Dr. Larry Allen is proof positive that in medicine, as in many things, patience and perseverance often pay off.

Allen, a cardiologist at UCHealth University of Colorado Hospital on the Anschutz Medical Campus and medical director of the Advanced Heart Failure Program at the University of Colorado School of Medicine, recently secured a five-year, $7 million grant from the Patient-Centered Outcomes Research Institute (PCORI). The goal: to study the power of electronic health records and innovative tools to increase the number of the most seriously ill heart failure patients who receive the proper doses of effective but underused classes of medications to improve their health.

The I-I-CAPTAIN-HF study, as it’s called, is a randomized trial that is set to launch on March 1. It aims to enroll a total of 2,000 patients from UCHealth and four other health systems and involve some 200 cardiologists. The systems will target heart failure patients at greatest risk: those with an ejection fraction – a key measure of the heart’s pumping power – of less than 40%.

More on I-I-CAPTAIN-HF later. A large part of the story of how that study came to be lies in groundwork Allen laid for it years before.

Reaching out to the most vulnerable heart failure patients

In 2019, Allen launched a study of heart failure patients with ejection fractions of 40% or less at UCHealth hospitals. Allen knew that many of these patients could benefit from receiving variations of four classes of heart failure medications recommended by the American Heart Association. The challenge was finding the patients, particularly with limited clinic visit times.

Allen’s study, dubbed EPIC-HF, set out to identify the patients by scouring the Epic electronic health records, then delivering them information about the recommended medications via a video and a medication checklist to help them review their own regimens before their clinic visits. He surmised that putting the information in patients’ hands could jump-start meaningful discussions with their cardiologists about the most effective therapies for managing their heart failure and improving their quality of life.

The EPIC-HF study produced promising results, which Allen and his colleagues published late in 2020 in the journal Circulation. Nearly 300 patients enrolled. Half received the video and medication checklist; the other half did not. Those who got the additional materials were far more likely to be prescribed the AHA-recommended medications or intensify their doses than those who received standard care.

“We pushed out [the video and checklist] to patients and showed that it did make the visit more proactive in terms of prescribing drugs that we think are good for heart failure,” Allen said. “And we wanted to see this used, not only in our own health system but also more widely and tested a little more thoroughly.”

A broader effort to bring cardiologists and heart failure patients together

It took significant time, but with the I-I-CAPTAIN-HF study, Allen and his much larger team of colleagues are getting that chance and more.

The new study will give EPIC-HF scrutiny on a more extensive scale. It also tests another electronic tool, PROMPT-HF, developed at the Yale School of Medicine, which helps clinicians make evidence-based decisions about prescribing the most effective medications for individual patients.

Patients will be randomly assigned to one of four groups. One will receive the EPIC-HF tools. A second will be cared for by cardiologists who use PROMPT-HF. A third group will receive care through both EPIC-HF and PROMPT-HF, and a control group will receive usual care.

But before the randomized trial begins, the study will focus on figuring out how to design versions of EPIC-HF and PROMPT-HF that can be used easily by providers in a variety of health care systems with different health records systems, clinical workflows, and cultures, Allen said.

“PCORI [gives] contracts to research organizations – not to develop tools but to take tools that are already proven to be effective and figure out how to get them used more broadly,” he said.

Building systems to address the pressing problems of heart failure

The more adaptable the electronic tools are, the more likely they are to be adopted by clinicians, said Dr. Faraz Ahmad, a heart failure specialist at Northwestern Medicine, one of the sites for the trial. Ahmad is principal site investigator at Northwestern and is also part of the team working to scale and standardize EPIC-HF and PROMPT-HF for as many systems as possible.

The need to do that is pressing, Ahmad added. The four AHA-recommended classes of heart failure medications have “enormous benefits in terms of decreasing hospitalizations, improving quality of life, and extending survival,” Ahmad said. “But we know from experience that there is a huge gap in prescribing [these medications].”

The consequences of that gap are also enormous. Allen noted that some 6.5 million people in the United States are living with heart failure and about 70% of the costs of the condition are related to hospitalization. Heart failure is the number-one cause of hospitalization and hospital readmissions among Medicare patients, Allen added. Those grim data provided motivation for the original EPIC-HF and PROMPT-HF studies and their I-I-CAPTAIN-HF successor, he said.

“Our goal is to say if we are more proactive and we move some of this therapy upstream [to patients], likely we will stabilize the heart failure and lower the rates of hospitalization,” Allen said.

Technology opens new doors for treating heart failure patients

The widespread adoption of electronic health records over the past decade has brought that goal within reach, Ahmad noted. Electronic systems enable providers and researchers to quickly probe medical records and identify and communicate with large numbers of patients with specific conditions who need the most effective therapies before their conditions worsen and a cascade of additional medical problems ensues.

“We are moving away from [assuming that] clinicians will do the right thing during clinic visits to thinking about how do we create systems that help get patients the right care at the right time,” Ahmad said. “We finally have the infrastructure to do that.”

On the clinical side, tools like PROMPT-HF synthesize data from the health records and generate best practice alerts that help medical providers decide on the best course of care for their patients. For example, Allen said, PROMPT-HF might quickly reveal that a patient’s last echocardiogram showed reduced heart function; suggest drugs to treat the problem most effectively; analyze possible drug interactions that might affect potassium levels or the kidneys; and display all the information in a discrete box or pop-up, Allen said.

“It allows the clinician to say, ‘I didn’t realize I should prescribe these one or two drugs. [The tool] gave me the data, it makes sense to me, I click this box and it makes the rest of the ordering easy,’” he said.

A future of fine-tuning tools for managing heart failure

Following the system design work, the randomized trial of I-I-CAPTAIN-HF will gather data that reveals the extent to which the electronic tools, alone or in combination, motivated patients and clinicians to improve their prescribed medication regimens during their clinic visits.

In the third phase, study leaders will conduct interviews and surveys with patients and providers. The goal: analyze not only which tools were most effective, but how best to encourage their use in health care systems.

“Once you complete a trial, you want to understand why it worked and how to do better next time,” Ahmad said. “Lessons we learn about heart failure might also be applied to other conditions.”