Decision Support for Opioid Use Disorder

Recruiting at 2 trial locations

Overseen By Laurel Buchanan, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Opioid use disorder medications

Disqualifiers: Under 18, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1088 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how emergency departments (EDs) initiate treatment for individuals with opioid use disorder (OUD). It tests a system called EMBED, which guides doctors in following best practices for administering buprenorphine, a medication that helps manage OUD. The trial will explore various methods to remind and motivate ED staff to use this system, including prompts for nurses and doctors and providing patient materials. Ideal participants are those who visit an ED, have moderate to severe OUD, and are not already receiving medication for it. As an unphased trial, this study allows participants to contribute to innovative approaches in emergency care for OUD.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those who are already receiving medication for opioid use disorder.

What prior data suggests that the EMBED clinical decision support system is safe for use in emergency departments?

Research has shown that the EMBED system helps emergency room doctors initiate buprenorphine treatment for patients with opioid use disorder. Buprenorphine is a safe, approved medication that reduces cravings and lowers the risk of overdose and death. Previous studies found that doctors find EMBED easy to use, and no major safety issues were reported with the system. This indicates that EMBED is generally safe for use in emergency settings. Since this study focuses on a tool to assist doctors rather than a new drug, the safety risks are minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Support for Opioid Use Disorder trial because it explores the use of EMBED, a clinical decision support system, to enhance the management of opioid use disorder. Unlike traditional treatments that rely heavily on medication-assisted therapies such as methadone or buprenorphine, EMBED integrates real-time prompts and educational materials for nurses, providers, and patients to improve decision-making in emergency departments. This approach aims to streamline patient care and ensure more timely and effective interventions. By incorporating prompts for completing assessments and providing discharge materials, EMBED may improve adherence to treatment protocols and patient outcomes, making it a potentially transformative addition to existing care strategies.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research shows that the EMBED system can assist emergency room doctors in initiating treatment for opioid addiction. In earlier studies, EMBED helped doctors identify opioid addiction, check for withdrawal symptoms, and encourage patients to begin treatment. This system also simplified the process by automating tasks like paperwork and prescriptions. The medication used, buprenorphine, has been proven to reduce cravings, overdoses, and death rates in people with opioid addiction. In this trial, participants will be assigned to different arms, such as EMBED CDS with nurse prompts, provider prompts, or patient-facing materials. With these additional prompts and materials, the researchers expect EMBED to further enhance the initiation of buprenorphine treatment in the emergency room. ^{1 2 5 6 7}

Who Is on the Research Team?

Edward Melnick, MD, MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for emergency department physicians and their patients with opioid use disorder. It aims to refine a decision support system called EMBED, which helps in diagnosing the disorder and initiating treatment with buprenorphine. The study excludes specific details on eligibility criteria.

Inclusion Criteria

* Emergency department patient

* Moderate to severe opioid use disorder

Timeline for a Trial Participant

Preparation

Preparation phase for the optimization of the EMBED clinical decision support system

Not specified

Optimization

Conduct a 2x2x2 factorial trial to expand EMBED with sustainable implementation strategies

Not specified

Confirmatory

Evaluation of the optimized CDS package compared to the original EMBED

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Not specified

What Are the Treatments Tested in This Trial?

Interventions

• EMBED

Trial Overview

The ADAPT trial tests enhancements to the EMBED system, including nurse prompts for withdrawal assessment, clinician prompts to use the CDS, and patient resources. It's a factorial trial aiming to optimize these interventions before comparing them in later stages.

How Is the Trial Designed?

Group I: EMBED CDS and provider prompt and patient facing materials Experimental Treatment 3 Interventions

EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED

Group II: EMBED CDS and provider prompt Experimental Treatment 2 Interventions

EMBED CDS and provider prompt for EMBED CDS

Group III: EMBED CDS and patient facing materials Experimental Treatment 2 Interventions

EMBED CDS and patient materials at patient discharge from ED

Group IV: EMBED CDS and nurse prompt and provider prompt and patient facing materials Experimental Treatment 4 Interventions

EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED

Group V: EMBED CDS and nurse prompt and provider prompt Experimental Treatment 3 Interventions

EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS

Group VI: EMBED CDS and nurse prompt and patient facing materials Experimental Treatment 3 Interventions

EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED

Group VII: EMBED CDS and nurse prompt Experimental Treatment 2 Interventions

EMBED CDS and nurse receives prompt to complete COWS

Group VIII: EMBED CDS Active Control 1 Intervention

Provider receives EMBED CDS

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+

Published Research Related to This Trial

The OUD-CDS tool was successfully developed and demonstrated to be functional and accurate, helping primary care providers (PCPs) identify and manage patients at risk for opioid use disorder (OUD).

Although the tool improved PCP confidence in screening and diagnosing OUD, it was used in only 5% of encounters with at-risk patients, indicating a need for better integration into primary care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the functionality and clinician acceptance of a clinical decision support tool to improve primary care of opioid use disorder. Rossom, RC., Sperl-Hillen, JM., O'Connor, PJ., et al.[2021]

In a study of 65 patients receiving buprenorphine for opioid use disorder, participants showed high engagement with digital phenotyping methods, meeting phone carrying criteria on 94% of study days and watch wearing criteria on 74% of days, indicating strong potential for real-time monitoring.

Despite high engagement with phone and smartwatch data, social media data collection was less consistent, with only 55-57% of participants providing data from platforms like Facebook and Instagram, suggesting a need for improved strategies to enhance social media data utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Engagement in a Multimodal Digital Phenotyping Study of Opioid Use Disorder. Campbell, CI., Chen, CH., Adams, SR., et al.[2023]

The Patient Decision Aid for Medication Treatment for Opioid Use Disorder (PtDA-MOUD) was developed with input from experts and patients, and it effectively provided information to help patients make informed treatment decisions during their initial clinical visit.

In a pilot test with 36 patients, those who used the PtDA-MOUD were more likely to start medication treatment for opioid use disorder (37% vs. 11% in controls) and received treatment for more days on average, suggesting that the decision aid may enhance treatment initiation and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. Mooney, LJ., Valdez, J., Cousins, SJ., et al.[2021]

This trial aims to evaluate the effectiveness of a user-centered clinical decision support (CDS) system in increasing the initiation of buprenorphine (BUP) treatment for individuals with opioid use disorder (OUD) in 20 emergency departments over 18 months.

The primary outcome will measure the rate of BUP initiation in the emergency department, while secondary outcomes will assess referral rates and clinician adherence to the CDS, ensuring a comprehensive evaluation of the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. Melnick, ER., Jeffery, MM., Dziura, JD., et al.[2023]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

Opioid withdrawal therapy agents and conditions like toxic encephalopathy and socioeconomic issues significantly increase the risk of adverse opioid-related events (AOEs), with relative risks as high as 33.4 for withdrawal therapy.

Patients with socioeconomic or mental health challenges are at a greater risk for AOEs, highlighting the importance of considering these factors when developing targeted interventions to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Health Trajectories Leading to Adverse Opioid-Related Events. Gilson, AS., Chartash, D., Chang, D., et al.[2021]

The TAAB study is a pilot randomized controlled trial designed to evaluate the effectiveness of video directly observed therapy (DOT) via a smartphone app on improving adherence to buprenorphine treatment for opioid use disorder, involving 13 weekly in-person visits and follow-ups at 12 and 24 weeks.

The primary outcome of the study is the percentage of weekly urine tests negative for opioids over 12 weeks, which will help assess whether video DOT can enhance treatment success by increasing accountability and structure for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial. Schramm, ZA., Leroux, BG., Radick, AC., et al.[2022]

From 2010 to 2014, the prevalence of opioid use disorder (OUD) diagnoses increased fourfold among commercially insured individuals, yet the proportion of those receiving medication for OUD decreased significantly from 25% to 16%.

Discontinuation rates for OUD medications were notably high, with over 50% of patients discontinuing injectable and oral naltrexone within 30 days, indicating a need for improved strategies to maintain treatment adherence, especially compared to sublingual buprenorphine/naloxone, which had lower discontinuation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. Morgan, JR., Schackman, BR., Leff, JA., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6414819/

Computerized Clinical Decision Support System for ...

This study aimed to design and formatively evaluate a user-centered decision support tool for ED initiation of BUP for patients with OUD.

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icpsr.umich.edu

icpsr.umich.edu/web/NAHDAP/studies/38568

EMBED: A Pragmatic Trial of User Centered Clinical Decision ...

The goal of this trial was to test the efficacy of a user centered clinical decision support (CDS) tool (EMBED) that was developed to facilitate ED clinicians.

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rethinkingclinicaltrials.org

rethinkingclinicaltrials.org/demonstration-projects/ug3-project-pragmatic-trial-of-user-centered-clinical-decision-support-to-implement-emergency-department-initiated-buprenorphine-for-opioid-use-disorder-embed/

UH3 Project: Pragmatic Trial of User-Centered Clinical ...

The system was designed to help clinicians diagnose opioid use disorder, assess withdrawal severity, motivate patients to accept treatment, and complete EHR ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06793696

Adaptive Decision Support for Addiction Treatment ...

This study is stage 1 of a larger study which refines and optimizes the EMBED* clinical decision support (CDS; see NCT03658642) to increase number of ED ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7164817/

A Pragmatic Trial of User-Centered Clinical Decision Support ...

Buprenorphine (BUP) can safely and effectively reduce craving, overdose, and mortality rates in people with opioid use disorder (OUD).

6.

bmj.com

bmj.com/content/377/bmj-2021-069271

EMBED pragmatic cluster randomized controlled trial

The EMBED intervention did not affect the rate of patients with opioid use disorder receiving buprenorphine in the emergency department (primary ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04918355

Study Details | NCT04918355 | A Health System Wide ...

The use of focused CDS tools is associated with better patient outcomes: decreasing high-risk, long-term, and aberrant opioid use. Specifically, we will test ...