Pilot Test of Patient Decision Aid for Opioid Use Disorder (PtDA-MAT)
Primary Purpose
Opioid Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Decision Aid
Sponsored by
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
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
Sites / Locations
- Tarzana Treatment Centers, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient Decision Aid
Record-only control group
Arm Description
Patients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.
Treatment records of patients receiving treatment in the same clinic in the prior 3 months will be abstracted for comparison purposes.
Outcomes
Primary Outcome Measures
Treatment Retention
Treatment retention will be defined as number of days from initial treatment admission to either MAT discontinuation or most recent clinic visit followed by 2 months gap in treatment
Secondary Outcome Measures
Drug screening results
Primarily opioid-negative urine testing (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
Full Information
NCT ID
NCT03394261
First Posted
January 3, 2018
Last Updated
November 12, 2020
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03394261
Brief Title
Pilot Test of Patient Decision Aid for Opioid Use Disorder
Acronym
PtDA-MAT
Official Title
Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.
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 project will conduct 1 year of R21 to develop and pilot-test the PtDA-MAT to facilitate shared decision making in CA H&SS, followed by 3 years of R33 to assess the effectiveness of the PtDA-MAT in a randomized controlled trial.
The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Patient Decision Aid for Medication Assisted Therapy (PtDA-MAT) will be pilot-tested by patients and clinicians during actual visits with OUD patients to assess its acceptability and feasibility. We will track patients receiving PtDAT-MAT using their clinical and administration data over a 3-month period and compare outcomes to those of treatment admissions during the 3 months prior to the pilot testing to assess preliminary outcomes associated with PtDAT-MAT.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Decision Aid
Arm Type
Experimental
Arm Description
Patients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.
Arm Title
Record-only control group
Arm Type
No Intervention
Arm Description
Treatment records of patients receiving treatment in the same clinic in the prior 3 months will be abstracted for comparison purposes.
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 number of days from initial treatment admission to either MAT discontinuation or most recent clinic visit followed by 2 months gap in treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Drug screening results
Description
Primarily opioid-negative urine testing (as collected by clinics as part of routine care) and other substance use per self-report (e.g., cannabis, benzodiazepines, cocaine, amphetamines)
Time Frame
3 month
Title
Treatment Adherence
Description
Treatment Adherence defined as proportion of clinic visits attended
Time Frame
3 month
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
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
Tarzana Treatment Centers, Inc.
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31668516
Citation
Mooney LJ, Valdez J, Cousins SJ, Yoo C, Zhu Y, Hser YI. Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. J Subst Abuse Treat. 2020 Jan;108:115-122. doi: 10.1016/j.jsat.2019.08.006. Epub 2019 Oct 24.
Results Reference
derived
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Pilot Test of Patient Decision Aid for Opioid Use Disorder
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