Opioid Use Disorder
Conditions
Keywords
Opioid Use Disorder (OUD), Medication Assisted Therapy (MAT), Patient Decision Aid, Medication Treatment for Opioid Use Disorder (MOUD)
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.
Interventions
BEHAVIORALPatient Decision Aid
PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 3 months | 3 months | Self-reported days of opioid use in past 4 weeks |
| Opioid Use at 6 months | 6 months | Self-reported days of opioid use in past 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed