Patient Decision Aid for Opioid Use Disorder

Overview

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.

Full Title of Study: “Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2021

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

  • Behavioral: Patient 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: Prior to 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 3 months
    • Time Frame: 3 months
    • Self-reported days of opioid use in past 4 weeks
  • Opioid Use at 6 months
    • Time Frame: 6 months
    • Self-reported days of opioid use in past 4 weeks

Secondary Measures

  • Substance Use
    • Time Frame: 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
    • Time Frame: 24 months
    • Treatment Adherence defined as proportion of clinic visits attended
  • Mortality
    • Time Frame: 24 months
    • National Death Index maintained by the national Centers for Disease Control and Prevention.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, Los Angeles
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yih-Ing Hser, Professor-in-Residence – University of California, Los Angeles
  • Overall Official(s)
    • Yih-Ing Hser, Ph.D., Principal Investigator, University of California, Los Angeles
    • Larissa Mooney, M.D., Principal Investigator, University of California, Los Angeles
  • Overall Contact(s)
    • Jonathan E Valdez, B.A., 3109833604, jvaldez20@g.ucla.edu

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