Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03658642 |
| Other study ID # |
HIC 2000023783 |
| Secondary ID |
UG3DA047003 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2019 |
| Est. completion date |
September 15, 2021 |
Study information
| Verified date |
June 2022 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
