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

Not Applicable

• Conditions: Opioid Use Disorder; Opioid Use Disorders
• Interventions: Other: Systems Analysis and Improvement Approach (SAIA)

• Registration Number: NCT06593353
• Lead Sponsor: University of Washington

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Study Start: 2024-11-15
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-26
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Implementation Outcomes (consented)

Group 1:

• clinic staff/providers at study clinics (JHS, OBOT, Pathways, Sound)
• age 18+

Group 2:

• current patients at SAIA clinic in the community (OBOT, Pathways, Sound) with jail involvement in the last 12 months
• age 18+

Clinical Outcomes (de-identified data, non consented)

Group 3:

• receive MOUD treatment while incarcerated in King County Jails (WA).
• age 18+
• on Medicaid
• released to community

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Exclusion Criteria

Group 1 & 2:

• do not consent

Group 3:

• not on Medicaid

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAIA MOUD clinics	Systems Analysis and Improvement Approach (SAIA)	MOUD clinics implementing the Systems Analysis and Improvement Approach (SAIA)

Primary Outcome Measures

Name	Time	Method
Linkage to MOUD Care Upon Release from Jail	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 Outcome Measures

Name	Time	Method
Retention in MOUD Care after Initial Linkage	30 days	the proportion of individuals who return for a second MOUD clinical visit within 30 days of initial linkage post jail release

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States