Improve the Meaning of Patient Reported Outcomes to Evaluate Effectiveness for Cardiac Care" (IMPROVE-Cardiac Care)

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PROJECT SUMMARY Cardiac conditions are the leading cause of morbidity and mortality globally. Over 400 million people are living with cardiac conditions, and 18 million people die annually. In the U.S., coronary heart disease affects 18.2 million adults and heart failure affects over 6.5 million people, of whom over 30% are hospitalized for acute exacerbations annually. Patient-reported outcomes provide healthcare professionals and patients with insight into where patients are on the disease trajectory, both during routine management and during recovery from a major clinical event. The overall goal of the Improve the Meaning of Patient-Reported Outcomes to eValuate Effectiveness for Cardiac Care” (IMPROVE: Cardiac Care) study is to establish population and individual minimally clinically important differences (MCIDS), which are the smallest improvement that is meaningful to patients with cardiac conditions. In Aim 1, the investigators will establish MCIDs in patient-reported outcomes for patients with coronary heart disease recovering from coronary artery bypass surgery, or with heart failure recovering from a hospitalization. In Aim 2, the investigators will establish MCIDs in patient-reported outcomes for patients with heart failure with preserved ejection fraction undergoing disease management in the ambulatory setting. For both Aims 1 and 2, we will use three statistical approaches including: 1) anchor-based methods (associated changes in PROs and clinical indicators, mean changes, receiver operating characteristics), and 2) conditional anchor-based methods (using multivariate logistic regression). In Aim 3, investigators will determine how patient-reported outcomes from patients with cardiac condition can inform clinical decision-making. Guided by the Data-Frame Theory of Sensemaking, we will evaluate 60 patient and healthcare professional dyads making clinical decisions using patient-reported outcome health information with: 1) video ethnography to measure communication behaviors; and 2) reflexive interviewing based on videoed clinical encounters to describe how patient-reported outcomes are incorporated into the sensemaking process. Overall, the IMPROVE: Cardiac Care study will establish minimally clinically important differences that can be used to identify patients who are not optimally recovering from a cardiac event, and use the MCIDs to target early interventions. The investigators will also develop a novel framework for how patient-reported outcomes can be meaningfully incorporated into clinical practice.