Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583239
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing and Evaluating a Hub-Based Engagement Navigator Service to Reduce CSC Disengagement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 feasibilityacceptability 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 Networks 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 andor 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 ACs 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 feasibilityacceptability 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
Specific Aim 1 To develop ENS in partnership with the ACs 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 feasibilityacceptability 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None