CClinicalTrials.gg
CompletedNCT03394261PtDA-MATUpdated Nov 16, 2020

Pilot Test of Patient Decision Aid for Opioid Use Disorder

An interventional study of Patient Decision Aid in Opioid Use Disorder, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-16.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Opioid Use Disorder

Keywords

  • Opioid Use Disorder (OUD)
  • Medication Assisted Therapy (MAT)
  • Patient Decision Aid
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)

Exclusion criteria

Exclusion Criteria:

  • Significant or unstable medical or psychiatric illness that may interfere with study participation
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralPatient 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.

05

What researchers measure

Primary outcomes

  1. Treatment Retention

    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

    Time frame: 3 months

Secondary outcomes

  1. Drug screening results

    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)

    Time frame: 3 month

  2. Treatment Adherence

    Treatment Adherence defined as proportion of clinic visits attended

    Time frame: 3 month

06

Study locations

1 site
  • Tarzana Treatment Centers, Inc.
    Tarzana, California 91356, United States
07

References and documents

Publications

  • 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. PubMed 31668516 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03394261
Lead sponsor
University of California, Los Angeles
Responsible party
Sponsor
First posted
Jan 9, 2018
Start date
Jun 14, 2018
Primary completion
Dec 21, 2018
Completion
Dec 21, 2018
Last update
Nov 16, 2020

Study contacts

Yih-Ing Hser, Ph.D.
principal investigator · University of California, Los Angeles
Larissa Mooney, M.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion