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.
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.
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.
Heart failure (HF) can dramatically impact patient quality of life. Clinician assessment of HF symptom burden is frequently discordant with health status reported by patients. Patient-reported outcome (PRO) measures can more accurately detect clinically meaningful changes in HF health status as compared to routine clinical assessment using New York Heart Association (NYHA) classification. As such, there has been increasing interest in expanding PROs from their traditional role in clinical trials to routine clinical practice. The 2022 American College of Cardiology/American Heart Association Heart Failure Clinical Practice Guidelines included a 2A recommendation to incorporate patient-reported health status into routine HF care. In addition, the Centers for Medicare & Medicaid Services now include the collection of HF patient-reported health status as a quality measure.
Despite the significant evidence supporting the validity and potential utility of PROs in HF care, the feasibility and impact of routine PRO assessment among HF patients is unknown. There are no prior studies evaluating the effect of collecting PROs on the quality of HF care. In addition, gaps remain in our understanding of how clinician engagement leads to successful PRO implementation and integration. This is critical as patients are less willing to complete PROs if they are not actively incorporated into clinical care.
Understanding the impact of PRO assessment on HF patient outcomes is necessary to determine the value of routinely collecting this data and to inform the extent to which health systems, clinical societies, and government agencies should invest in promoting widespread adoption of PROs in HF care. In addition, identifying factors that lead to successful PRO implementation will guide future interventions. We sought to determine the impact of routine collection of PROs from adult outpatients treated in HF clinic on patient-reported health status, therapy patterns, care utilization, patient experience, and the accuracy of clinician assessment of health status. We also sought to evaluate clinician perceptions regarding PRO implementation in a HF clinic.
The PRO-HF trial
The Patient-Reported Outcome Measurement in Heart Failure Clinic (PRO-HF) trial (NCT04164004) is a pragmatic, single-center, randomized controlled trial to evaluate the routine assessment of patient-reported health status among adults treated in HF clinic utilizing the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), a validated measure of patient-reported HF health status ( Figure 1 ). The study protocol is available on ClinicalTrials.gov. The study is approved by the Stanford Institutional Review Board (Protocol # 58104) and is consistent with the Declaration of Helsinki. Trial enrollment started on August 30, 2021, and was completed on June 30, 2022. The study is funded by the National Heart, Lung, and Blood Institute (1K23HL151672-01). An independent safety monitor is notified of any safety concerns and adverse events related to KCCQ-12 assessment. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.