Preventing Overdose in Supportive Housing: Stepped Wedge Randomized Controlled Trial of a Multi-Sector, Upstream Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,940
- 试验地点
- 1
- 主要终点
- Composite Score of Agency-Level Fidelity to Overdose Prevention Evidence-Based Practices
研究概览
简要总结
This community-partnered study examines a technical assistance intervention designed to help permanent supportive housing agencies implement evidence-based practices to prevent tenant overdose and improve tenant health.
详细描述
Homelessness and housing instability are strongly linked with overdose risk. Permanent supportive housing (PSH) -subsidized housing paired with supportive services-is a key strategy to end homelessness yet supportive housing tenants face high overdose risk due to a confluence of factors. This multi-sector, community-partnered, stepped wedge randomized controlled trial evaluates the impact of a technical assistance intervention designed to support supportive housing agencies in sustainably implementing evidence-based practices to reduce tenant overdose and improve tenant health more broadly. The technical assistance intervention will be delivered to supportive housing agencies in New Jersey and New York who are enrolled in the trial. Outcomes include PSH agency implementation of overdose prevention practices and downstream tenant overdose, substance use, and other health-related outcomes. Outcomes will be assessed using surveys, administrative data, and agency records. This trial is a part of the HEAL Initiative (https://heal.nih.gov/).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •We will be enrolling supportive housing agencies from NY and NJ to participate in this study. Trial enrollment and intervention delivery will occur at the level of the agency. There are anticipated to be 24 supportive housing agencies total that will be enrolled in the study; approximately 6 agencies will be randomly assigned to each of the four intervention waves in the stepped wedge randomized controlled trial.
- •Inclusion Criteria:
- •Supportive Housing Agencies/Individuals who Work at Supportive Housing Agencies:
- •Serve at least 40 tenants in New York and/or New Jersey
- •Have a significant concern for overdose (as demonstrated by past year tenant overdose)
- •Be willing to complete all activities required for participation in the trial
- •Tenants who Live in Supportive Housing Agencies:
- •Must live in an enrolled Supportive Housing Agency
- •Must be 18 years and older
排除标准
- •See inclusion criteria.
研究组 & 干预措施
Wave 1: Control, Intervention, Sustainment
Participants at agencies assigned to wave 1 will receive the control condition from months 1-6; intervention for months 6-12; and sustainment from months 12-45.
干预措施: TA Intervention (Behavioral)
Wave 2: Control, Intervention, Sustainment
Participants at agencies assigned to wave 2 will receive the control condition from months 1-13; intervention for months 13-19; and sustainment from months 19-45.
干预措施: TA Intervention (Behavioral)
Wave 3: Control, Intervention, Sustainment
Participants at agencies assigned to wave 3 will receive the control condition from months 1-20; intervention for months 20-26; and sustainment from months 26-45.
干预措施: TA Intervention (Behavioral)
Wave 4: Control, Intervention, Sustainment
Participants at agencies assigned to wave 4 will receive the control condition from months 1-27; intervention for months 27-33; and sustainment from months 33-45.
干预措施: TA Intervention (Behavioral)
结局指标
主要结局
Composite Score of Agency-Level Fidelity to Overdose Prevention Evidence-Based Practices
时间窗: Baseline, Month 12 (End of Wave 1), Month 19 (End of Wave 2), Month 26 (End of Wave 3), Month 33 (End of Wave 4)
Fidelity will be measured as the extent to which an intervention is implemented as intended by researchers; the specific method of measurement will be determined during the trial's preparatory phase, in consultation with multiple stakeholders. The measurement will comprise a composite score of multiple measures.
次要结局
未报告次要终点