Background: Randomized controlled trials typically require study-specific visits, which can burden participants and sites. Remote follow-up, such as centralized call centers for participant-reported or site-reported, holds promise for reducing costs and enhancing the pragmatism of trials. In this secondary analysis of the CONNECT-HF trial, we aimed to evaluate the completeness and validity of the remote follow-up process.
Methods and results: CONNECT-HF evaluated the effect of a post-discharge quality improvement intervention for heart failure compared to usual care for up to 1 year. Suspected events were reported either by participants or healthcare proxies through a centralized call center, or by sites through medical record queries. When potential hospitalization events were suspected, additional medical records were collected and adjudicated. Among 5,942 potential hospitalizations, 18% were only participant-reported, 28% were reported by both participants and sites, and 50% were only site-reported. Concordance rates between the participant/site reports and adjudication for hospitalization were high: 87% participant-reported, 86% both, and 86% site-reported. Rates of adjudicated heart failure hospitalization events among adjudicated all-cause hospitalization were lower but also consistent: 45% participant-reported, 50% both, and 50% site-reported.
Conclusions: Participant-only and site-only reports missed a substantial number of hospitalization events. We observed similar concordance between participant/site reports and adjudication for hospitalizations. Combining participant-reported and site-reported outcomes data are important to effectively capture and validate hospitalizations within pragmatic heart failure trials.
Keywords: centralized call center; heart failure; pragmatic trial; remote follow-up.
Copyright © 2024. Published by Elsevier Inc.