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Trial to Increase FEP Attendance

Primary Purpose

First-Episode Psychosis

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Financial Incentive and Text-Messages
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for First-Episode Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Implementation Survey Response
    Implementation survey. Results will be used to optimize intervention from implementation perspective.
    Implementation Survey Response
    Implementation survey. Results will be used to optimize intervention from implementation perspective.
    Implementation Survey Response
    Implementation survey. Results will be used to optimize intervention from implementation perspective.
    Motivation Survey Response
    Motivation survey. Results will be used to optimize intervention from motivation perspective.
    Motivation Survey Response
    Motivation survey. Results will be used to optimize intervention from motivation perspective.
    Motivation Survey Response
    Motivation survey. Results will be used to optimize intervention from motivation perspective.
    Ethical Concern Survey Response
    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
    Ethical Concern Survey Response
    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
    Ethical Concern Survey Response
    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.

    Full Information

    First Posted
    June 20, 2023
    Last Updated
    October 3, 2023
    Sponsor
    University of Pennsylvania
    Collaborators
    Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05967195
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pennsylvania
    Collaborators
    Penn Innovation in Suicide Prevention for Implementation Research (INSPIRE) Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    First-Episode Psychosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    145 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Financial Incentive and Text-Messages
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Acceptability of intervention measure (AIM)
    Description
    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.
    Time Frame
    Change at 11 months
    Title
    Acceptability of intervention measure (AIM)
    Description
    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.
    Time Frame
    Change at 8 months
    Title
    Acceptability of intervention measure (AIM)
    Description
    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.
    Time Frame
    Change at 5 months
    Title
    Feasibility of intervention measure (FIM)
    Description
    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.
    Time Frame
    Change at 11 months
    Title
    Feasibility of intervention measure (FIM)
    Description
    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.
    Time Frame
    Change at 8 months
    Title
    Feasibility of intervention measure (FIM)
    Description
    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.
    Time Frame
    Change at 5 months
    Secondary Outcome Measure Information:
    Title
    Implementation Survey Response
    Description
    Implementation survey. Results will be used to optimize intervention from implementation perspective.
    Time Frame
    Change at 1 year
    Title
    Implementation Survey Response
    Description
    Implementation survey. Results will be used to optimize intervention from implementation perspective.
    Time Frame
    Change at 9 months
    Title
    Implementation Survey Response
    Description
    Implementation survey. Results will be used to optimize intervention from implementation perspective.
    Time Frame
    Change at 6 months
    Title
    Motivation Survey Response
    Description
    Motivation survey. Results will be used to optimize intervention from motivation perspective.
    Time Frame
    Change at 1 year
    Title
    Motivation Survey Response
    Description
    Motivation survey. Results will be used to optimize intervention from motivation perspective.
    Time Frame
    Change at 9 months
    Title
    Motivation Survey Response
    Description
    Motivation survey. Results will be used to optimize intervention from motivation perspective.
    Time Frame
    Change at 6 months
    Title
    Ethical Concern Survey Response
    Description
    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
    Time Frame
    Change at 1 year
    Title
    Ethical Concern Survey Response
    Description
    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
    Time Frame
    Change at 9 months
    Title
    Ethical Concern Survey Response
    Description
    Ethical concern survey. Results will be used to optimize intervention from ethical acceptability perspective.
    Time Frame
    Change at 6 months
    Other Pre-specified Outcome Measures:
    Title
    attrition
    Description
    rate of attrition
    Time Frame
    Change at 1 year
    Title
    attrition
    Description
    rate of attrition
    Time Frame
    Change at 9 months
    Title
    attrition
    Description
    rate of attrition
    Time Frame
    Change at 6 months
    Title
    psychotic symptomology
    Description
    Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.
    Time Frame
    Change at 1 year
    Title
    psychotic symptomology
    Description
    Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.
    Time Frame
    Change at 9 months
    Title
    psychotic symptomology
    Description
    Compass-10. The Compass-10 is a self-report scale that measures multiple symptoms associated with psychosis, including mood symptoms. It consists of 10-items, each scored 0-6 with a minimum score of 0 and a maximum of 60. A higher score indicates greater symptomology.
    Time Frame
    Change at 6 months
    Title
    psychotic symptomology
    Description
    modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.
    Time Frame
    Change at 11 months
    Title
    psychotic symptomology
    Description
    modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.
    Time Frame
    Change at 8 months
    Title
    psychotic symptomology
    Description
    modified-Colorado Symptom Index. The modified-Colorado Symptom Index is a 14-item, clinician-rated scale with items ranked 0-4. Total minimum score = 0. Total maximum score = 56. A higher score indicates greater symptomology.
    Time Frame
    Change at 6 months
    Title
    depression
    Description
    abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)
    Time Frame
    Change at 1 year
    Title
    depression
    Description
    abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)
    Time Frame
    Change at 9 months
    Title
    depression
    Description
    abbreviated version of the Beck Depression Inventory-II (BDI-II) that has been previously validated (scale, min=0, max=21, higher mean score indicates more severe depressive symptomology)
    Time Frame
    Change at 6 months
    Title
    quality of life
    Description
    4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
    Time Frame
    Change at 11 months
    Title
    quality of life
    Description
    4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
    Time Frame
    Change at 8 months
    Title
    quality of life
    Description
    4-item version of the Lehman Quality of Life Scale (min = 4, max =28, higher score is improved quality of life)
    Time Frame
    Change at 5 months
    Title
    recovery
    Description
    5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
    Time Frame
    Change at 11 months
    Title
    recovery
    Description
    5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
    Time Frame
    Change at 8 months
    Title
    recovery
    Description
    5-item version of the Questionnaire about the Process of Recovery (scale, min=5, max=25, higher mean indicates more perceived recovery)
    Time Frame
    Change at 5 months
    Title
    treatment motivation (intrinsic versus extrinsic)
    Description
    Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.
    Time Frame
    Change at 11 months
    Title
    treatment motivation (intrinsic versus extrinsic)
    Description
    Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.
    Time Frame
    Change at 8 months
    Title
    treatment motivation (intrinsic versus extrinsic)
    Description
    Treatment Motivation Questionnaire-Revised (TMQ-R). The Treatment Motivation Questionnaire-Revised is a 25-item self-assessment survey that assesses several elements of treatment motivation, each ranked 1-5. It is not a single scale that results in an overall score. Some items suggest greatest motivation at a 5 and least at a 1, but others suggest greatest motivation at a 1 and least at a 5.
    Time Frame
    Change at 5 months
    Title
    Perceived coercion
    Description
    Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.
    Time Frame
    Change at 11 months
    Title
    Perceived coercion
    Description
    Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.
    Time Frame
    Change at 8 months
    Title
    Perceived coercion
    Description
    Modified version of the MacArthur Admission Experience Survey (AES). The MacArthur AES was developed as a self-assessment for assessing coercion and pressure during inpatient admission. It was previously modified for assisted outpatient treatment. We have modified it further to a 13-item scale for outpatient treatment generally. Each item is assessed as true or false, where true suggests great perception of pressure or coercion on some items, but less on others.
    Time Frame
    Change at 5 months
    Title
    attendance rate
    Description
    number of appointments attended in a given period divided by number of appointments scheduled
    Time Frame
    Change over 1 year
    Title
    attendance rate
    Description
    number of appointments attended in a given period divided by number of appointments scheduled
    Time Frame
    Change at 9 months
    Title
    attendance rate
    Description
    number of appointments attended in a given period divided by number of appointments scheduled
    Time Frame
    Change at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Willam R Smith, MD, PhD
    Phone
    215-898-7366
    Email
    wrsmith5@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Trial to Increase FEP Attendance

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