Hub-Based Engagement Navigator Service to Reduce CSC Disengagement

Not Applicable

Not yet recruiting

• Conditions: Disengagement
• Interventions: Other: Engagement Navigator Service (ENS)

• Registration Number: NCT06583239
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

This project will develop a hub-based engagement navigator service for participants and families at high risk for disengagement. We will use robust Participatory Research methods to ensure integration of Coordinated Specialty Care (CSC) program staff, participants, and family members in developing all aspects of and materials for the service, conduct feasibility/acceptability testing in three CSC programs, and use this information to guide refinements. This will be followed by a mixed methods hub wide evaluation using a hybrid type I open cohort stepped wedge design to examine feasibility, acceptability, and effectiveness to improve disengagement outcomes and address target mechanisms.

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 Timeline

• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-01
• Study First Posted: 2024-09-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Study Start: 2025-09-10
• Primary Completion: 2029-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

• Patient receiving services at an early episode psychosis treatment programs
• Age 13-35

Exclusion Criteria

• Do not meet inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Engagement Navigator Service (ENS)	Engagement Navigator Service (ENS)	ENS will be a centralized service, staffed by dedicated professional 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.

Primary Outcome Measures

Name	Time	Method
Rate of discharge	From enrollment to end of treatment at 2 years	The investigators will compare rate of disengagement for CSC participants with ENS access to those in usual care who do not have ENS access.
Time in treatment	From enrollment to end of treatment at 2 years	The investigators will compare time in treatment for participants with ENS access to that of participants in usual care who do not have ENS access.

Trial Locations

Locations (1)

University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States