Patient Decision Aid for Opioid Use Disorder (PtDA-MAT)

• ClinicalTrials.gov Identifier: NCT03568552
• Recruitment Status: Recruiting
• First Posted: June 26, 2018
• Last Update Posted: November 16, 2021
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Yih-Ing Hser, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use Disorder	Behavioral: Patient Decision Aid	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 5400 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
• Actual Study Start Date: August 3, 2020
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: August 2022

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. Opioid Use at 3 months [ Time Frame: 3 months ]
   Self-reported days of opioid use in past 4 weeks
3. Opioid Use at 6 months [ Time Frame: 6 months ]
   Self-reported days of opioid use in past 4 weeks

Secondary Outcome Measures :

1. 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)
2. Treatment Adherence [ Time Frame: 24 months ]
   Treatment Adherence defined as proportion of clinic visits attended
3. Mortality [ Time Frame: 24 months ]
   National Death Index maintained by the national Centers for Disease Control and Prevention.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Sarah Cousins, M.P.H.; 310-983-3604; scousins@mednet.ucla.edu

Locations

United States, California

UCLA Integrated Substance Abuse Programs; Recruiting

Los Angeles, California, United States, 90049

Contact: Sarah Cousins, MPH 310-983-3604 SCousins@mednet.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: Yih-Ing Hser, Ph.D.; University of California, Los Angeles
• Principal Investigator: Larissa Mooney, M.D.; University of California, Los Angeles

More Information

• Responsible Party: Yih-Ing Hser, Professor-in-Residence, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03568552
• Other Study ID Numbers: OPIOD1.1
• First Posted: June 26, 2018
• Last Update Posted: November 16, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yih-Ing Hser, University of California, Los Angeles:

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

Additional relevant MeSH terms:

Disease; Opioid-Related Disorders; Substance-Related Disorders; Pathologic Processes; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders