BOSTON – August 13, 2024 – 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.
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About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center is a leading academic medical center, where extraordinary care is supported by high-quality education and research. BIDMC is a teaching affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is the official hospital of the Boston Red Sox.
Beth Israel Deaconess Medical Center is a part of Beth Israel Lahey Health, a health care system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,700 physicians and 39,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education. For more information: bidmc.org
About OpenNotes
OpenNotes is an international movement spreading, studying, and teaching transparent communication among patients, families, and clinicians. When clinical notes are shared with patients, they are called ‘open notes.’ OpenNotes is motivated by evidence indicating that when health professionals offer patients and families ready access to clinical notes, the quality and safety of care improves. OpenNotes is a not-for-profit research lab based at Beth Israel Deaconess Medical Center, a major Harvard Medical School teaching hospital.
