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 : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder||Behavioral: Patient Decision Aid||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||72 participants|
|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)|
|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|
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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394261
|United States, California|
|Tarzana Treatment Centers, Inc.|
|Tarzana, California, United States, 91356|
|Principal Investigator:||Yih-Ing Hser, Ph.D.||University of California, Los Angeles|
|Principal Investigator:||Larissa Mooney, M.D.||University of California, Los Angeles|