The patient-reported outcome measurement in heart failure clinic trial: Rationale and methods of the PRO-HF trial.

Kalwani NM, Calma J, Varghese GM, Gupta A, Zheng J, Brown-Johnson C, Amano A, Vilendrer S, Winget M, Asch SM, Heidenreich P, Sandhu A. The patient-reported outcome measurement in heart failure clinic trial: Rationale and methods of the PRO-HF trial. American heart journal. 2023 Jan 1; 255:137-146.

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Abstract:

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 health care utilization, including clinic visits, testing, hospitalizations, and emergency department visits. As a sub-study, PRO-HF will also evaluate 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.