Clinical Decision Support for Opioid Use Disorder

Overseen By Jacob Perez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Opioid use disorder medications

Disqualifiers: Hospitalization, Suicidal, Cognitively impaired, others

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool designed to assist emergency room doctors in treating individuals with opioid use disorder (OUD) by considering social factors that might impact treatment. The goal is to determine if this approach improves patient adherence to medication and follow-up care. Two versions of the tool are under evaluation: a basic version (ED-Based Clinical Decision Support for Opioid Use Disorder) and one that includes social care information (Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder). Individuals with OUD who receive medication in the UCSF emergency room may be suitable candidates, particularly if OUD affects their daily life. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches that could enhance 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. It might be best to discuss this with the trial coordinators or your doctor.

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

Studies have shown that tools designed to assist doctors in treating opioid use disorder (OUD) are safe for users. Research indicates that these tools, which utilize electronic health records, are generally well-received by doctors.

An observational study found the emergency department (ED) version of this tool effective in identifying and treating patients with OUD without safety concerns. Similarly, a version that includes social factors aims to improve treatment, and trials have reported no safety issues.

These tools do not involve medication or procedures, reducing the risk of side effects. Instead, they aid healthcare providers in making better decisions, which other studies have linked to improved patient outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clinical Decision Support systems for opioid use disorder because they offer a fresh approach to tackling this challenging condition. Unlike standard treatments that primarily involve medication-assisted therapy like methadone or buprenorphine, these systems integrate decision-making tools directly into emergency care settings. The ED-Based Clinical Decision Support provides emergency providers with real-time guidance, potentially leading to quicker and more effective decision-making. Meanwhile, the Social Care-Enhanced version adds a layer of social care resources, aiming to address the broader social and behavioral factors that influence recovery. This holistic approach could significantly improve outcomes by offering personalized, situationally aware care in moments of critical need.

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

This trial will compare two clinical decision support (CDS) tools for opioid use disorder (OUD) in emergency departments. Studies have shown that CDS tools in emergency departments can effectively treat OUD. For instance, one study found that 86% of patients with OUD received buprenorphine treatment in the emergency department, and 50% continued treatment a month later. Participants in one arm of this trial will use the basic CDS tool, which helps start medication treatments and improves follow-up rates. The other arm will use the enhanced version, which includes social care elements and aims to improve outcomes by addressing patients' social needs. This enhanced tool has boosted healthcare providers' confidence in diagnosing and treating OUD. These tools guide healthcare providers to make informed treatment decisions quickly and effectively. ^{1 3 4 6 7}

Who Is on the Research Team?

Melanie F Molina, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adult patients in the emergency department with opioid use disorder. It's focused on those who might benefit from a decision support tool that considers social risks when treating their condition.

Inclusion Criteria

All University of California, San Francisco ED providers (residents, attendings, advanced practice providers) who have used either CDSv1 or CDSv2 will be eligible to participate in surveys and interviews regarding feasibility and acceptability

Exclusion Criteria

Participants will be excluded if they present from an extended care facility

Participants will be excluded if they are actively suicidal

I do not use opioids for pain management.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CDSv1 Deployment

Deployment of the basic ED-based clinical decision support tool for opioid use disorder

6 months

Ongoing ED visits

CDSv2 Deployment

Deployment of the social care-enhanced clinical decision support tool for opioid use disorder

6 months

Ongoing ED visits

Follow-up

Participants are monitored for treatment adherence and follow-up care

13 months

What Are the Treatments Tested in This Trial?

Interventions

• ED-Based Clinical Decision Support for Opioid Use Disorder
• Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder

Trial Overview The study tests an enhanced clinical decision support tool within electronic health records, designed to improve treatment adherence and follow-up for opioid use disorder by incorporating patient social risk factors.

How Is the Trial Designed?

Group I: Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder Experimental Treatment 1 Intervention

Emergency providers will no longer have access to the basic ED-based clinical decision support tool for opioid use disorder, but will instead have access to the social care-enhanced clinical decision support tool for opioid use disorder.

Group II: ED-Based Clinical Decision Support for Opioid Use Disorder Active Control 1 Intervention

Emergency providers will have access to the basic ED-based clinical decision support tool for opioid use disorder.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061936/

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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875925000323

Clinical decision support as an implementation strategy to ... ED MOUD have demonstrated effectiveness in treating opioid withdrawal, reducing rates of discharge against medical advice, and increasing the likelihood that ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03658642

Clinical Decision Support to Implement ED-initiated ... The goal of this trial is to determine whether implementation of a user-centered clinical decision support (CDS) system can increase adoption of initiation of ...

4. humanfactors.jmir.org humanfactors.jmir.org/2019/1/e13121/

Computerized Clinical Decision Support System for ... This prototype focused on key components necessary for implementing the ED-initiated BUP protocol, including modules to evaluate patients for ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814325

Emergency Department Access to Buprenorphine for ... In this cohort study of 464 patients with OUD, 86% received buprenorphine treatment in the ED and 50% remained engaged in OUD treatment 1 month later.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8380665/

Emergency department–based efforts to offer medication ... This study's objective is to identify features of ED-based OUD treatment programs that relate to program implementation, effectiveness, and sustainability.

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06872190

UCSF Opioid Use Trial → Clinical Decision Support to Provide ... The overarching goal of this proposal is to integrate patient social risk information into an existing electronic health record (EHR)-based clinical decision ...