EMBED: A Pragmatic Trial of User Centered Clinical Decision Support for EMergency Department Initiated BuprenorphinE for Opioid Use Disorder, 5 U.S. states, 2019-2021 (ICPSR 38568)

Version Date: Nov 3, 2022

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Principal Investigator(s):
Edward R. Melnick, Yale University. School of Medicine

https://doi.org/10.3886/ICPSR38568.v1

Version V1

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Summary

Buprenorphine (BUP) is a highly efficacious drug for treatment of addiction for Opioid Use Disorder (OUD) patients. Although it is safe and effective to initiate this treatment in the emergency departments (ED) where a lot of OUD patients seek care, due to challenges related to lack of knowledge, etc. this practice has not been widely adopted. The goal of this trial was to test the efficacy of a user centered clinical decision support (CDS) tool (EMBED) that was developed to facilitate ED clinicians to administer/prescribe BUP for OUD patients presenting to the ED. This was an 18-month long, pragmatic, parallel, group randomized trial implemented across 18 ED clusters (21 sites) in 5 healthcare systems randomly allocated in 1:1 ratio to intervention versus usual care arm. For the intervention, CDS was to support diagnosis and withdrawal assessment and automate electronic health record (EHR) documentation. The primary outcome was the initiation of BUP in ED at patient level.

Citation

Melnick, Edward R. EMBED: A Pragmatic Trial of User Centered Clinical Decision Support for EMergency Department Initiated BuprenorphinE for Opioid Use Disorder, 5 U.S. states, 2019-2021. Inter-university Consortium for Political and Social Research [distributor], 2022-11-03. https://doi.org/10.3886/ICPSR38568.v1

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Funding

United States Department of Health and Human Services. National Institutes of Health. National Institute on Drug Abuse (UH3DA047003)

Subject Terms

Geographic Coverage

Distributor(s)

Inter-university Consortium for Political and Social Research
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Time Period(s)

2019-10-15 -- 2021-05-31

Date of Collection

2019-10-15 -- 2021-05-31

Data Collection Notes

  1. Outcome data was collected via SQL query of the local Electronic Health Records (EHR) at each healthcare system at regular intervals from data routinely collected in each hospital's EHR.

  2. To enable consistent Electronic Health Records (EHR) data collection across sites, a master data dictionary of all data elements was created. Please see the zipped documentation.

  3. At each study site, the variables in the data dictionary were validated against the institutional Electronic Health Records (EHR) to ensure that the variables are correctly mapped to the EHR field that corresponds to the clinical intent of the variable after accounting for documentation practices and workflow at each site. For data quality assurance, the mapped variables were validated against the EHR to ensure that the data are clinically relevant to the goals of the project and correctly represents the clinical data that clinicians use to make decisions.

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Study Purpose

The purpose of this study was to test the efficacy of a user centered clinical decision support (CDS) tool (EMBED) that was developed to facilitate emergency department (ED) clinicians to administer/prescribe Buprenorphine for Opioid Use Disorder patients presenting to the ED.

Sample

The study sample was derived from all patient visits to the participating 18 emergency department (ED) clusters, across 5 healthcare systems in Alabama, Colorado, Connecticut, Massachusetts, and North Carolina, during November 2019 to May 2021. These 18 clusters included 21 ED sites, with 3 sites paired with a second ED within the same healthcare system due to low patient volume and/or high physician crossover rates between the 2 sites. Randomization was performed at the level of ED cluster, in a 1:1 ratio with clusters assigned to receive either the intervention or usual care.

Time Method

Cross-sectional

Universe

Patients aged 18 or older in 21 emergency department (ED) sites in 5 healthcare systems in 5 states, with probable Opioid Use Disorder (OUD) who were discharged from the ED, not pregnant, and not currently on medication for OUD as documented in the electronic health record.

Unit(s) of Observation

Individual

Data Source

Administrative records

Data Type(s)

Mode of Data Collection

Description of Variables

This study contains variables regarding the reason for participants' emergency department (ED) visits, what occurred during the ED visit, demographics of participants and providers, and variables about the use of Buprenorphine.

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Original Release Date

2022-11-03

Version History

2022-11-03 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:

  • Created variable labels and/or value labels.

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Notes

  • The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.

NAHDAP logo

This study is maintained and distributed by the National Addiction and Health Data Archive Program (NAHDAP). NAHDAP is supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH).