What is the clinical evidence from this study?

Study design: RCT. Population: Heart failure, atrial fibrillation, or coronary artery disease (n=50). Intervention: Electronic patient-reported outcome (ePRO) monitoring system vs. Usual care. Primary outcome: Patient satisfaction, quality of information provided by physicians, and disease knowledge (p=.01).

What does this research mean for the field?

An electronic patient-reported outcome (ePRO) monitoring system significantly improves patient satisfaction and patient-physician communication compared to usual care in cardiovascular outpatients. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

January 14, 2025Open Access

Electronic Patient-Reported Outcome System Implementation in Outpatient Cardiovascular Care

Key Result

An electronic patient-reported outcome monitoring system significantly improved patient satisfaction scores (1.61 vs 0.16; P=0.01) compared with usual care in cardiovascular outpatients.

Study Design

Type

RCT (n=50)

Blinding

Open-label

Randomization

1:1

Multicenter

Yes

Structured PICO

Does an electronic patient-reported outcome (ePRO) monitoring system improve patient satisfaction and quality of information provided by physicians in adult outpatients with heart failure, atrial fibrillation, or coronary artery disease?

Population

50 adults (>18 years) with a clinical diagnosis of heart failure (HF), atrial fibrillation (AF), or coronary artery disease (CAD), median age 71.0, 58.3% male, in outpatient clinics in Japan.

Intervention

Electronic patient-reported outcome (ePRO) monitoring system (KCCQ-12, AFEQT, or SAQ completed on smart tablets before clinical examination and reviewed by physicians) over 5 monthly outpatient visits.

Comparator

Usual care consisting of medication management, lifestyle modification, and invasive procedures in accordance with clinical guidelines over 5 monthly outpatient visits.

Outcome

Patient satisfaction, quality of information (QOI) provided by physicians, and disease knowledge assessed using questionnaires (e.g., Patient Satisfaction Questionnaire [PSQ]) at baseline and the fifth visit (over approximately 4 months).patient reported

Implementation of an ePRO monitoring system in outpatient cardiovascular care significantly enhanced patient-physician communication and patient satisfaction.

Main Result

Absolute Event Rate: 1.61% vs 0.16%

p-value: p=.01

Abstract

Importance: The integration of patient-reported outcome (PRO) assessments in cardiovascular care has encountered considerable obstacles despite their established clinical relevance. Objective: To assess the impact of a physician- and patient-friendly electronic PRO (ePRO) monitoring system on the quality of cardiovascular care in clinical practice. Design, Setting, and Participants: This open-label, multicenter, pilot randomized clinical trial was phase 2 of a multiphase study that was conducted from October 2022 to October 2023 and focused on the implementation and evaluation of an ePRO monitoring system in outpatient clinics in Japan. During phase 1 (conducted from December 2021 to March 2022), this ePRO monitoring system was developed at a single outpatient center using feedback from patients and physicians. Eligible patients were older than 18 years with a clinical diagnosis of heart failure (HF), atrial fibrillation (AF), or coronary artery disease (CAD). Participants were randomly assigned 1:1 to either the ePRO or control group. Statistical analysis was based on the intention-to-treat approach. Intervention: Patients in the ePRO group were asked to complete the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT), or Seattle Angina Questionnaire (SAQ) on smart tablets before their clinical examination. Results were reviewed by physicians at each outpatient visit. The control group received usual care consisting of medication management, lifestyle modification, and invasive procedures in accordance with clinical guidelines. Both groups had 5 monthly outpatient visits. Main Outcomes and Measures: Patient satisfaction, quality of information (QOI) provided by physicians, and disease knowledge were assessed using questionnaires (eg, Patient Satisfaction Questionnaire PSQ; score range: 5-25, with higher scores indicating greater patient satisfaction) at baseline and the fifth visit, over approximately 4 months. Results: Of the 50 patients included, 48 (median SD age, 71.0 62.3-75.0 years; 28 males 58.3%) completed follow-up. The prevalence was 56.2% (n = 27) for HF, 75.0% (n = 36) for AF, and 10.4% (n = 5) for CAD. The distribution of PRO measures used was 21 patients (43.8%) for KCCQ-12, 24 (50.0%) for AFEQT, and 3 (6.2%) for SAQ. Compared with the control group, the ePRO group showed significant improvements in mean (SD) PSQ score (0.16 2.06 vs 1.61 1.75; P = .01) and QOI score regarding treatment (-0.12 0.53 vs 0.35 0.71; P = .01). The ePRO group exhibited a greater increase in the PSQ score regarding communication (-0.12 0.53 vs 0.43 0.90; P = .01). Conclusions and Relevance: In this randomized clinical trial, implementation of the ePRO monitoring system significantly enhanced patient-physician communication and the clarity of physicians' explanations about treatment. These findings suggest that the ePRO monitoring system is capable of supporting patient-centered cardiovascular care. Trial Registration: University Hospital Medical Information Network Identifier: UMIN000049251.

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