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Clinical Trials/NCT03568552
NCT03568552
Completed
N/A

Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder

University of California, Los Angeles1 site in 1 country7,554 target enrollmentAugust 3, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
University of California, Los Angeles
Enrollment
7554
Locations
1
Primary Endpoint
Treatment Retention
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The aim of the study is to test the effectiveness of the Patient Decision Aid for Opioid Use Disorder (PtDA-MAT) by conducting a stepped-wedge cluster-randomized trial in CA H&SS (stratified by rural vs. non-rural areas) for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over approximately 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

Detailed Description

In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDA-MAT) for use in the CA H\&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The 3 year project will assess the effectiveness of the PtDA-MAT in a stepped-wedge cluster-randomized trial in CA H\&SS (stratified by rural vs. non-rural areas) for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over an average of 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

Registry
clinicaltrials.gov
Start Date
August 3, 2020
End Date
August 31, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yih-Ing Hser

Professor-in-Residence

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)

Exclusion Criteria

  • Significant or unstable medical or psychiatric illness that may interfere with study participation

Outcomes

Primary Outcomes

Treatment Retention

Time Frame: 24 months

Treatment retention will be defined as time from initial treatment admission to either MAT discontinuation or most recent clinic visit followed by 2 months gap in treatment

Opioid Use at 6 months

Time Frame: 6 months

Self-reported days of opioid use in past 4 weeks

Opioid Use at 3 months

Time Frame: 3 months

Self-reported days of opioid use in past 4 weeks

Secondary Outcomes

  • Substance Use(24 months)
  • Treatment Adherence(24 months)
  • Mortality(24 months)

Study Sites (1)

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