Clinical trial NCT06593353: Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail
Official title: Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-09-19
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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 \&amp; 2:

* do not consent

Group 3:

* not on Medicaid

Primary outcomes:
measure: Linkage to MOUD Care Upon Release from Jail
timeFrame: 30 days
Secondary outcomes:
measure: Retention in MOUD Care after Initial Linkage
timeFrame: 30 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Sarah Odell Gimbel-Sherr
role: PRINCIPAL_INVESTIGATOR
References: