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Recruiting NCT06843213

Teaching Health Resilience in a Hospital Setting: A Peer-led Intervention

No phase Interventional Opioid Use Disorder Harm Reduction Health Promotion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer Intervention, Enhanced Usual Care.
Who it may be relevant to
Registry conditions: Opioid Use Disorder, Harm Reduction, Health Promotion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Teaching Health Promotion and Resilience in Varied Environments: a Peer-led Intervention Following Hospital Discharge

Overview

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

Interventions

  • Behavioral Peer Intervention
    Participants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 3 centers
  • UPMC Mercy Hospital — Pittsburgh
  • UPMC Presbyterian-Montefiore Hospital — Pittsburgh
  • UPMC Shadyside Hospital — Pittsburgh

Publications

  • Harm Reduction Principles. National Harm Reduction Coalition. Accessed September 9, 2022. https://harmreduction.org/about-us/principles-of-harm-reduction/
  • Friedman SR, de Jong W, Rossi D, Touze G, Rockwell R, Des Jarlais DC, Elovich R. Harm reduction theory: users' culture, micro-social indigenous harm reduction, and the self-organization and outside-organizing of users' groups. Int J Drug Policy. 2007 Mar;18(2):107-17. doi: 10.1016/j.drugpo.2006.11.006. Epub 2006 Dec 28. PMID 17689353
  • Pauly BB, Reist D, Belle-Isle L, Schactman C. Housing and harm reduction: what is the role of harm reduction in addressing homelessness? Int J Drug Policy. 2013 Jul;24(4):284-90. doi: 10.1016/j.drugpo.2013.03.008. Epub 2013 Apr 25. PMID 23623720
  • Pauly B, Wallace B, Barber K. Turning a blind eye: implementation of harm reduction in a transitional programme setting. Drugs Educ Prev Policy. 2018;25(1):21-30. doi:10.1080/09687637.2017.1337081
  • Pauly B. Harm reduction through a social justice lens. Int J Drug Policy. 2008 Feb;19(1):4-10. doi: 10.1016/j.drugpo.2007.11.005. Epub 2008 Jan 15. PMID 18226520
  • Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21. PMID 32830383
  • Phillips KT, Stewart C, Anderson BJ, Liebschutz JM, Herman DS, Stein MD. A randomized controlled trial of a brief behavioral intervention to reduce skin and soft tissue infections among people who inject drugs. Drug Alcohol Depend. 2021 Apr 1;221:108646. doi: 10.1016/j.drugalcdep.2021.108646. Epub 2021 Feb 27. PMID 33677353
  • Moustaqim-Barrette A, Dhillon D, Ng J, Sundvick K, Ali F, Elton-Marshall T, Leece P, Rittenbach K, Ferguson M, Buxton JA. Take-home naloxone programs for suspected opioid overdose in community settings: a scoping umbrella review. BMC Public Health. 2021 Mar 26;21(1):597. doi: 10.1186/s12889-021-10497-2. PMID 33771150

Identifiers

NCT: NCT06843213 · 857581 · 1R01DA057633

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗