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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394261
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yih-Ing Hser, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Behavioral: Patient Decision Aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
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
Official Title: Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
Actual Study Start Date : June 14, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

Arm Intervention/treatment
Experimental: Patient Decision Aid
Patients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.
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.

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Treatment Adherence [ Time Frame: 3 month ]
    Treatment Adherence defined as proportion of clinic visits attended



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394261


Locations
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United States, California
Tarzana Treatment Centers, Inc.
Tarzana, California, United States, 91356
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Yih-Ing Hser, Ph.D. University of California, Los Angeles
Principal Investigator: Larissa Mooney, M.D. University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yih-Ing Hser, Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03394261    
Other Study ID Numbers: OPIOD1
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yih-Ing Hser, University of California, Los Angeles:
Opioid Use Disorder (OUD)
Medication Assisted Therapy (MAT)
Patient Decision Aid
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders