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

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Decision Aid
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Opioid Use Disorder (OUD), Medication Assisted Therapy (MAT), Patient Decision Aid, Medication Treatment for Opioid Use Disorder (MOUD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Integrated Substance Abuse ProgramsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Decision Aid

Prior to intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Treatment Adherence
Treatment Adherence defined as proportion of clinic visits attended
Mortality
National Death Index maintained by the national Centers for Disease Control and Prevention.

Full Information

First Posted
June 3, 2018
Last Updated
May 9, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03568552
Brief Title
Patient Decision Aid for Opioid Use Disorder
Acronym
PtDA-MAT
Official Title
Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
Opioid Use Disorder (OUD), Medication Assisted Therapy (MAT), Patient Decision Aid, Medication Treatment for Opioid Use Disorder (MOUD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
5400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Decision Aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Prior to intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Decision Aid
Intervention Description
PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options.
Primary Outcome Measure Information:
Title
Treatment Retention
Description
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
Time Frame
24 months
Title
Opioid Use at 3 months
Description
Self-reported days of opioid use in past 4 weeks
Time Frame
3 months
Title
Opioid Use at 6 months
Description
Self-reported days of opioid use in past 4 weeks
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Substance Use
Description
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)
Time Frame
24 months
Title
Treatment Adherence
Description
Treatment Adherence defined as proportion of clinic visits attended
Time Frame
24 months
Title
Mortality
Description
National Death Index maintained by the national Centers for Disease Control and Prevention.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Cousins, M.P.H.
Phone
310-983-3604
Email
scousins@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yih-Ing Hser, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larissa Mooney, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Programs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cousins, MPH
Phone
310-983-3604
Email
SCousins@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Patient Decision Aid for Opioid Use Disorder

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