Pilot Test of Patient Decision Aid for Opioid Use Disorder

NCT03394261 | Completed DMC

• 1 other identifier: OPIOD1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (2)

• Drug screening results

  3 month

• Treatment Adherence

  3 month

Study Arms (2)

Patient Decision Aid

EXPERIMENTAL

Patients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.

Behavioral: Patient Decision Aid

Record-only control group

NO INTERVENTION

Treatment records of patients receiving treatment in the same clinic in the prior 3 months will be abstracted for comparison purposes.

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)

Tarzana Treatment Centers, Inc.

Tarzana, California, 91356, United States

Location

Related Publications (1)

• 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.

  PMID: 31668516 DERIVED

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: June 14, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

US (1)