Opioid Use DisorderSAIA-MOUDNCT06593353
Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail
A study testing Systems Analysis and Improvement Approach (SAIA) in people with Opioid Use Disorder and Opioid Use Disorders, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Opioid Use Disorders
- What is being tested?
- Systems Analysis and Improvement Approach (SAIA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,186 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Group 1 \& 2:
- do not consent
- Group 3:
- not on Medicaid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98104
Sarah Gimbel, PhD, MPH, BSN, 206 291 4223, sgimbel@uw.edu
Emily Callen, ejcallen@uw.edu
About this study
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
- study the effectiveness of SAIA on MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics
- explore determinants of adoption, implementation, and sustainment of SAIA-MOUD across implementation clinics, and
- estimate the cost and cost-effectiveness of SAIA-MOUD
Read the 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.
- Conditions
- Opioid Use Disorder, Opioid Use Disorders
- Being tested
- Systems Analysis and Improvement Approach (SAIA)
- Keywords
- Systems Analysis and Improvement Approach (SAIA), Systems Engineering, Medications for Opioid Use Disorder, Continuous Quality Improvement (CQI), Jail, Buprenorphine, implementation science
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| SAIA MOUD clinics in Jail Health Services | Experimental | MOUD clinics within Jail Health Services implementing the Systems Analysis and Improvement Approach (SAIA) Receives: Other: Systems Analysis and Improvement Approach (SAIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
Retention in MOUD Care after Initial Linkage
the proportion of individuals who return for a second MOUD clinical visit within 30 days of initial linkage post jail release
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Nov 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 4,186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Sarah Odell Gimbel-Sherr, University of Washington
- Investigators
- Sarah Odell Gimbel-Sherr, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593353
- Sponsor's protocol ID
- STUDY00018542
- Other IDs
- R01NR021102
- Acronym
- SAIA-MOUD
- Status last verified
- May 2026
- First submitted
- 9 Sep 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39696305
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Analysis and Improvement to Optimize Opioid Use Disorder Care Quality and Continuity for Patients Exiting Jail
- ClinicalTrials.gov ID
- NCT06593353
- Acronym / sponsor ID
- SAIA-MOUD / STUDY00018542
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,186 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- study the effectiveness of SAIA on MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics
- explore determinants of adoption, implementation, and sustainment of SAIA-MOUD across implementation clinics, and
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| SAIA MOUD clinics in Jail Health Services | Experimental | Other: Systems Analysis and Improvement Approach (SAIA)MOUD clinics within Jail Health Services implementing the Systems Analysis and Improvement Approach (SAIA) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Implementation Outcomes (consented)
- clinic staff/providers at study clinics (JHS, OBOT, Pathways, Sound)
- age 18+
- current patients at SAIA clinic in the community (OBOT, Pathways, Sound) with jail involvement in the last 12 months
- age 18+
Key exclusion criteria (4 listed)
- do not consent
- not on Medicaid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | SAIA MOUD clinics in Jail Health Services |
Primary outcome
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
1 secondary outcome
Retention in MOUD Care after Initial Linkage
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 39696305Gimbel 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Odell Gimbel-Sherr principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systems Analysis and Improvement Approach (SAIA) in people with Opioid Use Disorder and Opioid Use Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Odell Gimbel-Sherr (206 291 4223, sgimbel@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to MOUD Care Upon Release from Jail (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06593353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.