Clinical trial NCT03394261: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder (OUD)
Medication Assisted Therapy (MAT)
Patient Decision Aid
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Retention
timeFrame: 3 months
Secondary outcomes:
measure: Drug screening results
timeFrame: 3 month
measure: Treatment Adherence
timeFrame: 3 month
Other outcomes:
Locations:
city: Tarzana
country: United States
facility: Tarzana Treatment Centers, Inc.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Yih-Ing Hser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Larissa Mooney, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.