Researchers at Wake Forest School of Medicine hope to answer those questions with a $29.9 million, six-and-a-half-year award from Patient-Centered Outcomes Research Institute (PCORI) – an independent, nonprofit research funding organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with evidence-based information needed to make better-informed health care decisions.
PCORI’s Board has approved this award pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
The multi-center, patient-randomized control trial is being led by Cheryl D. Bushnell, M.D., stroke division chief and professor of neurology at Wake Forest School of Medicine. This award will fund the first study of its kind to test two interventions to lower blood pressure in the first six months following a stroke—one utilizes telehealth, and the other is in-person clinic management.
“Using telehealth was necessary during the COVID-19 pandemic,” Bushnell said. “And we believe telehealth could be an effective strategy for managing patient risk factors, specifically lowering blood pressure to targets that ultimately reduce the risk of recurrent stroke and cardiovascular events.”
Study participants will be randomized to either an Intensive Tailored Telehealth Management (ITTM) or Intensive Clinic Management (ICM) intervention. The ITTM intervention involves monitoring blood pressure at home through use of a Bluetooth-enabled blood pressure cuff, individualized health care coaching and remote clinical care, while the ICM intervention occurs in-person, with frequent blood pressure monitoring and clinical care.
“Stroke is one of the leading causes of death and disability, and high blood pressure is a modifiable risk factor,” Bushnell said. “No matter which intervention proves most effective, we believe this trial will have a major impact on blood pressure management in stroke patients, especially in under-represented minorities, the elderly and those with residual disabilities.”
The study is an extension of a previous research collaboration between Wake Forest School of Medicine and the UNC Gillings School of Global Public Health on post-acute stroke care—COMprehensive Post-Acute Stroke Services Study (COMPASS).
As part of the new trial, the Gillings School team will receive $8.2 million of the award to lead the data coordinating center with co-investigator Wayne Rosamond, Ph.D., professor of epidemiology.
“This study leverages advances in technology to enhance remote patient-clinician interaction around the common problem of blood pressure management that could have an impact on clinical practice of stroke care, as well as other conditions,” Rosamond said.
Participating clinic sites, all located in the southeast, include UNC Medical Center, Duke University Medical Center, Medical University of South Carolina, Health Sciences South Carolina, Vanderbilt University Medical Center, Mayo Clinic Florida, University of Alabama Hospital and Erlanger Health.
Myra Wright, firstname.lastname@example.org, 336-713-8806