Larry Allen, MD, chief of the Division of Cardiology at the University of Colorado School of Medicine, will receive a funding award for a nationwide study that he hopes will lead to more heart-failure patients getting the life-saving medications they need.
The $7 million in support, announced Nov. 28, is from the nonprofit Patient-Centered Outcomes Research Institute (PCORI), the leading U.S. funder of comparative clinical effectiveness research centered on patients.
Allen, a professor of cardiology in the CU Department of Medicine, says the funding award includes $2.5 million in direct support to CU, another $2.5 million to four other health systems in other states that will take part in the study, and $2 million to fund infrastructure for the research.
The five-year study will investigate whether use of a pair of electronic tools, either individually or together, can expand use of drugs to treat a weakened heart that isn’t pumping enough blood, a condition that affects nearly 3 million Americans.
Treatments are underutilized
“Heart failure is one of the most common chronic diseases in the United States, especially among older people,” Allen says. “It’s a significant problem. It’s associated with many symptoms, like shortness of breath and a lot of fatigue. It’s the most common cause of hospitalization among Medicare beneficiaries.”
The good news, he says, is that “over the last 20 to 30 years, several treatments for heart failure have been developed, and what’s even better is that they’re additive, so the treatments in combination can really improve cardiac function, keeping people out of the hospital and living longer. It’s important that people who are eligible for these therapies get them, and at the right doses.”
However, on the flip side, Allen emphasizes, “these drugs are not used as much as they could be for many patients.” One problem is that simultaneously administering multiple drugs can be complicated. In some cases, doses must be titrated, or adjusted periodically. “And then there can be a fair number of side effects. These medicines generally don’t make you magically feel better,” he says.
It can be a lot of work for busy clinicians to optimize therapies, he notes. As a result, “many patients are significantly under-treated.”
Compare and contrast
To help address these issues, there are two electronic tools available to assist patients and clinicians. One is EPIC-HF, a short video and checklist covering available treatments, delivered electronically to patients before a cardiac clinic visit. The other is PROMPT-HF, which delivers messages to health care providers to inform their decisions about patient treatment. “They’re aimed at encouraging patients and their clinicians to be more proactive about optimizing therapies,” Allen says.
These tools have been shown in studies to improve heart-failure drug prescribing, he says. But they aren’t being widely used. “Reasons include problems adding these tools into complicated electronic health record software, concerns about providers and patients getting too many alerts, and questions about whether these tools work outside of the hospitals where they were developed,” Allen writes in his proposal to PCORI.
The PCORI award will fund what Allen calls a “compare and contrast” study that will examine whether versions of EPIC-HF and PROMPT-HF, modified to fit into each of the five health systems’ clinical workflow, work better individually or in combination to improve treatment of heart-failure patients. The study will include a randomized trial involving about 200 cardiology providers and 2,000 patients.
In addition to the UCHealth system, participating partners include Yale New Haven Health in Connecticut, Northwestern Medicine in Illinois, University of Utah Health, and Sutter Health in Northern California.
According to PCORI, Allen’s study “was selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals. It was selected for funding through a PCORI program designed to support research that produces results that are broadly applicable to a diverse range of patients and care situations and can be more quickly taken up in routine clinical practice.”
PCORI is an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers, and clinicians with the evidence-based information they need to make better informed health care decisions.