Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail (SAIA-MOUD)

May 15, 2026 updated by: Sarah Odell Gimbel-Sherr, University of Washington

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

4186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sarah Odell Gimbel-Sherr
  • Phone Number: 206 291 4223
  • Email: sgimbel@uw.edu

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington
        • Contact:
          • Sarah Gimbel, PhD, MPH, BSN
          • Phone Number: 206 291 4223
          • Email: sgimbel@uw.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAIA MOUD clinics in Jail Health Services
MOUD clinics within Jail Health Services implementing the Systems Analysis and Improvement Approach (SAIA)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in MOUD Care after Initial Linkage
Time Frame: 30 days
the proportion of individuals who return for a second MOUD clinical visit within 30 days of initial linkage post jail release
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Sarah Odell Gimbel-Sherr, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00018542
  • R01NR021102 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The county level data is being sourced from the integrated data hub run by two county level agencies in King County. As a PI, I have requested access but it is not in my rights to give IPD to others, rather it is the right of those who manage the dataset.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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