Financial Incentives to Increase Treatment Attendance in First-Episode Psychosis Care: A Non-Randomized, Adaptive Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
- 试验地点
- 3
- 主要终点
- Acceptability of intervention measure (AIM)
研究概览
简要总结
Individuals with first-episode psychosis (FEP) are at high-risk for several poor functional and clinical outcomes, including suicide. Coordinated Specialty Care (CSC) is a multidisciplinary, team-based intervention known to improve such outcomes, including suicide risk. However, 30-50% of patients disengage from CSC, thereby limiting its impact. This pilot study will develop and test feasibility of a behavioral change program that uses moderate financial incentives to encourage treatment engagement in 2 CSC programs. A single-arm of 80 patient-participants at these two clinics will be recruited to assess feasibility and acceptability from patient perspectives. Additionally,15 clinicians at these two clinics will be recruited to assess feasibility and acceptability from clinician perspectives, and 50 clinicians from peer clinics not involved in the intervention will be recruited to assess scalability of the intervention. The trial will feature an three-month period for recruitment and baseline data collection and will subsequently feature three intervention periods (3 months each) where modifications to the interventions will be tested (each informed by the feasibility and acceptability findings of the prior period) with the aim of sequentially improving it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •For all participants, age ≥ 18 years old.
- •For intervention trial and patient feasibility and acceptability measurement: Patients with first-episode psychosis, enrolled in Coordinated Specialty Care at the Psychosis Education, Assessment, Care and Empowerment (PEACE) clinic and Psychosis Evaluation and Recovery Center (PERC).
- •For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
- •For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: Clinicians in Connection LHS who work at sites other than PEACE and PERC.Participants must sign the informed consent form
排除标准
- •For intervention trial and patient feasibility and acceptability measurement: Expectation of leaving coordinated specialty care programing within 6 months (which will exclude all of the PI's patient panel) and/or intellectual disability of sufficient degree that the patient's primary psychiatrist expects to compromise capacity to consent to this research and/or psychosis secondary to another medical condition (which may not share the same motivational features that are otherwise understood about the primary psychiatric conditions with psychosis).
- •For clinician feasibility and acceptability measurement at intervention sites: Study investigators who work at these clinics will be excluded from participation in the feasibility and acceptability study component given their role in the trial planning and execution.
- •For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.
结局指标
主要结局
Acceptability of intervention measure (AIM)
时间窗: Change at 4 months
The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.
Feasibility of intervention measure (FIM)
时间窗: Change at 4 months
The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.
Acceptability of intervention measure (AIM)
时间窗: Change at 8 months
The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.
Acceptability of intervention measure (AIM)
时间窗: Change at 6 months
The AIM is a 4-item scale measuring acceptability. Each item is scored 1-5 with 5 indicating greater acceptability. Minimum score is 4; maximum is 20.
Feasibility of intervention measure (FIM)
时间窗: Change at 8 months
The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.
Feasibility of intervention measure (FIM)
时间窗: Change at 6 months
The FIM is a 4-item scale measuring feasibility. Each item is scored 1-5 with 5 indicating greater feasibility. Minimum score is 4; maximum is 20.
次要结局
- Implementation Survey Response(Change at 4 months)
- Motivation Survey Response(Change at 4 months)
- Ethical Concern Survey Response(Change at 4 months)
- Implementation Survey Response(Change at 8 months)
- Implementation Survey Response(Change at 6 months)
- Motivation Survey Response(Change at 8 months)
- Motivation Survey Response(Change at 6 months)
- Ethical Concern Survey Response(Change at 8 months)
- Ethical Concern Survey Response(Change at 6 months)
研究者
William Smith
Principal Investigator
University of Pennsylvania