Background: The impact of routine clinic use of patient-reported outcome (PRO) measures on clinical outcomes in patients with heart failure (HF) has not been well-characterized. We tested if clinic-based use of a disease-specific PRO improves patient-reported quality of life at 1 year.
Methods: PRO-HF was an open-label, parallel, patient-level randomized clinical trial of routine PRO assessment or usual care at an academic HF clinic between August 30, 2021, and June 30, 2022, with 1 year of follow-up. In the PRO assessment arm, participants completed the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at each HF clinic visit and results were shared with their treating clinician. The usual care arm completed the KCCQ-12 at randomization and 1 year later, which was not shared with the treating clinician. The primary outcome was the KCCQ-12 Overall Summary Score (OSS) between 12-15 months post-randomization. Secondary outcomes included domains of the KCCQ-12, hospitalization and emergency department visit rates, HF medication therapy, clinic visit frequency, and testing rates.
Results: Across 17 clinicians, 1,248 participants were enrolled and randomized to PRO assessment (n=624) or usual care (n=624). The median age was 63.9 (interquartile range [IQR] 51.8-72.8), 38.9% were women, and the median baseline KCCQ-12 OSS was 82.3 (IQR 58.3-94.8). Final KCCQ-12 (available in 87.9% of the PRO arm and 85.1% in usual care [p=0.16]) median OSS scores were 87.5 (IQR 68.8-96.9) in the PRO arm and 87.6 (IQR 69.7-96.9) in the usual care arm with a baseline-adjusted mean difference of 0.2 (95% CI: -1.7 to 2.0; p=0.85). The results were consistent across pre-specified subgroups. A post hoc analysis demonstrated a significant interaction with greater benefit among participants with baseline KCCQ-12 OSS scores of 60-80 but not in less or more symptomatic participants. No significant differences were found in 1-year mortality, hospitalizations, ED visits, medication therapy, clinic follow-up, or testing rates between arms.
Conclusions: Routine PRO assessment in HF clinic visits did not impact patient-reported quality of life or other clinical outcomes. Alternate strategies and settings for embedding PROs into routine clinical care should be tested.