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

• ClinicalTrials.gov Identifier: NCT03394261
• Recruitment Status: Completed
• First Posted: January 9, 2018
• Last Update Posted: November 16, 2020
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): University of California, Los Angeles

Tracking Information

• First Submitted Date: January 3, 2018
• First Posted Date: January 9, 2018
• Last Update Posted Date: November 16, 2020
• Actual Study Start Date: June 14, 2018
• Actual Primary Completion Date: December 21, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 8, 2018)

Treatment Retention [ Time Frame: 3 months ]

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

Original Primary Outcome Measures (submitted: January 3, 2018)

Treatment Retention [ Time Frame: 3 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

Current Secondary Outcome Measures (submitted: January 8, 2018)

• Drug screening results [ Time Frame: 3 month ]
  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 [ Time Frame: 3 month ]
  Treatment Adherence defined as proportion of clinic visits attended

Original Secondary Outcome Measures (submitted: January 3, 2018)

• Drug screening results [ Time Frame: 3 month ]
  Primarily opioid-negative UDS (as collected by clinics as part of routine care) and other substance use per self-report and UDS (e.g., cannabis, benzodiazepines, cocaine, amphetamines)
• Treatment Adherence [ Time Frame: 3 month ]
  Treatment Adherence defined as proportion of clinic visits attended

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Test of Patient Decision Aid for Opioid Use Disorder
• Official Title: Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment

• Condition: Opioid Use Disorder

Intervention

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.

Study Arms

• Experimental: Patient Decision Aid
  Patients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.
  Intervention: Behavioral: Patient Decision Aid
• No Intervention: Record-only control group
  Treatment records of patients receiving treatment in the same clinic in the prior 3 months will be abstracted for comparison purposes.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2019): 72
• Original Estimated Enrollment (submitted: January 3, 2018): 60
• Actual Study Completion Date: December 21, 2018
• Actual Primary Completion Date: December 21, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03394261
• Other Study ID Numbers: OPIOD1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University of California, Los Angeles
• Original Responsible Party: Yih-Ing Hser, University of California, Los Angeles, Professor-in-Residence
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of California, Los Angeles
• Verification Date: November 2020