Patient Decision Aid for Opioid Use Disorder

LJ
Overseen ByLindsey Jennings, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Patient Decision Aid for Opioid Use Disorder. It aims to help individuals with opioid use disorder (OUD) make informed decisions about starting buprenorphine treatment, a medication that can help manage OUD. Researchers aim to determine if this decision aid increases patients' feelings of being informed and confident about their treatment choices compared to those receiving standard care. The trial suits English-speaking adults with moderate-to-severe OUD who are not currently on medication for their condition and have been recently discharged from the emergency department. Participants should also have access to video calls or email. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance decision-making tools for OUD treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not be currently prescribed medications for opioid use disorder.

What prior data suggests that this patient decision aid is safe for opioid use disorder?

Research has shown that tools designed to assist people with opioid use disorder in decision-making are generally safe. One study found that individuals using a similar tool reported better outcomes, such as increased recovery resources. Specifically, their scores on a recovery support test improved significantly, rising from 37 to 43. This suggests that the decision tool is well-received and may aid in making better treatment choices. No reports of negative effects from using these tools have emerged, indicating a positive safety profile.12345

Why are researchers excited about this trial?

Researchers are excited about the Patient Decision Aid for Opioid Use Disorder because it offers a fresh approach to treatment. Unlike traditional methods that often focus solely on medication-assisted treatment or behavioral therapy, this aid empowers patients to actively participate in their treatment choices, potentially leading to more personalized and effective care. By improving decision-making, it could enhance treatment adherence and outcomes, addressing a critical need in managing opioid use disorder.

What evidence suggests that this patient decision aid is effective for opioid use disorder?

Research has shown that tools called patient decision aids (PtDAs) can help people choose the right medication for opioid use disorder (OUD). These aids simplify understanding of treatment options, enabling informed choices. In this trial, one group will receive the patient decision aid, while another will receive standard treatment without the aid. When patients receive their preferred treatment, they often manage substance use more effectively. Early findings suggest that people using PtDAs feel more confident and less uncertain about their decisions. This tool could encourage more people to start using buprenorphine, a common medication for OUD, by making the decision process clearer and more user-friendly.678910

Who Is on the Research Team?

LJ

Lindsey Jennings, MD, MPH

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals who visit the emergency department and struggle with opioid use disorder. The study will focus on those who may benefit from a treatment involving buprenorphine, which is used to reduce cravings and withdrawal symptoms.

Inclusion Criteria

I am not taking medication for opioid addiction.
I am 18 years old or older.
Speaks and reads English
See 2 more

Exclusion Criteria

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive either the patient decision aid or treatment as usual for emergency department-initiated buprenorphine treatment

1 day
1 visit (in-person)

Follow-up

Participants are monitored for knowledge, decisional conflict, and buprenorphine uptake

1 week
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Patient Decision Aid for Opioid Use Disorder

Trial Overview

The trial is testing a new tool called a Patient Decision Aid designed to help patients make informed choices about starting buprenorphine treatment in the emergency setting. It'll be compared with the usual approach to see if it improves knowledge and reduces indecision.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Patient Decision AidExperimental Treatment1 Intervention
Group II: Treatment as UsualActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Patient Decision Aid for Medication Treatment for Opioid ...

The developed decision aid provides information on MOUD and captures patient characteristics relevant to medication treatment decisions.

Patient decision aid for medication treatment for opioid use ...

Conclusions. Patient perceptions of the decision aid were favorable and it showed promise as a tool in the OUD treatment process. Pilot testing results ...

Patient decision aid for medication treatment for opioid use ...

The developed decision aid provides information on MOUD and captures patient characteristics relevant to medication treatment decisions.

MOUD SHARED DECISION-MAKING

Patients that were matched to their preferred treatment had improved substance use outcomes compared to those who were unmatched to their preferred treatment.

Use of a Decision Aid in Medication Initiation Among Patients ...

Patient decision aids have been successful in affecting decision-making in other populations. However, no decision aid for medication for opioid ...

Three-month outcomes from a patient-centered program to ...

Most participants reported increased recovery capital. The median Assessment of Recovery Capital (ARC) score went from 37 at enrollment to 43 (p < 0.01).

Pilot Test of Patient Decision Aid for Opioid Use Disorder

The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support ...

Patient and provider medication preferences affect ...

This secondary data analysis seeks to characterize patient and provider preferences for MOUD treatment pathways, and test for associations between baseline MOUD ...

A pilot randomized controlled trial of a patient decision aid ...

The Disclosing Recovery intervention appears to be an acceptable, feasible, and appropriate patient decision aid for addressing disclosure processes among ...

Three-month outcomes from a patient-centered program to ...

This study shows that people with OUD can achieve a high treatment retention rate, cut down their use of illicit drugs, and build their recovery ...