For the nearly 3 million Americans who have a weakened heart (heart failure with a low ejection fraction), symptoms of shortness of breath, swelling and fatigue are common. Worsening disease often leads to hospital stays and possibly death. Fortunately, multiple types of drugs have been developed for heart failure, and when taken together can improve quality of life, keep people out of the hospital and even help people live longer. Unfortunately, these drugs are not used as much as they could be for many patients. Reasons for this include that treatments are complicated, patients may not feel they are involved in their healthcare decisions and some busy healthcare providers may feel it is better to “leave well enough alone.”
To help patients get these life-saving drugs, electronic tools delivered directly to patients (the EPIC-HF video and checklist) and their providers (the PROMPT-HF decision support) around the time of a cardiology clinic visit have been shown in scientific studies to improve heart failure drug prescribing. Despite interest within the heart failure community regarding the potential for these simple tools to make care better for patients, neither EPIC-HF nor PROMPT-HF are being 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.
The I-I-CAPTAIN-HF study—Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal medicines for Heart Failure with reduced ejection fraction—aims to determine how to easily put the EPIC-HF and PROMPT-HF tools into the work flow at any clinic and test how well they improve prescribing of heart failure drugs. A team of researchers, healthcare providers and patients from five diverse health systems across the United States (Colorado UCHealth, Yale New Haven Health, Northwestern Medicine, University of Utah Health and Sutter Health Northern California) will participate in this work.
The five-year study is proposed in three parts. First, all health systems will work with the research team, specialists in electronic health record software design, heart failure providers and patients to develop versions of EPIC-HF and PROMPT-HF that can be added into their clinic workflow. Designs must keep key pieces of the tools while making changes that increase the use of the tools across diverse settings.
Second, a large randomized trial of the two tools at the five health systems will be conducted. The study team will enroll approximately 200 cardiology providers and 2,000 patients. The cardiology providers and their patients will be randomized to one of four groups:
- Usual care
- EPIC-HF patient tool
- PROMPT-HF provider tool
- Both tools together
The trial will test how well the EPIC-HF and PROMPT-HF tools activate patients and their cardiology providers to improve drug prescribing during the clinic visit (by collecting prescription orders from the electronic health record). Researchers will also collect data on how patients do over the 30 days after the clinic visit, including effects of heart failure drug changes (hospital stays, low blood pressure, slow heart rate, kidney failure, high potassium).
Third, along with the large randomized trial, the study team will conduct patient and provider surveys and interviews to understand how the EPIC-HF and PROMPT-HF tools are being used, learning about what works well and what does not, so that by the end of the study the team will have helped answer the following questions:
- Are patient-facing or clinician-facing tools more effective?
- Do the two tools work better together?
- What are key pieces and changes to the tools that increase the spread of information to patients with heart failure?
- How can these tools be made for easy use in diverse health systems?
The lessons learned from I-I-CAPTAIN-HF about how to best use the patient-facing EPIC-HF and provider-facing PROMPT-HF tools will improve patient-provider interactions and drug prescribing for the growing number of people living with chronic disease.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.