In HF, possible longer-term benefits emerge with remote management strategy
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Among adults with HF, temporary exposure to a remote patient monitoring strategy was not associated with lower risk for all-cause death or hospitalization compared with usual care, though some longer-term benefits were observed, data show.
In the prior Interdisciplinary Network Heart Failure (INH) trial, a 6-month telephone-based, nurse-coordinated remote patient management strategy, HeartNetCare-HF, did not reduce the primary outcome of time to all-cause death or rehospitalization in patients after acute decompensation for systolic HF compared with usual care; however, all-cause mortality was lower and quality of life measures were better in the remote management group.
Data were derived Angermann CE, et al. JACC Heart Fail. 2023;doi:10.1016/j.jchf.2022.10.016.
The extended INH (E-INH) trial investigated the effects of 18 months’ application of remote management in a larger population. The intervention included an initial 6-month period with frequent telephone contacts between specialized nurses and patients, followed by 12 months of less frequent contacts. After remote management stopped, researchers followed surviving participants up to 60 months for primary outcome events and up to 120 months for all-cause mortality.
“Few randomized remote patient management trials have considered intervention duration and frequency or have assessed quality of life or whether benefits persist after intervention termination, and most health systems have not widely implemented remote patient management into clinical practice,” Christiane E. Angermann, MD, professor of cardiology at the University Hospital of Würzburg in Germany, and colleagues wrote in the study background. “In the COVID-19 era, however, changes in policy and reimbursement improved the feasibility of remote patient management, and there is increasing demand for evidence-based and easily implemented remote patient management strategies.”
Lower rates of CV death, hospitalization
Angermann and colleagues analyzed data from 1,022 adults hospitalized for acute HF and with a predischarge ejection fraction of 40% or lower randomly assigned remote patient management plus usual care (n = 509) or usual care alone (n = 513).
“During the first month, weekly calls served to establish remote patient management,” the researchers wrote. “Contact frequencies were then individualized depending on NYHA class at discharge. Through months 7 to 18, call frequencies were reduced (depending on current NYHA functional class), but were individually adaptable according to nurses’ decision. Feedback calls were scheduled after major changes in guideline-directed medical therapy.”
Usual care included standard discharge planning and a discharge letter with recommendations for guideline-directed medical therapy plus a medical appointment within 7 to 14 days. In-person follow-up visits for the cohort took place every 6 months during remote management and then at 36, 60 and 120 months. The primary efficacy outcome was time to a first event of the composite of all-cause death or hospitalization. Secondary outcomes included all-cause death and all-cause hospitalization, CV mortality and/or CV hospitalization and changes in health-related quality of life.
The findings were published in JACC: Heart Failure.
The primary outcome did not differ between groups at 18 months (remote management, 60.7%; usual care, 61.2%; HR = 0.96; 95% CI, 0.82-1.13; P = .63) or at 60 months (remote management, 78.1%; usual care, 82.8%; HR = 0.88; 95% CI, 0.77-1.01; P = .077).
At 60 and 120 months, all-cause mortality was lower among patients who were previously assigned remote patient management compared with patients in the usual care group, with rates of 41.1% vs. 47.4% at 60 months (P = .04) and 64% vs. 69.6% at 120 months (P = .019).
At all visits, health-related quality of life was better among patients exposed to HeartNetCare-HF compared with usual care, according to the researchers.
“The E-INH study showed no significant differences between the remote patient management and control groups in the composite primary outcome of time to all-cause death or hospitalization at 18 and 60 months,” the researchers wrote. “However, at both time points, lower rates of cardiovascular death and cardiovascular hospitalization were consistently observed in the remote patient management vs. control group.”
Improved quality of life measures
The researchers noted that lower 120-month all-cause and CV mortality rates among patients previously exposed to HeartNetCare-HF suggest beneficial longer-term effects, although the possibility of a chance finding remains.
“Although the primary composite outcome of time to death or hospitalization did not differ significantly between the remote patient management and control groups at the end of the 18-month HeartNetCare-HF intervention and at 60-month follow-up, increasing between-group differences in both primary outcome components and in cardiovascular mortality and/or morbidity developed in longer-term survivors of acute HF, and health-related quality of life was improved throughout the 120-month study period,” the researchers wrote.
Shift to ‘meaningful outcomes’ needed
In a related editorial, Muhammad Shahzeb Khan, MD, MSc, assistant professor of medicine at Duke University School of Medicine, and Harriette G.C. Van Spall, MD, MPH, FRCPC, associate professor of medicine and scientist at the Population Health Research Institute at McMaster University in Hamilton, Ontario, Canada, wrote that trialists should consider shifting primary outcomes for health service trials toward “meaningful process outcomes,” such as uptake of evidence-based medical therapies, or patient-reported outcomes, such as health status or satisfaction with care.
“Important outcomes such as access, efficiency, and cost of care should also be considered,” Khan and Van Spall wrote. “Although the appeal of designing health service intervention trials with all-cause primary efficacy endpoints is understandable, we think that such an approach may not actually be necessary and may hinder the implementation of health care services that are beneficial to patients and the health care system.”
References:
- Angermann CE, et al. Circ Heart Fail. 2012;doi:10.1161/CIRCHEARTFAILURE.111.962969.
- Khan MS, et al. JACC Heart Fail. 2023;doi:10.1016/j.jchf.2022.10.015.
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