Patient Decision Aid for Opioid Use Disorder
- Conditions
- Opioid Use Disorder
- Interventions
- Behavioral: Patient Decision Aid
- Registration Number
- NCT03568552
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5400
- Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)
- Significant or unstable medical or psychiatric illness that may interfere with study participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Patient Decision Aid Patient Decision Aid Participating clinics (and their patients) will be randomly selected to implement the intervention, at which time their patients will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.
- Primary Outcome Measures
Name Time Method Treatment Retention 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 6 months Self-reported days of opioid use in past 4 weeks
Opioid Use at 3 months 3 months Self-reported days of opioid use in past 4 weeks
- Secondary Outcome Measures
Name Time Method Substance Use 24 months Opioid-negative urine drug screen results (as collected by clinics as part of routine care) and other substance use per self-report (e.g., cannabis, benzodiazepines, cocaine, amphetamines)
Treatment Adherence 24 months Treatment Adherence defined as proportion of clinic visits attended
Mortality 24 months National Death Index maintained by the national Centers for Disease Control and Prevention.
Trial Locations
- Locations (1)
UCLA Integrated Substance Abuse Programs
🇺🇸Los Angeles, California, United States