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NCT Number: NCT06593353

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

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

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systems Analysis and Improvement Approach (SAIA)

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.

Primary outcomes

  1. 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

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Callen

CONTACT

[email protected]

5182572197

Sarah Odell Gimbel-Sherr

CONTACT

[email protected]

206 291 4223

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: SAIA-MOUD

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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