Pilot Evaluation of a Peer Recovery Support Program Adapted to Target Retention in Clinic-based Medication for Opioid Use Disorder Treatment
Phase: NA
Conditions: Opioid Use Disorder
Sponsor: Geisinger Clinic

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Research Protocol – 2024-0862
Pilot evaluation of a peer recovery support program adapted to target 
retention in clinic-based medication for opioid use disorder treatment
Version:
5 08 2025
Principal Investigator:
Melissa Poulsen
100 N. Academy Ave.
Danville, PA 17837
570-214-9322
IRB NUMBER: 2024-0862
IRB Approved:  05/19/2025

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TABLE OF CONTENTS
1
ABBREVIATIONS USED IN THE PROTOCOL ................................................................4
2
ABSTRACT...........................................................................................................................5
3
BACKGROUND AND SIGNIFICANCE .............................................................................6
4
SPECIFIC AIM......................................................................................................................8
5
STUDY DESIGN...................................................................................................................8
5.1
Description....................................................................................................................8
5.2
Study Population...........................................................................................................9
5.2.1
Approximate Number of Subjects..................................................................9
5.2.2
Inclusion Criteria............................................................................................9
5.2.3
Exclusion Criteria...........................................................................................9
5.3
Recruitment...................................................................................................................9
5.4
Study Duration............................................................................................................13
5.4.1
Approximate Duration of Subject Participation...........................................13
5.4.2
Approximate Duration of Study...................................................................13
5.4.3
Peer Recovery Support Program..................................................................14
5.4.4
Data Collection Procedures..........................................................................14
5.5
Primary Endpoints ......................................................................................................18
5.6
Analysis ......................................................................................................................19
5.6.1
Analysis Plan................................................................................................19
5.6.2
Sample Size Considerations.........................................................................19
5.7
Data Management.......................................................................................................20
5.7.1
Data Collection and Storage.........................................................................20
5.7.2
Records Retention ........................................................................................20
6
PROTECTION OF HUMAN SUBJECTS...........................................................................20
6.1
Informed Consent and HIPAA Authorization............................................................20
6.2
Potential Risks/Benefits and Protection of Human Subjects Against Risks...............21
IRB NUMBER: 2024-0862
IRB Approved:  05/19/2025

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SAFETY MONITORING....................................................................................................23
7.1
Adverse Event Reporting............................................................................................23
7.2
Serious Adverse Event Reporting...............................................................................24
7.3
Recording and Reporting............................................................................................24
7.4
Data Monitoring Plan .................................................................................................25
8
REFERENCES.....................................................................................................................25
IRB NUMBER: 2024-0862
IRB Approved:  05/19/2025

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1
 ABBREVIATIONS USED IN THE PROTOCOL
Abbreviation
Term
AE
CRS
EHR
Adverse Event
Certified Recovery Specialist
Electronic Health Record
GIRB
Geisinger Institutional Review Board
HIPAA
IRB
MOUD
MRN
OUD
PACDC
PHI
PI
PRS
RCT
SAE
Health Insurance Portability and Accountability 
Act
Institutional Review Board
Medication for Opioid Use Disorder
Medical Record Number
Opioid Use Disorder
Phenomic Analytics and Clinical Data Core
Protected Health Information
Principal Investigator
Peer Recovery Support
Randomized Controlled Trial
Serious Adverse Event 
IRB NUMBER: 2024-0862
IRB Approved:  05/19/2025

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2
ABSTRACT
Drug overdoses are at record levels in the US, driven primarily by the ongoing opioid use 
disorder (OUD) epidemic. Medications for opioid use disorder (MOUD) have been shown to 
safely and effectively treat OUD, reduce overdose and overdose death, and facilitate long-term 
recovery. However, retention in MOUD treatment often falls short of the 6-12-month duration 
necessary for sustained recovery, and early termination from MOUD is a risk factor for 
overdose. Peer recovery support (PRS; i.e., support services provided by trained “peers” with
lived experience of addiction and recovery) holds substantial promise as a strategy for improving 
retention in MOUD, yet virtually no rigorous research has been conducted on its effectiveness in 
this setting. To fill this gap, the proposed project will pilot test a PRS program that was 
developed in collaboration with community partners for use in outpatient clinical addiction 
treatment settings. The pilot test will be conducted in two of Geisinger’s outpatient addiction 
treatment clinics to assess the feasibility of implementing the PRS program and of the study 
procedures. Information gathered during the pilot study will inform refinements to the PRS 
program and study components for a future clinical trial that will evaluate the effectiveness of 
the PRS program in increasing retention in MOUD treatment. 
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3
BACKGROUND AND SIGNIFICANCE
Opioid use disorder (OUD) is a public health crisis, contributing to substantial mortality and 
morbidity via an epidemic of opioid overdose. In 2021, approximately 108,000 overdose deaths 
were recorded in the US [1], with 70% associated with synthetic opioids [2]. Opioid overdose 
deaths will continue to rise without effective interventions [3]. Overdose death is just one 
devastating outcome of OUD, which impacts ~2.7 million Americans ages 12 and up [4]. 
Innovative and creative scientific efforts are needed to combat the >130 daily deaths and 
economic burden to society of $786.8 billion annually resulting from OUD in the US [5-7].
Medications for opioid use disorder (MOUD) are essential to responding to the opioid epidemic, 
with maintenance treatment a critical component of their life-saving potential. MOUD—
including methadone, buprenorphine, and naltrexone—are the standard of care for OUD, greatly 
reducing risk for overdose and facilitating long-term recovery [8]. Maintenance MOUD 
treatment is most effective for preventing relapse to opioid misuse and subsequent overdose [8]. 
However, many patients who initiate MOUD fall short of effective treatment durations, 
increasing overdose risk. Many patients only take buprenorphine and naltrexone for 30-60 days 
[9-13], while research supports a minimum of 6-12 months for sustained recovery [14,15]. 
Median retention in MOUD at six months is just 57%, but as low as 19% in some settings and 
populations [16]. Early treatment discontinuation is linked to deleterious outcomes, including 
relapse, overdose, and all-cause mortality [17-19], and prevents patients from achieving long-
term OUD remission [20]. Patients with OUD often follow a cyclic pattern of initiating MOUD 
followed by return to opioid misuse. This is a risky cycle, as fatal overdose is common during 
the first month following MOUD dropout [21]. 
Patient engagement in MOUD is influenced by modifiable risk and protective factors. In prior 
qualitative research with Geisinger patients with OUD, we identified multilevel barriers and 
facilitators to MOUD engagement including attitudes toward MOUD, motivation, mental health 
comorbidity, stigma around OUD/MOUD, social support, a therapeutic environment, and access 
barriers [22]. Findings were consistent with prior studies [23, 24-30], highlighting common 
constraints to MOUD retention faced by patients from diverse settings. Risk factors for dropout 
are compounded in rural areas due to a lack of MOUD providers, low acceptability of MOUD 
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among providers and patients, and poor access to recovery support services [31]. Little research 
has focused on efforts to improve this health disparity. 
Innovative and cost-effective approaches to target modifiable risk factors for MOUD dropout are 
an imminent need. In a dynamic modeling analysis of public health strategies to reduce opioid 
overdose deaths in the US, recovery supports—particularly peer recovery support (PRS)—were 
identified as having the greatest potential to reduce projected overdose deaths [32]. PRS is 
defined as non-clinical mentoring, education, and support services provided by trained “peers” 
with lived experience with addiction and recovery. PRS offers patient-centered, non-stigmatizing 
support that may help overcome the aforementioned barriers to MOUD engagement through 
emotional, informational, instrumental, and affiliational support [33]. Evidence suggests PRS has 
the potential to address many of the barriers to MOUD treatment retention, with positive effects 
on internalized stigma, self-efficacy, recovery capital (internal and external assets to sustain 
recovery), and social determinants of health such as housing stability [34-38]. Working one-on-
one with patients, peers can help troubleshoot logistical barriers to MOUD engagement while 
providing encouragement and hope [39]. 
The question of whether PRS services can be utilized to improve treatment retention in MOUD 
has yet to be empirically tested [40]. Observational studies provide preliminary support, having 
found that MOUD patients who used PRS services were more likely to attend medical 
appointments related to OUD [41]; display improved buprenorphine treatment engagement and 
opioid abstinence [42]; and attend clinical appointments, including therapy [43]. However, the 
design of these studies precludes disentanglement of person-level characteristics that might 
account for both PRS utilization and positive treatment outcomes. Additional support comes 
from an open label pilot trial that found that patients in methadone treatment who received a 
PRS- delivered intervention were more likely to be retained in treatment than a comparison 
cohort [44]. These studies suggest PRS has promise for improving MOUD retention but 
highlight the need for randomized trials.
In sum, although PRS has strong potential to improve retention across a range of MOUD 
settings, no rigorously designed studies have documented the effectiveness of PRS for this 
purpose, despite calls for more rigorous research [45,40,46,47]. Further, little is known about 
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PRS program characteristics that may be most effective in improving MOUD retention, and the 
OUD field has largely lacked patient input in developing strategies to improve treatment 
outcomes [48]. The proposed project addresses weaknesses in rigor of previous studies [40]. 
Motivated by research findings [22] demonstrating enthusiasm for embedding PRS into the 
outpatient addiction medicine program at Geisinger, the proposed pilot study will evaluate the 
feasibility of a PRS program that was developed by the study team in collaboration with 
community partners for the MOUD setting. The pilot test results will inform a future randomized 
controlled trial (RCT) to determine the PRS program’s impact on MOUD retention. The project 
has great potential to advance the design of MOUD programs to improve MOUD retention, 
ultimately leading to fewer overdoses and overdose deaths. 
4
SPECIFIC AIM
This is a pilot study with goals of evaluating the feasibility and acceptability of: 1) implementing 
a PRS program adapted to support patient engagement in MOUD in Geisinger’s outpatient 
addiction treatment clinics; and 2) the study procedures (e.g., assessments, incentives, 
recruitment methods, etc.). Information gathered during this pilot study will inform refinements 
to the PRS program and study components for a future clinical trial that will evaluate the 
effectiveness of the PRS program in increasing patient retention in MOUD. 
5
STUDY DESIGN
5.1
Description
This pilot study will implement a PRS program with a small number of patients newly receiving 
MOUD at Geisinger to test the program’s feasibility and acceptability. The program will be 
delivered by a Certified Recovery Specialist (CRS; a person with personal, lived experience with 
substance use disorder recovery and specialized training and certification to deliver support to 
individuals in their recovery) in two of Geisinger’s addiction medicine clinics (in Scranton and 
Wilkes-Barre). We will collect data to assess the feasibility of administering the program and of 
our research processes, and to identify areas where improvements can be made to prepare for a 
large clinical trial.
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5.2
Study Population
The target population for this study includes adult patients who initiate MOUD at the Geisinger 
addiction medicine clinics in Wilkes-Barre and Scranton.
5.2.1
Approximate Number of Subjects
Up to 25 Geisinger patients will participate in the pilot study.  
5.2.2
Inclusion Criteria

Adult ≥ 18 years of age

Initiated MOUD at one of the Geisinger addiction medicine clinics in Wilkes-Barre or 
Scranton within the past 45 days

Willing to participate in the PRS program

Able and willing to provide consent
5.2.3
Exclusion Criteria

Received MOUD at any of the four Geisinger addiction medicine clinics in the 90 days 
prior to the treatment initiation date

Not proficient in English
5.3
Recruitment
Participants will be recruited from the pool of patients initiating MOUD treatment in two of 
Geisinger’s outpatient addiction medicine clinics (in Scranton and Wilkes-Barre). All patients 
meeting eligibility criteria will be recruited.
Potential participants will be identified via Geisinger’s electronic health record (EHR) using a 
process employed by the study team in prior studies. Specifically, a data broker will use an 
automated algorithm to identify eligible patients (i.e., adults who have initiated MOUD at one of 
the two clinics in the past 45 days). Patients meet criteria for initiation of MOUD at Geisinger if 
they receive an order for a qualifying medication (buprenorphine or naltrexone) for the treatment 
of OUD and have not received MOUD at one of Geisinger’s four addiction medicine clinics in 
the previous 90 days. In this way, patients may be recruited if they are returning to treatment 
after a treatment lapse of at least 90 days. The data broker will send a list of eligible patients and 
their contact information to the study team weekly. Information for eligible patients will be 
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delivered via secure email to Geisinger study staff. This information will include the variables 
needed to identify, verify, and contact potential patients, including: 

MRN

Name

Contact information (email address, phone numbers, address)

Enrollment in MyGeisinger patient portal

Demographics (age, sex, race, ethnicity, insurance type)

Addiction medicine encounter dates and specific department/clinic

Medications ordered for OUD treatment and dates

Duration since a past encounter in any of Geisinger’s addiction medicine clinics
A Study ID will be generated for all eligible patients to protect their privacy and confidentiality. 
A consistent Study ID will be maintained for each eligible patient to connect study data collected 
via various methods (i.e., participant assessments and interviews as well as EHR data, as 
described in section 5.4.4). A file containing identifiers (i.e., MRN, name, contact information) 
will only be used for recruitment and for keeping a link between MRN and Study ID. This 
password-protected database will be kept separate from other study data and will be stored on 
Geisinger’s secure network. 
A member of the approved Geisinger study team may manually screen patient records in Epic to 
confirm eligibility or identify updated contact information. Study staff completing such 
screening will be trained on chart reviewing in Epic. 
The study team will contact eligible patients to invite them to participate in the study as soon as 
they are identified by the data broker. Patients will be invited to participate via email, patient 
portal (MyGeisinger) electronic message, phone, and/or mailed letter depending upon the type of 
contact information available for each patient within the EHR. Multiple methods of contact may 
be used to reach each patient. Follow-up emails/MyGeisinger messages may be sent if patients 
do not respond to initial attempts. Similarly, study staff may call patients up to 5 times during 
initial recruitment efforts. MyGeisinger recruitment messages were reviewed and approved by 
Digital Engagement. All proposed recruitment and reminder materials are outlined in Table 1 
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below and included as study attachments. The study team recently recruited the same patient 
population at Geisinger for a survey study and achieved a 29% enrollment rate using a similar 
process (GIRB# 2021-0744). In-clinic recruitment by research staff may also be considered if 
other methods are not successful. To encourage participation, clinic staff will be provided with 
study flyers to distribute to eligible patients. The flyers were developed in collaboration with 
Geisinger Marketing and contain details about the study and information about how to contact a 
study team member for more information. To ensure that potential participants can be reached, 
the study team will also utilize mailed recruitment letters. Once data is received from the data 
analyst, the study team will prepare a mailing using an IRB-approved recruitment letter. Within 
this population, it is feasible that phone numbers and email addresses are incorrect and thus the 
mailed letter will accompany the other recruitment methods listed above. The recruitment letter 
will contain a URL and QR code that the potential participant can use to learn more about the 
study or enroll if they so choose.
Information about the study will be provided to patients through an online survey link in 
REDCap, where participants will also provide informed consent, provide information that will be 
needed for randomization in the future trial (to assess feasibility of collecting this information), 
and complete a baseline assessment of potential risk factors for dropout and moderators and 
mediators of the effectiveness of the PRS program on MOUD retention. Potential participants 
can review the study information and consent document on their own time to determine whether 
they are interested in participating. A phone number and email address will be provided so that 
patients who wish to discuss the study or consent process can reach study staff. If patients are 
contacted by phone, research staff will explain the study and direct them to the online consent 
form and baseline assessment. If patients prefer, the baseline assessment can be completed with 
the research staff member over the phone, with electronic consent obtained first. Participants will 
also be asked to provide additional methods of contacting them to facilitate retention (e.g., a 
friend or family member’s phone number, an alternative email address). This information will be 
stored with the original recruitment data. 
Participants who complete the consent will be prompted by email, text message, MyGeisinger 
message, phone, and/or letter to complete the follow-up assessment after initiating MOUD (see 
Table 1 and study attachments). The first form of communication used to contact them will 
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depend upon how they were successfully contacted for recruitment and the information they 
provide regarding how best to contact them in the future, though multiple methods may be used. 
Follow-up text messages will only be sent to participants who opt-in to receive text messages 
during the consent process. The consent form informs participants that they may be contacted via 
text by the study team and communicates the risks related to text messaging (i.e., standard text 
messaging rates will apply, a person other than the participant may see the text). In the consent 
document, participants can opt-in to receive text messages. Text messages will be sent via 
REDCap using the Geisinger ISO-approved platform and will contain a minimum amount of 
information in case someone other than the participant views the message. The study team 
received approval from Digital Engagement for the text messages. 
To encourage participation, clinic staff will be invited to briefly mention the study to eligible 
patient participants at their next appointment. A member of the Geisinger study team will email a 
list of patients identified as eligible for the study to the appropriate clinic staff each week, along 
with a basic description of the study. The staff members will then have the option to mention the 
study to the eligible patient participants whenever they are seen next, either as the patient checks 
in for or out of their appointment. A simple statement from the staff member, such as “you may 
be eligible for a study that is currently happening at Geisinger related to your treatment here—if 
so, you will receive an email or phone call from the study team soon,” will lend legitimacy to the 
study. Clinic may also provide a flyer to eligible patient participants (described above).
Table 1. PEERS recruitment and reminder attachments
Reminder to 
complete baseline 
(BL) questionnaire
Reminder to 
complete follow-up 
(FU) questionnaire
Mode of 
communication
Initial recruitment
For consented participants
Email
Recruitment email
BL reminder email
FU reminder email
MyGeisinger
Recruitment MyG 
letter
n/a
FU reminder MyG 
letter
Phone
Recruitment telephone 
and voicemail script
BL reminder telephone 
and reminder script
FU reminder telephone 
and voicemail script
Text
n/a
BL reminder text 
script 
FU reminder text 
script 
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Letter
Recruitment Letter
n/a
FU reminder letter
Flyer
Recruitment flyer 
n/a
n/a
5.4
Study Duration
5.4.1
Approximate Duration of Subject Participation
Individuals will participate in the pilot study for up to a maximum of 6 months, during which 
time they will participate in the PRS program. Study participation begins with consent and 
enrollment in the PRS program, soon after patients initiate MOUD treatment at Geisinger. They 
will complete an online study assessment at enrollment (baseline), an interview after 1-3 months 
of PRS program participation, and a second online study assessment after MOUD initiation 
(follow-up). Collection of outcome data from patients’ EHRs will also occur at post-treatment 
initiation. 
5.4.2
Approximate Duration of Study
The pilot study will be completed in approximately 12 months. The end of the study is the end of 
all participants’ 6-month PRS program participation. 
5.4.3
Peer Recovery Support Program
After completing recruitment procedures and obtaining informed consent, participants will be 
offered services from a CRS (i.e., the PRS program). This will entail a CRS meeting one-on-one 
with the patient at regular intervals (e.g., weekly) to provide support to the patient for up to a 6-
month period. CRS services are patient-centered and driven by a patient’s own recovery goals, 
thus the frequency, timing, duration, modality (in-person, phone), and location of meetings (in 
the clinic or in a community setting such as a coffeeshop) are flexible and determined 
collaboratively by the CRS and patient. These meetings can involve the CRS providing 
emotional support; helping patients to identify their recovery assets, goals, and barriers; guiding 
patients in creating a recovery plan; helping patients to increase their coping skills; and assisting 
patients in connecting to community and recovery resources. The PRS program will not pose any 
risk over and above usual outpatient addiction treatment services. Patients who are not enrolled 
in the study will not be offered CRS services, as this service is paid for by grant funding. 
The grant timeline will only allow for participants to meet with the CRS for up to 6 months. This 
duration is consistent with other programs that offer CRS services as part of case management 
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for a substance use disorder. Part of the role of the CRS is to help patients connect with other 
recovery resources; thus, the CRS for this study will help participants establish other supports 
during the 6-month PRS program.  
5.4.4
Data Collection Procedures
Data collection for this study will include the following activities: 1) online participant 
assessments at baseline and follow-up; 2) participant interviews following 1-3 months of PRS 
program participation; 3) EHR data for all patients eligible for the study; 4) CRS and clinical 
staff feedback; and 5) completion of study logs. Data from assessments, participant interviews, 
and the EHR will be linked to individuals using their Study ID to avoid use of identifiers (e.g., 
MRN). A consistent Study ID will be maintained for participants across data sources 
(assessments, interviews, EHR) via the password-protected recruitment database (described in 
section 5.3) that will contain MRN and Study ID and will be stored separately from study data, 
on Geisinger’s secure network. 
5.4.4.1
Online participant assessments
Participants will be asked to complete online assessments of potential risk factors for dropout 
and moderators and mediators of the effectiveness of the PRS program on MOUD retention via 
REDCap at study enrollment (baseline) and after initiating MOUD (follow-up). Consented 
participants may also complete the questionnaires over the phone with a study team member. 
Participants will be asked to complete the baseline assessment at the time of consent and will be 
recontacted to complete the follow-up assessment, as described in Recruitment. Participants will 
complete measures on a range of topics including illicit drug use, treatment intentions and 
expectations, beliefs about MOUD, barriers to treatment retention, mental health diagnoses, 
recovery capital, stigma, social support, hopefulness for the future, self-efficacy to abstain from 
opioid use, social determinants of health, readiness for change, reasons for and motivation to quit 
substances, coping strategies, medication satisfaction, recovery progress, and feasibility of 
completing the assessments. See baseline questionnaire and follow-up questionnaire attachments 
for specific items. Participants will be compensated for their time with a $40 gift card for the 
baseline assessment and a $75 gift card for the follow-up assessment.
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5.4.4.2
Participant interviews
Telephone/video interviews will be completed 1-3 months after participants enroll in the study 
and will focus on their experience with the PRS program, including barriers to PRS program 
participation and perceived patient-centeredness and helpfulness of the program in staying 
engaged in MOUD. See interview guide attachment for specific topics. Study staff trained on 
qualitative interviewing techniques will complete the interviews. Interviews will be 30-60 
minutes in duration. They will be audio-recorded and transcribed verbatim. Participants will be 
compensated for their time with a $50 gift card for interview participation.
5.4.4.3
Electronic health record data
We will obtain information from EHRs for all patients identified as eligible for participation in 
the study by the data broker. This includes all adult patients who initiated MOUD at one of 
Geisinger’s addiction treatment clinics in Scranton or Wilkes-Barre in the past 45 days (from 
time of data pull) but had not received MOUD at one of Geisinger’s four addiction medicine 
clinics in the previous 90 days. Participants will be informed of the use of their EHR data during 
the informed consent process. Using EHR data will reduce participant burden, as these measures 
will not need to be included in the assessments and will provide greater accuracy than self-
reported data. Most data will be collected for the study period (baseline through follow-up), 
though some historical data will be required to determine patient’s prior treatment history for 
OUD, such as encounters and medication orders related to addiction treatment, and co-occurring 
health conditions. EHR data will be used to evaluate patients’ baseline and co-occurring 
conditions that may impact their treatment outcomes and thereby moderate the effect of PRS 
services and to determine primary and secondary outcomes. 
We will obtain EHR data for all patients eligible for the study to assess bias in who participates 
in the study, a critical aspect of assessing study feasibility and improving recruitment methods to 
reduce these biases in the future randomized trial. This includes patients who do not respond to 
recruitment attempts but excludes patients who specifically decline participation. During the 
consent process, patients who decline active participation in the study will be given an 
opportunity to consent to share their medical record information. If they consent, we will also 
obtain EHR data for these patients. Patients who consent to full study participation or to sharing 
EHR data will receive a $15 gift card. 
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EHR data to be collected includes:

Demographics (age, sex, race, ethnicity)

Insurance type

Utilization and encounter location data, including but not limited to encounters at the four 
outpatient addiction medicine clinics 

Medication orders, including but not limited to medications used to treat OUD

Laboratory measures, including but not limited to drug toxicology screening results 

Addiction Severity Index data

Mental health diagnoses (e.g., depression, anxiety, bipolar, post-traumatic stress disorder)

Substance use disorder diagnoses, including opioid use disorder, alcohol use disorder, 
tobacco use disorder, cocaine use disorder, cannabis use disorder, and other substance use 
disorders

Additional clinical data (e.g., body mass index, comorbidity scores, comorbid conditions)

Clinical notes (outpatient, inpatient, emergency department), including progress notes 
from the CRS and participant interactions that are documented in EPIC. In the standard 
of care, it is the policy that CRS interactions are documented in EPIC to assist with 
aligning care between the patient’s care team.

Dates 

Residential address (for geocoding purposes)
Mental health data are necessary to meet the aims of the study, as we hypothesize that mental 
health diagnoses are key factors that influence patient engagement in MOUD. Mental health 
diagnoses are highly prevalent among patients with OUD. For example, prior studies of 
Geisinger patients have reported that 35% of patients with an opioid overdose had a diagnosis for 
a mental health condition (depression, anxiety, psychosis, personality disorder, drug/alcohol use 
disorder), and among patients with prescription opioid dependence, 14% had alcohol 
dependence, 43% had tobacco dependence, 51% had major depressive disorder, 20% had anxiety 
disorder, 22% had post-traumatic stress disorder, and had 33% had antisocial personality 
disorder. 
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A member of the approved study staff may also manually screen patient records in Epic to 
extract additional information from encounter notes, such as the reason for discontinuing 
treatment at the addiction medicine clinic. This will be particularly important for participants 
who do not complete the follow-up assessment, which we hypothesize will be subject to 
selection bias (with patients being more likely to respond if they have remained in treatment). 
Study staff completing such screening will be trained on chart reviewing in Epic. 
Participants will be geocoded based on their response to an assessment item regarding the 
location of their current residence; if data are missing, and for non-participating eligible patients, 
we will use the address from the EHR. This will allow us to determine geographic factors that 
influence MOUD retention and study participation bias such as rurality and distance from clinic.
5.4.4.4
CRS and clinical staff feedback
Feedback from the CRS and CRS supervisor will be solicited throughout the pilot phase during 
regularly scheduled meetings and will focus on what is working well (or not) about the PRS 
program and in which areas the CRS needs additional training and support. After all pilot 
participants have completed two months of the PRS program, we will engage clinicians and staff 
working in the Scranton and Wilkes-Barre addiction treatment clinics in debriefing meetings to 
solicit feedback pertaining to PRS program adoption. Feedback will be strictly about the 
program, not about individual patients or participants in the study. The study team will document 
feedback from the CRS, CRS supervisor, and clinic staff, which will be used to improve the 
program.  
5.4.4.5
Study logs
Additional information will be obtained through study logs, including: 1) a database of
eligible patients to track participation, which will contain demographic and clinical information 
obtained through the EHR (described in 5.4.4.3) and thus allow us to compare characteristics of 
those agreeing and declining participation, as well as reasons for declining study participation 
when provided; 2) the CRS’s interactions with study participants (e.g., dates, lengths, and 
modalities of meetings; general topics covered during meetings); and 3) observations made by 
the research team regarding the success of various trial processes (e.g., coordination with 
addiction medicine clinic and staff; obtaining retention outcomes from the EHR). The study logs 
will be used only for the purposes of documenting the dates, lengths, and modalities of 
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interactions, and the general focus of the interaction (e.g., “set recovery goals”) without 
documenting details during these interactions. 
5.5
Primary Endpoints
The primary endpoints for the pilot study pertain to the feasibility and acceptability of the PRS 
program and study procedures. These data will be used to make refinements in advance of a 
future randomized controlled trial evaluating MOUD retention outcomes. Pilot study endpoints 
include:

Proportion of eligible patients who enroll, biases in enrollment, and barriers to 
participation

Feasibility of data collection procedures (e.g., assessments), including successful 
attainment of EHR-based measures 

Participant acceptability of data collection procedures (i.e., assessments) and incentives, 
and completion rates of assessments

Feasibility of PRS program delivery, including adequacy of CRS training and program 
implementation challenges

CRS and clinic staff acceptability of the PRS program

Fidelity of CRS to PRS program protocol and adaptations made by CRS

Participant acceptability of the PRS program

Degree of patient participation in CRS meetings
5.6
Analysis
Quantitative and qualitative data analyses will be led by the study MPIs and carried out by 
members of the study team. 
5.6.1
Analysis Plan
The goals of the analysis are to integrate qualitative and quantitative data and information 
collected about the pilot processes to 1) assess feasibility of a future clinical trial;
2) identify deficiencies and strengths related to reach, effectiveness, adoption, and 
implementation of the PRS program, CRS training/supervision, and trial logistics; and 3) to 
generate ideas for refinements. 
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Quantitative data analysis will be descriptive, focusing on the proportion of patients who enroll 
in the study, complete each assessment, and participate in the PRS program; demographic and 
clinical differences between study participants and non-participants; the number and duration of 
PRS program sessions completed with each participant; and participant satisfaction ratings. 
Qualitative interviews will be audio recorded and transcribed verbatim. To analyze the 
qualitative data, given the applied nature of the pilot evaluation and the short timeframe for 
completing it, we will utilize a rapid qualitative data analysis approach, the RADaR (“rigorous 
and accelerated data reduction”) technique, which is advantageous for small pilot projects. This 
process streamlines data analysis through production of a series of data tables that are 
systematically analyzed and reduced, ultimately producing a condensed and concise presentation 
of textual data that can be rapidly coded and interpreted. 
We will present the pilot evaluation results to community partners for discussion of potential 
refinements to the PRS program, peer training/supervision plan, and trial design. Based on their 
feedback, refinements will be made for board member approval in advance of the future 
randomized controlled trial.
5.6.2
Sample Size Considerations
We will recruit at least 12, and up to 25 patients for the pilot study, a sample size that is feasible in 
the time frame and that will provide sufficient data on feasibility and feedback to refine the 
program.
5.7
Data Management
5.7.1
Data Collection and Storage
Only IRB-approved study staff will have access to data collected for this research. All data will 
be stored on Geisinger’s secure network. A data use agreement will be put in place to share 
deidentified baseline/follow-up assessment data and interview data with study team members at 
the University of Connecticut Health Center. 
5.7.2
Records Retention
Records of data generated during this study and stored will not be de-identified. Data will 
be kept indefinitely and can be used for other IRB approved research. 
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6
PROTECTION OF HUMAN SUBJECTS
All personnel collecting and manipulating data will have completed Human Subjects Research 
Training with the Collaborative Institutional Training Initiative (CITI). All research staff also 
receive extensive confidentiality training as part of their job training. Further, MPI Poulsen will 
meet with staff regularly to ensure strict compliance with the Data and Safety Monitoring Plan 
(DSMP). Only study personnel (investigators and research staff) will have access to research 
data. No data will be released to other agencies unless the participant signs a release of 
information. Finally, a DSMP is provided to describe monitoring of and responses to adverse 
events. All GIRB and regulatory procedures will be followed.
6.1
Informed Consent and HIPAA Authorization
Potential participants will be recruited by research staff through patient portal message, email, or 
phone, as described in the Recruitment section above. These various modes of communication 
will direct patients to an online survey in REDCap, where they will be provided with information 
about the study and the informed consent document. The informed consent document will 
explain the purpose of the study, its risks and benefits, and will emphasize the voluntary nature 
of the research and that the patient’s decision to participate in no way affects their treatment at 
Geisinger (see consent document attachment). Potential participants will have time to review the 
consent document before electronically signing it. Following the consent document and before 
the signature page, we will provide patients with options to 1) enroll in the study (directing them 
to the electronic signature page); 2) decline participation but agree to share their medical record 
information (directing them to a separate electronic signature page); 3) request a study team 
member to contact them so they can get more information; or 4) fully decline participation (and 
provide a reason for doing so, if they choose). See study attachment detailing these “pre-consent” 
options. The consent document will also provide a study phone number and email address for 
patients to contact us to ask questions or discuss the study. A copy of the consent document will 
be provided to each participant by email or mail.
Before any procedures specified in this protocol are performed, a participant must:

Be informed of all pertinent aspects of the study and all elements of informed consent. 

Be given time to ask questions and to consider the decision to participate.
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
Voluntarily agree to participate in the study. 

Electronically sign and date a GIRB-approved informed consent document. 
We are requesting a partial waiver of HIPAA Authorization for recruitment purposes to identify 
potential participants via an EHR data pull. The data pull will be used to call, email, or send a 
MyGeisinger message to contact potential patient participants. This research could not be 
practically conducted without the waiver requested, as in-person clinic recruitment would be 
burdensome for study staff as well as for clinic staff whose workflow may be interrupted.
We are also requesting a full waiver of HIPAA authorization and a waiver of consent to access 
medical record information for patients who are identified as eligible for the study but who do 
not respond to recruitment attempts. The study team is requesting this data as it is vital to better 
understanding the differences between patients who choose to enroll in the research and those 
who do not. These data will facilitate evaluation of potential sample bias and can inform 
modifications to our recruitment methods. This evaluation of bias could not be practically 
conducted without the waivers requested, as individuals who do not respond to recruitment 
attempts are highly unlikely to respond to attempts to have them sign an authorization/e-consent. 
We will not obtain medical record information for patients who specifically decline participation, 
unless they consent to sharing their medical record information, as described in section 5.4.4.3.
6.2
Potential Risks/Benefits and Protection of Human Subjects Against Risks
Potential Risks
Potential risks to participants include inadvertent identification of the participant as having a 
substance use disorder or receiving treatment for a substance use disorder to other individuals 
during recruitment processes (e.g., to household members); perceived coercion to participate; 
potential distress if information obtained during the assessments were released to outside parties; 
and physical or psychological discomfort due to assessment questions.
To protect against (1) inadvertent identification of the participant as having a substance use 
disorder or receiving treatment for a substance use disorder to other individuals during 
recruitment processes, we will ensure that recruitment materials do not specifically mention 
participant’s condition or treatment. Rather, recruitment messages (emails, text messages, etc.) 
will refer to “recent treatment” the participant received at Geisinger. Information about the 
nature of the study will only be divulged by phone (once research staff have confirmed the 
participants’ identity) or once patients log into the REDCap survey to learn about the study.
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To protect against (2) perceived coercion to participate, patient participants will be informed that 
their decision to participate will not impact their treatment at the addiction medicine clinic or at 
Geisinger. The voluntary nature of the study will also be emphasized in the consent process.
 
To protect against (3) potential distress if information obtained during the assessments were 
released to outside parties, data will be linked to participant Study ID number rather than by 
name or MRN. For interview data, audio-recordings will be transcribed and de-identified. Once 
transcripts are reviewed for validity, audio-recordings will be deleted. Transcripts will be stored 
within a secure computing environment at Geisinger. All direct identifiers (e.g., names, contact 
information) will be removed and replaced with participant Study ID numbers. A link between 
Study ID and identifiers will be kept in a separate password-protected database, as previously 
described. No information will be provided about patients enrolled in this study to anyone 
outside of the research team, except in emergency situations (e.g., subject deemed a threat to 
themselves or others) or as required by law. To further protect confidentiality, as per NIH 
regulations, the study will automatically have a Certificate of Confidentiality (CoC) from the 
U.S. Department of Health and Human Services (DHHS). While such Certificates do not prohibit 
making voluntary disclosures, they provide researchers with protection from voluntary and 
involuntary disclosures that might be required or requested by state or local authorities.
Regarding data management and storage, most data from patient participants will be collected 
using REDCap, a secure, on-line platform. Survey forms will be identified by Study ID numbers, 
not patient identifiers. All other study data, including EHR data, will be stored in databases on 
Geisinger’s password protected secure server. Additional protections for data safety are 
described in the DSMP.
To protect against (4) physical or psychological discomfort due to assessment questions, the 
consent document will emphasize to participants that they may choose not to answer any 
component of the assessments. It will also clearly state that the participant has the right to 
withdraw from this study at any time.
Benefits
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Participants may benefit from the peer recovery support program, as it is designed to provide 
additional support to patients to assist in their recovery from opioid use disorder. Participants 
may indirectly benefit from the research in that the information gained from the study will help 
understand and potentially improve strategies for improving retention in MOUD treatment. 
Improving MOUD retention and reducing treatment dropout would have substantial benefits to 
individuals, families, clinics, and society.
7
SAFETY MONITORING 
MPIs Poulsen and Zajac, co-investigators, and study team personnel will provide safety 
oversight for the study. They will review safety data monthly and make any decisions about 
modifications of the study. The monitoring plan includes tracking participant safety and 
demographics, monitoring the safety of the data, and monitoring and appropriately reporting 
adverse events (AEs). Study staff will be trained to identify risks to safety for participants. Given 
the low-risk nature of the study and the low likelihood of serious adverse events related to or 
possibly related to the study, the data and safety monitoring plan will be carried out by MPIs 
Poulsen and Zajac. SAE and AE reporting requirements will be adhered to in accordance with 
Geisinger and NIDA guidelines. A localized AE/SAE database will be maintained and available 
for GIRB review upon request. 
7.1
Adverse Event Reporting 
Clinical AEs will be monitored throughout the study. No specific AEs are anticipated for this 
study. Due to the nature of this study, the study team has a reasonable expectation that no AEs 
will be related to study procedures or participation in the PEERS program. 
7.2
Serious Adverse Event Reporting
Types of expected SAEs in this patient population are as follows: (a) onset of clinically 
significant suicidal intent or action; (b) onset of clinically significant homicidal intent or action; 
and (c) deterioration of physical or mental status to an extent that renders need for inpatient 
medical treatment. If there is any doubt about whether an AE constitutes an SAE, the 
information is treated as an SAE. All SAEs will result in the completion of a Serious Adverse 
Event Form, which is sent within 24 hours to the Project Manager. All deaths and study-related 
or possibly related SAEs will be reported immediately to the PI and to NIH within 48 hours. 
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All 1) study-related SAEs and 2) possibly study-related SAEs that may place participants at 
greater risk than previously recognized will be reported within five business days of becoming 
aware of the occurrence to the GIRB. The study will be temporarily stopped if it is determined 
that SAEs potentially related to the study occur in ≥5% of the sample. At this point, consultation 
with NIH and the GIRB will be sought. If it is determined that procedures need to be changed 
prior to resuming the trial, revised procedures will be approved by NIH and the GIRB prior to 
implementation.  Due to the low-risk nature of the study, it is anticipated that there is a low 
likelihood of any SAEs occurring because of study participation. 
7.3
Recording and Reporting
A participant’s SAEs will be recorded and reported from the signing of the informed consent 
form to the end of study participation in accordance with GIRB policy guidelines. Detailed 
information will be collected about all SAEs, and a database of all SAEs will be maintained by 
the Project Manager. The SAE database will be available for GIRB review upon request. The 
database will include the date and time of onset of the SAE and the outcome (to the degree 
known); the study team member who reported the SAE; and whether the SAE was related to 
study participation. Once per month, in research team meetings, all SAEs will be reviewed that 
occurred over the previous month. Per NIH guidelines, any serious SAE that results in death will 
be reported to the NIH within 48 hours regardless of whether or not the SAE is considered to be 
study related.
7.4
Data Monitoring Plan 
All research staff will be thoroughly trained and supervised regarding administration of 
participant assessments, handling of electronic health record (EHR) data, and completion of all 
necessary forms. Data will be collected via online assessments completed by participants and 
from the EHR, and consent will be obtained electronically. Therefore, there will be no paper 
copies of research data. All data will be stored on Geisinger’s secure server and will be 
accessible only to appropriate project staff. Study ID numbers, not participant names, will be 
used to identify and link all assessments and other data collected. Geisinger’s computing and 
data storage systems are protected from outside access by firewall systems. 
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IRB NUMBER: 2024-0862
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