Remote Follow-up in a Heart Failure Pragmatic Trial: Insights From the CONNECT-HF

Area of Science:

• Clinical Trials
• Cardiology
• Health Services Research

Background:

• Randomized controlled trials (RCTs) often necessitate in-person visits, increasing participant and site burden.
• Remote follow-up methods, including centralized call centers for participant-reported outcomes (PROs), offer potential cost savings and improved trial pragmatism.
• This study analyzes the CONNECT-HF trial to assess the completeness and validity of remote follow-up processes.

Purpose of the Study:

• To evaluate the completeness and validity of remote follow-up in the CONNECT-HF trial.
• To compare participant-reported versus site-reported data for hospitalization events.
• To determine the optimal strategy for capturing and validating outcomes in pragmatic heart failure trials.

Main Methods:

• Secondary analysis of the CONNECT-HF trial, comparing a quality-improvement intervention to usual care.
• Utilized a centralized call center for participant/proxy-reported events and medical record queries for site-reported events.
• Adjudication of collected medical records for suspected hospitalization events.

Main Results:

• Out of 5942 potential hospitalizations, 18% were participant-reported only, 50% site-reported only, and 28% reported by both.
• High concordance between reports and adjudication for all-cause hospitalizations (86-87%).
• Consistent rates for adjudicated heart failure hospitalizations (45-50%) across reporting methods.

Conclusions:

• Relying solely on participant-only or site-only reports misses significant hospitalization events.
• Participant and site reports demonstrate similar concordance with adjudicated outcomes.
• Integrating both participant- and site-reported data is essential for effective hospitalization capture and validation in pragmatic heart failure trials.