Teaching Health Resilience in a Hospital Setting: A Peer-led Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Peer Intervention
BehavioralParticipants will receive one peer-led, in-person session boosted by weekly text messages over a 12-week period.
Enhanced Usual Care
Other interventionParticipants will receive a handout that includes health resilience education and resources in their local area as part of enhanced usual care.
Treatment groups
262 Participants
are divided into 2 treatment groupsGroup A: Peer InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Cumulative incidence of non-fatal overdose OR skin and soft tissue infection
Time frame
Baseline to 6 monthsSecondary outcomes
1
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses
Cumulative incidence of non-fatal overdose
Time frame
Baseline to 6 months2
Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections
Cumulative incidence of skin and soft tissue infection
Time frame
Baseline to 6 monthsOther outcomes
1
Effectiveness of the THRIVE intervention on change in higher risk infection behaviors (characterized by BIRSI score) compared to EUC
Change in higher risk infection behaviors measured as the total score on the BIRSI
Time frame
Baseline to 6 months2
Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (a)
(a) Change in the proportion of participants who self-report naloxone use in past 30 days to reverse another person's overdose
Time frame
Baseline to 6 months3
Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (b)
(b) Change in the proportion of participants who self-report currently carrying naloxone
Time frame
Baseline to 6 months4
Effectiveness of the THRIVE intervention on change in health resilience adoption compared to EUC (c)
(c) Change in the proportion of participants who self-report using at least one drug checking strategy in the past 30 days
Time frame
Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of Pittsburgh
Collaborator
Source ClinicalTrials.gov