- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06843213
Teaching Health Resilience in a Hospital Setting: A Peer-led Intervention (THRIVE)
Teaching Health Promotion and Resilience in Varied Environments: a Peer-led Intervention Following Hospital Discharge
The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of health resilience and promotion services to be delivered in the hospital setting, called the THRIVE intervention.
The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care?
Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections.
Intervention participants will:
- Receive one in-person session from a peer support specialist while in the hospital
- Receive weekly text messages from the peer support specialist for a 12-week period
- Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
- Complete a baseline, 3-month, and 6-month assessment with Research Assistants
Enhanced usual care participants will:
- Receive a handout with health resilience education and resources in their local area
- Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
- Complete a baseline, 3-month, and 6-month assessment with Research Assistants
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research Program Coordinator
- Phone Number: 412-679-9848
- Email: thriving@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Not yet recruiting
- UPMC Shadyside Hospital
-
Contact:
- Research Program Coordinator
- Phone Number: 412-679-9848
- Email: thriving@pitt.edu
-
Principal Investigator:
- Jane M Liebschutz, MD
-
Pittsburgh, Pennsylvania, United States, 15203
- Not yet recruiting
- UPMC Mercy Hospital
-
Contact:
- Research Program Coordinator
- Phone Number: 412-679-9848
- Email: thriving@pitt.edu
-
Principal Investigator:
- Jane M Liebschutz, MD
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- UPMC Presbyterian-Montefiore Hospital
-
Contact:
- Research Program Coordinator
- Phone Number: 412-679-9848
- Email: thriving@pitt.edu
-
Principal Investigator:
- Jane M Liebschutz, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who are: a) admitted to University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, UPMC Presbyterian-Montefiore Hospital, UPMC Mercy Hospital for inpatient or observation status, or b) seen in the Emergency Department setting at UPMC Presbyterian-Montefiore Hospital and UPMC Mercy Hospital.
- Participants must have a current diagnosis of Opioid Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
- Participants must be at least 18 years of age on day of admission.
- Participants must be able to speak and read English.
Exclusion Criteria:
- Participants diagnosed with dementia and/or cognitive impairments.
- Participants with acute psychiatric complications, such as schizophrenia with acute psychosis, acute mania, or suicidal ideation (which may impact the ability of a participant to consent and actively participate in treatment).
- Participants who are pregnant or lactating at onset of study.
- Participants who cannot read or speak English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Enhanced Usual Care
|
Participants will receive a handout that includes health resilience education and resources in their local area as part of enhanced usual care.
|
|
Experimental: Peer Intervention
|
Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of the THRIVE intervention compared to enhanced usual care (EUC) at lowering the incidence of non-fatal overdoses OR skin and soft tissue infections
Time Frame: Baseline to 6 months
|
Cumulative incidence of non-fatal overdose OR skin and soft tissue infection
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses
Time Frame: Baseline to 6 months
|
Cumulative incidence of non-fatal overdose
|
Baseline to 6 months
|
|
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections
Time Frame: Baseline to 6 months
|
Cumulative incidence of skin and soft tissue infection
|
Baseline to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of the THRIVE intervention on change in higher risk infection behaviors (characterized by BIRSI score) compared to EUC
Time Frame: Baseline to 6 months
|
Change in higher risk infection behaviors measured as the total score on the BIRSI
|
Baseline to 6 months
|
|
Heterogeneity of treatment effect by race (Black versus white) in the THRIVE intervention arm
Time Frame: Baseline to 6 months
|
Cumulative incidence of non-fatal overdose OR skin or soft tissue infection, by race (Black versus white)
|
Baseline to 6 months
|
|
Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (a)
Time Frame: Baseline to 6 months
|
(a) Change in the proportion of participants who self-report naloxone use in past 30 days to reverse another person's overdose
|
Baseline to 6 months
|
|
Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (b)
Time Frame: Baseline to 6 months
|
(b) Change in the proportion of participants who self-report currently carrying naloxone
|
Baseline to 6 months
|
|
Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (c)
Time Frame: Baseline to 6 months
|
(c) Change in the proportion of participants who self-report using at least one drug checking strategy in the past 30 days
|
Baseline to 6 months
|
|
Effectiveness of the THRIVE intervention on health resilience access compared to EUC (a)
Time Frame: Baseline to 6 months
|
(a) Change in the proportion of participants who self-report having received at least one of: naloxone, syringes, or new or unused pipes in past 30 days
|
Baseline to 6 months
|
|
Effectiveness of the THRIVE intervention on health resilience access compared to EUC (b)
Time Frame: Baseline to 6 months
|
(b) Change in the proportion of participants who self-report visiting a syringe services program in past 30 days
|
Baseline to 6 months
|
|
Effectiveness of the THRIVE intervention on health resilience access compared to EUC (c)
Time Frame: Baseline to 6 months
|
(c) Change in the proportion of participants who self-report receiving any health resilience services from a needle exchange facility in past 30 days
|
Baseline to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacqueline D Wilson, MD, University of Pennsylvania
Publications and helpful links
General Publications
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- Stack E, Hildebran C, Leichtling G, Waddell EN, Leahy JM, Martin E, Korthuis PT. Peer Recovery Support Services Across the Continuum: In Community, Hospital, Corrections, and Treatment and Recovery Agency Settings - A Narrative Review. J Addict Med. 2022 Jan-Feb 01;16(1):93-100. doi: 10.1097/ADM.0000000000000810.
- Mercer F, Miler JA, Pauly B, Carver H, Hnizdilova K, Foster R, Parkes T. Peer Support and Overdose Prevention Responses: A Systematic 'State-of-the-Art' Review. Int J Environ Res Public Health. 2021 Nov 17;18(22):12073. doi: 10.3390/ijerph182212073.
- Kennedy MC, Boyd J, Mayer S, Collins A, Kerr T, McNeil R. Peer worker involvement in low-threshold supervised consumption facilities in the context of an overdose epidemic in Vancouver, Canada. Soc Sci Med. 2019 Mar;225:60-68. doi: 10.1016/j.socscimed.2019.02.014. Epub 2019 Feb 10.
- Owczarzak J, Weicker N, Urquhart G, Morris M, Park JN, Sherman SG. "We know the streets:" race, place, and the politics of harm reduction. Health Place. 2020 Jul;64:102376. doi: 10.1016/j.healthplace.2020.102376. Epub 2020 Jul 22.
- Bardwell G, Kerr T, Boyd J, McNeil R. Characterizing peer roles in an overdose crisis: Preferences for peer workers in overdose response programs in emergency shelters. Drug Alcohol Depend. 2018 Sep 1;190:6-8. doi: 10.1016/j.drugalcdep.2018.05.023. Epub 2018 Jun 26.
- Pauly B, Wallace B, Pagan F, Phillips J, Wilson M, Hobbs H, Connolly J. Impact of overdose prevention sites during a public health emergency in Victoria, Canada. PLoS One. 2020 May 21;15(5):e0229208. doi: 10.1371/journal.pone.0229208. eCollection 2020.
- Small W, Wood E, Tobin D, Rikley J, Lapushinsky D, Kerr T. The Injection Support Team: a peer-driven program to address unsafe injecting in a Canadian setting. Subst Use Misuse. 2012 Apr;47(5):491-501. doi: 10.3109/10826084.2012.644107.
- Hayashi K, Wood E, Wiebe L, Qi J, Kerr T. An external evaluation of a peer-run outreach-based syringe exchange in Vancouver, Canada. Int J Drug Policy. 2010 Sep;21(5):418-21. doi: 10.1016/j.drugpo.2010.03.002. Epub 2010 Mar 31.
- Dechman MK. Peer helpers' struggles to care for "others" who inject drugs. Int J Drug Policy. 2015 May;26(5):492-500. doi: 10.1016/j.drugpo.2014.12.010. Epub 2015 Jan 8.
- Marshall C, Perreault M, Archambault L, Milton D. Experiences of peer-trainers in a take-home naloxone program: Results from a qualitative study. Int J Drug Policy. 2017 Mar;41:19-28. doi: 10.1016/j.drugpo.2016.11.015. Epub 2016 Dec 24.
- Callon C, Charles G, Alexander R, Small W, Kerr T. 'On the same level': facilitators' experiences running a drug user-led safer injecting education campaign. Harm Reduct J. 2013 Mar 6;10:4. doi: 10.1186/1477-7517-10-4.
- Colon RM, Deren S, Guarino H, Mino M, Kang SY. Challenges in recruiting and training drug treatment patients as peer outreach workers: a perspective from the field. Subst Use Misuse. 2010 Oct;45(12):1892-908. doi: 10.3109/10826081003684863.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 857581
- 1R01DA057633 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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