Trial to Increase FEP Attendance

Study Overview
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Brief Summary
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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.

Official Title
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Financial Incentives to Increase Treatment Attendance in First-Episode Psychosis Care: A Non-Randomized, Adaptive Pilot Study

Conditions
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First-Episode Psychosis

Intervention / Treatment
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* Behavioral: Financial Incentive and Text-Messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Financial Incentive and Text-Messages|Patient-participants will receive modest financial incentive for attending therapy or medication management appointments combined with text messages to encourage attendance at these appointments. Text messages will be informed by principles of behavioral economics. Maximum incentive = $50/month if all appointments attended. Incentives will be pro-rated by percentage of appointments attended. Pro-rating strategies (e.g., uniform amount per appointment, escalating [aka, 'back-loaded'], or decreasing [aka 'frontloaded'] will be sequentially changed based on acceptability and other intervention-related data gathered from participants during the trial. Clinician-participants will not receive any intervention, but will receive surveys and interviews to assess their perceptions about the optimization, acceptability, scalability, and other implementation barriers/facilitators for the intervention.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of intervention measure (AIM) | 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. | Change at 11 months | 
| Acceptability of intervention measure (AIM) | 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. | Change at 8 months | 
| Acceptability of intervention measure (AIM) | 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. | Change at 5 months | 
| Feasibility of intervention measure (FIM) | 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. | Change at 11 months | 
| Feasibility of intervention measure (FIM) | 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. | Change at 8 months | 
| Feasibility of intervention measure (FIM) | 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. | Change at 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation Survey Response | Implementation survey. Results will be used to optimize intervention from implementation perspective. | Change at 1 year | 
| Implementation Survey Response | Implementation survey. Results will be used to optimize intervention from implementation perspective. | Change at 9 months | 
| Implementation Survey Response | Implementation survey. Results will be used to optimize intervention from implementation perspective. | Change at 6 months | 
| Motivation Survey Response | Motivation survey. Results will be used to optimize intervention from motivation perspective. | Change at 1 year | 
| Motivation Survey Response | Motivation survey. Results will be used to optimize intervention from motivation perspective. | Change at 9 months | 
| Motivation Survey Response | Motivation survey. Results will be used to optimize intervention from motivation perspective. | Change at 6 months | 
| Ethical Concern Survey Response | Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective. | Change at 1 year | 
| Ethical Concern Survey Response | Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective. | Change at 9 months | 
| Ethical Concern Survey Response | Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective. | Change at 6 months |