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

Trial Summary

What is the purpose of this trial?

The overarching goal of this proposal is to integrate patient social risk information into an existing electronic health record (EHR)-based clinical decision support (CDS) tool (CDSv1) to facilitate emergency department (ED)-initiated, social risk-informed opioid use disorder (OUD) medication treatment and ultimately improve treatment adherence and follow up. The investigators will evaluate the feasibility and acceptability of the social care-enhanced CDS tool, CDSv2, (compared to CDSv1) at a single study site (UCSF) as an intervention to increase medication treatment adherence and follow up for adult ED patients experiencing opioid use disorder using a mixed-methods, before-after approach.

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

Research shows that using a clinical decision support system in emergency departments can increase the initiation of buprenorphine, a drug that helps reduce cravings and overdose risk in people with opioid use disorder. Pilot testing in one emergency department led to more doctors starting this treatment and prescribing naloxone, which can reverse overdoses. ^{1 2 3 4 5}

Is the Clinical Decision Support for Opioid Use Disorder safe for humans?

The Clinical Decision Support system for opioid use disorder, particularly for initiating buprenorphine in emergency departments, has been implemented and tested in multiple healthcare settings. While the studies focus on its effectiveness and integration, they do not report any specific safety concerns related to its use. ^{1 2 3 4 6}

How is the ED-Based Clinical Decision Support for Opioid Use Disorder treatment different from other treatments?

This treatment is unique because it uses a computerized clinical decision support system to help emergency department clinicians initiate buprenorphine (a medication for opioid use disorder) more effectively, addressing barriers like unfamiliarity and perceived complexity. ^{1 2 3 5 7}

Research Team

Melanie F Molina, MD, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

References

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

Interrupted Time Series of User-centered Clinical Decision Support Implementation for Emergency Department-initiated Buprenorphine for Opioid Use Disorder. [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. 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]

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

Progress Report on EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder. [2022]

5. 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]

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

Feasibility and acceptability of electronic administration of patient reported outcomes using mHealth platform in emergency department patients with non-medical opioid use. [2022]

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

Clinician Perceptions About a Decision Support System to Identify and Manage Opioid Use Disorder. [2023]