Objective: To assess the impact of supplementing nurse case management with Internet-connected telemonitoring on clinical outcomes in an elderly heart failure (HF) population.
Study design: Randomized clinical trial allocating high-risk HF subjects to the telehealth system with case management (THCM) versus case management (CM) alone.
Methods: Medicare Advantage members with HF and recent hospitalization were randomized to THCM or CM. Consenting participants received THCM for 6 months or the health plan's usual Medicare specialized CM as long as deemed necessary. The primary outcome measure was a composite of all-cause hospitalization, ED visit, or death. Because only a subset of those who were randomized consented and participated, the strategies were evaluated as-treated rather than by intention-to-treat, with multivariate adjustment in logistic regression models for confounding introduced by postrandomization exclusions.
Results: The treated sample size was 164 subjects in THCM and 152 in CM. Treatment arms did not differ significantly for the primary composite outcome (45% for THCM vs 40% for CM, relative risk 1.18; P = .22). Telehealth alerts prompted frequent telephonic contact, increasing THCM case managers' workload. The participant population overall had 42% fewer inpatient days during the intervention period compared with the previous year.
Conclusions: Despite effective implementation of an Internet-based telehealth intervention in an elderly HF population, there was no discernible impact on overall morbidity or mortality. Notably, limited postrandomization participation decreased power to detect a difference. The reduction in days hospitalized for trial participants overall underscores the benefit of CM for such HF patients.