Systems Improvement for Opioid Use Disorder

(SAIA-MOUD Trial)

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: MOUD

Disqualifiers: Not on Medicaid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the management of opioid use disorder (OUD) by testing the Systems Analysis and Improvement Approach (SAIA). SAIA employs tools like flow mapping and quality checks to ensure patients transitioning from jail to clinics receive necessary care. The trial will evaluate SAIA's effectiveness in linking individuals from jails to treatment clinics and its cost-effectiveness. Suitable participants include those involved with jails in the past year and currently receiving care at specific community clinics. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for enhancing care transitions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this health systems strategy is safe for managing opioid use disorder?

Research has shown that the Systems Analysis and Improvement Approach (SAIA) uses tools to enhance the management of opioid use disorder care, particularly for patients transitioning from jail to clinics. This method does not involve administering new drugs or treatments directly to individuals, so no side effects have been reported from the approach itself. Instead, it focuses on improving healthcare systems to ensure individuals receive better care and support. Since this is not a drug or direct medical treatment, the usual safety concerns in drug trials do not apply. The method improves how care is provided, making it a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Systems Analysis and Improvement Approach (SAIA) for opioid use disorder because it focuses on improving how treatment systems work, rather than introducing a new medication. While most current treatments for opioid use disorder rely on medications like methadone, buprenorphine, or naltrexone to manage symptoms, SAIA aims to streamline and optimize the delivery of these existing treatments within jail health services. This approach could lead to more efficient and effective care for individuals with opioid use disorder, particularly in challenging environments like jails, by ensuring that the systems in place support the best possible outcomes.

What evidence suggests that the Systems Analysis and Improvement Approach (SAIA) is effective for managing opioid use disorder?

Research has shown that the Systems Analysis and Improvement Approach (SAIA), which participants in this trial will experience in MOUD clinics within Jail Health Services, can enhance the quality and consistency of care for people with opioid use disorder (OUD). In earlier studies, SAIA used tools like cascade analysis and flow mapping to improve care delivery. These tools identify and address issues in the care process, ensuring better connections between jails and clinics. Initial results suggest that SAIA is easy to use and affordable, simplifying adoption and maintenance for clinics. This approach aims to improve treatment outcomes for people with OUD, especially those transitioning from jail to community clinics. ^{1 2 3 4 5}

Who Is on the Research Team?

Sarah Odell Gimbel-Sherr

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are on Medicaid, have been treated for opioid use disorder while in King County Jails (WA), and will be released to the community. They must currently be patients at a SAIA clinic with jail involvement within the last year.

Inclusion Criteria

I have agreed to participate in the study's follow-up procedures.

I am treated by staff at JHS, OBOT, Pathways, or Sound clinics.

I have been involved with the jail system in the past year and am currently a patient at a SAIA clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Implementation

Implementation of the Systems Analysis and Improvement Approach (SAIA) in jail and referral clinics to optimize MOUD care

2 years

Sustainment

Sustainment of SAIA implementation to ensure continued optimization of MOUD care

1 year

Follow-up

Participants are monitored for linkage to MOUD care and retention in care post-release from jail

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Systems Analysis and Improvement Approach (SAIA)

Trial Overview The study tests a health systems strategy called SAIA, which uses tools like cascade analysis and flow mapping to improve opioid addiction care after release from jail. It aims to enhance quality and continuity of care between jails and clinics.

How Is the Trial Designed?

Group I: SAIA MOUD clinics in Jail Health Services Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The HEAL Prevention Cooperative (HPC) is focused on implementing and testing effective interventions to prevent opioid misuse among youth and young adults, addressing the urgent need due to rising overdose rates in the USA.

This study will analyze the implementation experiences of nine research projects to identify best practices and adaptable components of prevention interventions, ultimately creating resources to aid in the effective adoption and implementation of these strategies in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerating Solutions for the Overdose Crisis: an Effectiveness-Implementation Hybrid Protocol for the HEAL Prevention Cooperative. Patel, SV., Cance, JD., Bonar, EE., et al.[2023]

There is a critical need for better dissemination and implementation strategies for evidence-based practices to combat the opioid crisis, as current addiction journals often overlook practical quality improvement projects.

The special issue aims to showcase implementation and quality improvement projects that can provide real-world guidance on translating research into effective practices for treating opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying and advancing best practices in opioid use disorder and addiction treatment: Introduction to the special issue on implementation science and quality improvement scholarship. Gordon, AJ., Oliva, EM.[2019]

The demonstration project involved 30 Change Teams from 12 treatment agencies in Los Angeles County, focusing on rapid-cycle changes to improve substance abuse treatment processes, such as reducing wait times and no-shows.

The project highlighted that a clear methodology, peer interaction, and ongoing technical support are crucial for successfully implementing evidence-based improvements in addiction treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving client engagement and retention in treatment: the Los Angeles County experience. Rutkowski, BA., Gallon, S., Rawson, RA., et al.[2010]

Citations

1. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-024-01409-0

Systems analysis and improvement to optimize opioid use ... Data sources. Multiple routine data sources will be used to measure our effectiveness outcomes, which are routinely integrated into the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39696305/

Systems analysis and improvement to optimize opioid use ... Systems analysis and improvement to optimize opioid use disorder care quality and continuity for patients exiting jail (SAIA-MOUD) · Abstract.

3. d-nb.info d-nb.info/1358245916/34

Systems analysis and improvement to optimize opioid use ... Our study examines whether the introduction of an evidence-based, user-friendly, low-cost package of sys- tems engineering tools can optimize investments in.

4. researchgate.net researchgate.net/publication/387185084_Systems_analysis_and_improvement_to_optimize_opioid_use_disorder_care_quality_and_continuity_for_patients_exiting_jail_SAIA-MOUD

Systems analysis and improvement to optimize opioid use ... Methods We will conduct a quasi-experimental evaluation of SAIA effectiveness on improving MOUD care cascade quality and continuity for patients ...

5. withpower.com withpower.com/trial/phase-opioid-use-disorder-oud-9-2024-d2f44

Systems Improvement for Opioid Use Disorder This study evaluates the effectiveness of a health systems strategy (the Systems Analysis and Improvement Approach - SAIA) that packages systems engineering ...