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Pilot Test of Patient Decision Aid for Opioid Use Disorder

NCT ID: NCT03394261

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2018-12-21

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient Decision Aid

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

Group Type EXPERIMENTAL

Patient Decision Aid

Intervention Type BEHAVIORAL

PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yih-Ing Hser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Larissa Mooney, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Tarzana Treatment Centers, Inc.

Tarzana, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31668516 (View on PubMed)

Other Identifiers

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OPIOD1

Identifier Type: -

Identifier Source: org_study_id