Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
Developing and Evaluating a Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
Study Overview
Status
Conditions
Detailed Description
Coordinated Specialty Care (CSC) disengagement is alarmingly common and compromises the vision of CSC to support recovery in first episode psychosis (FEP; see Overall Section). The Early Psychosis Intervention Network's (EPINET) hub-based structure offers an opportunity to circumvent program-level implementation barriers by developing and implementing systems-level strategies to address disengagement. One strategy employs a centralized service, staffed by dedicated professionals working across a hub, to (1) receive and organize referrals, (2) complete ongoing specialized training in engagement science and evidence-based strategies, (3) provide unbiased support when participants' and/or families' relationships with a CSC program are poor, (4) re-engage participants in CSC or actively connect them with other services if preferred, and (5) continue contact with those who refuse treatment in case they reconsider. Currently, no hub-based strategy exists to address disengagement. The primary objective of this project is to use participatory research methods within a learning health system research framework to develop and evaluate a hub-based Engagement Navigator Service (ENS) to prevent CSC disengagement. Our central hypothesis is that, once developed, ENS will support more months in treatment and lower disengagement rates than usual care (UC). Our long-term goal is to co-produce a hub-based navigator service to reduce disengagement. We will attain our objectives via the following specific aims:
Specific Aim 1. To develop ENS in partnership with the AC's Lived Experience and Family Member Collectives and CSC Program Implementation Subunit. Using participatory research, we will specify ENS structure, training, and procedures for referrals. This aim will create the tools and resources needed to implement ENS at the hub-level.
Specific Aim 2. To conduct mixed methods feasibility/acceptability testing in three CSC programs. We will track rates of and reasons for referral, length of time for navigators to contact and engage participants, and track needs that navigators address. We will collect participant input via qualitative interviews. In this aim, feasibility and acceptability data and intervention experiences will be used to refine ENS.
Specific Aim 3. To conduct a mixed methods evaluation of ENS offered hub wide. Specific Aim 3a. In a hybrid type I, stepped wedge cluster randomized controlled trial, determine if access to ENS decreases disengagement compared to UC and improves target mechanisms. H1: Time in treatment for CSC participants with ENS access will be significantly longer than in UC. H2: Rate of disengagement for CSC participants with ENS access will be significantly lower than in UC. H3: Measures of autonomy, competence, and relatedness will be significantly higher for CSC participants with ENS access compared to UC. H4 (Exploratory): Autonomy, competence, and relatedness scores will mediate the treatment effect. Specific Aim 3b. Using a multi-stakeholder mixed methods process evaluation, examine feasibility, fidelity, and acceptability of ENS and identify implementation barriers and facilitators. This aim will evaluate ENS and detail experiences offering it across CLHS. This will prepare us to conduct a larger trial in the future.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brian Brandler
- Email: bbrandler@som.umaryland.edu
Study Contact Backup
- Name: Melanie Bennett
- Phone Number: 4107060892
- Email: mbennett@som.umaryland.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient receiving services at an early episode psychosis treatment programs
- Age 13-35
Exclusion Criteria:
- Do not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of discharge
Time Frame: From enrollment to end of treatment at 2 years
|
We will compare rate of disengagement for CSC participants with ENS access to those in usual care who do not have ENS access.
|
From enrollment to end of treatment at 2 years
|
|
Time in treatment
Time Frame: From enrollment to end of treatment at 2 years
|
We will compare time in treatment for participants with ENS access to that of participants in usual care who do not have ENS access.
|
From enrollment to end of treatment at 2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1P01MH139228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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