PRO-HF
Trial question
What is the role of routine patient-reported outcome assessment in patients with HF?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 1248
1248 patients (485 female, 763 male)
Inclusion criteria: patients with HF
Key exclusion criteria: enrolment in alternate clinical trials that focused on patient-reported outcomes as primary or secondary outcomes
Interventions
N=624 PRO assessment (sharing the results of patient-completed Kansas City Cardiomyopathy Questionnaire-12 with the treating clinician at each clinic visit)
N=624 usual care (not utilizing the patient-completed Kansas City Cardiomyopathy Questionnaire-12 assessment)
Primary outcome
Mean improvement in Kansas City Cardiomyopathy Questionnaire-12 Overall Summary Score at 12 months
3.3
2.7
3.3 points
2.5 points
1.6 points
0.8 points
0.0 points
PRO
assessment
Usual
care
No significant
difference ↔
No significant difference in mean improvement in Kansas City Cardiomyopathy Questionnaire-12 Overall Summary Score at 12 months (3.3 points vs. 2.7 points; MD 0.2, 95% CI -1.7 to 2)
Secondary outcomes
No significant difference in mean improvement in Kansas City Cardiomyopathy Questionnaire-12 Clinical Summary Score at 12 months (2.2 points vs. 1.7 points; MD 0.6, 95% CI -1.1 to 2.4)
No significant difference in emergency department visit (22.4% vs. 22.1%; OR 1.03, 95% CI 0.77 to 1.36)
No significant difference in hospitalizations (17.6% vs. 19.7%; OR 0.87, 95% CI 0.68 to 1.12)
Conclusion
In patients with HF, PRO assessment was not superior to usual care with respect to mean improvement in Kansas City Cardiomyopathy Questionnaire-12 Overall Summary Score at 12 months.
Reference
Alexander T Sandhu, Jamie Calma, Megan Skye et al. Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic. Circulation. 2024 May 28;149(22):1717-1728.
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