Patient Decision Aid for Opioid Use Disorder

NCT03568552 | Completed DMC

• 1 other identifier: OPIOD1.1
• Study Type: interventional
• Target: 7,554
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Opioid Use Disorder (OUD); Medication Assisted Therapy (MAT); Patient Decision Aid; Medication Treatment for Opioid Use Disorder (MOUD)

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Substance Use

  24 months

• Treatment Adherence

  24 months

• Mortality

  24 months

Study Arms (2)

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.

Behavioral: Patient Decision Aid

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.

Interventions

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.

Patient Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Integrated Substance Abuse Programs

Los Angeles, California, 90049, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Yih-Ing Hser, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Larissa Mooney, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-in-Residence

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: June 26, 2018
• Study Start: August 3, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)