BIDMC’s Richard A. and Susan F. Smith Center for Outcomes Research Awarded $30 Million by PCORI for Large Study on Cardiac Implantable Electrical Devices

BOSTON - Today, Beth Israel Deaconess Medical Center (BIDMC) announced a research team at the Richard A. and Susan F. Smith Center for Outcomes Research, in close partnership with Harvard T.H. Chan School of Public Health’s CAUSALab, has been approved for $30 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) for a large study on management strategies for patients with pacemakers and implantable cardioverter-defibrillators (ICDs).

This project, “Remote Alert Pathway to Optimize CaRe of Cardiac Implantable Electrical Devices: RAPTOR-CIED,” will be led by Daniel B. Kramer, MD, MPH, Section Head of Electrophysiology and Digital Health at the Smith Center and Associate Professor of Medicine at Harvard Medical School. Issa Dahabreh, MD, ScD, of Harvard Chan School’s CAUSALab and also of the Smith Center, will direct the analytic center for this study.

“This funding award aligns with the Smith Center’s mission to lead innovative research that improves clinical care and outcomes for cardiovascular patients,” said Kramer. “Modern pacemakers and ICDs collect and transmit enormous amounts of data to clinical sites. While this can be very helpful, we need better strategies for managing this deluge of information. Our project has the potential to change practice for a large and growing patient population with these devices.”
 
In this study, Kramer and colleagues will compare two strategies for managing patients living with pacemakers and ICDs. Current practice involves annual in-office device evaluations and wireless remote monitoring transmissions from patients’ devices, which include frequent scheduled transmissions, patient-initiated transmissions, and alert transmissions sent automatically. This standard strategy is effective, but imposes many burdens on patients related to time, cost, and complexity. An alternative strategy on remote monitoring alone with focus just on automatic alerts may be just as safe while reducing burdens on patients and clinical teams.

Collaborators from OpenNotes, the international movement of clinicians, patients and social scientists based at BIDMC that both encourages and evaluates transparent communication in healthcare, will work with Kramer and his team to explore patients’ and clinicians’ experiences throughout the study and analyze the data.

“This study was selected for PCORI funding based on its scientific merit and commitment to engaging patients in conducting a major research effort on cardiac electrophysiology,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “The study has the potential to fill an important evidence gap relevant to a range of health care decision makers and help them better assess their care options. We look forward to following the study’s progress and working with the Smith Center to share its results.”

This study was selected for funding through a PCORI initiative to support large-scale, high-impact comparative effectiveness research trials in a multi-phase format allowing for testing and refinement of the study approach. The study will involve an initial feasibility phase to maximize the likelihood of full trial success. This project was selected through a highly competitive review process in which patients, caregivers and other stakeholders joined scientists to evaluate the proposals.

This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.