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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Decision Aid | Experimental | 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. |
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| Prior to intervention | No Intervention | All participating clinics will start with a baseline period without the intervention. The clinics and their patients will remain in the no intervention condition until randomly selected to crossover to receive the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Decision Aid | Behavioral | PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Retention | 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 | 24 months |
| Opioid Use at 3 months | Self-reported days of opioid use in past 4 weeks | 3 months |
| Opioid Use at 6 months | Self-reported days of opioid use in past 4 weeks | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Substance Use | 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) | 24 months |
| Treatment Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yih-Ing Hser, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Larissa Mooney, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Integrated Substance Abuse Programs | Los Angeles | California | 90049 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 20, 2026 | |
| Reset | Apr 8, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 20, 2026 | Apr 8, 2026 | |||
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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The Patient Decision Aid for Medication Assisted Therapy (PtDA-MAT) will be tested by patients and clinicians during actual visits with OUD patients to assess its acceptability and effectiveness. We will track patients receiving PtDAT-MAT using their clinical and administration data over a 24-month period to assess outcomes associated with PtDAT-MAT. Participating clinics will be randomly selected in sequence to implement the intervention.
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Treatment Adherence defined as proportion of clinic visits attended
| 24 months |
| Mortality | National Death Index maintained by the national Centers for Disease Control and Prevention. | 24 months |