Clinical trial NCT05967195: Trial to Increase FEP Attendance
Official title: Financial Incentives to Increase Treatment Attendance in First-Episode Psychosis Care: A Non-Randomized, Adaptive Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: First-Episode Psychosis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center
First posted: 2023-08-01
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. For all participants, age ≥ 18 years old.
2. 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).
3. For clinician feasibility and acceptability measurement at intervention sites: Clinicians working at PEACE and PERC where the intervention will be piloted.
4. 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:

1. 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).
2. 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.
3. For clinician implementation facilitator and barrier assessment at other Connection LHS sites to assess for scalability: none.

Primary outcomes:
measure: Acceptability of intervention measure (AIM)
timeFrame: Change at 8 months
measure: Acceptability of intervention measure (AIM)
timeFrame: Change at 6 months
measure: Acceptability of intervention measure (AIM)
timeFrame: Change at 4 months
measure: Feasibility of intervention measure (FIM)
timeFrame: Change at 8 months
measure: Feasibility of intervention measure (FIM)
timeFrame: Change at 6 months
measure: Feasibility of intervention measure (FIM)
timeFrame: Change at 4 months
Secondary outcomes:
measure: Implementation Survey Response
timeFrame: Change at 8 months
measure: Implementation Survey Response
timeFrame: Change at 6 months
measure: Implementation Survey Response
timeFrame: Change at 4 months
measure: Motivation Survey Response
timeFrame: Change at 8 months
measure: Motivation Survey Response
timeFrame: Change at 6 months
measure: Motivation Survey Response
timeFrame: Change at 4 months
measure: Ethical Concern Survey Response
timeFrame: Change at 8 months
measure: Ethical Concern Survey Response
timeFrame: Change at 6 months
measure: Ethical Concern Survey Response
timeFrame: Change at 4 months
Other outcomes:
measure: attrition
timeFrame: Change at 8 months
measure: attrition
timeFrame: Change at 6 months
measure: attrition
timeFrame: Change at 4 months
measure: psychotic symptomology
timeFrame: Change at 8 months
measure: psychotic symptomology
timeFrame: Change at 6 months
measure: psychotic symptomology
timeFrame: Change at 4 months
measure: psychotic symptomology
timeFrame: Change at 8 months
measure: psychotic symptomology
timeFrame: Change at 6 months
measure: psychotic symptomology
timeFrame: Change at 4 months
measure: depression
timeFrame: Change at 8 months
measure: depression
timeFrame: Change at 6 months
measure: depression
timeFrame: Change at 4 months
measure: quality of life
timeFrame: Change at 8 months
measure: quality of life
timeFrame: Change at 6 months
measure: quality of life
timeFrame: Change at 4 months
measure: recovery
timeFrame: Change at 8 months
measure: recovery
timeFrame: Change at 6 months
measure: recovery
timeFrame: Change at 4 months
measure: treatment motivation (intrinsic versus extrinsic)
timeFrame: Change at 8 months
measure: treatment motivation (intrinsic versus extrinsic)
timeFrame: Change at 6 months
measure: treatment motivation (intrinsic versus extrinsic)
timeFrame: Change at 4 months
measure: Perceived coercion
timeFrame: Change at 8 months
measure: Perceived coercion
timeFrame: Change at 6 months
measure: Perceived coercion
timeFrame: Change at 4 months
measure: attendance rate
timeFrame: Change over 8 months
measure: attendance rate
timeFrame: Change at 6 months
measure: attendance rate
timeFrame: Change at 4 months
Locations:
city: Raleigh
country: United States
facility: University of North Carolina at Chapel Hill (ENCOMPASS Program)
state: North Carolina
city: Philadelphia
country: United States
facility: PEACE Program, Horizon House, Inc.
state: Pennsylvania
city: Philadephia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: