Edward Melnick

July 14, 2022: Solving Unexpected Challenges in Pragmatic Trial Data Collection

Posted on by Elizabeth Mccamic

Headshot of Dr. Keith MarsoloDuring the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core, moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” Four panelists shared their experiences collecting and aggregating data from diverse data sets and how they solved unexpected challenges.

The panelists included Drs. Ted Melnick (EMBED), Holt Oliver (ICD-Pieces), Margaret Kuklinski (GGC4H), and Andrea Cheville (NOHARM).

During the discussion, panelists shared lessons learned from collecting electronic health record (EHR) data during large pragmatic clinical trials across multiple health systems. Common challenges included:

  • Privacy concerns and not having the ability to collect deidentified patient or clinician demographic information
  • Working across health systems that use different EHR platforms and collecting data consistently across sites
  • Turnover of IT staff at participating sites and changes in site data agencies during the study period
  • Updates to the EHR that affect study algorithms and other issues with algorithms not identifying data as expected
  • Overcoming technical barriers with practice workflows and integrating with IT systems

The panelists shared solutions and possible best practices for future studies, including the need for planning, coordinating, and testing before study launch, the importance of being able to pivot and change directions as problems arise, being open to alternative data collection methods such as surveys to augment findings, and having the right team at the right time to be responsive to problems, which for one study meant having informaticists and expert EHR builders embedded in the trial team.

Panelists identified two key policy and infrastructure changes that would help trials be successful in the future. These changes include development of a national unique patient identifier across health systems and incentivizing EHR vendors to find common ground to better support research.

The Electronic Health Records Core continues to learn from experiences of the program’s NIH Collaboratory Trials and shares emerging information, resources, and EHR-related recommendations to improve future pragmatic research.

View slides from the discussion panel.

Learn more

View video collection that highlights advances in Electronic Health Records for pragmatic research.

Watch the August 2021 Interview with Electronic Health Record Core leaders Drs. Rachel Richesson and Keith Marsolo

June 27, 2022: EMBED Publishes Results From Study of Buprenorphine Initiation in Emergency Departments

Posted on by Elizabeth Mccamic
Headshots of Dr. Edward Melnick and Dr. Gail D'Onofrio
Dr. Ted Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED

Implementation of a user-centered clinical decision support tool did not increase the rate of patients receiving buprenorphine for treatment of opioid use disorder in the emergency department (ED) when compared to usual care.

When the tool was used, it was associated with high rates of buprenorphine initiation, and the tool increased the number of physicians who provided ED-initiated buprenorphine and naloxone prescriptions.

The findings of EMBED were published in the BMJ on June 27.

From November 2019 to May 2021, researchers conducted EMBED, an NIH Pragmatic Trials Collaboratory Trial, in 18 clusters across 5 healthcare systems in 5 states, representing the Northeast, Southeast, and Western regions of the United States.

The 18 clusters included 21 EDs, with 3 sites paired with a second ED within the same healthcare system due to low patient volume or high physician crossover rates between the 2 sites. Each cluster received either the intervention or maintained usual care.

The study sample was made up of all patient visits to the ED during the study period. Eligible patient encounters were identified using criteria in the electronic health record. For patients with multiple ED visits during the trial, only the first ED visit was included in the analysis.

ED attending physicians caring for patients who met the trial’s inclusion criteria were the primary study subjects, but all ED clinicians practicing at intervention sites had access to the EMBED tool for all patients in their care at that site. A total of 5,047 patients (2,787 intervention and 2,260 usual care) were eligible for analysis along with the 599 physicians who cared for them (340 intervention, 259 usual care).

The intervention did not affect the patient-level rate of ED-initiated buprenorphine (which was 12.5% in the intervention arm and 12.0% in the usual care arm). The proportion of physicians who initiated buprenorphine in the ED at least once was higher at intervention sites compared to usual care sites (44.4% vs 34.0%).

In the intervention arm, the EMBED tool was launched by physicians for 261 of 2,787 eligible patients. When the tool was launched, buprenorphine was ordered for 161 patients (67% of 261 encounters).

“We built tools that work within the electronic health record that make it easier for clinicians to treat patients with addiction, using medications that physicians may initially find complex and unfamiliar,” said Dr. Edward Melnick of Yale University, co–principal investigator of the study. “We’ve tried to make that easier for clinicians to allow this practice to be adopted into routine care.”

“EMBED offers a major opportunity to accelerate adoption by offering a simple, automated, rapid solution to initiating treatment and referral for people suffering from opioid use disorder,” said Dr. Gail D’Onofrio of Yale University, co–principal investigator of the study. “Additional prompts and interventions will be needed to increase more universal implementation into the routine care of ED patients with opioid use disorder.”

Watch Dr. Melnick discuss the EMBED project in this NIH Pragmatic Trials Collaboratory interview from April 2022.

EMBED was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

January 26, 2022: PCT Grand Rounds to Highlight Primary Results of EMBED Trial

Posted on by Damon Seils
Headshots of Dr. Edward Melnick and Dr. Gail D'Onofrio
Dr. Edward Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED

In this Friday’s PCT Grand Rounds, the principal investigators of EMBED, an NIH Collaboratory Trial, will announce the study’s primary results.

Co–principal investigators Dr. Edward Melnick and Dr. Gail D’Onofrio of Yale University will present “EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder.” The Grand Rounds session will be held on Friday, January 28, at 1:00 pm eastern.

EMBED is a pragmatic trial to evaluate the effect of user-centered computerized clinical decision support on rates of emergency department–initiated buprenorphine and referral for ongoing medication-assisted treatment for patients with opioid use disorder.

Join the online meeting.

EMBED is supported within the NIH Collaboratory by the NIH Common Fund and by a cooperative agreement from the National Institute on Drug Abuse.