Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial

Author:

Sandhu Alexander T.123ORCID,Calma Jamie1ORCID,Skye Megan13,Kalwani Neil13ORCID,Zheng Jimmy4ORCID,Schirmer Jessica1ORCID,Din Natasha3ORCID,Brown Johnson Cati4ORCID,Gupta Anshal4,Lan Roy4ORCID,Yu Brian4ORCID,Spertus John A.5ORCID,Heidenreich Paul A.13ORCID

Affiliation:

1. Division of Cardiovascular Medicine (A.T.S., J.C., M.S., N.K., J.S., P.A.H.), Stanford University, CA.

2. Stanford Prevention Research Center (A.T.S.), Stanford University, CA.

3. Palo Alto Veteran’s Affairs Healthcare System, CA (A.T.S., M.S., N.K., N.D., P.A.H.).

4. Department of Medicine (J.Z., C.B.J., A.G., R.L., B.Y.), Stanford University, CA.

5. University of Missouri–Kansas City Healthcare Institute for Innovations in Quality and Saint Luke’s Mid America Heart Institute, Kansas City, MO (J.A.S.).

Abstract

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: The PRO-HF trial (Patient-Reported Outcome Measurement in Heart Failure Clinic) 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 and 15 months after 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, 1248 participants were enrolled and randomized to PRO assessment (n=624) or usual care (n=624). The median age was 63.9 years (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 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 prespecified subgroups. A post hoc analysis demonstrated a significant interaction with greater benefit among participants with a baseline KCCQ-12 OSS of 60 to 80 but not in less or more symptomatic participants. No significant differences were found in 1-year mortality, hospitalizations, emergency department 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. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04164004.

Funder

National Heart Lung and Blood Institute

National Institute of Health

Stanford Institutional Funds

Publisher

Ovid Technologies (Wolters Kluwer Health)

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