Accepted for/Published in: JMIR Formative Research
Date Submitted: Apr 22, 2023
Date Accepted: Mar 15, 2024
Remote Symptom Monitoring Using Patient-Reported Outcomes in Patients With Chronic Kidney Disease: A Process Evaluation of a Randomized Controlled Trial
ABSTRACT
Background:
In Denmark, outpatient follow-up in patients with chronic kidney disease is changing from in-hospital visits toward more remote health care delivery. We developed and implemented an intervention using patient-reported outcome (PRO) measures to monitor the outpatients remotely.
Objective:
This study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician utilization patterns, (3) patient adherence to the intervention and (4) clinical engagement.
Methods:
A process evaluation determining the reach, dose, fidelity and clinical engagement was carried out alongside a multicenter randomized controlled trial. Data was collected for the PRO intervention arms in the trial from 4 sources: (1) PRO-data from the participants to determine personal factors, (2) the web-based PRO-system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semi-structured interviews conducted with a subset of involved physicians.
Results:
Among the 320 invited patients, 152 (48%) accepted to participate. The study population reflected the target population. The adherence rate to the PRO intervention arms was 82%, 95% CI (76;87). The response rate of the questionnaires was 539/544 (99.1%) and the mean item response rate was 14,314/14,788 (96.7%). Physicians assessed 424/539 (79%) of the questionnaires. Physicians found PRO-based remote follow-up beneficial for assessing the patient's health. However, some barriers were emphasized, such as loss of personal relation to the patient and the risk of missing important symptoms in the absence of a face-to-face assessment.
Conclusions:
Overall, utilization of the system showed high usage of the components; reach, dose and fidelity. Qualitative findings suggested a combination of remote and face-to-face consultations as the best approach to manage outpatients. The findings provide guidance on how the intervention may be improved and targeted to the most suitable patients. Clinical Trial: ClinicalTrials.gov Identifier: NCT03847766
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