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临床试验/NCT06843213
NCT06843213招募中不适用

Teaching Harm Reduction in Vulnerable Environments (THRIVE): A Peer-led Intervention Bridging Acute Care Settings and the Discharge to the Community

University of Pennsylvania6 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2025年2月18日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
390
试验地点
6
主要终点
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

研究概览

简要总结

The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of harm reduction 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 harm reduction 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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Baseline to 6 months

Cumulative incidence of non-fatal overdose OR skin and soft tissue infection

次要结局

  • Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of non-fatal overdoses(Baseline to 6 months)
  • Effectiveness of the THRIVE intervention compared to EUC at lowering the incidence of skin and soft tissue infections(Baseline to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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