Clinical trial NCT03658642: Clinical Decision Support to Implement ED-initiated Buprenorphine for OUD
Official title: Pragmatic Trial of User-centered Clinical Decision Support to Implement EMergency Department-initiated BuprenorphinE for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Decision Support
Buprenorphine
Opioid-use Disorder
Keywords: Opioid Use Disorder
Buprenorphine
Opioid-use Disorder
Health IT
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of North Carolina
name: University of Alabama at Birmingham
name: Mayo Clinic
name: The Cooper Health System
name: University of California, Davis
First posted: 2018-09-05
Enrollment: 5047
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel cluster randomized
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Count of Initiating BUP in the ED With Referral for Ongoing MOUD With User-centered CDS Compared With Usual Care
timeFrame: Upon discharge (Up to 1 day)
Secondary outcomes:
measure: Count of Those With Referral to Follow-up for Ongoing MOUD Treatment (Patient Level)
timeFrame: Upon discharge (Up to 1 day)
measure: Rates Receiving a MAT Appointment Who go to the Appointment
timeFrame: 18 months
measure: Number of Clinicians Providing ED-initiated BUP
timeFrame: 18 months
measure: Number of Clinicians Providing Referral of Any Ongoing MOUD Treatment
timeFrame: 18 months
measure: Number of Clinicians Who Have Received Drug Addiction Treatment Act (DATA) of 2000 Training
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Medicine Highlands - Highlands ED, (HED)
state: Alabama
city: Birmingham
country: United States
facility: UAB - University Hospital ED (UED)
state: Alabama
city: Gardendale
country: United States
facility: UAB Freestanding Emergency Department of Gardendale (GED)
state: Alabama
city: Aurora
country: United States
facility: UCHealth Anschutz Medical Campus (AMC)
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital Central
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital North (MHN)
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Poudre Valley Hospital (PVH)
state: Colorado
city: Loveland
country: United States
facility: UCHealth Medical Center of the Rockies
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital ED (BPT), YNHHS
state: Connecticut
city: Greenwich
country: United States
facility: Greenwich Hospital ED (GH), YNHHS
state: Connecticut
city: New Haven
country: United States
facility: St Raphael's Campus (SRC), YNHHS
state: Connecticut
city: New London
country: United States
facility: Lawrence + Memorial Hospital ED (L&M), YNHHS
state: Connecticut
city: Greenfield
country: United States
facility: Baystate Franklin
state: Massachusetts
city: Palmer
country: United States
facility: Baystate Wing Hospital ED
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Springfield Hospital ED
state: Massachusetts
city: Ware
country: United States
facility: Baystate Mary Lane Hospital ED
state: Massachusetts
city: Westfield
country: United States
facility: Baystate Noble
state: Massachusetts
city: Chapel Hill
country: United States
facility: UNC Hospitals Emergency Department, UNCHS
state: North Carolina
city: Raleigh
country: United States
facility: REX Healthcare Emergency Department, UNCHS
state: North Carolina
city: Rocky Mount
country: United States
facility: Emergency Care Center at Nash General Hospital, UNCHS
state: North Carolina
city: Siler City
country: United States
facility: Chatham Hospital ED, UNCHS
state: North Carolina
city: Smithfield
country: United States
facility: Johnston Health ED, UNCHS
state: North Carolina
Study officials:
affiliation: Yale University
name: Edward Melnick, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.