Clinical trial NCT06583239: Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
Official title: Developing and Evaluating a Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disengagement
Keywords: first episode psychosis
Coordinated Specialty Care
treatment disengagement
mental health services
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 555
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This project will develop a hub-based engagement navigator service for participants and families at high risk for disengagement. The investigators 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. The central hypothesis is that, once developed, ENS will support more months in treatment and lower disengagement rates than usual care (UC). The long-term goal is to co-produce a hub-based navigator service to reduce disengagement. The investigators will attain these 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, the investigators 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. The investigators will track rates of and reasons for referral, length of time for navigators to contact and engage participants, and track needs that navigators address. The investigators 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.

Eligibility criteria: Inclusion Criteria:

* Patients receiving services at Coordinated Specialty Care programs for the treatment of early episode psychosis
* Age 13-35

Exclusion Criteria:

* Do not meet inclusion criteria

Primary outcomes:
measure: Rate of discharge
timeFrame: From enrollment to end of treatment at 2 years
measure: Time in treatment
timeFrame: From enrollment to end of treatment at 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
Study officials:
References: