Telehealth-Clinical Advocacy Project
Phase: NA
Conditions: Substance Use
Sponsor: Texas Christian University

Study Title: Telehealth-Clinical Advocacy Project (T-CAP) 
IRB Protocol Approval Date: 12/07/2022
NCT04911426 

The TCU Institutional Review Board (IRB) is responsible for protecting the welfare and rights of 
the individuals who are participants of any research conducted by faculty, staff, or students at 
TCU. Approval by the IRB must be obtained prior to initiation of a project, whether conducted 
on-campus or off-campus. While student research is encouraged at both the undergraduate and 
graduate level, only TCU faculty or staff may serve as Principal Investigator and submit a 
protocol for review.     
Please submit this protocol electronically to IRBSubmit (Word preferred).  
-   
INSTITUTIONAL REVIEW BOARD
PROTOCOL    
REVIEW REQUEST 
1. Date:  12/15/2021
2. Study Title:  Telehealth-Clinical Advocacy Project (T-CAP)
3. Principal Investigator (must be a TCU faculty or staff):  Jennifer Pankow, Ph.D.
4. Department:  Institute of Behavioral Research
5. Other Investigators: List all faculty, staff, and students conducting the study including
those not affiliated with TCU.
Wayne Lehman, Ph. D., Kevin Knight, Ph. D., Amanda Wiese, Ahrein Bennett
6. Project Period (mm/yyyy - mm/yyyy):  08/2019 – 07/
7. If you have external and/or internal funding for this project – for Funding Agency:  :
08/01/2019National Institute on Drug Abuse    Project #:  1 R21 DA048232-01  Date
8. If you intend to seek/are seeking external funding for this project –  Funding Agency:
N/A  Amount Requested From Funding Agency:  N/A Due
Date for Funding Proposal:  N/A
9. Purpose: Describe the objectives and hypotheses of the study and what you expect to
learn or demonstrate:  This application proposes the Telehealth-Clinical Advocacy Project
 2023
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10. Background: Describe the theory or data supporting the objectives of the study and
(T-CAP), a technology-based intervention development and feasibility R21 study to 
examine the impact of integrating clinical telehealth services within an existing Illinois (IL)  
police Opioid Diversion Program (ODP). The study includes three key components: 1) 
Development and testing of the proposed multidisciplinary telehealth intervention integrated 
within a state-supported police diversion program; 2) use of telehealth technology to provide 
ODP participants with access to clinically qualified staff (referred to as the Coach); and 3) 
expanding and strengthening the available service infrastructure including pain management 
alternatives to the use of potentially addictive medications and by having the Coach reach 
out to new and underutilized providers in local communities (e.g., underutilized physicians 
and other medical providers such as certified nurse practitioners). Modifications target use of 
virtual consenting and utilizing FedEx mail to issue study cell phones to participants, 
replacing in-person meetings with the T-CAP research assistant. No modifications have 
been made to the T-CAP telehealth intervention and no in-person interactions will occur 
as a part of this study.  10.28.2022 modification will include the removal of the 
randomization procedure; specifically, no one will be assigned to what was previously 
referred to as the “Treatment as Usual” condition. All participants will receive the T-CAP 
telehealth intervention.  
The specific aims for the proposed research are as follows: (Aim 1) Demonstrate 
intervention feasibility by measuring study participant receptivity and utilization of the 
telehealth approach, and (Aim 2) Evaluate the proposed T-CAP measures to assess their 
performance in gauging the impact of telehealth on initiation of in-person Substance Use 
(SU) treatment, short-term retention in referred SU treatment, and access to other 
appropriate treatment services.     
Successful completion of the aims is expected to: 1) establish preliminary evidence to 
support the efficacy of telehealth technology to augment SU treatment for individuals with 
misused any form of opioids, alcohol, or other substances, 2) provide support for integrating 
a clinical role in police opioid diversion practices recently expanded to include individuals at 
high risk for opioid and/or other substance misuse, 3) provide an empirical examination of 
how clinical advocacy and telehealth can support individuals with substance use treatment, 
and 4) demonstrate the value in building relationships with stakeholders to leverage 
community resources for addressing the SU treatment needs. Findings from this research 
will inform a future R01 application that will include a multi-site randomized clinical trial, 
testing the T-CAP intervention and taking a closer look at characteristics of individuals (e.g., 
sex and race/ethnicity) in relation to intervention response and outcomes in an effort to 
understand how best to tailor the T-CAP intervention for specific subgroups.    
include a bibliography of key references as applicable.
This project focuses on opioid use and other serious substance and alcohol use placing individuals
at high risk for behavioral and healthcare problems. The opioid crisis has reached epidemic
proportions (Gomes et al., 2018), driven by abuse of prescription opioids and illicit use of fentanyl
(CBHSQ, 2017; Moore et al., 2017; O’Donnell  et al., 2017; Rudd et al., 2016). The overdose deaths
attributed to these drugs (CDC, 2017; Warner et al., 2016) is impacting nearly every community.
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(Cosden et al., 2005; Ramirez et al., 2015). Similarly, the IL Police ODP offers an 
unprecedented opportunity to address the current widespread opioid use, evidenced by an 
increase of more than 70% from 2013 and a 32% increase from 2015 to 2016 (IDHA, 2017). 
IL ODP programs are part of a State priority to improve access to a spectrum of justice involved 
treatment options, including linking individuals to SU treatment, Medication Assisted Treatment 
(MAT), and alternative pain management services. Major challenges are impacting uptake and 
adherence to opioid treatment services, consistent with those identified in multiple studies 
(Knudsen et al., 2011). While MAT is acknowledged as a best practice treatment option (Mattick 
et al., 2009; Mattick et al., 2014) and a key IL ODP component, access to the identified 
providers is limited (e.g., limited transportation options) and frequently underutilized. Another 
challenge is the ODP focuses on narrowly defined SU treatment options; the ODP and its 
participants would benefit from referrals to a wider spectrum of treatment options, including 
referral to alternative pain management services such as meditation or yoga centers (Cherkin et 
al., 2016). Treating the comorbidities of opioid use and chronic pain is critical; over 87 million 
adults report using opioids for pain management and over 10 million of this group indicate 
misusing these medications 
(CBHSQ, 2017). Additionally, research shows an increased risk of developing opioid use 
disorder (OUD) from abusing opioid pain medication (Muhuri et al., 2013) and transitioning to 
heroin use when obtaining prescription opioids becomes challenging (Al-Tayyib et al., 2017; 
Cicero et al., 2014; Compton et al., 2016). Thus, expanding the ODP service delivery 
infrastructure to include a broader array of services has significant potential to improve 
clinical practice and lessen the effects of the opioid crisis.     
The current IL ODP model 1) lacks inclusion of trained clinical staff (ODP staff receive 4 hours of 
training) and 2) provides limited clinical recovery support for clients after program intake. As 
outlined in a recent State report (Reichert et al., 2017), officers are being asked to make clinical-
level decisions for which they have not been hired or trained. Furthermore, there is minimal ODP 
contact with clients after they enter SU treatment. Integrating clinically qualified staff in the 
ODP process to work with the police during the screening and referral process, and 
providing ODP clients with continued clinical support after program intake, has 
significant potential to improve clinical practice and lessen the effects of the opioid 
crisis. Inclusion of the clinical advocate role is based on research showing the importance of 
trained clinicians during brief client encounters and interventions (Gaume et al., 2014).    
Bibliography:     
Addiction Policy Forum. (2017, March). Focus on innovation: Montgomery County STEER. 
Retrieved June 1, 2018 from   
http://docs.wixstatic.com/ugd/bfe1ed_f5af4fa0a38444fab5259aad85ea6e59.pdf 
Al-Tayyib, A. A., Koester, S., & Riggs, P. (2017). Prescription opioids prior to injection drug use: 
Comparisons and public health implications. Addictive Behaviors, 65, 224-228. 
CBHSQ (Center for Behavioral Health Statistics and Quality). (2017, September). 2016 National 
Survey on Drug Use and Health: Detailed Tables. Rockville, MD: Substance Abuse and 
Mental Health Services Administration. Retrieved June 1, 2018 from  
https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs- 
In response, IL and several other states are experimenting with diversion program models 
(Addiction Policy Forum, 2017; Schiff et al., 2017) to intervene with people at the point of contact with 
police. These individuals are diverted into services designed to prevent further drug use and related 
problems (Schiff et al., 2017; Reichert et al., 2017). Diversion programs, such as established mental health 
courts, have been in operation for over two decades and have a proven record of efficacy
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2016/NSDUHDetTabs2016.pdf  
CDC (Centers for Disease Control and Prevention). (2017, December). Drug overdose death 
data. Retrieved June 1, 2018 from    
https://www.cdc.gov/drugoverdose/data/statedeaths.html 
Cherkin, D. C., Sherman, K. J., Balderson, B. H., Cook, A. J., Anderson, M. L., Hawkes, R. J., . . 
. Turner, J. A. (2016). Effect of mindfulness-based stress reduction vs cognitive 
behavioral therapy or usual care on back pain and functional limitations in adults with 
chronic low back pain: A randomized clinical trial. JAMA, 315(12), 1240-1249. DOI:    
10.1001/jama.2016.2323     
Cicero, T. J., Ellis, M. S., Surrant, H. L., & Kurtz, S. P. (2014). The changing face of heroin use 
in the United States: A retrospective analysis of the past 50 years. JAMA Psychiatry, 
71(7), 821-826. doi: 10.1001/jamapsychiatry.2014.366     
Compton, W. M., Jones, C. M., & Baldwin, G. T. (2016). Relationship between nonmedical 
prescription-opioid use and heroin use. The New England Journal of Medicine, 374(2), 
154-163. doi: 10.1056/NEJMra1508490
Cosden, M., Ellens, J., Schnell, J., & Yamini-Diouf, Y. (2005). Efficacy of a mental health 
treatment court with assertive community treatment. Behavioral Sciences & the Law, 
23(2), 199-214. doi: 10.1002/bsl.638     
Gaume, J., Magill, M., Longabaugh, R., Bertholet, N., Gmel, G., & Daeppen, J.-B. (2014). 
Influence of counselor characteristics and behaviors on the efficacy of a brief 
motivational intervention for heavy drinking in yo0ung men – A randomized controlled 
trial. Alcoholism: Clinical & Experimental Research, 38(7), 2138-2147. doi:    
10.1111/acer.12469    
Gomes, T., Tadrous, M., Mamdani, M. M., Paterson, J. M., & Juurlink, D. N. (2018). The burden 
of opioid‐related mortality in the United States. JAMA Network Open, 1(2):e180217. 
Retrieved June 4, 2018 from   
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2682878     
IDHS (Illinois Department of Human Services). (2017). The opioid crisis in Illinois: Data and the 
State’s response. Retrieved June 4, 2018 from 
http://www.dhs.state.il.us/page.aspx?item=96730 
Knudsen, H. K., Abraham, A. J., & Oser, C. B. (2011). Barriers to the implementation of 
medication-assisted treatment for substance use disorders: The importance of funding 
policies and medical infrastructure. Evaluation and Program Planning, 34(4), 375-381.  
doi: 10.1016/j.evalprogplan.2011.02.004     
Mattick, R., Breen, C., Kimber, J., & Davoli, M. (2009). Methadone maintenance therapy versus 
no opioid replacement therapy for opioid dependence. Cochrane Database of 
Systematic Reviews, (3), CD002209. doi: 10.1002/14651858.CD002209.pub2 
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Mattick, R., Breen, C., Kimber, J., & Davoli, M. (2014). Buprenorphine maintenance versus 
placebo or methadone maintenance for opioid dependence. Cochrane Database of 
Systematic Reviews, (2), CD002207. doi:10.1002/14651858.CD002207.pub4     
Moore, P. Q., Weber, J., Cina, S., & Aks, S. (2017). Syndrome surveillance of fentanyl-laced 
heroin outbreaks: Utilization of EMS, Medical Examiner and Poison Center databases. 
American Journal of Emergency Medicine, 35(11), 1706-1708.    
Muhuri, P. K., Gfroerer, J. C., & Davies, M. C. (2013, August). CBHSQ Data Review: 
Associations of nonmedical pain reliever use and initiation of heroin use in the United 
States (Substance Abuse and Mental Health Services Administration, Center for  
Behavioral Health Statistics and Quality). Retrieved June 4, 2018 from 
https://archive.samhsa.gov/data/2k13/DataReview/DR006/nonmedical-
painrelieveruse2013.pdf     
O’Donnell, J. K., Halpin, J., Mattson, C. L., Goldberger, B. A., & Gladden, R. M. (2017). Deaths 
involving fentanyl, fentanyl analogs, and U-47700 – 10 States, July–December 2016. 
Morbidity and Mortality Weekly Report, 66(43), 1197-1202. Retrieved January 4, 2018 
from https://www.cdc.gov/mmwr/volumes/66/wr/mm6643e1.htm     
Ramirez, A. M., Andretta, J. R., Barnes, M. E., & Woodland, M. H. (2015). Recidivism and 
psychiatric symptom outcomes in a juvenile mental health court. Juvenile and Family 
Court Journal, 66(1), 31-46. doi: 10.1111/jfcj.12025     
Reichert, J., Gleicher, L., Mock, L., Adams. S., & Lopez, K. (2017). Police-led referrals to 
treatment for substance use disorders in rural Illinois: An examination of the Safe  
Passage Initiative. Chicago, IL: Illinois Criminal Justice Information Authority, Center for 
Justice Research and Evaluation. Retrieved June 4, 2018 from   
http://www.icjia.state.il.us/assets/articles/Safe_Passage_Report_100217.pdf    
Rudd, R. A., Seth, P., David, F., & Scholl, L. (2016, December). Increases in drug and 
opioidinvolved overdose deaths – United States, 2010-2015. Morbidity and Mortality 
Weekly Report, 65(50 & 51), 1445-1452. Retrieved June 4, 2018 from 
https://www.cdc.gov/mmwr/volumes/65/wr/pdfs/mm655051e1.pdf     
Schiff, D. M., Drainoni, M.-L., Weinstein, Z. M., Chan, L., Bair-Merritt, M., & Rosenbloom, D. 
(2017). A police-led addiction treatment referral program in Gloucester, MA:    
Implementation and participants’ experiences. Journal of Substance Abuse Treatment, 
82, 41-47. Retrieved June 5, 2018 from https://doi.org/10.1016/j.jsat.2017.09.003     
Warner, M., Trinidad, J. P., Bastian, B. A., Miniño, A. M., & Hedegaard, H. (2016, December). 
Drugs most frequently involved in drug overdose deaths: United States, 2010-2014    
(National Vital Statistic Reports, 65, No. 10). Hyattsville, MD: National Center for Health 
Statistics. Retrieved June 4, 2018 from  
https://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_10.pdf    
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11. Subject Population: Describe the characteristics of the participant population
including the inclusion and exclusion criteria and the number of participants you plan
to recruit:
A total of 40 clients admitted to the Opioid Diversion Program (ODP) will be enrolled for the
12. Recruitment Procedure: Describe your recruitment strategies including how the
potential participants will be approached and precautions that will be taken to
minimize the possibility of undue influence or coercion. Include copies of the
recruitment letters, leaflets, etc. in your submission.
Recruitment will take place with clients who are recently accepted into the police Opioid
Diversion Program (ODP) available in participating police agencies in Lake County, Illinois.
We will coordinate with police agencies to put up an informational poster in each agency,
introducing the research opportunity; length of the intervention (12 weeks); and eligibility
criteria (stated in #11 above). The poster will also state that participation is voluntary , and (c)
compensation for completed study activities. This same information will be included in a
Recruitment Flier (see Appendix) that will be available to new ODP clients after they have
completed the intake screening for the diversion program. Clients who are interested in
hearing more about the study will be asked by Lake County Health Department (LCHD) staff
to electronically sign a release authorizing LCHD to release the client’s name and contact
information to the T-CAP Research Assistant (RA). The release will be signed before ODP
clients start outpatient or residential treatment, following ODP intake (screening and
treatment referral). The TCU RA will contact the client a via phone to schedule a time for the
virtual Informed Consent session that is convenient to the individual.
13. Consenting Procedure: Describe the consenting procedure, whether participation is
completely voluntary, whether the participants can withdraw at any time without
T-CAP study and all will receive the T-CAP intervention. Since the sample will be drawn from
the existing ODP, sociodemographic characteristics are expected to be similar to census
demographics for the corresponding communities, with approximately 59% male, 88% white,
and average age of 32. In addition, we expect approximately 40% will need mental health
services as part of their treatment and 60% will need services for medical problems. The ODP
screens out individuals who have a criminal record of violent offenses. While all current ODP
clients have a recent history (within the past 12 months) of opioid use or other substance use,
we will confirm this during the RA’s administration of the TCU Drug Screen 5 and TCU Drug
Screen 5—Opioid Supplement. If this process reveals that the individual does not have a
recent history of opioid or substance use, they will be offered the opportunity to remain in the
study but excluded from the primary analyses. Furthermore, individuals who are not willing to
consent to granting research staff permission to access their police and treatment services
records, and individuals who do not understand the informed consent (see appendix for the
Informed Consent Comprehension Questions), will be excluded from the study. Individuals
must demonstrate the ability to speak and understand English and be at least 18 years old to
participate in this study. At the Informed Consent meeting, the RA will determine that these
criteria are met.
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penalty, the procedures for withdrawing, and whether an incentive (describe it) will be 
offered for participation.  If students are used as participants, indicate an alternative 
in lieu of participation if course credit is provided for participation. If a vulnerable 
population is recruited, describe the measures that will be taken to obtain surrogate 
consent (e.g., cognitively impaired participants) or assent from minors and 
permission from parents of minors.       
In T-CAP, the RA will be 
the only researcher who 
will Administer informed 
Consent. The RA will 
contact clients going 
into outpatient (OP) 
treatment by phone 
within 3 business    
days of the ODP intake to describe the study and answer questions. For clients who are  
entering residential treatment, the RA will contact the residential provider to speak to the  
client to describe the study and answer questions. For recruiting, we will call the residential 
provider phone number and ask to speak with individuals in treatment for the Opioid 
Diversion Program who are ready to be released from treatment.  The provider will not be 
involved in recruiting for the study and will not have knowledge about an individual’s decision 
to learn more about the project and plans to meet with the Research Assistant (RA) at an 
arranged location, once released. The RA will arrange                   phone meetings with 
interested clients; within 4 days of the ODP intake for clients in OP treatment and within 4 
days of discharge for clients in residential care. During the scheduled phone meeting, the 
RA will explain the consent process and steps to complete the virtual Consent form 
accessed through Qualtrics, describe the project, and answer any questions. The RA will 
then send the Qualtrics link to the individual’s cell, tablet, or PC. Consent as well as 
responses to the Eligibility Questions (see Eligibility Questions in the Appendix) will be 
recorded via Qualtrics where participants will click on their responses for consent such as “I 
agree to participate” or “I do not agree to participate.” The RA will confirm the consent 
agreement to participate in the study by reviewing the Qualtrics data, before calling back to 
ask if the participant has follow-up questions about the study and to describe the steps to 
complete baseline data collection. Participation will be completely voluntary and clients will 
be told that there are no legal consequences for declining participation, including having no 
effect on ODP status.    
There are two Consent versions for the study activities in T-CAP; the Primary Study 
Informed Consent document will be used with the main study sample (N=40). In addition, we 
will contact participants by phone to recruit and consent a random sample of 6 to 8 of 
participants for a follow-up interview to be conducted virtually with the T-CAP app video 
feature at the end of the 12-week intervention, to ask about their experiences with T-CAP. 
The consent for this qualitative activity is the Participant Interview Informed Consent, as well 
as the Media Authorization to record interviews. [Virtual consent documentation is attached 
in the appendix].Consent documents are written with language that is appropriate for a 5th 
grade reading level (Consents and the Media Authorization are included in the Appendix). 
Both Consents will contain contact information for research staff and potential risks of 
participating. Compensation will be explained in the Primary Study 
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Informed Consent document; an $80 e-gift card for the time to complete intake surveys at 
the start of the study and $40 e-gift cards for completing assessments at week 6 (the 
midpoint) and week 12 (the end of the intervention period) during the    
3-month study (eligible for up to $160) in the form of electronic gift cards to online merchants
(e.g., Walmart, Amazon). Participants who use their own smartphone will get a $25
electronic gift card each month they participate in the study for messaging and data charges
(a total of $75 for 3 months). Participants will not be responsible for any costs to participate in
this study. The Participant Interview Informed Consent document will indicate that
compensation is a $20 electronic gift card for completing a scheduled interview with a
member of the research team. Participants who volunteer to be interviewed at the end of the
study will be contacted by the RA to schedule a virtual interview. Both Consent documents
will also have information indicating that participation or lack of participation will not affect the
individual’s status in the ODP, treatment, or treatment status in any possible way. Therefore,
participation will be strictly voluntary and should clients choose not to participate or withdraw
from the study at a later time, they may do so without repercussion. Participants can
withdraw from the study by contacting the RA or Coach by phone and stating that they wish
to stop participating. In cases where the Coach is contacted, the Coach will relay the
decision to the RA for administrative purposes. The Consent will explain that the research-
issued smart phone equipment will be collected by the RA at a time to be arranged with the
participant. The Informed Consents will also describe the confidentiality assurances and the
procedures employed to safeguard the data. In particular, it will be explained that information
collected will be identified only by a random participant Research ID number and research
reports will only be in aggregate form, whereby no individual can be identified. Recorded
interviews will be redacted and identified only by the Research ID for tracking purposes. No
individual data (survey, agency, or recorded opinions) will be reported to the ODP authorities
or any other entity. The Primary Study Informed Consent will include language to allow
release of behavioral healthcare agency data from the substance use treatment provider
(providing services as part of the Opioid Diversion Program) to the research team for
tracking participants across the 12-week intervention, thus providing treatment performance
indicators. The Primary Study Informed Consent will also state that behavioral healthcare
data will be requested by the research team using a variation of the Research ID (referred to
as the Treatment Code) to link data to a participant. The Treatment Code is an arbitrary
number assigned to each participant by the research team. The Code will be provided to the
behavioral healthcare provider in a file that links the Code to the participant’s name.
Therefore, data requests from the research team will include only the Treatment Code, which
providers will use to identify the client from the linking file. Behavioral healthcare providers
will use only the Treatment Code in submitting data to the research team. Behavioral agency
data will be shared with the research team via upload to TCU Box, a secure online data
sharing platform. After an Informed Consent has been administered, the RA will answer
questions and the client will then be asked to provide written consent.
Study Procedures: Provide a chronological description of the procedures, tests, and 
interventions that will be implemented during the course of the study. Indicate the 
number of visits, length of each visit, and the time it would take to undergo the 
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various tests, procedures, and interventions. If blood or tissue is to be collected, 
indicate exactly how much in simple terms. Flow diagrams may be used to clarify 
complex projects.     
Research ID. After participants have electronically consented to participate on an    
Informed Consent document, they will receive the Qualtrics link to complete the 
Demographic Forms, and Contact Information Forms. Each participant, will then  be 
assigned a Research ID that will be the only identification used on any project data. Because 
study participants are referred by the Diversion program to distinctly different forms of 
treatment (either outpatient or residential), the Research ID’s will be based on two separate 
3-digit series; 100 for participants in outpatient and 200 for participants released from
residential.  The Research ID will be written on the signed Informed Consent and entered
into a Master Link File that will pair the participant name with the Research ID. This file will
be kept on password protected laptops used by the RA and Coaches and password
protected computers used by the PI and Project Coordinator at the IBR.
Baseline Survey Administration. After completing the Informed Consent, Demographics  
Form (e.g., age, gender, race/ethnicity, education level, previous use of telehealth), and 
Contact Information Form, the participant will receive the Qualtrics link via SMS text or email, 
to complete the Survey Baseline battery (included in the Appendix). The Qualtrics Survey 
Baseline assessment battery is completed on a participant’s smart phone, hand-held tablet, 
or PC. The RA will provide the participant with their unique Research ID number, and this will 
be entered on the first screen by the participant. The Baseline assessment battery consists of 
forms available on our website (ibr.tcu.edu) and are widely used in substance abuse 
treatment settings and in our own research. The Baseline battery will also include a measure 
to gauge chronic pain. The Qualtrics Baseline battery, Demographics Form and Contact 
Information Form are expected to take up to1 hour to complete, in addition to the time it takes 
to complete the  Informed Consent administration (estimated at 20 minutes). Following 
completion of the Qualtrics Survey Baseline assessments, participants will receive an 
electronic gift card in the amount of $80. At the end of the meeting, information on the next 
study meeting will be provided where participants will meet with their assigned Coach. 
Participants will receive instructions from the RA to (1) access the app on the phone 
equipment and (2) expect a text message from the Coach to schedule their first telehealth 
video call. The RA will explain the steps (listed below in "baseline procedures”) that the 
Coach will use to schedule the first telehealth video call. The RA will further explain that the 
Coach will text message the participant the same day or next business day, except in cases 
where a participant joins the study on a Friday, in which case the Coach will text message the 
participant no later than the Monday that follows. 
 Procedures for Qualtrics surveys.  Data from surveys completed using Qualtrics on a phone 
or tablet are accessible for download by authorized T-CAP research staff from the TCU 
Qualtrics server. Data will not be stored on the Qualtrics server after download to an Excel 
file on a secure server in the IBR offices. The server where the Excel files will be stored at 
the IBR follows TCU Information Technology security policies, including high-level security 
and encryption, and includes access password protection. In addition, the computer drives 
and partitions where the files are located are encrypted by BitLocker with a 256-bit key, and 
individual files will be password protected by the study PI. This file security protocol is NIH-
compliant, and current TCU IRB-approved (as well as past IRB-approved studies) follow this 
protocol.  Research data in paper form are kept for a period of 3 years and then shredded. 
Electronic data records will be maintained for a period of 5 years.    
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Procedures for handling of paper and pencil forms. The RA will have paper versions 
available as an alternate to the Qualtrics Survey versions in case of issues with technology.  
In the event that the participant encounters issues with accessing the Qualtrics link to 
complete the baseline documents, paper forms will be mailed to participants at their home 
address along with two stamped FedEx return envelopes (one for surveys and one to return 
the Demographics and Contact Information Form at baseline) addressed to the TCU IBR 
(attention to: Jen Pankow). However, paper forms are intended only as a back-up option and 
will not be offered to participants as an alternative to the virtual Qualtrics survey.  Again, the 
data on paper forms will be identified only with the Research ID which will be entered by Jen 
Pankow, PI, into the participant tracking spreadsheet listing the issued   Research ID’s that 
are included in each FedEx package.   
At the IBR, these documents will be stored in a locked file cabinet in a locked room, and all 
will be kept separate from all study data at all times, accessible only to authorized project 
staff at IBR offices. IBR project staff will enter the information from these forms into an excel 
database on a secure computer accessible only to authorized project staff at IBR offices.    
Baseline procedures. The RA will describe the participant’s options for phone equipment. In 
the event that the participant chooses to use their own phone for the study, the RA will assist 
the participant with downloading the T-CAP app. Participants who choose to use a study-
issued phone will receive a FedEx delivered smart phone with the T-CAP app pre-loaded 
and instructions for use. For participants who choose to use their own phone equipment, the 
study will reimburse in the amount of $25 (in the form of an electronic gift card) per month to 
participants who are engaged in the entire 12-week intervention.  For participants who opt to 
use the research smart phone equipment, phones will be on an unlimited plan maintained 
through the IBR.      
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After the phone equipment decision is made by the participant, the RA will document (in the 
participant tracking spreadsheet) the date, whether the phone is owned or research-issued, 
phone number, and the phone FCC ID number for each participant. In the event that a 
participant loses a research-issued phone, the participant will be advised by the RA, that the 
project will provide 1 replacement phone. In the event that a participant loses their own 
phone, they can request a research-issued phone or if they obtain another phone of their 
own, the same reimbursement at end-of-study will apply. Participants can arrange for a 
replacement phone by emailing or calling the T-CAP RA at the contact information on the T-
CAP Flier, included with the participant’s copy of the Consent document. In the event that a 
participant does not have access to email or a borrowed phone, they can contact  the RA 
through the Lake County Health Department.      
Phone and T-CAP app instructions, included in the mailed FedEx package, will explain the 
app to the participant, describing the app features (text messaging and video call options).  
The app will be pre-populated with phone numbers for the RA and the Coach. The app also 
features an icon for support, should a participant have an issue with a login or password. 
The instructions will guide the participant to turn on the phone. Participants will receive a 
welcome message from the RA, and the RA will provide the participant with the name of the 
Coach and describe the steps (below) for scheduling the first telehealth video call for later 
that same day or the next day. In cases where a participant joins the study on a Friday, the 
Coach will text message the participant no later than the Monday that follows (i.e., within 3 
days after baseline surveys are completed).    
After the baseline procedures are complete, the RA will confirm that all participant 
information has been entered in the tracking spreadsheet on the RA password protected 
laptop and then uploaded to TCU Box. The RA will then send a text message to the 
assigned Coach, indicating that there is an updated tracking spreadsheet with new 
participant information, ready for download.     
Steps for scheduling the first telehealth video call: 
(1) The participant will receive a text message from the Coach indicating the day, date,
and time for the first telehealth session.
(2) The participant will send a reply to confirm the scheduled video call.
(3) At the scheduled time, the Coach will initiate the video call and the participant will
have the option to “Accept” or “Decline” the call (similar to the feature on Zoom).
During the first telehealth session, the participant and Coach will determine a
standing day and time for the remaining 6 telehealth calls.
The standing video call arrangements will be entered into the tracking spreadsheet by the 
Coach and uploaded to TCU Box. The Coach will then alert the RA that the spreadsheet is 
ready for download. The RA will download and proceed to set up the 6 remaining telehealth 
sessions in the app scheduling feature. The RA will send a confirmation text or email to the 
participant with the schedule.  The day prior to each of the 6 telehealth calls, the app will 
generate an automated reminder message about the upcoming telehealth call. We anticipate 
that there will be changes to the video call schedules, and participants will be advised to 
contact the RA for any schedule changes on video calls.     
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T-CAP Intervention. Coaching will be provided to the total study sample (N=40) by two
licensed substance use treatment counselors, currently available through the Lake County
Health Department. The Coach position requires professional training as a substance abuse
counselor or equivalent (e.g., counselor with mental health credentials). Each Coach will be
responsible for 20 participants during the 11-month implementation period. The study calls
for two half-time Coaches, one to cover responsibilities in the event that one Coach is not
available (e.g., due to vacation). In the event that one or both Coaches are unable to
continue the study, replacements will be engaged for the project [the IBR has a strong
collaborative relationship with several behavioral service provides in Lake and Cook
Counties in Illinois.] Each participant will be assigned to only one of the Coaches for the
duration of the intervention.
The 12-week telehealth intervention features 7 video calls on a smart phone, that will 
connect the participant with a Coach who will deliver the 3 components of the intervention: 
brief Motivational Interviewing (MI) sessions (see Appendix for MI scripts), recovery support, 
and assertive referrals to services that are intended to augment ODP substance use 
treatment or during post-treatment when there is an additional treatment need during 
recovery, as identified by the participant.      
MI telehealth sessions are scripted; session 1 introduces the participant to MI, sessions 2-6 
continue the dialog aimed at motivating the participant to identify issues and solutions, and 
session 7 focus is on continuing recovery with a plan.  Coaches will keep brief case notes on 
paper versions of the MI scripts, and this information will be entered into the Coach 
Procedural Fidelity Checklist in Qualtrics . Coaches will use the information to prepare for the 
upcoming telehealth session. In addition, 10% of MI sessions will be audio-recorded for 
further evaluation of the fidelity to the MI script content. For each Coach, this is 7 MI 
sessions during the 11-month study window. MI sessions will be randomly selected for 
recording by the Project  Coordinator, who will add an entry in the caseload tracking 
spreadsheet, flagging the video call MI portion to be recorded. This information will be 
provided to the Coaches in the caseload tracking spreadsheet that is downloaded by the 
Coaches from TCU Box-our secure file-sharing method. Coaches will be provided with hand-
held recorders to capture only the MI portion of the video call. Coaches will upload the 
recordings to TCU Box, for download by the Project Coordinator. Coaches will delete the 
recording off the recorder. MI recording will be evaluated by only the PI and Project 
Coordinator, who is trained in MI. Downloaded files will be kept on the IBR secure server for 
the duration of the study. When the project is completed, the audio files will be destroyed. No 
MI fidelity recordings will be stored in TCU Box.      
Scheduled Telehealth Sessions. Planned telehealth sessions (N=7) are front-loaded during 
the 12-week intervention, with 1 telehealth MI each week for the first four weeks, MI 5 in 
week 6, MI 6 in week 8, and MI 7 in week 12. The MI portion of each session is designed to 
be a brief 15 minute activity.  In addition to MI, the Coach and participant will update on 
relapse concerns and recovery progress, and identified treatment needs for medical or 
additional behavioral healthcare treatment. The Coach will assist the participant with 
arranging services/appointments with an assertive referral, which involves the Coach 
providing the participant with treatment options and contacting a prospective provider on 
behalf of the participant to arrange for an appointment. To support the Coaches with 
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resources to complete the assertive referrals, the RA will maintain an Excel spreadsheet 
with area providers, available services, payment options, and contact information. Before the 
end of the telehealth session, the Coach will also confirm the next scheduled telehealth 
session with the participant. Overall, the telehealth sessions with MI and coaching support 
are expected to last up to 30 minutes. In addition to the Coach-initiated telehealth sessions, 
participants will be encouraged by the Coach to request additional telehealth sessions as 
needed. Participants will send a text message to the RA requesting a video call. The RA will 
reply via text message with scheduling options, based on availability of the Coach. We 
anticipate that special requests for video calls will be a response to a pressing issue that is 
weighing on the participant, so these calls will occur within the same day as the request 
whenever possible.  The T-CAP research procedures for RA and Coach will be monitored 
with a monthly Procedural Fidelity Checklist (included in the Appendix).    
Telehealth app data collection. There are two types of data from the T-CAP app: (1) function 
data (e.g., frequency of messaging, date/time of video calls and duration of calls), and (2) 
two telehealth satisfaction questions completed by participants at the end of each telehealth 
session (see appendix). Both data types will be available for download (from the cloud) to 
TCU Box. The data will be identified by the phone number. The phone number will be 
replaced with the Research ID by the Project Coordinator, so that no identifying information 
will be included in the analytic dataset.     
Qualtrics Survey Mid-Intervention battery (T2). Participants will be contacted in week 5 by 
the RA to schedule a date and time to complete Mid-Intervention assessments battery in 
Qualtrics on a smart phone. The Mid-Intervention battery (and follow-up survey battery) 
repeats the baseline measures. To start the survey, The RA will confirm the unique 
Research ID number with each participant before sending the Qualtrics survey link, and this 
will be entered on the first Qualtrics screen. To start the survey, the participant will receive 
an SMS message with the Qualtrics survey link. At this timepoint in the study (and at follow-
up), participants will also be asked to complete the Qualtrics version of the Telehealth 
Usability Questionnaire (TUQ), a 21-item measure rating the telehealth experience. The 
Qualtrics Survey Mid-Intervention assessment battery is expected to take 60 minutes to 
complete.Following completion of the battery, participants will receive an electronic $40 gift 
card.  
Follow-up surveys (T3). Following the same scheduling procedures used for the   
Mid-Intervention survey battery, participants will be contacted in week 11 to arrange the 
Follow-up Survey battery, expected to take 60 minutes to complete. Following completion of 
the assessments, participants will receive an electronic gift card in the amount of $40. 
Following completion of the Qualtrics survey, the RA will contact the participants to thank 
each for their contributions to the project.  All individuals will be invited to participate in an 
interview with a member of the research team. Our goal is to obtain feedback at the study 
closeout (Time 3) from a minimum of 6-8 participants. Interested participants may have the 
Participant Interview Informed Consent administered with the Media Authorization at this 
time, or the RA will schedule another meeting on a date and time that is convenient for the 
participant to complete the Informed Consent. The RA will FedEx the signed 
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documents overnight to the IBR research team and enter the information into the tracking 
spreadsheet, which is then uploaded to TCU Box for download by authorized project staff. 
Individual interviews. A member of the research team will coordinate interview scheduling 
with the RA, who in turn will text message virtual meeting options to the participant. The 
scheduled meeting will be confirmed by the RA with both parties.  The semi-structured 
interview with a member of the research team will take via meeting-specific HIPAA 
compliant Zoom chat or by phone. Audio recordings will be processed at the IBR. 
Participants will be advised that all identifying information will be removed from the 
transcribed interview and no identifying information will be reported for the project. 
Interviews are expected to take 30 minutes to complete and participants will receive an 
electronic gift card ($20) for their participation. Participants who are interested will receive a 
Qualtrics link for the Participant Interview Consent and Media Release documents. 
Responses will be recorded via Qualtrics where participants will click on their responses 
such as “I agree to participate” or “I do not agree to participate.” Audio files will be 
transcribed for qualitative analysis. Agency Records. Behavioral healthcare data will be 
obtained for participants in both conditions.    
Participants will authorize the release of these data to the research team by signing the 
Primary Study Informed Consent at the start of the study. As part of the data-sharing piece, 
the research team will also obtain a Memorandum of Understanding (MOU), signed by the 
behavioral provider and the T-CAP PI.  To request treatment data, the IBR research staff will 
send via email, monthly requests to providers with an attached Provider Data Request Form 
(included in the Appendix) for each participant receiving services at their agency. The form 
will include only a unique identification number (i.e., Treatment Code) which the provider will 
use to identify the participant. No participant name will appear on the form or in the email. 
The form has space for the provider to include the following information items:      
•
Primary diagnosis
•
Level of care (outpatient, intensive outpatient, residential, detox)
•
Length of program (number of weeks)
•
Treatment initiation date
•
Number of sessions scheduled this month
•
Number of missed sessions this month
•
Drug test results for this month
•
Treatment discharge date
Completed Provider Data Request Forms will be uploaded by the provider to TCU Box and 
available for download by authorized project staff. Data from the forms will be entered into a 
provider data tracking Microsoft Excel file at the IBR and maintained on a secure server at 
the IBR office.     
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14. Data Analyses: Describe how you will analyze your data to answer the study question
Aim 1: Demonstrate intervention feasibility by measuring study participant receptivity and
utilization of the telehealth approach. Feasibility will be primarily assessed by descriptive
analyses of participation, satisfaction, and telehealth usability data. We will examine
distributions on these measures as well as characteristics of participants with high and low
participation sample size, we will be more interested in trends than in statistical significance.
Receptivity and utilization will be assessed by self-report measures as well as participation data
from the T-CAP app. Self-report measures will include the Telehealth Usability Questionnaire
(TUQ), Telehealth Session surveys, and semi-structured closeout interviews. The TUQ gauges
constructs that are consistent with those in the telehealth literature and include: Usefulness,
Ease of Use Interaction Quality, Satisfaction and Future Use, Interface Quality; and Reliability.
TUQ scores of 4.0 (agree) and above on each domain indicate high receptivity. Scores below
4.0 will be interpreted as an indication that the participant encountered some challenge in that
area of using the telehealth system. Data from the TCAP app will provide evidence of utilization
(i.e., process data on session completion, duration, and number of unscheduled contacts). Two
satisfaction questions are asked after each video conferencing session. We will primarily
examine counts and distributions of these data but will also examine characteristics of
participants with high and low levels of participation. All individuals will be invited to participate
in an interview with a member of the research team. Our goal is to obtain feedback at the study
closeout (Time 3) from a minimum of 6-8 participants. Drawing on our extensive qualitative
experience, a semi-structured interview with questions from the TUQ, paired with relevant
probes, will guide the interview to help us gain a better understanding about how the telehealth
experience impacted participants.
Aim 2: Evaluate the proposed T-CAP measures to assess their performance in gauging the 
impact of telehealth on initiation of in-person Substance Use (SU) treatment, short-term 
retention in referred SU treatment, and access to other appropriate treatment services (e.g., 
MAT). Our multidimensional approach includes data from self-report attendance and treatment 
engagement, self-report drug use, Coaches’ advocate records on number of completed 
assertive referrals, and agency records from police and BH providers (including intake and 
during-program UA test results). In order to examine groups differences for intervention 
completers (C) vs non-completers (NC) (i.e., individuals who do not complete the 7 coaching 
video calls), group differences using t-tests and chi-square tests and we will estimate effect 
sizes needed for determining a sample size for a future R01 proposal. To assess potential 
assignment bias, we will test to see if there are baseline differences in demographics: 
participant race, gender, age and other demographic characteristics, as well as baseline 
measures of opioid use frequency and amount will be examined using chi-square and t-tests. 
Effect sizes will be computed for group differences on multiple outcomes (treatment initiation, 
retention, referrals to expanded SU service options, missed appointments). Service attendance 
records will be corroborated monthly with service provider records. Examinations of referrals to 
MAT and alternative pain management care between the C and NC groups, utilizing agency 
records data and the Coach tracking, will be conducted using a z-score to test differences in 
proportions of referral types. This will be calculated for all assertive referrals (resulting in 
scheduled appointments) collectively for a participant, as well as for different types of services. 
Analyses of Secondary outcomes. We will examine differences between C and NC groups on 
several secondary outcomes. Analyses will typically involve t-tests, chi-square tests, and 
correlations. For example, we will use t-tests to assess differences between groups on the 3-
month follow-up measures 
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15. Potential Risks and Precautions to Reduce Risk: Indicate any physical, psychological,
social, or privacy risk which the subject may incur. Risk(s) must be specified. Also
describe what measures have been or will be taken to prevent and minimize each of
the risks identified. If any deception is to be used, describe it in detail and the plans
for debriefing.
Breach of confidentiality. This risk will be minimized with procedures to safeguard the
confidentiality of participants include assigning Research ID’s to subjects. This number will
be used as an identifier for all study materials including the participant’s responses to the
surveys, data stored from existing records, qualitative data, and T-CAP telehealth session
data. Data from the T-CAP telehealth app will be stripped of participant phone number by
the Project Coordinator, and the Research ID will be entered into the dataset. Participants
will only be identified using this number and data will be reported in aggregate only. Consent
forms with participant study numbers will be kept in a locked filing cabinet in a locked room
in the IBR offices, accessible by authorized researchers.  Electronic research data will be
encrypted and password protected. Participants will be made aware during the consent
process and prior to every research session that all information provided is considered to be
confidential. Further procedures to protect confidentiality are described below. Only
authorized research staff will have access to the de-identified data. Only the PI and Project
Coordinator will have access to the T-CAP app data with the phone number when it is
downloaded to the IBR secure server. These same authorized researchers will also have
access to qualitative interview data, behavioral healthcare provider data, Qualtrics survey
data with Research ID, and case notes from the Coaches. The RA will use the Research ID
for reporting scheduling information (electronic files and demographic forms) to the IBR
research team, and the Coach will use the Research ID when reporting case notes to the
research team (electronic and paper files).
Coercion. While both the ODP participation and T-CAP participation are completely
voluntary, there is a risk of perceived coercion that clients in the police diversion program
may experience. This risk will be minimized in several ways. Participants will be informed
that participation in this study will not in any way affect their status in the ODP. Further, ODP
staff and officers will not be actively included as part of the study and will not be given
feedback about any participant or any progress they have made in the study. Before the full
rollout of the study, we will conduct presentations with ODP leadership and Lake County
Health Department staff, and other stakeholders (e.g., community behavioral healthcare
providers) to provide an overview of the study, and we will stress that study participation is
voluntary and the participants may drop out of the study at any time if they wish.
Possible discomfort to study materials.  Participants in the study will be asked to complete
three survey batteries and seven telehealth sessions featuring MI with the Coach. Study
participants may
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of treatment motivation and psychosocial function from the TCU Client Evaluation of Self 
and Treatment (TCU CEST), a widely used form listed on the IBR web page. Validation of 
recent (last few days) self-reported opioid use will be compared with drug testing outcomes 
at each assessment time point using McNemar’s test for change of state, as well as 
computing sensitivity and specificity statistics and the kappa statistic as a measure of 
agreement. We will compare self-report, as well as urinalysis (UA) results from agency drug 
screens between the two groups. 

experience some personal embarrassment or emotional discomfort from some of the survey 
questions or talking with the Coach.  However, participants will be instructed that they can 
skip questions in surveys or during MI sessions that they do not feel comfortable answering. 
16. Procedures to Maintain Confidentiality: Describe how the data will be collected,
deidentified, stored, used, and disposed to protect confidentiality. If protected health
information is to be re-identified at a later date, describe the procedure for doing so.
All signed consents and hard data must be stored for a minimum of 3 years in a
locked filing cabinet (and locked room) in the principal investigator’s office, lab, or
storage closet at TCU. Your professional society may recommend keeping the
materials for a longer period of time.
Data from five sources will be subject to confidentiality procedure: (1) Qualtrics Surveys at 
baseline, 6 weeks and 12 weeks, (2) data from telehealth sessions, (3) data from Coaches, 
(4) data from community behavioral health providers, and (5) qualitative data from
participant interviews.
The first step in maintaining confidentiality is to assign each participant an arbitrary 
Research ID that will be used on all data for that participant.  A Master Link File will be 
maintained by the PI, Project Coordinator, Coaches and the field RA that will include the 
participant’s name, Research ID, and study phone number. Treatment Code (described 
below) will only be included in the Master Link File maintained by the PI and Project 
Coordinator. This file will be encrypted and stored at the IBR on a secure computer separate 
from any other participant data. The Master Link File will be password protected, stored 
electronically, and kept separate from all other data files. It will be accessible only to 
authorized project staff.      
Surveys. The RA will need to have the Master Link File on their TCU-owned secure laptop 
computer for tracking participants and obtaining Research IDs to enter on project materials. 
The laptop will be protected by a strong password and the link file, a Microsoft Excel 
database, will be encrypted and protected by a strong password.  Every time a participant 
comes to complete a survey battery, the RA will use the participant name to look up the 
Research ID in the database. This will bring up the name and Research ID for that 
participant. The RA will enter the Research ID on the Qualtrics survey battery or on the 
paper version alternative. Updated Master Link Files will be uploaded by the RA via TCU 
Box for download by the IBR authorized researchers (PI or Project Coordinator).Master Link 
Files will not be stored in a TCU Box folder.    
The RA will instruct the participant not to put their name or other identifying information on 
any paper forms. The Demographics Form—completed only at baseline—includes questions 
on demographics and background information, and does not have any questions of a 
sensitive nature.  When the participant returns the Demographics Form, it will be mailed to 
the IBR in an envelope with the Contact Information Form. In the event that the Baseline 
battery of assessments is completed on paper (this is a back-up option in the event that 
internet access is not functioning), the survey will be mailed to the IBR in a FedEx envelope, 
separate from the Demographics Form and Contact Information Form. Data collection on 
Qualtrics will not have other data that could be used to identify the participant.  When 
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surveys are completed using Qualtrics, the resulting data file is not readable until it is 
uploaded to the secure Qualtrics server on the TCU campus.    
Telehealth session data. The 2-question telehealth satisfaction survey completed on a smart 
phone at the end of each telehealth session will be available for download through the TCAP 
app to TCU Box, accessible only by the PI and Project Coordinator. The data will be linked 
to the phone number and will not include any information that can identify the participant. 
The phone number in the .csv dataset will be replaced by the Research ID when the data is 
downloaded by the Project Coordinator at the IBR.    
Data from Coaches. Each Coach will need to have a caseload tracking file with participants’ 
name, Research ID, and phone number, accessible on their TCU-owned secure laptop 
computers in a Master Linking file. Each laptop will be protected by a strong password and 
the caseload tracking file—a Microsoft Excel database—will be encrypted and protected by 
a strong password and used for documenting assertive referrals and other support services  
(e.g., assistance with obtaining clothing, housing, or transportation) for individual 
participants, as well as case notes on MI telehealth sessions. The tracking files maintained 
by Coaches will be uploaded to TCU Box on a weekly basis for the duration of the study. 
Downloaded caseload tracking files will be stored at the IBR on a TCU-secure computer 
accessible by authorized IBR researchers; tracking files will be separate from the Master 
Link File.      
Behavioral healthcare provider data. Data requests to behavioral healthcare treatment 
providers will be conducted on a monthly basis. To facilitate the requests and maintain 
confidentiality, providers will be given a Treatment Code number (not the Research ID)  at 
the start of the study for individuals receiving services at their agency. The Provider Data 
Request Form (included in the Appendix), will include only the Treatment Code; no 
participant name or Research ID will appear on the form or in the email requesting the data. 
Completed forms will be uploaded by the provider to TCU Box and available for download by 
authorized project staff. Data from the forms will be entered into a provider data tracking 
Microsoft Excel file at the IBR. The Treatment Code will be maintained in the Master Linking 
File that will be encrypted and stored at the IBR on a secure computer separate from any 
other participant data.     
Participant interviews. The semi-structured interview (Individual Interview Guide is included 
in the Appendix) with a member of the research team will take place via meeting-specific 
HIPAA compliant Zoom chat or by phone. Audio recordings will be processed at the IBR.   
Audio files will be uploaded on password protected computers the IBR by the PI or Project   
Coordinator and transcribed for coding by a transcript service that we have used on multiple 
Federally-funded projects.  Transcription files will be redacted and formatted before upload 
to Atlas.ti coding software. Original audio files and transcripts will be stored at the IBR on a 
separate secure computer, accessible only to authorized project staff.    
17. Potential Benefits: Describe the potential benefits of the research to the participants,
to others with similar problems, and to society.
Participation in this research may increase individuals’ knowledge, self-efficacy, and skills
that they can use to deal with life problems that impede successful recovery. From a larger
perspective, participation may help to improve the quality of care for persons experiencing
life-threatening use of opioids or other substances, and this may benefit not only the
individual by reducing his/her pain and risk of overdose, but also by lessening the burden
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18. Training for Protecting Human Research Participants: Submit training certificates for
all the study investigators. The training link is available on the TCU IRB webpage at
www.research.tcu.edu.
19. Check List for the Items That Need to be Submitted:  Please combine all the files into
one pdf document before submitting the materials electronically to the IRB. To
prevent any delay in the approval of your protocol, use the most recent template for
the protocol, consent document, and HIPAA form by downloading them from
www.research.tcu.edu each time you prepare your materials.
a. Protocol
b. Consent document
c.
HIPAA form if applicable
d. Protecting Human Research Participants Training certificate  for
each investigator
e. Recruitment fliers, letters, ads, etc.
f.
Questionnaires or other documents utilized in screening and
data collection
Principal Investigator Assurance 
20. By signing below, I certify to the following:
•
The project described herein will be conducted in accordance with applicable TCU policies
and procedures, as determined by the IRB of record. All Human Subject Research projects
occurring at TCU must be conducted in compliance with the Office of Human Protection
(“OHRP”) regulations at 45 CFR 46 and all other applicable federal and state laws and
regulations (collectively “Applicable Law”)
•
I have a working knowledge of Applicable Law
•
All personnel who work with human participants under this protocol have received, or will
receive, appropriate training in protocol procedures and protection of human subjects prior
to working with humans.
placed on their family and society at large. A more effective intervention for supporting 
recovery also benefits behavioral healthcare programs by improving health outcomes 
thereby saving staff time and program costs. We anticipate that this research may also have 
important benefits for public health by reducing the risk of opioid overdose fatalities.     
Participation in this intervention will provide information on the usefulness of telehealth 
services for changing attitudes and intentions and subsequent behavioral risks with regard to 
serious opioid or other substance use. We will also gain valuable information about the use 
of telehealth technology for delivering the intervention with individuals in recovery.      
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•
All experiments involving human participants will be performed only by the qualified
individuals listed in this protocol and individuals not listed in this protocol will not participate
in the protocol experiments.
•
Procedures on experimental subjects described in this IRB protocol accurately reflect those
described in the funding applications and awards, if externally supported.
•
I and all personnel have read and will comply with any pertinent safety information, IRB
requirements, and security procedures.
•
I will maintain records of all human participants and the procedures carried out throughout
the entire term of my project.
•
As Principal Investigator, I am aware that I have the ultimate responsibility, on a day-to-day
basis, for the proper care, treatment, and protection of the human participants.
12/13/2021_______ 
Signature of Principal Investigator 
 Date   
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