Key Points
- Clinicians estimate heart failure (HF) health status using New York Heart Association (NYHA) class; however, this is often discordant with patient-reported symptom burden.
- The Patient-Reported Outcomes in Heart Failure Clinic (PRO-HF) is a pragmatic, randomized, unblinded trial comparing routine Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) collection prior to outpatient HF clinic visits, which is then shared with the treating clinician, to usual care.
- The primary objectives in this pre-specified sub study were to determine the effect of this intervention on the accuracy of clinician assessment of patient health status and patient experience.
- Provider assessment of NYHA class in the KCCQ-12 arm was more accurate, and patients in the KCCQ-12 arm felt their providers better understood their symptoms.
- Future investigations will determine the effect of routine KCCQ-12 administration on longer term clinical outcomes.
The early results of the Patient Reported Outcome Measurement in Heart Failure Clinic (PRO-HF) trial were presented by Alexander Sandhu, MD, MS, of Stanford University during the Late Breaking Science: Breakthrough Strategies in the HF Journey session of the American Heart Association conference on November 5, 2022.
This study, funded by the National Heart, Lung, and Blood Institute, was motivated by the fact that clinician assessment of the NYHA class of the patient is often discordant with the patient’s self-reported health status and that the patient-reported health status has been shown to a be better prognostic marker than NYHA class. While the 2022 American College of Cardiology/American Heart Association Guidelines recommend incorporating patient reported health status using a validated instrument into clinic practice for these reasons, there are no randomized trials investigating whether this improves outcomes.1
The KCCQ-12 is a validated patient-completed questionnaire that assesses heart failure-specific function and social limitations, symptom burden, and quality of life, with a numeric output ranging from 0-100, with lower score representing poorer health status.
The PRO-HF trial was a pragmatic, randomized, unblinded trial comparing the routine administration of the KCCQ-12 assessment to adult outpatients in HF clinic to usual care. The primary outcome was patient reported health status at 12 months, and the secondary outcomes included the impact of this intervention on treatment patterns, care utilization, accuracy of clinician assessment of health status, and patient experience. The sub-study results presented by Dr. Sandhu focused on these last two secondary outcomes.
Patients with an upcoming HF clinic visit at Stanford within one week were contacted and consented using email, text, or phone call. After enrollment they were randomized to the intervention arm, which received a KCCQ-12 at their initial visit, each visit thereafter, and at one year, with the results made available to the treating clinician, or the control arm, who received a KCCQ-12 only at their first visit and one year, the results of which were not available to the treating clinician.
Dr. Sandhu presented preliminary data from 1051 patients enrolled between Oct 2021 and June 2022; after their first visit, the patients were surveyed about their experiences with the provider, and the providers were asked to assess the health status of the patient. Additionally, providers were interviewed about their experience with KCCQ-12 implementation. The results he shared were simultaneously published in Circulation: Heart Failure.1
The mean age of participants was 64 years; 39% were female, 5% Black, 12% Asian, and 8% Hispanic, with an overall mean KCCQ-12 score of 82.
The results of this sub-study were as follows: When the patient-determined KCCQ-12 score and the clinician determined NYHA class were compared, the correlation between the two was significantly higher in the intervention arm compared to the usual care arm (-0.73 vs. -0.61, p<0.001), indicating that providers who had access to the KCCQ-12 score more accurately assessed patient’s health status compared to those who did not. This was consistent across subgroups.
In terms of patient experience, patients in the KCCQ-12 arm were significantly more likely to strongly agree with the statements “My clinician understood symptoms related to my heart” (95.2% vs 89.7%, Odds Ratio [OR] 2.27, Confidence Interval [CI] 1.32-3.87) and “My clinician and I agreed on how I was doing overall” (93.3% vs 86.5%, OR 2.18, CI 1.37-3.48).
Through qualitative interviews, investigators found that clinicians thought the KCCQ-12 helped them to accurately assess a patient’s health status and to track their health over time, however providers did not feel that they were using it to guide treatment decisions.
This study is limited by its single center, non-blinded nature; the patient population also had a low self-reported symptom burden (given the baseline high KCCQ-12 score).
In conclusion and according to Dr. Sandhu and his colleagues, the routine administration of KCCQ-12 during outpatient HF visits (and making the results accessible to the treating clinician) improves the accuracy of the provider’s health assessment of the patient. In addition, patients perceive this improvement. Those in the intervention arm thought their provider had greater insight into their symptom burden and overall health status.
While promising, what affect this intervention has on management decisions and outcomes remains unknown. The eagerly anticipated primary analysis of the PRO-HF study will help shed light on the clinical impact of patient reported outcomes in HF and will provide randomized data on which to base future guidelines.
- Sandhu AT, Zheng J, Kalwani N, et al. Impact of Patient-Reported Outcome Measurement in Heart Failure Clinic on Clinician Health Status Assessment and Patient Experience:A Sub-Study of the PRO-HF Trial. Circ Hear Fail [Internet] 2022;Available from: https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.122.010280