Remote Monitoring Not Successful at Reducing Death, Readmission From HF

Neither mortality rate nor hospital readmission rate were positively affected by a 1-year remote monitoring program among individuals with a history of hospitalization for heart failure (HF), according to EMPOWER study findings published online today in JAMA Internal Medicine.

The patients with a HF diagnosis could have HF with preserved ejection fraction (HFpEF) or HF with reduced ejection fraction (HFrEF), and the program included $1.40/day financial incentives in the form of a regret lottery (“people are notified whether they won or would have won,” the authors wrote) for both weight loss and medication adherence.

“Clinicians need timely awareness of often subtle changes in weight or adherence to intervene before clinical deterioration, and yet those indicators are typically out of view,” the authors explained. “The result is a combination of awareness of the many potential opportunities for intervention along the pathway to HF readmission, and yet no efficient approaches to implement them.”

Among the participants randomized 1:1 to the compound intervention group (n = 272) or the usual care/control group (n = 280), the mean (SD) HF ejection fraction was 43% (18.1%). Overall, totals for hospital readmissions and death rates were comparable among the groups, despite the absolute count being higher in the control group.

Patients were excluded from analysis if they had a history of kidney failure, were in line to receive a heart transplant or ventricular assist device, or had a history of an uncontrolled psychiatric condition that could have a detrimental effect on their study participation.

The usual care group had 423 readmissions and 26 deaths, which comes out to 1.5 hospitalizations per group participant and a 9.3% mortality rate. The study group had 377 readmissions and 23 deaths, or the equivalent of 1.4 hospitalizations per group participant and an 8.5% mortality rate.

Those in the compound intervention cohort got electronic pill bottles for their diuretic medications and digital scales. They also received the financial incentive, but its receipt was predicated on the participants being adherent to their medication regimens and weight measures, which were automatically recorded each day. For example, any weight increases beyond 1.4 kg/24 hours triggered an alert to the treating physician, as did medication nonadherence of 5 days. But even after 2 days of not taking their medications or weighing themselves, patients got an automatic motivational message. However, only one-third (34.4%) of weight change alerts even generated a physician response.

The study included a 1-year follow-up, and recruitment took place between May 25, 2016, and April 8, 2019, at 3 hospitals in Pennsylvania, New Jersey, and Delaware, within the Penn Medicine system. Most participants were Black (52.7%) and male (52.9%), and their mean age was 64.5 (11.8) years. Everyone in both cohorts received $25 for their study participation.

Study analyses also showed that no significant differences were seen when comparing outcomes between patients with HFpEF or HFrEF (HR for interaction, 0.72; 95% CI, 0.46-1.11; P = .13).

Overall, there was an 80% adherence to weight measurements and medication regimens seen among three-fourths of the compound intervention group. And for the primary outcome of all-cause inpatient readmission or death, a risk difference of 9% was seen (unadjusted HR, 0.91; 95% CI, 0.74-1.13; P = .40) between both groups, but the study authors deemed this statistically insignificant—despite the intervention group trending toward shorter lengths of stay in hospital. There was a zero mean weight change from study start to finish, and the authors noted that engagement decreased over the 1-year follow-up.

“The patients in the intervention group did no better than those receiving usual care,” the authors concluded. “The results suggest that the combination of elements in this intervention when executed at this level of success was insufficient to alter these patients’ trajectories.”

They proposed several reasons for the lack of improvement in the compound intervention group vs the usual care group:

• Trial enrollment and device set up took too long
• Adherence thresholds for medication and weight measures could have been higher
• Weight change thresholds were too insensitive
• Patient population was too broad in that it included patients with HFrEF or HFpEF

To make progress, the authors suggested that interventions among patients with HF take place earlier and encompass measures beyond just physical parameters, such as “the many non-HF reasons that prompt readmissions of patients with HF.”

Reference

Asch DA, Troxel AB, Goldberg LR, et al. Remote monitoring and behavioral economics in managing heart failure in patients discharged from the hospital a randomized clinical trial. JAMA Intern Med. Published online May 9, 2022. doi:10.1001/jamainternmed.2022.1383