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

Trial Summary

What is the purpose of this trial?

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 physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment. Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial. \*EMBED is a user centered, clinician facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community

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 data supports the effectiveness of the treatment EMBED for opioid use disorder?

The EMBED trial showed that while the clinical decision support tool did not increase overall buprenorphine treatment rates, it did lead to more emergency department doctors starting buprenorphine treatment at least once compared to usual care (44.4% vs 34.0%). This suggests the tool may help increase the adoption of buprenorphine initiation. ^{1 2 3 4 5}

Is the digital therapeutic for opioid use disorder safe for humans?

The digital therapeutic for opioid use disorder has been evaluated for safety in a clinical trial, indicating it is generally safe for humans when used alongside buprenorphine, a medication for opioid use disorder. ^{1 6 7 8 9}

How is the EMBED treatment for opioid use disorder different from other treatments?

The EMBED treatment is unique because it involves a clinical decision support tool designed to help primary care providers better diagnose and treat opioid use disorder, addressing a significant treatment gap in general healthcare settings. ^{1 10 11 12 13}

Research Team

Edward Melnick, MD, MHS

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. [2021]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Using nominal group technique to identify barriers, facilitators, and preferences among patients seeking treatment for opioid use disorder: A needs assessment for decision making support. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Implementation strategies to address the determinants of adoption, implementation, and maintenance of a clinical decision support tool for emergency department buprenorphine initiation: a qualitative study. [2023]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of Health Trajectories Leading to Adverse Opioid-Related Events. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Assessing the readiness of digital data infrastructure for opioid use disorder research. [2021]

9. United States 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. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Patient Engagement in a Multimodal Digital Phenotyping Study of Opioid Use Disorder. [2023]

11. England 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. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Prospective acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder: A multisite qualitative study. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Classifying Characteristics of Opioid Use Disorder From Hospital Discharge Summaries Using Natural Language Processing. [2023]