The Patient-Reported Outcome Measurement in Heart Failure Clinic Trial: Rationale and Methods of The PRO-HF Trial. American heart journal Kalwani, N. M., Calma, J., Varghese, G. M., Gupta, A., Zheng, J., Brown-Johnson, C., Amano, A., Vilendrer, S., Winget, M., Asch, S. M., Heidenreich, P., Sandhu, A. 2022


BACKGROUND: Among patients with heart failure (HF), patient-reported health status provides information beyond standard clinician assessment. Although HF management guidelines recommend collecting patient-reported health status as part of routine care, there is minimal data on the impact of this intervention.STUDY DESIGN: The Patient-Reported Outcomes in Heart Failure Clinic (PRO-HF) trial is a pragmatic, randomized, implementation-effectiveness trial testing the hypothesis that routine health status assessment via the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) leads to an improvement in patient-reported health status among patients treated in a tertiary health system HF clinic. PRO-HF has completed randomization of 1,248 participants to routine KCCQ-12 assessment or usual care. Patients randomized to the KCCQ-12 arm complete KCCQ-12 assessments before each HF clinic visit with the results shared with their treating clinician. Clinicians received education regarding the interpretation and potential utility of the KCCQ-12. The primary endpoint is the change in KCCQ-12 over 1 year. Secondary outcomes are HF therapy patterns and healthcare utilization, including clinic visits, testing, hospitalizations, and emergency department (ED) visits. As a sub-study, PRO-HF also evaluated the impact of routine KCCQ-12 assessment on patient experience and the accuracy of clinician-assessed health status. In addition, clinicians completed semi-structured interviews to capture their perceptions on the trial's implementation of routine KCCQ-12 assessment in clinical practice.CONCLUSIONS: PRO-HF is a pragmatic, randomized trial based in a real-world HF clinic to determine the feasibility of routinely assessing patient-reported health status and the impact of this intervention on health status, care delivery, patient experience, and the accuracy of clinician health status assessment.

View details for DOI 10.1016/j.ahj.2022.10.081

View details for PubMedID 36309127