Clinical Decision Support to Implement ED-initiated Buprenorphine for OUD

NCT ID: NCT03658642

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5047 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2021-09-15

Brief Summary

Emergency Departments (EDs) frequently care for individuals with Opioid Use Disorder (OUD). Buprenorphine (BUP) is an effective treatment option for patients with OUD that can safely be initiated in the ED. At present, BUP is rarely initiated as a part of routine ED care. Clinical decision support (CDS) represents a potential approach to accelerate adoption of this best practice into routine emergency care. 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 BUP into the routine emergency care of individuals with OUD.

Detailed Description

The study design is an 18-month pragmatic, parallel, cluster randomized, superiority trial using constrained randomization of clusters to arms. The unit of randomization (i.e. cluster) is the ED. EDs will be randomly allocated with an allocation ratio of 1:1. Adequate lead time will be allotted to install the intervention in the electronic health records (EHR) at all intervention sites--including a three month implementation and washout phase. The intervention will then begin at the same time across all sites with the CDS intervention fully implemented in the intervention sites' EHRs at the start of the trial. Clinicians at control sites will retain all control of their practice and practice as usual without the CDS intervention installed in their EHR.

Pragmatic trials study an intervention under the usual conditions in which it will be applied; as opposed to an explanatory trial which would test an intervention under ideal conditions. In cluster randomized trials, treatment intervention is allocated to clusters (i.e. groups of individuals) rather than individuals. This is done to manipulate the physical or social environment of the intervention when an individual intervention would likely result in contamination between intervention and control participants at the group level. The parallel cluster randomized design was chosen over a stepped wedge design due to the high likelihood of confounding by temporal trends from ongoing efforts to mitigate the opioid epidemic. A major challenge of the cluster randomized design is from potential confounding due to a limited number of heterogeneous groups. Constrained randomization offers a solution to this source of confounding by balancing key cluster-level prognostic factors across the study to avoid distorting estimates of treatment effect due to the confounding factors. This allocation technique more evenly distributes potential confounders between intervention arms by specifying the confounding factors, characterizing each cluster in terms of these factors, identifying a subset of randomization combinations of clusters that adequately balance confounding factors between intervention arms and randomly selecting one of these combinations as the allocation scheme. Potential confounders that will be used for this trial are: EHR vendor, ED annual volume, ED type (e.g., academic, community, urban, rural, etc), ratio of ED clinicians who have a waiver to prescribe BUP, current rate of ED BUP prescribing, resources in ED to facilitate management of patients with OUD, and willingness of staff to adopt the practice of ED-initiation of BUP.

Intervention:

The intervention for this study includes the user-centered CDS as well as education of ED clinicians practicing at all study sites.

The need for flexibility in the graphical user interface of the intervention resulted in the decision to develop the CDS as a web application. This provides the ability to access the tool both embedded within the EHR or directly over the Internet. The web application was developed as a single-page application (SPA) based on React JavaScript library. The CDS is a user-initiated, Substitutable Medical Applications and Reusable Technologies (SMART) on Fast Health Interoperability Resources (FHIR) application that streamlines a flow diagram of the clinical protocol for ED-initiated BUP.

The intervention's graphical user interface is an intuitive, simple layout presenting four care pathways in columns based on the patient's diagnosis of OUD, the severity of withdrawal, and readiness to start treatment. There is additional, optional decision support available for guidance to: 1) evaluate OUD severity based on diagnostic and statistical manual of mental disorders (DSM)-5 criteria, 2) assess withdrawal severity using the clinical opiate withdrawal scale (COWS) score, and 3) motivate patient willingness and readiness to initiate medications for opioid use disorder (MOUD) treatment with a brief motivational interview. These materials are also available to share with other members of the care team via a web address, text messaging, or Quick Response (QR) code. The interface also includes a toggle switch for the user based on whether or not they have a waiver to prescribe BUP. Clinicians without a waiver cannot prescribe BUP but can administer a one-time dose of BUP in the ED for up to 72-hours. When integrated into the local EHR system, launching a care pathway enables the user to: place orders, refer for ongoing MOUD treatment, and update clinical notes.

The educational plan will be site-specific and tailored to the usual care at that institution. It will be administered within three months of the study start date. The details of the plan will be developed in partnership with local champions who self-identify an interest in helping to implement an ED-initiated BUP protocol at their site. Specifically, the education plan will be required to include:

1) A didactic on opioid use disorder, its diagnosis, assessment of withdrawal severity, and local resources for referral for ongoing MOUD treatment, 2)Circulation and posting in each study site ED of the flow diagram of the study's clinical protocol for ED-initiated BUP. Since this protocol is considered best practice, clinicians at control sites will retain all control of their practice and be encouraged to follow this protocol even though the CDS will not be available to them. 3) Intervention sites will include strategies to increase use of the intervention by training clinicians on how to launch and use the CDS. Use of the intervention will be tracked with site-specific audit and feedback that is consistent with typical quality improvement initiatives at that site.

Given the ongoing and escalating opioid epidemic and wide scope of this trial, the investigators anticipate that there may be concomitant interventions to stem OUD at study sites during the trial. The investigators plan to permit these interventions as long as they are: (1) implemented before randomization so that they can be tracked and accounted for in the constrained randomization process, and (2) they are not a health IT intervention targeted at clinicians to initiate BUP in the ED.

Conditions

Clinical Decision Support; Buprenorphine; Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical Decision Support for BUP

The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.

Group Type: EXPERIMENTAL

Clinical Decision Support (CDS)

Intervention Type: BEHAVIORAL

This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)

Usual Care

The CDS will not be activated and patients will receive care as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical Decision Support (CDS)

This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Clinicians

• All clinicians working in Emergency Departments in the selected sites

Patients

• 18 years or older
• Will meet an EHR-derived phenotype suggesting possible OUD will be included in the analysis
• Will be discharged from the ED
• Not pregnant
• Not currently taking any medication for Opioid Use Disorder

Exclusion Criteria

Patients

• Have a medical or psychiatric condition that requires hospitalization during the ED visit
• Have prior enrollment in the current study
• Currently in addiction treatment
• Be a prisoner or in police custody at the time of ED visit

Note: The CDS will also be available for physicians to use when patients do not meet the EHR phenotype. These patients will be excluded from the primary analyses

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of North Carolina

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

The Cooper Health System

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Melnick, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

UAB Medicine Highlands - Highlands ED, (HED)

Birmingham, Alabama, United States

UAB - University Hospital ED (UED)

Birmingham, Alabama, United States

UAB Freestanding Emergency Department of Gardendale (GED)

Gardendale, Alabama, United States

UCHealth Anschutz Medical Campus (AMC)

Aurora, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital North (MHN)

Colorado Springs, Colorado, United States

UCHealth Poudre Valley Hospital (PVH)

Fort Collins, Colorado, United States

UCHealth Medical Center of the Rockies

Loveland, Colorado, United States

Bridgeport Hospital ED (BPT), YNHHS

Bridgeport, Connecticut, United States

Greenwich Hospital ED (GH), YNHHS

Greenwich, Connecticut, United States

St Raphael's Campus (SRC), YNHHS

New Haven, Connecticut, United States

Lawrence + Memorial Hospital ED (L&M), YNHHS

New London, Connecticut, United States

Baystate Franklin

Greenfield, Massachusetts, United States

Baystate Wing Hospital ED

Palmer, Massachusetts, United States

Baystate Springfield Hospital ED

Springfield, Massachusetts, United States

Baystate Mary Lane Hospital ED

Ware, Massachusetts, United States

Baystate Noble

Westfield, Massachusetts, United States

UNC Hospitals Emergency Department, UNCHS

Chapel Hill, North Carolina, United States

REX Healthcare Emergency Department, UNCHS

Raleigh, North Carolina, United States

Emergency Care Center at Nash General Hospital, UNCHS

Rocky Mount, North Carolina, United States

Chatham Hospital ED, UNCHS

Siler City, North Carolina, United States

Johnston Health ED, UNCHS

Smithfield, North Carolina, United States

Countries

United States

References

Gao E, Melnick ER, Paek H, Nath B, Taylor RA, Loza AJ. Adoption of Emergency Department-Initiated Buprenorphine for Patients With Opioid Use Disorder: Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342786. doi: 10.1001/jamanetworkopen.2023.42786.

Reference Type: DERIVED

PMID: 37948075 (View on PubMed)

Melnick ER, Nath B, Dziura JD, Casey MF, Jeffery MM, Paek H, Soares WE 3rd, Hoppe JA, Rajeevan H, Li F, Skains RM, Walter LA, Patel MD, Chari SV, Platts-Mills TF, Hess EP, D'Onofrio G. User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial. BMJ. 2022 Jun 27;377:e069271. doi: 10.1136/bmj-2021-069271.

Reference Type: DERIVED

PMID: 35760423 (View on PubMed)

Melnick ER, Nath B, Ahmed OM, Brandt C, Chartash D, Dziura JD, Hess EP, Holland WC, Hoppe JA, Jeffery MM, Katsovich L, Li F, Lu CC, Maciejewski K, Maleska M, Mao JA, Martel S, Michael S, Paek H, Patel MD, Platts-Mills TF, Rajeevan H, Ray JM, Skains RM, Soares WE 3rd, Deutsch A, Solad Y, D'Onofrio G. Progress Report on EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder. J Psychiatr Brain Sci. 2020;5:e200003. doi: 10.20900/jpbs.20200003. Epub 2020 Feb 21.

Reference Type: DERIVED

PMID: 32309637 (View on PubMed)

Melnick ER, Jeffery MM, Dziura JD, Mao JA, Hess EP, Platts-Mills TF, Solad Y, Paek H, Martel S, Patel MD, Bankowski L, Lu C, Brandt C, D'Onofrio G. User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. BMJ Open. 2019 May 30;9(5):e028488. doi: 10.1136/bmjopen-2018-028488.

Reference Type: DERIVED

PMID: 31152039 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UG3DA047003

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HIC 2000023783

Identifier Type: -

Identifier Source: org_study_id