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

NCT ID: NCT06593353

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder Opioid Use Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

The SAIA (an evidence-based implementation strategy) will be implemented monthly at clinics providing MOUD care. The investigators will apply SAIA at the clinics in Jail Health Services in King County, WA. Those patients who exit jail to the community on MOUD will be tracked to see if they link to any MOUD care services within 30 days. The primary outcome is linkage to MOUD care upon release at any MOUD provider in King County. The secondary outcome assesses whether the patient comes back after initially linking post jail release. SAIA will be implemented in 3 low barrier clinics and the rate of return (sustainment in care -- measured as second visit within 30 days of the first linkage visit will be compared between the three community based MOUD clinics implementing SAIA and all other community-based MOUD clinics.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SAIA MOUD clinics in Jail Health Services

MOUD clinics within Jail Health Services implementing the Systems Analysis and Improvement Approach (SAIA)

Group Type EXPERIMENTAL

Systems Analysis and Improvement Approach (SAIA)

Intervention Type OTHER

SAIA an evidence-based, multi-prong, implementation strategy to improve systems thinking amongst frontline care teams to optimize care quality and continuity. The intervention includes monthly meetings where patient care cascades, process mapping and continuous quality improvement are used to identify bottlenecks and prioritize clinic based solutions.

Interventions

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Systems Analysis and Improvement Approach (SAIA)

SAIA an evidence-based, multi-prong, implementation strategy to improve systems thinking amongst frontline care teams to optimize care quality and continuity. The intervention includes monthly meetings where patient care cascades, process mapping and continuous quality improvement are used to identify bottlenecks and prioritize clinic based solutions.

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

Group 1 \& 2:

* do not consent

Group 3:

* not on Medicaid
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Sarah Odell Gimbel-Sherr

Professor, Child, Family, and Population Health Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Odell Gimbel-Sherr

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Odell Gimbel-Sherr

Role: CONTACT

206 291 4223

Emily Callen

Role: CONTACT

5182572197

Facility Contacts

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Sarah Gimbel, PhD, MPH, BSN

Role: primary

206 291 4223

Emily Callen

Role: backup

References

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Gimbel S, Basu A, Callen E, Flaxman AD, Heidari O, Hood JE, Kellogg A, Kern E, Tsui JI, Turley E, Sherr K. Systems analysis and improvement to optimize opioid use disorder care quality and continuity for patients exiting jail (SAIA-MOUD). Implement Sci. 2024 Dec 18;19(1):80. doi: 10.1186/s13012-024-01409-0.

Reference Type DERIVED
PMID: 39696305 (View on PubMed)

Other Identifiers

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R01NR021102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00018542

Identifier Type: -

Identifier Source: org_study_id

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