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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Behavioral: Patient Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT03568552

OPIOD1.1

Details and patient eligibility

About

The aim of the study is to test the effectiveness of the Patient Decision Aid for Opioid Use Disorder (PtDA-MAT) by conducting a stepped-wedge cluster-randomized trial in CA H&SS (stratified by rural vs. non-rural areas) for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over approximately 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

Full 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 3 year project will assess the effectiveness of the PtDA-MAT in a stepped-wedge cluster-randomized trial in CA H&SS (stratified by rural vs. non-rural areas) for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over an average of 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

Enrollment: 7,554 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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7,554 participants in 2 patient groups

Patient Decision Aid

Experimental group

Description:

Participating clinics (and their patients) will be randomly selected to implement the intervention, at which time their patients will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder.

Treatment:

Behavioral: Patient Decision Aid

Prior to intervention

No Intervention group

Description:

All participating clinics will start with a baseline period without the intervention. The clinics and their patients will remain in the no intervention condition until randomly selected to crossover to receive the intervention.