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Decision Support for Opioid Use Disorder

No longer recruiting at 2 trial locations
LB
EM
Overseen ByEdward Melnick, MD, MHS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
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 aims to improve how emergency department doctors treat patients with opioid use disorder. It tests a new system, Refined EMBED CDS, which helps doctors follow treatment guidelines, particularly with buprenorphine, a medication for opioid addiction. The trial consists of two parts: one uses the EMBED system with a nurse prompt, while the other uses only the EMBED system. Suitable participants have moderate to severe opioid use disorder and seek help in an emergency department. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in emergency care for opioid use disorder.

Will I have to stop taking my current medications?

If you are currently receiving medication for opioid use disorder, you cannot participate in this trial.

What prior data suggests that this clinical decision support is safe for use in opioid use disorder treatment?

Research has shown that the EMBED clinical decision support (CDS) tools are designed to help doctors treat opioid use disorder (OUD) more effectively. Studies have demonstrated that these tools assist in using buprenorphine, a medication already approved and considered safe for managing OUD. Buprenorphine reduces cravings and the risk of overdose, making it a trusted choice for many healthcare providers.

Previous findings suggest that doctors find the EMBED system helpful in providing treatment. The system does not involve administering new drugs or procedures, so it poses no direct risks to participants. Instead, it guides decision-making in emergency departments. Since this study focuses on improving an existing tool rather than testing a new treatment, safety concerns are minimal. Overall, using EMBED CDS with buprenorphine is well-tolerated and aims to enhance patient care.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a new way to help manage opioid use disorder by using decision support systems in healthcare settings. Unlike traditional treatments that focus primarily on medication-assisted therapies like methadone or buprenorphine, this trial is testing the effectiveness of the Refined EMBED CDS, a clinical decision support tool, which aims to enhance the decision-making process for healthcare providers. One distinctive feature is the integration of nurse prompts to ensure comprehensive assessment, which could lead to more personalized and timely interventions. This approach could potentially change how care is delivered by making it more efficient and tailored to individual patient needs, which is why researchers are keen to see the outcomes.

What evidence suggests that the Refined EMBED CDS is effective for opioid use disorder?

Research shows that the EMBED clinical decision support (CDS) system helps emergency room doctors initiate buprenorphine treatment for patients with opioid use disorder (OUD). Buprenorphine safely and effectively reduces cravings, overdoses, and death rates in people with OUD. The EMBED system aims to assist doctors in following best practices when prescribing buprenorphine. Although one study found that an earlier version of EMBED did not affect treatment rates, ongoing improvements aim to enhance its effectiveness. In this trial, participants will be in one of two groups: one receiving the updated Refined EMBED CDS and another receiving the Refined EMBED plus a nurse prompt to complete COWS documentation. The updated EMBED CDS is designed to increase the number of doctors adhering to standard care guidelines, potentially leading to better patient outcomes through more consistent treatment.16789

Who Is on the Research Team?

EM

Edward Melnick, MD, MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who come to the emergency department and have moderate to severe opioid use disorder.

Inclusion Criteria

* Emergency department patient
I am 18 years old or older.
* Moderate to severe opioid use disorder

Timeline for a Trial Participant

Preparation

Initial phase to prepare for the optimization of the clinical decision support system

4 weeks

Optimization

Conduct serial rapid-cycle randomized testing to refine the CDS interface and workflow

12 weeks
Multiple rounds of A-B testing

Evaluation

Randomized trial comparing the optimized CDS package to the original EMBED CDS

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the evaluation phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Refined EMBED CDS

Trial Overview

The study is testing two ways to help nurses and doctors follow best practices when treating opioid addiction: a nurse prompt to complete an assessment, and an improved electronic support tool. The goal is to see which helps more with proper treatment decisions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Refined EMBED plus nurse prompt to complete COWS placed under required documentation in EpicExperimental Treatment2 Interventions
Group II: Refined EMBED CDSActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Adaptive Decision Support for Addiction Treatment Master

This study refines and optimizes the EMBED* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care ...

Decision Support for Opioid Use Disorder

Research has shown that the EMBED system helps emergency room doctors initiate buprenorphine treatment for patients with opioid use disorder. Buprenorphine is a ...

A Measurement Science Framework to Optimize CDS for ...

In the emergency department-initiated buprenorphine for opioid use disorder (EMBED) trial, a clinical decision support (CDS) tool had no effect on rates of ...

Using Clinical Decision Support to Provide Social Risk ...

The overarching goal of this proposal is to integrate patient social risk information into an existing electronic health record (EHR)-based clinical decision ...

Clinical effectiveness of decision support for prescribing ...

This prospective cohort study examines clinical effectiveness of electronic medical record clinical decision support (EMR CDS) for opioid prescribing.

Computerized Clinical Decision Support System for ...

Emergency departments (EDs) frequently care for individuals with opioid use disorder (OUD). Buprenorphine (BUP) is an effective treatment option for ...

Adaptive decision support for addiction treatment to implement ...

In the preparation phase, the EMBED intervention will be refined into a multicomponent CDS intervention to improve ED initiation of ...

Environmental Scan

Naloxone is a life-saving rescue medication, and persons with OUD, those using opioids to manage chronic pain, and others who spend time with people from these.

Implementation of an Opioid Use Disorder (OUD) Machine- ...

35.66% and 36.43%; naloxone med list rates were 15.39% and 16.44%. 161. Phenotype Model Outcomes. 162. 163. The random forest classifier model ...