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Decision Aid

Baseline Counseling As Usual for Opioid Use Disorder

N/A
Waitlist Available
Led By Michael J. Durkin, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test whether an evidence-based method for making treatment decisions, called a "decision aid," can reduce stigma around opioid use disorder (OUD) and increase engagement in treatment among patients and providers in rural Missouri.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of recruitment/randomization
Acceptability of the intervention to patients
Contamination of arms for patients
+3 more

Trial Design

3Treatment groups
Active Control
Group I: Baseline Counseling As UsualActive Control1 Intervention
Patients randomized to the baseline counseling as usual arm will receive provision of one of 3 MAT options, prescription and referral to community providers; overdose prevention education and access to naloxone kits; harm reduction counseling (e.g safe injection practices, referral to PrEP); lab testing for HIV, HBV, HCV infection, and routine vaccinations (e.g. Hepatitis A). That includes wrap-around services modeled on the Ryan White Program, with access to social worker, case manager, and mental health counselor who follow up with patients, enroll them in insurance as eligible, and provide ongoing support. This will be a 10-minute tablet- or web-based intervention administered by one of our wraparound care service team members in-person or via telehealth (or possibly in person depending on pandemic procedures). IT will be a 10-minute procedure with summary of decision considerations and patient value assessment.
Group II: Shared Decision Making AidActive Control1 Intervention
Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute tablet- or web-based intervention administered by one of our wraparound care service team members in-person or via telehealth (or possibly in person depending on pandemic procedures). IT will be a 10-minute procedure with summary of decision considerations and patient value assessment.The provider will have access to then have access to this summary in making final care decisions with the patient.
Group III: Assessing Stigma of ProvidersActive Control1 Intervention
Providers who provide care for patients enrolled in this project will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder. This will be a 10-minute tablet- or web-based in-person survey administered by one of our wraparound care service team members.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,944 Previous Clinical Trials
2,304,432 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,485 Previous Clinical Trials
2,622,319 Total Patients Enrolled
Michael J. Durkin, MDPrincipal InvestigatorWashington University School of Medicine
~20 spots leftby Jun 2025
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