July 24, 2023
Penn Medicine Researchers Awarded $27.5 Million for Large Palliative Care Study
From the Penn Medicine News Press Release:
Palliative care is medical care that focuses on reducing suffering and improving quality of life for patients with serious illnesses, and a large new study aims to help determine how to best improve the efficacy and reach of this type of care in the hospital setting. A research team from the Palliative and Advanced Illness Research (PAIR) Center in the Perelman School of Medicine at the University of Pennsylvania has been approved for a $27.5 million funding award from the Patient-Centered Outcomes Research Institute (PCORI) for the study, led by Scott D. Halpern, MD, PhD, the John M. Eisenberg Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy, and Kate Courtright, MD, MS, an assistant professor of Critical Care and Palliative Medicine.
National guidelines recommend that clinicians provide palliative care as a standard part of care for serious illnesses—which affect millions of Americans and their families—and studies have shown that palliative care delivery improves outcomes for seriously ill hospitalized patients. Palliative care also helps patients and their loved ones spend more of their time pursuing their life goals without symptoms or other burdens.
However, the best way to deliver palliative care for hospitalized patients with chronic, incurable, or life-limiting diseases remains uncertain. There aren’t enough palliative care specialists to reach all patients in need, a problem that is expected to grow as the population ages and more people are affected by serious illnesses. One solution may be to train and prompt generalists—the nurses, advanced practice providers, physicians, and social workers who make up a patient’s primary hospital team—to provide palliative care themselves. But while this approach should be able to reach more patients, it's unknown if this would be as effective as specialist-led care, or which patients might benefit most from which approach.
“As the need for palliative care continues to grow with the aging baby boomer population, it is critical to determine how to most effectively and equitably meet this need,” said Halpern, who is also the founding director of the PAIR Center. “With this large study, we hope to provide enough data to help health systems across the United States understand how to effectively scale and deliver palliative care so that it can have the greatest impact for all hospitalized patients.”
The randomized clinical trial, expected to launch in fall 2025 and last two and a half years, will include more than 43,000 seriously ill patients who are predicted to have at least a 50% chance of dying within the next year and who are admitted to 48 hospitals across 17 states in two of the largest health systems in the U.S. The hospitals in the study will be randomly assigned to one of three arms: usual care, interventions to train generalist clinicians to provide palliative care and to nudge them to use their new skills, or interventions to nudge increased uptake of specialist palliative care consultation. With this design, the investigators hope to assess both how effective each type of care is and what percentage of eligible patients are reached by each strategy.
The study is designed to enroll a large, diverse cohort of patients, so that the investigators can also measure outcomes across subgroups, including race, gender, age, diagnosis, and social determinants of health. In addition to being one of the largest studies of its kind for palliative care, the project also represents one of the largest clinical trials to use a Learning Health System approach. This emerging model of continuous learning and improvement centers on the idea of systemically gathering and creating evidence and actively applying that knowledge to improve care.
“We expect this study to be a field-defining trial for inpatient palliative care going forward,” Courtright said. “We want all patients facing a serious illness to have access to high-quality palliative care and hope that this study will provide a step forward for health equity in palliative care delivery.”
The award was funded 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 award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
Another group of Penn Medicine researchers also has been awarded funding from PCORI: Anuja Dokras MD, MHCI, PhD, a professor of Obstetrics and Gynecology, and Sunni Mumford, PhD, a professor of Epidemiology, will serve as co-principal investigators on a project investigating connections between people with polycystic ovary syndrome (PCOS) and their risk of developing cardiovascular disease, particularly with an eye on whether there are any links to prescribed first-line medications such as metformin or hormonal birth control medications. They hope their work can inform long-term care for PCOS and provide a clearer picture for counseling patients on the heart-related effects of common medication-based treatments. Their funding award is for $2 million spanning three years.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions.