treatment effects.  
 
2. TRIAL DESIGN 
2.1 Overview 
 
We are proposing to conduct a randomized controlled trial to determine the effectiveness of various text-based 
and contingency management interventions on Opioid Use Disorder patients. Our goals are to measure their 
engagement with recovery treatment. We plan to enroll 1,808 participants into one of the following 4 arms.  
 
Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility 
criteria will be enrolled in this randomized control trial and randomized to: 
1. Augmented usual care (standard Way to Health CareConnect Textline) Patients can call or text the 
on-call substance use navigators (SUN) from 9a-9p, 7 days a week. 
2. Augmented usual care + text-message check-ins (standard Way to Health CareConnect Textline) 
Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND 
(text-message check-ins) patients will receive automated text-message check-ins up to once per day 
for 30 days to see if the patient needs help with anything. 
3. Augmented usual care + contingency management (standard Way to Health CareConnect Textline) 
and, participants will be compensated for going to their follow-up appointments.   
4. Augmented usual care + CM + Text-message check-ins (standard Way to Health CareConnect 
Textline) AND text-message check-ins—patients will receive automated text-message check-ins up to 
once per day for 30 days to see if the patient needs help with anything AND, participants will receive 
compensation for attending their follow-up appointments.  
 
Patients enrolled in the trial will also be invited to complete the intake survey and follow-up surveys. Patients 
will receive financial compensation for completing these surveys. We plan to enroll 1,808 participants for this 
study. However, when participants are presented with information about the study, they will only be notified 
they will earn compensation for completing surveys and may qualify for additional payments and may receive 
check-in texts and encouragement. However, while we disclose participants may qualify for additional 
payments, further details on intervention will not be detailed in the opt-out consent-message explaining the 
study as we believe incomplete consent is required for this population and this study design. Reasons why this 
is necessary for the execution of this research are highlighted in section 2.5 and 2.17 below. 
 
Definitions:  
 
Standard of Care: Patient receive access through discharge documents to local substance use navigators 
and follow-up clinic information. When patient engage with Substance Use Navigators (SUNs), members of 
the clinical team, they assist patients with accessing recovery care, including access to buprenorphine, 
scheduling follow-up appointments, providing transportation to treatment visits, and more. Patients can access 
the SUNs by calling or texting the CareConnect Warmline. All of the clinical care SUNs provide is documented 
in EPIC and RedCap for analysis and ways to improve the program. 
 

 
 
RCT Protocol v.1.6; 7/08/24 
Augmented Usual Care: patients receive a text message with information about how to more easily access 
the local substance use navigators by phone call or by text message through the Way to Health texting 
platform. 
 
Enhancements to Augmented Usual Care to be tested in the RCT: 
 
Bi-directional texting check-ins: patients randomized to this intervention will receive daily check-ins 
for the first 14 days after enrollment, then tapering check-ins for the remainder of the 30-day 
intervention period.  
 
Contingency Management: participants randomized to this intervention will receive financial rewards 
for filling their buprenorphine prescription and for being engaged in addiction treatment at 14 and 30 
days.   
 
Survey administration: intake survey and recurring follow-up surveys to assess outcomes.  
 
2.2 Setting 
The study will recruit patients seen in Emergency Departments and low barrier addiction medicine clinics in 
three health systems:  
• 
Penn Medicine: Hospital of the University of Pennsylvania (HUP Main and HUP Cedar), Penn 
Presbyterian, Pennsylvania Hospital, and the CareConnect addiction medicine virtual bridge clinic in 
Philadelphia, Pennsylvania 
• 
Cooper University Hospital in the Cooper Health system emergency department and bridge/walk-in 
clinic in Camden, New Jersey 
• 
Highland Hospital, San Leandro Hospital, and Alameda Hospital emergency departments and the 
Highland Hospital bridge clinic in the Alameda Health System in California.  
 
2.3 Inclusion Criteria 
1. 18 years of age or older 
2. Clinical impression or Diagnosis code for OUD or ED triage screen positive for OUD 
3. English reading ability 
4. Have a mobile phone capable of receiving text messages 
5. Bridge buprenorphine prescription (emergency department (ED) enrollment - Buprenorphine 
prescription at ED discharge; Bridge clinic enrollment – new buprenorphine prescription associated 
with on-demand or drop-in encounter  
6. Not a prisoner 
 
 
2.4 Participant Identification 
Clinician enrollment pathway. Patients with OUD will be approached to participate in the Way to Health 
CareConnect Textline as is the current standard of care. ED and bridge clinic staff will continue to determine 
eligibility of patients, based on clinical inclusion criteria (age of 18 or older, clinical impression of opioid use 
disorder, and having a mobile phone).  As is done currently, ED and bridge clinic staff will discuss the 
CareConnect textline with patients in the ED. After clinicians confirm that a patient is willing to received text 
messages from this program, the clinician navigates to the Way to Health section in the Epic EHR and 
completes a checkbox enrollment screener confirming the patient’s phone number, age older than 18, and 
whether or not the patient is being given a bridge buprenorphine prescription, and then clicks the “enroll” 

 
 
RCT Protocol v.1.6; 7/08/24 
button. Patients will then receive the Augmented Usual Care “Welcome Text” Message (see attached 
message logic and copy).    
The Welcome Text gives an explanation of the Clinical Care Program CareConnect and what it provides, as 
well as a number they can call and text for resources to assist with their OUD, a link to the CareConnect 
Warmline website that is run by Penn Medicine and hosted by the Center for Medicine and Policy. At this 
point, patients can text “bye” and will not receive further messaging. Patients enrolled in the CareConnect 
textline that that have received buprenorphine script at discharge will be invited to participate in the trial (see 
Section 2.5).   
Patients without phones may be provided with a phone and a 30-day data plan depending on availability of 
phones for distribution in the ED. Patients can opt-out of receiving further text messaged by texting back the 
word BYE. 
For patients enrolled at Cooper and Alameda emergency departments, they will receive the same explanation 
of the study, the same messaging with different nomenclature to highlight the branding of their SUNs hotline 
and research staff, and the link to the website will be for their respective bridge clinics. 
Academic associates (AAs) at Penn’s Hospital of the University of Pennsylvania and Presbyterian Medical 
Center will also be in the ED to help identify patients that may be eligible for the study. The AAs will approach 
the physician if they believe a patient is eligible and suggest if they meet the eligibility criteria, to enroll the 
patient. AA’s will also have the opportunity to enroll the participant if the Clinician is unable to.  
Staff enrollment pathway.  For patients that were not approached by a physician or ED staff about 
enrollment into a study, research coordinators will review an Epic EHR report of patients that meet inclusion 
criteria for the trial (See Section 2.3). They will then use the Way to Health platform to send eligible patients a 
text-message about a program that may help them at Penn, Cooper or Alameda. As is now standard practice 
with other text message engagement programs approved by Penn’s privacy office, the text-message will 
provide their first name and last initial of the patient, and ask the patient to confirm their identity before sending 
the same “Welcome Text” as detailed above in the clinician enrollment pathway. After participants confirm 
their identity, they will then be invited to enroll in the trial (See Section 2.5) below).  
 
2.5. Consent Procedures 
We will seek approval from the University of Pennsylvania (Penn) IRB, as the central IRB of record, to conduct 
the trial using an opt-out consent process. This approach is known as a waiver or alteration of the requirement 
for individual informed consent and is advocated for pragmatic trials testing methods for comparing and 
improving the delivery of established interventions within health care systems (References 1-4). 
Recent NIH-funded research by our group in the Center for Health Incentives and Behavioral Economics 
(CHIBE) and others reveals that patients generally endorse opt-out consent or simple notification approaches 
in pragmatic trials when such mechanisms help achieve the goals of the study (References 5-7). Although 
large-scale, pragmatic trials have previously been undertaken without consent at all, including by PI Delgado 
(IRB 844043) and other CHIBE faculty such as Scott Halpern (IRB Protocols 822134, 826933, and 814063) 
(References 8-9) both our investigative team and our study Stakeholder Advisory Committee strongly 
advocated for an opt-out consent process. This is the same opt-out approach was adopted in three prior 
studies addressing tobacco use disorder (a substance use disorder) that were conducted using a waiver or 
alteration of consent using the Way to Health platform (IRB Protocols 833713, 820451, and 814761) 
(References 10-12). Directly following eligibility screening, eligible participants will receive messaging in W2H 
about this voluntary program, will be directed to further information providing details on the study, and given 

 
 
RCT Protocol v.1.6; 7/08/24 
the opportunity to easily opt-out via text message. Please see language in the Way to Health Messaging 
_PCORI_10.6.23 document attached to this submission. 
References  
1. Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clin Trials 2015;12:442-8.  
2. Solomon MZ, Bonham AC. Ethical oversight of research on patient care. Hastings Cent Rep 2013;43:S2-3. 
 3. Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care 
system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep 2013;Spec No:S16-27.  
4. Asch DA, Ziolek TA, Mehta SJ. Misdirections in Informed Consent - Impediments to Health Care Innovation. N Engl J 
Med 2017;377:1412-4.  
5. Kraybill A, Dember L, Joffe S, et al. Patient and physician views about protocolized dialysis treatment in randomized 
trials and clinical care. AJOB Empirical Bioethics 2016;7.  
6. Cho MK, Magnus D, Constantine M, et al. Attitudes Toward Risk and Informed Consent for Research on Medical 
Practices: A Cross-sectional Survey. Annals of internal medicine 2015;162:690-6. 
7. Kraft SA, Cho MK, Constantine M, et al. A comparison of institutional review board professionals' and patients' views 
on consent for research on medical practices. Clin Trials Jun 1 2016. Epub ahead of print.  
8. Courtright KR, Madden V, Gabler NB, et al. Rationale and Design of the Randomized Evaluation of Default Access to 
Palliative Services (REDAPS) Trial. Ann Am Thorac Soc 2016;13:1629-39.  
9. Kerlin MP, Small DS, Cooney E, Fuchs BD, Bellini LM, Mikkelsen ME, Schweickert WD, Bakhru RN, Gabler NB, Harhay 
MO, Hansen-Flaschen J, Halpern SD.A randomized trial of nighttime physician staffing in an intensive care unit. New 
England Journal of Medicine 2013 368 (23):2201-9  
10. Halpern SD, French B, Small DS, et al. A randomized trial of four financial incentive programs for smoking cessation. 
New England Journal of Medicine 2015;372:2108-17.  
11.Halpern SD, Harhay MO, Saulsgiver K, Brophy C, Troxel AB, Volpp KG. A pragmatic trial of ecigarettes, incentives, and 
drugs for smoking cessation. New England Journal of Medicine 2018;E-pubahead of print May 23, 2018. 
12. Kohn R, Vachani A, Small D, Stephens-Shields AJ, Sheu D, Madden VL, Bayes BA, Chowdhury M, Friday S, Kim J, Gould 
MK, Ismail MH, Creekmur B, Facktor MA, Collins C, Blessing KK, Neslund-Dudas CM, Simoff MJ, Alleman ER, Epstein LH, 
Horst MA, Scott ME, Volpp KG, Halpern SD, Hart JL; Stakeholder Advisory Committee. Comparing Smoking Cessation 
Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol. Ann Am 
Thorac Soc. 2022 Feb;19(2):303-314.  
 
This trial will be conducted with a waiver or alteration of informed consent, using an Opt-Out Consent 
procedure: 
The research involves no more than minimal risk to subjects. The risks to subjects of participating in this 
comparative effectiveness study are minimal. Indeed, the only foreseeable study-related risk is a breach of 
confidentially. We outline below the safeguards we have in place to prevent any such breach. Furthermore, 
the risks are no more than minimal because both interventions exceed the standard of care routinely provided 
to patients with OUD discharged from the ED. The current standard of care for patients with OUD is to offer a 
discharge prescription for buprenorphine and provide discharge papers with a phone number to call to arrange 
a follow up appointment. To augment usual care, our clinical operations team has created the Way to Health 

 
 
RCT Protocol v.1.6; 7/08/24 
program CareConnect Textline to connect patients with phones directly to a team of substance use navigators 
(SUNs) available from 9a-9p by phone or text message. The SUNs assist with troubleshooting issues with 
obtaining buprenorphine, helping to arrange follow up appointments, and helping to address social needs such 
as transportation. To date the CareConnect Textline has already served over 70 patients with OUD discharged 
from the ED. Patients enrolled in this trial will continue to receive the same exact care as provided by the 
CareConnect Textline and can also reach the SUNs by the phone number provided on the discharge papers 
from the ED. The interventions tested here could be rolled out as part of normal operations and quality 
improvement Those enrolled in the trial will have the option to complete a baseline survey and two follow up 
surveys or opt-out. Completion of the surveys is voluntary. Survey data will be collected through HIPPA secure 
Way to Health mobile surveys and identifiers will be stored separately and securely from the survey data (see 
section 6 below). 
Impact on Subject Rights and Welfare. The waiver will not adversely affect the rights and welfare of patients 
because they will receive information both prior to, and directly after, randomization about what is involved in 
the program. Patients will be informed that the care that they receive will not be affected if they decline the 
program. All materials on the Way to Health platform will use plain language and adopt messaging strategies 
developed with our patient stakeholder committee that are culturally competent and use supportive person first 
language.  
The research aims cannot be practicably conducted without an opt-out consent process. This trial 
seeks to evaluate the effectiveness of adding automated text message check ins to the existing, standard of 
care of the existing OUD CareConnect program in an overall population of patients with OUD discharged from 
the ED. Requiring individual informed consent would introduce important selection biases. Specifically, 
socioeconomically disadvantaged populations who have experienced the greatest burden from OUD have 
historically participated in research at lower levels than the general population and would be less likely to 
enroll in this study. A major goal of this study is to understand and create knowledge that is generalizable to 
these marginalized populations. Furthermore, unlike a pharmaceutical trial where outcomes are primarily 
determined by physiologic effects of a medication, in this study of behavioral interventions, those who consent 
are likely to have behavioral characteristics that are not representative of those who would not consent and 
therefore potentially biasing the outcomes of a behavioral study. Therefore, requiring consent would render the 
study invalid since it would not have generalizability in applying to the desired population, particularly those 
experiencing the greatest disparities in outcomes due to OUD.  
This population of patients with OUD discharged from the ED with a buprenorphine prescription is precisely 
the population of interest for health systems. There is no real-world setting in which the interventions would 
only be made available to those patients who were discharged from the ED with a buprenorphine prescription 
and would opt in to participate in a research study. Yet that is the sample that would be obtained if we did not 
use an opt-out consent model, whereby patients are engaged with the program unless they actively choose 
otherwise. As programs similar to the current trial are being developed and disseminated across the country, it 
is imperative that we examine how these interventions perform across diverse health systems using their full 
eligible patient populations, lest these systems will make care decisions based on flawed information from 
highly selected patient samples. Furthermore, employing a waiver of consent for this trial will help to connect 
high-risk patients with OUD to potentially helpful treatments that they may not otherwise seek out.  
Although the foregoing discussion of how opt-out consent is the only way in which we can answer the 
research question is the most important reason by that approach is essential, there are also logistical 
considerations. Due to the large sample size needed for this study it would be impractical to employ study staff 
to manually recruit and consent 1,808 participants across more than 7 EDs and clinics in multiple health 
systems. Traditional recruitment, outreach, and consent by study staff for this trial would exhaust all of our 
financial and labor resources, as well as significantly lengthen the time needed to conduct this trial. It would be 

 
 
RCT Protocol v.1.6; 7/08/24 
impractical to conduct this study in the traditional manner. Using an opt-out approach will allow this research to 
be conducted in a more time- and cost-efficient manner. 
The text opt-out messaging will be comprised of a link to the study landing page/informed consent form/study 
information. This page will outline the study in detail. The landing page will provide information on what 
potential participants can expect if they participate, including who is eligible, surveys they will be asked to 
complete, length of time the survey is available, and that a study team member can help the participant 
complete the survey over the phone if they’d prefer. The opt-out landing page will also detail compensation 
amounts and distribution type (a physical Clincard). If participants are uninterested, they will have to opt-out of 
the research team collecting their protected health information. The landing page will also highlight the HIPPA 
agreement and detail what study information will be collected, including name, telephone number, birth date, 
email, demographics, health conditions, ED/Hospital/CareConnect use, and opioid/other substance use. The 
HIPPA language will also detail who their data may be shared with. A majority of the data shared will be de-
identified, if shared with study partners at research sites, our funders at PCORI and in agreement with their 
data sharing practices, and the data safety monitoring board. However, to confirm care engagement with care 
clinics outside of the Penn Health system, the research team may need to share the first and last name of 
patients, and potentially the DOB to confirm they’ve engaged with care at treatment centers or Primary care 
locations (outlined in image three).  The portion of the landing page is the Release Agreement. This form is 
required for the research team to confirm patients have attended their follow-up care appointments outside of 
the Penn Health System, an outcome measure, and compensation requirement for some interventions arms. 
The Release Agreement information on the landing page will state that participants allow any treatment facility 
they receive care to release information from their Health record to the CareConnect study team, specifically 
information on their attendance at specialty clinics and treatment centers for Opioid Use Disorder. This 
information will cover a period from the day of enrollment until 180 days later. Patients will also be asked to 
sign a physical copy of a medical release form that may be shared with clinics to confirm engagement in care.  
Based on feedback from peers in recovery, patients, and family, we’ve designed the opt-out consent to be 
easily understandable by participants. Usual HIPPA, Release agreements and Consent documents are written 
at reading levels that are not easy to understand by patients with low health literacy. We designed these forms 
to be written at a 6th grade reading level, which has been demonstrated to increase comprehension among 
patients with low health literacy. And furthermore, we designed these forms to be as succinct as possible to 
minimize cognitive load and increase patient autonomy and informed consent. 
The final text participant will receive will ask patients to text “BYE” if they wish to be un-enrolled from the 
program.  
Once a participant has received the opt-out consent message, they will then be enrolled into the trial and 
randomized to one of the four trial arms. If participants do not complete the intake survey, we have a reminder 
text notifying participants if they are interested and have read the consent, they are still enrolled and can 
participate. During this second text-message, the study team will send the reminder consent text as an image 
of the consent language.  
To ensure we provide ample opt-out opportunities, during each of the initial survey messages sent, we will 
remind participants to text BYE if they would prefer to leave the study. The Medical release form and other 
patient facing materials will not detail the various intervention arms. We are seeking to apply for incomplete 
disclosure for the enrollment process as it is necessary to carry out this research, as fully disclosing the study 
purpose may affect the participant’s responses, retention, and outcomes. This is standard practice in prior 
trials of contingency management interventions (Ghani et al, 2022; Hofmeyer, 2013). The following incomplete 
disclosure requirements are met: 

 
 
RCT Protocol v.1.6; 7/08/24 
1) The research is no more than minimal risk to participants. All participants will receive augmented usual 
care, will complete study questionnaires, and have their data collected from the electronic health 
record. The interventions do not introduce any significant risks to their typical standard or care. 
2) The incomplete disclosure will not adversely affect the rights and welfare of participants for either the 
groups that do receive the contingency management intervention and those that do not.  
3) The research cannot practicably be carried out without the alternation. Fully informing the participants 
that there may be financial rewards for engaging in treatment may have a subsequent effect on 
participation in the trial or their engagement in treatment if they are assigned to group without 
contingency management. Differential retention by randomization arm would bias outcomes and 
therefore prevent us from comparing the effectiveness of adding contingency management to usual 
care and text messaging facilitated telehealth for treatment engagement. 
Participants will be provided with additional pertinent information after participation. Once participants 
have been enrolled and randomized, they will receive a message explaining the study further, the 
details of the arm they have been randomized to, and for those enrolled in arms with contingency 
management, they will be informed of incentive amounts they will receive for engaging in care. We are 
requesting not to debrief the groups that are not receiving contingency management while they are 
actively participating in the trial because if they know that others in the study were receiving financial 
incentives that they are not receiving, they make think it is unfair and decide not to participate in the 
research and possibly their addiction treatment, which would have an impact on their health. However, 
participants will be debriefed once they have completed the study via end of study text message with a 
link to a debriefing statement (see attached).  
 
However, once a participant is randomized, we will then inform them of the arm they have been assigned to 
and what they can expect to occur. This language is in the Way to Health Messageing_PCORI_10.6.23 
document attached to this submission.  
Participants can unenroll from the study at any point by texting “stop” or “Bye”.  
Participants that are enrolled in the ED will receive a ClinCard and will sign the Medical Release form. At Penn 
facilities, the ClinCard and medical release form will be distributed by Academic associates at HUP and 
Presby, a Clinical research coordinator that will rotate between all Penn sites, and Social Workers and Nurses 
at each site.  The AAs, and other clinical staff distributing study materials, will also distribute a brochure with 
payment details for the surveys and length of the study to participants.  
After the AAs, and other clinical staff, have provided the Clincard for the participant, they will complete a 
Qualtrics survey with information needed for the study team to register the ClinCard (First name, last name, 
DOB, ClinCard token number, Clincard number, and upload a copy of the Medical Release form signed and 
dated). The Medical Release forms will be stored in a locked drawer in an office that requires badge and 
security clearance to enter.  
Addition of Consent for Qualitative Study. In addition to participation in the randomized controlled trial, we are 
also seeking consent to invite participants to a separate qualitative study designed to understand participants' 
experiences with the CareConnect program. Those who agree to participate in the RCT will also be informed that 
they may be contacted for an optional survey and interview to discuss their experiences. 
Participants will receive a separate opt-in consent process for the qualitative study, where they can voluntarily 
agree to participate. Those who opt in will be provided with additional details regarding the qualitative study, 
including the nature of the interviews, the estimated time commitment, and confidentiality measures. 
Participation in the qualitative study is entirely voluntary and will not impact their participation in the main RCT. 
2.6. Contact Information 

 
 
RCT Protocol v.1.6; 7/08/24 
When enrolling in the ED, participants will confirm their name, phone number, and DOB. If the patient does not 
have a cell phone, one may be provided to them depending on the availability of phones for distribution in the 
ED. The number will be entered by clinician enrolling the patients via the Way to Health CareConnect Textline 
enrollment screen in PennChart, and Cooper and Alameda’s instance of EPIC.  
After patients are enrolled into the CareConnect program in the ED, patients will be asked to sign a medical 
record release form at the time so that research staff can confirm engagement with OUD treatment during the 
study period. If patient is discharged from the ED and leaves before the research coordinator can provide 
them with a Clincard and medical release forms, the research coordinator will organize a time and place to 
meet the patients to distribute the Clincard and sign medical records release. 
2.7 Intake Survey 
After participants are enrolled into the program, they will receive a text-message containing a link to the intake 
survey. The survey will take 10 minutes or less to complete and will include demographic information, which 
includes sex, race, and ethnicity data. A shortened version of the Brief Addiction Monitor (BAM), which 
measures self-reported prior 7 or 14-day opioid, alcohol, cocaine, methamphetamine, and benzodiazepine 
use, prior addiction treatment history including MOUDs, and a baseline Substance Use Recovery Evaluator 
(SURE) assessment, a brief but comprehensive assessment of substance use, self-care, relationships, 
material resources, and outlook on life, and a Commitment to Sobriety scale Survey (CSS). Lastly, participants 
will complete the 5-trial adjusting delay discounting task, which takes 1 minute to complete and measures 
delay discounting function, a measure present bias. Participants will have 7 days to complete the intake 
survey before the survey is closed. Participants will be sent two survey reminders via text. Participants will 
have the option to have the survey administered over the phone by texting back SURVEY to the study 
message prompt or calling the study team. Participants will be compensated $20 for the intake survey which 
will be loaded onto their Clincard. 
2.8. Follow-up Surveys 
On Day 15 and 30, month 3 and 6, participants will receive a text-message to complete the follow-up surveys. 
Participants will have 7 days to complete the day 15 survey and 14 days to complete the day 30, 90, and 180 
surveys and receive reminder messages on day 16, 17, day 31, 32, day 91, 92, and day 181, 182. Participants 
will have the option to have the survey administered over phone by texting back SURVEY to the message 
prompt or calling the study team.  Participants that complete the survey will have $25 and $30 loaded onto 
their Clincards for the day 15, 30 survey and day 90 and 180 surveys, respectively.  
The interventions for this survey will end at day 30. As part of the follow-up period, participants will receive a 
text-message to complete the follow-up surveys at day 90, and day 180. Participants will receive reminders to 
complete the surveys on day 91 and 92, and day 182 and 183. Participants will have the option to have the 
survey administered over the phone by texting back SURVEY to the message prompt or calling the study 
team.  Participants that complete the survey will have $30 each loaded onto their Clincards for the day 90 and 
day 180 surveys. 
 
2.9. Allocation to Treatment 
Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility 
criteria will be enrolled in this randomized control trial and automatically randomized by Way to Health to 1 of 4 
arms outlined in section 2.10. Randomization will be stratified by health system and by enrollment type (ED vs. 
bridge/walk-in clinic in-person, and bridge clinic telehealth). Within enrollment type, randomizations will be 
balanced in blocks of size 12. 

 
 
RCT Protocol v.1.6; 7/08/24 
2.10. Behavioral Interventions 
Intervention 
Arm 
Description 
Incentive/Notification 
Timing  
Size 
1. Augmented 
Usual Care 
(AUC) 
AUC: Patients can call or text the on-call substance 
use navigators (SUN) from 9a-9p, 7 days a week  
Intake 
Survey + 
survey at 
day 15, day 
30, month 3 
and month 
6th. 
$20 for 
Intake 
survey, $25 
for 
completing 
day 15 
survey, $25 
for day 30 
survey, $30 
for month 3 
survey, and 
$30 for 
month 6 
survey.  
2. AUC + text-
messaging 
enhanced 
telehealth 
service 
AUC: (Patients can call or text the on-call substance 
use navigators (SUN) from 9a-9p, 7 days a week  
 
Txt message check-in: Patients will receive daily SMS 
check-ins for the first 14 days, then staggered check-
ins until day 30. 
 
 
Intake 
survey + 
Daily SMS 
Check-in + 
survey at 
day 15, day 
30, month 3 
and month 
6th.  
$20 for 
Intake 
survey, $25 
for 
completing 
day 15 
survey, $25 
for day 30 
survey, $30 
for month 3 
survey, and 
$30 for 
month 6 
survey. 
 
3. AUC + financial 
incentives (for 
treatment 
initiation and 
early 
engagement) 
AUC: Participant will receive a text message with the 
CareConnect number they can utilize if they are ever 
need of services. 
 
CM: Patients will also receive incentives for 
engagement with treatment  
Intake 
survey + 
survey at 
day 15, day 
30, month 3 
and month 
6th.  
Same survey 
incentive 
structure + 
$25 for 
attending 1st 
treatment 
appointment, 
$25 for 2nd 
treatment 
appointment. 
4. AUC + text 
messaging 
enhanced 
telehealth 
services + 
financial 
incentives 
 
AUC: Patients can call or text the on-call substance 
use navigators (SUN) from 9a-9p, 7 days a week  
 
 Txt message check-in: Patients will receive daily SMS 
check-ins for the first 14 days, then staggered check-
ins until day 30. 
 
 
CM: Patients will also receive incentives for 
engagement with treatment  
Daily SMS 
Check-in + 
Intake 
survey + 
survey at 
day 15, day 
30, month 3 
and month 
6th. 
Same survey 
incentive 
structure + 
$25 for 
attending 1st 
treatment 
appointment, 
$25 for 2nd 
treatment 
appointment 

 
 
RCT Protocol v.1.6; 7/08/24 
 
2.11 Observation Arm 
Augmented usual care: Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 
days a week 
2.12: Study Procedures: by schedule 
 
Augmente
d Usual 
Care 
(standard 
clinical 
program) 
Arm 1: 
Augmented 
Usual Care 
Arm 2: Bi-
Directional Text 
Messaging 
Arm 3: 
Contingency 
Management 
Arm 4: Bi-
Directional Text 
Messaging + 
Contingency 
Management 
Day 0 (pre-
randomizatio
n): 
Welcome 
text (1A) 
Welcome text 
(1) 
Welcome text 
(1) 
Welcome text 
(1) 
Welcome text 
(1) 
Day 0 to 30. 
Appt 
information 
(sent if appt 
scheduled) 
Text Appt 
Details for 
follow-up 
(1B) 
Text Appt Details 
for follow-up 
(1B) 
Text Appt 
Details for 
follow-up (1B) 
 
Text Appt Details 
for follow-up 
(1B) 
 
Text Appt 
Details for 
follow-up (1B) 
 
Day 0 (pre-
randomizatio
n) 
 
Study 
Information/Opt
-out 
Consent/Intake 
survey 1 (2) 
Study 
Information/Opt
-out 
Consent/Intake 
survey 1 (2) 
Study 
Information/Opt
-out 
Consent/Intake 
survey 1 (2) 
Study 
Information/Opt
-out 
Consent/Intake 
survey 1 (2) 
Randomized 
 
 
 
 
 
Arm 
Assignment 
Message 
(post-
randomizatio
n) Day 0 [1 
hour after 
welcome 
messages) 
 
Arm assignment 
message (1C.a) 
 
Arm assignment 
message (1C.2) 
 
Arm assignment 
message (1C.3) 
 
Arm assignment 
message (1C.4) 
 
Day 0 (post-
randomizatio
n) 
 
 
Bupe fill 
reminder (8) 
 
Bupe fill 
reminder (14) 
Day 0 
 
 
Initial treatment 
engagement 
nudge (9) 
 
Initial treatment 
engagement 
nudge (15) 
Day 0 
 
 
 
Contingency 
management 
reminders (11, 
12) 
Contingency 
management 
reminders (14, 
15) 

 
 
RCT Protocol v.1.6; 7/08/24 
Day 0 
 
10 am: intake 
survey (3) 
10 am: intake 
survey (3) 
10 am: intake 
survey (3) 
10 am: intake 
survey (3) 
Day 1 
 
Consent 
reminder 
message (for 
those that didn’t 
complete 
survey) (2) 
Consent 
reminder 
message (for 
those that didn’t 
complete 
survey) (2) 
Consent 
reminder 
message (for 
those that didn’t 
complete 
survey) (2) 
Consent 
reminder 
message (for 
those that didn’t 
complete 
survey) (2) 
Day 1 
 
(10 am: intake 
survey reminder 
prn), (3) 
(10 am: intake 
survey reminder 
prn), (3) 
(10 am: intake 
survey reminder 
prn), (3) 
(10 am: intake 
survey reminder 
prn), (3)  
Day 1-14 
 
 
11am: daily 
check-in (10a) 
 
11 am: daily 
check-in (10b) 
Day 15 
 
10 am: Day 15 
survey (4) 
10 am: Day 15 
survey (4) 
10 am: Day 15 
survey (4) 
10 am: Day 15 
survey (4) 
Day 16-17 
 
(10 am: Day 15 
survey reminder 
prn), (4) 
(10 am: Day 15 
survey reminder 
prn), (4) 
(10 am: Day 15 
survey reminder 
prn), (4) 
(10 am: Day 15 
survey reminder 
prn), (4) 
Day 18 
 
 
Treatment 
engagement 
nudge (16a) 
 
Treatment 
engagement 
nudge (16b) 
Day 18 
 
 
 
Contingency 
management 
reminder (17) 
Contingency 
management 
reminder (16b) 
Day 15-30 
 
 
11am: daily 
check-in, 
tapered 
schedule (10) 
 
11am: daily 
check-in, 
tapered 
schedule (10) 
Day 30 
 
10 am: Day 30 
survey (5) 
10 am: Day 30 
survey (5) 
10 am: Day 30 
survey (5) 
10 am: Day 30 
survey (5) 
Day 31-32 
 
(10 am: Day 30 
survey reminder 
prn) (5) 
(10 am: Day 30 
survey reminder 
prn) (5) 
(10 am: Day 30 
survey reminder 
prn) (5) 
(10 am: Day 30 
survey reminder 
prn) (5) 
Day 90 
 
Day 90 follow-up 
survey 
Day 90 follow-
up survey 
Day 90 follow-up 
survey 
Day 90 follow-
up survey 
Day 92-93 
 
Day 90 follow-up 
survey reminder 
Day 90 follow-
up survey 
reminder 
Day 90 follow-up 
survey reminder 
Day 90 follow-
up survey 
reminder 
Day 180 
 
Day 180 follow-
up survey  
Day 180 follow-
up survey 
Day 180 follow-
up survey 
Day 180 follow-
up survey 
Day 181-182 
 
Day 180 follow-
up survey 
reminder 
Day 180 follow-
up survey 
reminder 
Day 180 follow-
up survey 
reminder 
Day 180 follow-
up survey 
reminder 
Active 
Program End 
(Day 30) 
NPS survey 
(6)  
NPS survey (6) 
NPS survey (6) 
NPS survey (6) 
NPS survey (6) 
 
 

 
 
RCT Protocol v.1.6; 7/08/24 
Arm assignment message: After participants have been randomized to a study intervention arm. They will 
receive a message detailing the arm they have been randomized, what they can expect of the study, and how 
much they may receive in incentives depending on the arm they’ve been randomized to. This will include the 
frequency of text-message check ins, schedule and compensation for completing study assessments, and schedule and 
compensation for contingency management incentives [if patient was randomized to arms 3 or 4]). 
CM management arm: 
For participants enrolled in the Contingency management arms, a Clinical Research Coordinator will confirm 
patients have filled their buprenorphine script by checking the patients EMR before loading the compensation 
onto the patients Clincard.  
The same process will be used to confirm patients attended their follow-up appointments. The CRC will review 
the EMR and compensate patients that complete their follow-up treatment within 14 days. The CRC will repeat 
this procedure for patients that engaged in follow-up care within days 15-30. If the EMR does not show a 
follow-up appointment at day 14, the CRC will call the patient to confirm they haven’t attended a follow-up 
appointment. If the patient states they have attended an appointment and it is outside of the Penn Health 
system, the CRC will contact the clinic site the participant was treated at to confirm their attendance with the 
assistant of the Medical Release Form patients consented to prior to enrolling into the research study.  
Surveys: 
For all participants the surveys will be hosted on Way to Health. When a participant completes a survey, an 
alert will be sent to the research team, the patient will check Way to Health and confirm the survey was 
completed and then proceed to load the patients Clincard with the respective renumeration.  
If a patient requests the CRC call the participant to administer the survey, the CRC will reach out to the 
participant to complete the survey over the phone and renumerate the participant via Clincard. If the 
participant has not completed the survey, the CRC will call the participant on day 3 of the survey and ask if the 
participant would like the survey administered over the phone. If the participant wants to complete the survey 
over the phone, the CRC will proceed to administer the survey over the phone and then upload the respective 
incentive for the completed survey. 
 
2.13. Assessment Controls 
Augmented usual care (standard Way to Health Care textline. Patients can call or text the on-call 
substance use navigators (SUN) from 9a-9p, 7 days a week). 
 
2.14. Compensation 
Participants have the potential to earn up to $70 in the form of a Clincard reloadable debit card for completing 
surveys during the intervention period. 
Compensation structure for surveys:  
- 
$20 for completing the intake survey 
- 
$25 for completing the follow-up survey at day 15 
- 
$25 for completing the follow-up survey at day 30.  
Participants in the contingency management arms will have the ability to earn up to $75 additional dollars for 
attending their follow-up care appointments.  

 
 
RCT Protocol v.1.6; 7/08/24 
Compensation structure for Contingency Management: 
- 
$25 for filling buprenorphine Rx 
- 
$25 for attending follow-up appointment 1 
- 
$25 for attending follow-up appointment 2 
After the intervention period ends at day 30, participants will be asked to complete follow-up surveys at month 
3 and 6. Participants can earn up to $60 added to their Clincard reloadable debit card. 
Compensation structure for follow-up surveys: 
- 
$30 for completing follow-up survey at month 3.  
- 
$30 for completing follow-up survey at month 6.  
 
Patients will be compensated via Clincard. Research staff will be available in EDs to distribute Clincard at time 
of enrollment. Patients will be asked to consent to a medical record release form at the time of enrollment so 
that research staff can confirm engagement with OUD treatment. If patient is discharged from the ED and 
leaves before the research coordinator can provide them with a Clincard, the research coordinator will 
organize a time and place to meet the patients to distribute the Clincard and sign medical records release. If 
the patient is unable to return to the ED, ClinCard will be mailed to the patient. Mailing address only will be 
collected if patient requests their materials be sent by mail. If patient cannot return to the ED, and the patient 
prefers a virtual card, a virtual card will be sent to patient by email and an electronic medical release consent 
will be sent to the patient using Qualtrics or RedCap. Email address will only be collected if patient requests a 
virtual card.  
To confirm Contingency Management payments, clinical research coordinators will review the electronic 
medical record of participants enrolled to confirm buprenorphine prescriptions have been filled. As standard of 
care for OUD patients enrolled into clinical programs at Penn, their PDMP information is logged and entered 
into EPIC, and other treatment encounters. Clinical research coordinators will also confirm with clinic sites and 
or pharmacists that patient attended appointments or pharmacist received a prescription and pay the 
respective amount for filling their buprenorphine script and attending their follow-up appointments. Telehealth 
appointments will also be considered as attending follow-up appointments. The lead physician of this study 
may reach out to care clinics to confirm this information as well. 
 
2.15. Regulatory 
This study will be approved and monitored by the Institutional Review Board at the University of Pennsylvania.  
2.16. Contingencies and Participant Withdrawal 
If a participant withdraws from the study, further communication will be stopped. Data collected prior to 
withdrawal will be maintained in deidentified files and may still be used for research purposes. However, 
additional data will not be collected after the point of withdrawal.  
Participants will be told that they can withdraw from the study at any time by texting “Bye”.  
 
2.17 Deception 
Participants will be informed that they may qualify for additional payments in the in the informed consent 
document, but we will not share further details about the Contingency Management arms during the consent 
process as we believe this will lead to bias (Hofmeyer, 2013 and Ghani et al. 2022). Fully informing the 

 
 
RCT Protocol v.1.6; 7/08/24 
participants that there may be financial rewards for engaging in treatment may have a subsequent effect on 
participation in the trial or their engagement in treatment if they are assigned to group without contingency 
management. Differential retention by randomization arm would bias outcomes and therefore prevent us from 
comparing the effectiveness of adding contingency management to usual care and text messaging facilitated 
telehealth for treatment engagement. However, we will notify participants once they’ve been randomized of the 
details of the intervention, they have been randomized to 
A. Deception/incomplete disclosure is typically only acceptable in studies with no more than minimal 
risk. Please detail why this study is minimal risk.  
This study is minimal risk, there is no harm in not disclosing the amount of money or the intervention 
arms participants may be enrolled into. Participants will not be at risk of additional harm while 
participating in this study than they already would be exposed to in usual care.  
  
B. The deception/incomplete disclosure should have no adverse effects on welfare. Please outline 
how all adverse effects are minimized. 
Incomplete disclosure of the intervention arms and incentive amounts for the respective arms, will 
have no adverse effects on the welfare of participants. Participants will still have access to care 
regardless of the arm they have been randomized to. The total contingency management incentive 
amounts that participants are eligible to receive if randomized to arms 3 and 4 ($75) is less than the 
total amount participants in all study arms can receive from completing all study assessments ($130).  
 
C. The IRB must determine that the value of the study is sufficient to warrant waiving some aspects 
of the requirement for full disclosure in the informed consent process. Please outline the scientific 
validity for using deception in this instance.  
Some arms involve contingency management as an intervention, being compensated for attending 
addiction recovery appointments. We believe for this population; participants may become upset and 
unenroll with the intention of re-enrolling with the intention of being randomized into a more favorable 
arm (the arm with additional incentives) for attending the same appointments they otherwise would 
not have been paid for attending. To maintain the integrity of the study design, we believe that 
incomplete disclosure of financial incentives is necessary.  
  
D. There is no alternative to address the scientific question in a valid manner but to use deception/ 
incomplete disclosure. Other effective, non-deceptive approaches are not feasible. Please detail why 
alternatives are not feasible.  
There is no alternative to studying the effectiveness of contingency management vs non-contingency 
management arms without deception for this population for the reasons listed in section C.  
  
E. Debriefing is done, when appropriate, and the deception/incomplete disclosure is explained to the 
participant before the end of participation in the research. Please detail if you are debriefing 
participants, and if not, why not.  

 
 
RCT Protocol v.1.6; 7/08/24 
Participants will be debriefed once they have completed the study with an end of study text message 
and link to a study debriefing statement (see attached. We will also notify participants the study was 
posted on PCORI and Clinical trials websites, provide the NCT number if they are interested in 
viewing the results, and further explain that no identifiable information was added onto this website. 
We are neglecting to notify participants of the PCORI and Clinical Trials websites at the onset of the 
study for the reasons listed in sections a-d above.  
  
F. When appropriate, subjects could be informed prospectively of the use of deception/incomplete 
disclosure and consent to its use: see the suggested consent language: "In some research studies, 
the investigators cannot tell you exactly what the study is about before you participate in the study. 
We will describe the tasks in the study in a general way, but we can't explain the real purpose of the 
study until after you complete these tasks. When you are done, we will explain why we are doing this 
study, what we are looking at, and any other information you should know about this study. You will 
also be able to ask any questions you might have about the study's purpose and the tasks you did. 
Though we may not be able to explain the real purpose of the study until after you complete the 
tasks, there are no additional risks to those that have been described in this consent form."  
We don't believe it's appropriate to inform participants prospectively of the use of deception or 
incomplete disclosure for this study in the consent form for reasons listed in section a-e above.  
 
3. OUTCOMES 
3.1. Primary outcome 
The primary outcome will be engagement in any addiction treatment at 30 days from randomization 
(measured on Day 31).   Participants will consent to allow research coordinators to confirm this outcome via 
agreements with referral clinics; our sites are experienced with collecting this standardized outcome as part of 
a National Institute on Drug Abuse multicenter study (CTN-0099RCT). Data collected during this assessment 
includes provider type, program and treatments received (buprenorphine, methadone, naltrexone) using a 
standardized reporting form. Engagement in treatment at 30 days will be defined as either: (1) filling a 
buprenorphine prescription that covers Day 30 or a buprenorphine prescription that covers at least 7 of the 14 
days between Days 15 and 30 based on documentation of PDMP review; (2) EHR documentation of 
engagement in addiction treatment including a telehealth clinic encounter, office based treatment, inpatient 
addiction detox or rehabilitation, intensive outpatient treatment, or opioid treatment program (including 
documentation of methadone dose confirmations or 2 or more visits on consecutive days for methadone guest 
dosing in the ED); or (3) contacting the patient up to 3 times for site of addiction treatment and then confirming 
with the treatment facility whether the patient was engaged with one of the above forms of addiction treatment. 
Data is expected to be missing at low frequency based on prior ED-based trials in which only 1% of patients had 
missing data on this outcome.9 The combined absence of buprenorphine fills, EHR documentation of addiction 
treatment, and the inability to reach the patient will be counted as lack of engagement in addiction treatment at 
30 days. This will be reassessed at 30 days, 3 months, and 6 months. 
3.2. Secondary outcome 
We will measure two key secondary outcomes: 
Filling a buprenorphine prescription within 7 days of randomization based on documentation of PDMP review. 

 
 
RCT Protocol v.1.6; 7/08/24 
Engagement in treatment with 14 days will be defined as either: (1) filling a second buprenorphine prescription 
within 14 days of enrollment based PDMP review; (2) EHR documentation of engagement in addiction 
treatment including a telehealth clinic encounter, office based treatment, inpatient addiction detox or 
rehabilitation, intensive outpatient treatment, or opioid treatment program (including documentation of 
methadone dose confirmations or 2 or more visits on consecutive days for methadone guest dosing in the 
ED); or (3) contacting the patient up to 3 times for site of addiction treatment and then confirming with the 
treatment facility whether the patient was engaged with one of the above forms of addiction treatment. Data is 
expected to be missing at low frequency based on prior ED-based trials in which only 1% of patients had 
missing data on this outcome.9 The combined absence of buprenorphine fills, EHR documentation of addiction 
treatment, and the inability to reach the patient will be counted as lack of engagement in addiction treatment at 
14 days. 
We will measure the following exploratory outcomes: 
Patient reported outcomes. We will measure questions adapted from the SURE and BAM at intake and all 
follow-up assessments providing data on substance use, self-care, relationships, material resources, and 
outlook on life. We will also measure treatment appropriateness and acceptability 15 days using validated 
measures. 
Subsequent ED and hospital utilization and mortality. We have developed standardized data queries to 
capture all ED visits, hospitalizations, and mortality out to 6 months from enrollment. To capture encounters 
outside study health systems, as we have done previously, we will obtain linked records from the regional 
health information exchanges (HIEs) – HealthShare Exchange for Penn and Cooper, Care Everywhere for 
Alameda). Will subsequently link the patient data to the National Death Index to capture of out-of-hospital 
mortality not captured in EHRs or HIEs. 
 
4. STATISTICAL ANALYSIS PLAN 
4.1. Analytic Methods 
We will produce data summaries using frequencies for categorical variables and means, medians, and ranges 
for continuous variables. To evaluate randomization balance, we will compare baseline values of all variables 
across groups using nonparametric tests. We will include variables with imbalances as covariates in sensitivity 
analyses. In the models described below, we will check the validity using standardized residuals, influence 
diagnostics, and graphical displays. 
We will use intention-to-treat analyses, in which all participants are analyzed as randomized to measure 
effectiveness. We will test our primary hypothesis using a logistic regression model108 with a binary indicator of 
attendance at outpatient addiction treatment clinic 30 days post-randomization as the response. To 
accommodate the stratified randomization, the model will include categorical variables for hospital system, 
enrollment site (ED vs. bridge clinic), and for ethnicity (white/non-white). The hypothesis will be addressed by 
including binary factors for incentives and for telehealth, and we will include their interaction to allow the effect 
of either the telehealth or incentive intervention to vary across the levels of the other. Our main comparisons, 
of each of the three interventions vs. enhanced usual care, will be based on this interaction model. We will 
report the rates of attendance for each of the four treatment groups, and the odds ratios and relative risks 
corresponding to the three primary comparisons, along with associated standard errors, confidence intervals 
and p-values. We will also report the effect sizes for the pairwise comparisons among the three active 
intervention strategies. 
Sample size and power. Primary Outcome: Engagement in Treatment at 30 days. An important strength of this 
study, unlike prior RCTs of text-messaging, telehealth interventions, and incentives for OUD, is that we will be 

 
 
RCT Protocol v.1.6; 7/08/24 
powered to determine whether these interventions are effective among non-white patients. Specifically, we 
power the study to provide 80% power to detect differences of 17.5% or greater between the interventions and 
usual care, within the non-white subgroup. We use two-sided tests, with a Bonferonni-corrected alpha level of 
0.05/3=0.017. We also assume a 10% dropout rate between randomization and the 30-day time point. Based 
on prior data from the study sites, we expect a 35% engagement rate at 30-days in the usual care group, and 
that approximately 48% of our sample will be non-white. With these assumptions, a full sample of 1628, 
equally distributed across the four groups, yields 80% power for a risk difference of 17.5% or more for 
comparisons with usual care within the non-white subsample. For the full sample, this sample size yields 80% 
power for a corresponding risk difference of 12% or more. However, while we anticipate that we will lose 
contact with some participants through the first 30 days, our engagement outcome will be available on all 
randomized participants, as “loss of contact” will be regarded as equivalent to “non-engaged”. Under this 
assumption, we have 89% power to detect a difference of 17.5% at 30-days, and 82% power to detect a 
difference of 16% at 30 days. For the full sample (white and non-white) we have power for smaller effects: with 
the same alpha level of 0.017, we have 84% power to detect a risk difference of 11% (35% vs 46%) in the 
three comparisons with control. 
Secondary Outcome: Engagement in Treatment Within 14 Days. Based on the nature of the interventions, we 
anticipate a potentially smaller effect than at 30-days. Therefore, to have 80% power for risk differences of 
15% in the non-white population, we would need total sample size of 1808, which will be the target enrollment 
for trial. 
 
Missing data. We anticipate that between 10% and 15% of the sample will drop out between randomization 
and 30-day assessment. When possible, we plan to record and report all reasons for patient drop-out, 
including non-response and patient choice to not participate assessments. We will characterize the subgroup 
of participants who drop out in terms of baseline demographic, socioeconomic, and behavioral characteristics. 
Next, we will use a logistic regression model, including most of the baseline variables, treatment group, and 
interactions, to develop a prediction model for dropout. From this model, we will obtain predicted probabilities 
of treatment retention through 30-days, and use these predicted probabilities as weights in an inverse-
probability-weighted re-fitting of the models described for Aim 1 and 2.  
Adherence to assigned intervention. We expect that some participants will not adhere to their assigned 
treatment. Non-adherence will be defined as not responding to intervention text-messages in the active 
treatment arms. To accommodate this in our analyses, we will use an instrumental variables approach, using 
the randomization variable as an instrument, to separately compare the usual care group to each of the other 
three groups, using a two-stage least squares approach. Next, we will use the multiple-group methods 110,111 to 
obtain adherence-adjusted estimates of effect for all groups simultaneously. 
Secondary hypotheses. We will test the secondary hypotheses on filling the initial buprenorphine prescription 
within 7 day and engagement in treatment within 14 days using logistic regression models specified in the 
same way as those above. We will use similarly specified generalized linear models,112 with link functions and 
mean-variance relationships chosen as appropriate for the various response distributions, to test the 
secondary hypotheses on the patient-reported measures.  
Exploratory hypotheses. For the exploratory outcomes at 30-days post-randomization, we will use similar 
logistic regression models to compare the groups on enrollment and receipt of treatment, and on UDS for illicit 
opioids. For ED visits and hospitalizations, we will use zero-inflated negative binomial regression models113 if 
there is sufficient variability in these responses, and logistic regression models (for dichotomized versions of 
these responses) otherwise. We will also conduct interaction analyses to determine if enrollment site (ED vs. 
bridge clinic) moderates the intervention effects on the primary and secondary outcomes.  

 
 
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5. DATA COLLECTION AND MANAGEMENT 
5.1. Data Collection Process 
The solicitation text message will include a link to Way to Health’s study page. Contact information, and survey 
data will be collected by Way to Health. Outcome variables will be obtained prospectively from elective 
surveys, through EHR and/or health information exchange, local research coordinator chart review/phone 
calls, and Way to Health Data. Way to Health will access SMS messaging, mobile survey, or central research 
coordinator phone call, and include EPIC integration.  
5.2. Variables 
A detailed account of the data we will obtain, our Measures library, is included in the Appendix.  
5.3 Transfer of Data 
Once participants have enrolled and completed the intake process, the research team will export their 
participant information (EPIC data, comorbid conditions, ED encounter data, Prior ED/Hospital use) will be 
integrated into Way to Health. Way to Health’s integration with EPIC will log each participant’s phone number, 
Study ID, and study name, which will then trigger a message to each participant with a link to the study site. 
Health information exchange data from Cooper and Alameda will be collected by their respective sites, linked 
with the MRNs. Once the data has been linked, the MRNs will be removed and the data will be de-identified 
and shared to the Penn team via RedCap.  
5.4. Data Storage and Security 
Any datasets and computer files are referred to by study ID. The study ID is also used on all analytical files. 
Way to Health will store all data securely sent to the Penn research team.  All data for this project will be 
stored on Way to Health, or Pennbox, in data files that will be protected by multiple password layers, requiring 
staff with access to the folders to sign-in to Pennbox with their Penn ID and duo dual authentication, Penn has 
executed HIPPA-compliant Business Associate Agreements with the Box services.  
All personal information that the participant is asked to provide will be collected via Way to Health. Through 
Way to Health, we will collect participants’ names, dates of birth, email addresses, and phone numbers. To 
assure that participant confidentiality is preserved, individual identifiers are stored in a single password 
protected system that is accessible only to study research, analysis, and IT staff. An investigator or statistician 
who logs in will be able to access only non-identifiable data. The Way to Health administrative group and 
research coordinators responsible for contacting participants for follow-up study visits or responding to 
questions about the study are able to view participant names and contact information. The Way to Health web 
development team and Project Director currently have administrative access to PHI. All of these personnel will 
have completed Human Subjects Protection and HIPAA privacy training. The system automatically generates 
logs of all data queries which can be reviewed by research staff to ensure that no unauthorized persons have 
gained access to identifiable information. 
This system is hosted on site at The University of Pennsylvania and is protected by a secure firewall and 
several layers of operational security. Once a participant has been entered into this system, they are given a 
unique study identification number (ID). Any datasets and computer files that leave the firewall are stripped of 
all identifiers and individuals are referred to by their study ID. The study ID is also used on all analytical files. 
The Penn Medicine Academic Computing Services (PMACS) is the hub for the hardware and database 
infrastructure that supports the project and the Way To Health web portal is built on this infrastructure. The 
data collected for Way To Health based studies is stored in mySQL databases on a PMACS-operated blade 
server environment devoted specifically to Way To Health. The data center is housed in Information Systems 

 
 
RCT Protocol v.1.6; 7/08/24 
and Computing at 3401 Walnut Street. All data are stored in a single relational database, allowing researchers 
to correct mistakes. Every SQL transaction, including accessing and changing data, is logged for auditing 
purposes. Datasets are stripped of all personally identifiable information when exported for analysis. The web 
application automatically removes all identifiers when a researcher requests an analytic dataset. The only 
people with access to identifiable participant information are pre-specified Research Coordinators responsible 
for contacting participants for follow-up. Personal information and research data will be stored in separate SQL 
tables and will be linked by a computer-generated ID number. Additionally, any information that leaves this 
system to communicate with third party data sources (i.e. survey software) is stripped of any identifiers and 
transmitted in encrypted format.  
6. HUMAN SUBJECTS 
6.1. Risks to Human Subjects 
This project poses minimal risk. There is a risk of breach of confidentiality for participants receiving study 
information on their phones. Any demographic, survey, and EPIC data will be stripped of identifiers before the 
datasets are combined and analyzed. Penn will collect contact information (cell phone for SMS 
communication, and DOB for ClinCard registration required for compensation).  
6.2. Protection against Risk 
In order to protect study participants from potential risks related to the loss of confidentiality and due to any 
discomfort that they may experience in answering any questions, the following steps will be taken: 1) 
Participants will be told that they can withdraw from the study at any time by contacting us. They will also be 
able to stop receiving text messages simply by replying, “STOP” to the study phone number at any point 
during the study; 2) All information provided by the participant will be referenced to a Study ID. The 
participant’s contact information will not be connected to any other study data. Their survey data can only be 
connected to their demographic and survey data through the Study ID, which will be created and stored on 
Way to Health. All data and files will be entered on computers protected by passwords and stored in a locked 
office. 3) All research staff will be trained in the importance of maintaining confidentiality and will meet all 
training requirements for human subjects’ research. 4) All participant data will be presented in aggregate and 
no individuals will be identified individually. Additionally, all datasets will be de-identified before analysis. 
Once all data has been linked for analysis, identifiers will be stripped and identifiable data will be destroyed a 
year after data analysis is complete. All data on Way to health will be destroyed 6 months after the study has 
closed.  
 
 
6.3. Adequacy of Protection Against Risk 
Participants are Emergency Medicine patients that have screened positive for OUD. The study poses no more 
than minimal risk, as it’s testing various interventions that have been tested in the field previously and showed 
to be of minimal risk. We intend to apply these interventions on top of to the current standard of care. The 
current standard of care is discharging OUD patients with access to the CareConnect warmline. A Penn run 
program that staffs substance use navigators from 9 am – 9 pm, to assistant patients with opioid use disorder 
access care.  Cooper and Alameda have similar clinical programs staffed by substance use navigators as the 
standard of care at their sites. We will be applying these interventions over their current standard of care.  
Way to Health will assign a study ID to each Study Participant. Data will be transferred between EPIC with 
Way to Health, secure email, and SecureShare. Penn and the other sites will collect contact information (cell 
phone for SMS communication, DOB for ClinCard registration). When files are exported from Way to Health to 
Pennbox, this identifiable information will be stored in a file separate from survey data, demographic data, and 
EPIC data. 

 
 
RCT Protocol v.1.6; 7/08/24 
 
6.4 Potential Benefits to Individual Participants 
This information could allow the research team to gain insight about effective program strategies for increasing 
engagement in OUD research. Participants may gain more access to the health system and open avenues for 
personal care and recovery treatment.  
6.5 Clinical Trials  
This study will be registered on clinical trials.gov once the study has received IRB approval. An NCT 
registration number will be added to the IRB once it has been created. Language regarding the study being on 
clinicaltrials.gov will not be added to any consent or patient facing document as it will allow participants to see 
the study intervention, which we are purposely blinding participants to. We will provide participants with the 
Clinical Trials NCT number once they have completed the study at 6 months.  
7. Data and Safety Monitoring 
All data received will be de-identified and will remain de-identified. All data obtained in the study will be used 
exclusively for the purposes of the proposed research. Users of this platform have been assigned a Study ID# 
and no identifiers will be contained in this file. This data will be linked by a programmer utilizing coded study 
IDs and operating behind a University firewall.  Data from Way to health will be protected by a strong 
password to access the computer of the user who has access to the database and a strong password to 
access the database. No results will be reported in a personally identifiable manner. (Variables in Appendix) 
 
8. FUNDING 
Funding for this trial is provided by the Patient Centered Outcomes Research Institute (PCORI). Penn is 
responsible for the overall design, conduct, collection, management, analysis, and interpretation of the data; 
preparation, review, and approval of the manuscript; and the decision to submit the manuscript for publication.  
 
9. PUBLICATIONS 
We plan to publish the findings in conference proceedings and/or peer-reviewed journals. 
 
10. DATA SHARING 
Data for this study may be shared in aggregate with our collaborators at Highland Alameda Health System and 
Cooper Health and resolve any technical issues with Way to Health, where they will act as enrollment sites. 
No PHI will be shared in this process. However, we will receive PHI from these institutions, as their patients 
will be enrolled into Way to Health and this data will be de-identified for analysis purposes. We will also comply 
with the sponsor (PCORI) data sharing policy in which de-identified study data will be transferred to a 
repository managed by PCORI at the end of the study https://www.pcori.org/about/governance/policy-data-
management-and-data-sharing). 
We will enter into a Data Use Agreement with Alameda and Cooper regarding how the data will be transferred 
to Penn for analysis. Any data that is not collected in Way to Health from the Cooper and Alameda sites, will 
be extracted from EPIC and Health Exchange data. The sites will use the MRNs to link all of the data, once 
the data has been linked by the sites, the identifiers will be stripped, and the Way to Health identification 
number will be added.  The EPIC and health exchange data will be entered into a RedCap data base with to 

 
 
RCT Protocol v.1.6; 7/08/24 
link the Way to Health ID. Penn will download the de-identified data for analysis purposes and use the W2H ID 
in the RedCap forms to link the patient data with the W2H data. 
A main outcome of our study is confirming engagement with OUD care. At Alameda and Cooper, they have 
integrated systems that allow for this care to be done within the health system and stored in EPIC. However, 
at Penn, patients that engage with the emergency department for OUD often receive follow-up care from 
clinics outside of Penn’s system. To account for this, we will have participants that enroll into the study 
complete a Medical Release form (detailed in sections 2.5 and 2.6), where patients have agreed to have the 
research team contact their clinical sights to confirm they’ve received care via text and further by filling out the 
medical release form.  
We will have CRC’s, PM’s and or Clinicians on the team, call the clinics and share the participant’s first and 
last name, and DOB with the clinic sites to confirm the patient attended care, and will receive the dates the 
patient attended care at the clinics. If the clinics request a medical release form, we will then fax or email a 
copy of the patient’s signed medical release form to the clinic to receive this information. This information will 
be logged into Way to Health. Those in the contingency management arm will be compensated once we’ve 
confirmed engagement in care.  
11. TASKS AND RESPONSIBILITIES 
Principal investigator: Overall responsibility for protocol development, intervention development, budget 
overview, data dictionary development, ethical approval, trial registration, trial oversight, and the data and 
safety monitoring board, assessment of overall recruitments, potential, data analysis, and dissemination and 
presentation of results.  
 
Co-Investigators: Protocol development, data dictionary development, trial oversight, dissemination of results.  
 
11.1. Principal Investigator 
Mucio Kit Delgado, MD, MS 
 
11.2. Co-Investigators 
University of Pennsylvania: 
Margaret Lowenstein 
Jeanmarie Perrone 
James McKay, PhD 
David Mandell, ScD 
Austin Kilaru, MD  
Anna Morgan, MD 
Jeff Ebert, PhD 
Dina Abdel-Rahman, BS 
Maya Nelson, BS 
Aria Xiong, MS 
Neda Khan, MCHI 
Krishleen Kaur 
Laurel Adams 
 
 
Alameda Health System: 
Andrew Herring, MD 
Erik Andersson, MD 

 
 
RCT Protocol v.1.6; 7/08/24 
 
Cooper Medicine: 
Matthew Salzman, MD 
 
Rowan University: 
Bethany Raiff, PhD 
 
 
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RCT Protocol v.1.6; 7/08/24 
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(2020): 109-119. 
 
 
 

 
 
RCT Protocol v.1.6; 7/08/24 
Appendix  
Table of Measures  
Data collected by or transferred to Penn 
Source 
Variables 
Time from ED 
Discharge 
EHR 
  
 
  
Demographics 
Intake 
  
Comorbid conditions 
Intake 
  
ED Encounter data 
Intake 
  
Prior ED/Hospital Use 
 
Intake 
Way to Health 
  
 
  
W2H ID 
Intake 
  
Engagement with substance use navigators  
Intake 
Local 
Research 
Coordinator 
chart 
review/phone 
calls  
 
 
  
Engaged in Addiction Treatment  
Intake, day 15, day 30, 
month 3, month 6 
 Mobile 
Survey 
 
 
  
Addiction treatment history 
Intake,  
 
Brief Addiction Monitor -Revised (BAM-R) 
Intake, day 15, day 30, 
month 3, month 6 
 
Substance Use Recovery Evaluator (SURE) 
Intake, day 15, day 30, 
month 3, month 6  
 
Commitment to Sobriety Scale (CSS) 
Intake, day 15, day 30, 
month 3, month 6 
 
Immediate barriers to addiction treatment and 
recovery 
Intake, day 15, day 30, 
month 3, month 6 

 
 
RCT Protocol v.1.6; 7/08/24 
 
Delay discounting function 
Intake 
 
Appropriateness  
Intake 
 
Acceptability  
Intake 
 
 
 

 
 
RCT Protocol v.1.6; 7/08/24 
2. Study Consent   
 
We want to improve CareConnect and are enrolling patients prescribed buprenorphine to be in a 6-month 
research study. Those who participate may benefit from improved treatment. Unless we hear from you, you 
will be enrolled in the study. If you do not want to be in the study, text BYE. You will still have access to 
CareConnect helpline.   
In the study you’ll be texted links to 5 optional surveys about opioid use. You’ll receive a survey tomorrow and 
in 15, 30, 90, and 180 days, and have 3 days to take each. A CareConnect member can also call you to ask 
the survey questions. Each pays $20, $25 or $30 by ClinCard debit card. You may be eligible for additional 
payments. You may also get texts that check in or encourage you to attend treatment. After 30 days, you may 
be invited to an optional survey and interview about CareConnect ($50 payment).  
By participating you agree to allow the research team to use your protected health information and access 
information about your addiction treatment.  See HIPAA and release agreements. Data will be securely stored 
and shared for future research. Identifying info will be removed. We strive for confidentiality, but there’s always 
a risk.    
You can withdraw from the study at any time by texting BYE. We can also end the study anytime. Study 
questions? Call 609-248-0229. Questions about your rights? Call Penn IRB at 215-898-2614 and ask about 
study #853153.  
HIPAA Agreement   
Our study uses protected health information from your survey responses and medical records: name, 
telephone #, birth date, medical record #, demographics, health conditions, ED/hospital/CareConnect use, 
opioid/other substance use, addiction medication and treatment. This information is needed to do, evaluate, 
and oversee the study. It will be stored in electronic medical record and Way to Health, which meet HIPAA 
standards. ClinCard will use name, birth date; possibly email.  
Besides the study team, other approved people at Penn may access your information. It may also be shared 
with addiction treatment centers, subcontractors, non-Penn study researchers, Patient-Centered Outcomes 
Research Institute, U.S. Office of Human Research Protections, the study’s data and safety monitoring board. 
If your information is shared outside Penn, it may no longer be covered by federal privacy regulations. By 
participating you agree to allow this use of your protected health information with no end date. To end this 
agreement, text BYE.  
Release Agreement  
By participating, you agree to allow any treatment facility where you receive care to release information from 
your health record to the CareConnect study team. The study team will request information on your 
attendance at specialty clinics and treatment centers for opioid use disorder. This information will cover a 
period from today until 180 days later. The purpose of this information is to let the team know if you got 
treatment as a follow up to care in the emergency department or bridge clinic. You may end this agreement by 
texting BYE; ending the agreement means that new information cannot be shared with the study team.