‘Home time’: A new outcome for heart failure trials?

The authors of a study published in the Journal of the American College of Cardiology made the case for measuring “home time” as a clinical endpoint for heart failure (HF) patients. Time spent alive and out of healthcare institutions can be calculated from claims data and represents an important, easy-to-grasp outcome for patients, they said.

“Description of home time may be more easily understood by HF patients and may better communicate associated morbidity and mortality, including the burden of repeated hospitalizations and time spent in rehabilitation and nursing facilities,” wrote lead author Stephen J. Greene, MD, with Duke Clinical Research Institute, and colleagues. “From a clinical trial perspective, home time could represent a novel trial endpoint that intrinsically reflects traditionally reported mortality and hospitalization events, but with a patient-centered dimension and potential added sensitivity to detect changes in downstream clinical course.”

Greene et al. combined Medicare claims data with registry data from hospitals participating in the Get With the Guidelines-Heart Failure registry. From there, they were able to analyze clinical events and mortality rates as well as time spent in hospitals, skilled nursing facilities (SNFs) or rehabilitation facilities over periods of 30 days, one year and two years.

For almost 60,000 patients in the study—average age 80.7; median ejection fraction of 50 percent—home time was readily determined for 97.1 percent of the patients at 30 days and 70.6 percent of the patients at one year. The median days spent at home were 21.6 for the first 30 days after discharge and 243.9 for the first year.

Days spent in a SNF were most likely to contribute to reduced home time in that initial month, while death was the biggest contributor to a reduced home time over the first year—accounting for more than four times the reduction associated with SNF stays and about 10 times the reduction associated with rehospitalizations.

“Substantial reductions in home time were seen early and late after HF hospitalization, with only 56 percent and 19 percent of patients achieving 100 percent home time through 30 days and one year post-discharge, respectively,” the authors noted.

They also found more home time was strongly associated with both freedom from mortality and heart failure rehospitalizations at the longer follow-up points.

“Although not completely evaluated or studied as a quality metric, home time may better gauge overall health resource use as compared with the hospital readmission rate, with the ability to capture both the time-dependent and location-dependent elements of post-discharge care,” Greene and colleagues wrote.

Importantly, the analysis was restricted to Medicare beneficiaries older than 65 at hospitals participating in the Get With the Guidelines-Heart Failure program. The researchers said it is unknown whether the findings would translate to other populations of heart failure patients or to hospitals with different case mixes and resource availability.

In addition, the authors pointed out home time calculations aren’t possible until data are available for the entire time period in question. For this reason, there may be delays in determining this outcome, they said.

In an accompanying editorial, Edgar Lichstein, MD, and Abhishek Sharma, MD, said home time gets past some of the downsides of other clinical trial endpoints. Mortality often has an event rate so low that thousands of patients have to be enrolled to detect a difference in treatment, making trials more expensive. On the other hand, individual components of composite endpoints are not always guaranteed to move in the same direction in response to a treatment, they wrote.

“Home time offers greater statistical power and flexibility in analysis, as it can be treated as an ordinal variable or continuous measure with an expanded range,” Lichstein and Sharma wrote.

Also, those calculations can be retrospectively captured from already existing claims databases, allowing for analysis even when other clinical variables are unable to be assessed via in-person visits with patients.

However, home time has limitations of its own and could be affected by other factors such as social support and socioeconomic status, Lichstein and Sharma said.

“Longer home time would not always mean better quality of care,” they wrote. “Sometimes appropriate time in health care institutions such as an inpatient rehabilitation facility may improve the quality of future home time and functional outcomes. … It would be of interest to evaluate the role of socioeconomic, geographic location, and discharge disposition on home time following hospitalization for HF in future studies.”