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Clinical Trials/NCT06593353
NCT06593353
Recruiting
Not Applicable

Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail

University of Washington1 site in 1 country4,165 target enrollmentNovember 21, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
University of Washington
Enrollment
4165
Locations
1
Primary Endpoint
Linkage to MOUD Care Upon Release from Jail
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

This study evaluates the effectiveness of a health systems strategy (the Systems Analysis and Improvement Approach - SAIA) that packages systems engineering tools (including cascade analysis, flow mapping, and continuous quality improvement) to optimize the management of opioid use disorder (MOUD) care cascade and improve linkages between jails and clinical referral sites.

The investigators will

  1. study the effectiveness of SAIA on MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics
  2. explore determinants of adoption, implementation, and sustainment of SAIA-MOUD across implementation clinics, and
  3. estimate the cost and cost-effectiveness of SAIA-MOUD

Detailed Description

SAIA is an evidence-based implementation strategy of bundled systems engineering tools designed to optimize complex healthcare delivery systems and improve linkages between clinical and community providers. The SAIA-MOUD study aims to strengthen the quality and continuity of MOUD care, and linkages to social services, across jail and referral clinics in King County, WA. The investigators will implement the SAIA for three years-including a two-year intensive phase and one year of sustainment-at one jail based MOUD program and three referral MOUD clinics. The investigators will then evaluate the effectiveness of SAIA on improving MOUD cascade quality and continuity for patients receiving care in jail and exiting to referral clinics, determining the effect of SAIA in the jail clinics on linkage to care for community-based MOUD clinics within 30 days of release. A secondary outcome of retention (those who return for a second MOUD pick up within 30 days of initial linkage) will be considered. The investigators will also describe-and explore determinants of-adoption, implementation, and sustainment of SAIA-MOUD via qualitative inquiry with jail and clinic staff. Analysis will be guided by the Consolidated Framework for Implementation Research (CFIR) and the Framework for Reporting Adaptations and Modification to Evidence-based Implementation Strategies (FRAME-IS) will be used to document implementation strategy adaptations. The investigators will estimate the cost and cost-effectiveness of SAIA-MOUD using the cost per quality-adjusted life year gained from the county government, healthcare sector, and societal perspectives. Using a micro-costing approach, the investigators will estimate the incremental costs of implementing and sustaining SAIA in jail and community-based clinics.

Registry
clinicaltrials.gov
Start Date
November 21, 2024
End Date
June 30, 2028
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Odell Gimbel-Sherr

Professor, Child, Family, and Population Health Nursing

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Implementation Outcomes (consented)
  • clinic staff/providers at study clinics (JHS, OBOT, Pathways, Sound)
  • current patients at SAIA clinic in the community (OBOT, Pathways, Sound) with jail involvement in the last 12 months
  • Clinical Outcomes (de-identified data, non consented)
  • receive MOUD treatment while incarcerated in King County Jails (WA).
  • on Medicaid
  • released to community

Exclusion Criteria

  • Group 1 \& 2:
  • do not consent
  • not on Medicaid

Outcomes

Primary Outcomes

Linkage to MOUD Care Upon Release from Jail

Time Frame: 30 days

the proportion of individuals exiting jails in King County on MOUD who link to any MOUD clinical provider in the community within 30 days

Secondary Outcomes

  • Retention in MOUD Care after Initial Linkage(30 days)

Study Sites (1)

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