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

NCT06593353 | Recruiting

• 2 other identifiers: STUDY00018542R01NR021102
• Study Type: interventional
• Target: 4,165
• Locations: 1 country
• Sites: 1

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. 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. 2.explore determinants of adoption, implementation, and sustainment of SAIA-MOUD across implementation clinics, and
3. 3.estimate the cost and cost-effectiveness of SAIA-MOUD

Conditions

Opioid Use Disorder; Opioid Use Disorders

Keywords

Systems Analysis and Improvement Approach (SAIA); Systems Engineering; Medications for Opioid Use Disorder; Continuous Quality Improvement (CQI); Jail; Buprenorphine; implementation science

Outcome Measures

Primary Outcomes (1)

• Linkage to MOUD Care Upon Release from Jail

  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 Outcomes (1)

• Retention in MOUD Care after Initial Linkage

  30 days

Study Arms (1)

SAIA MOUD clinics in Jail Health Services

EXPERIMENTAL

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

Other: Systems Analysis and Improvement Approach (SAIA)

Interventions

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.

SAIA MOUD clinics in Jail Health Services

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Group 1 \& 2:
• do not consent
• Group 3:
• not on Medicaid

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39696305 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sarah Odell Gimbel-Sherr

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Odell Gimbel-Sherr

CONTACT

206 291 4223; sgimbel@uw.edu

Emily Callen

CONTACT

5182572197; ejcallen@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Child, Family, and Population Health Nursing

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)