AHA: Telephone-based remote HF monitoring reaps no rewards
Telemonitoring of heart failure patients did not improve outcomes and researchers say the results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption, according to the Tele-HF study reported at the American Heart Association (AHA) conference in Chicago this week, and simultaneously published online Nov. 16 in the New England Journal of Medicine.
"In an environment in which vendors promote their products to health systems that are under increasing pressure to reduce readmission rates, the knowledge that telemonitoring is ineffective suggests the need to consider alternative approaches to improving care," researchers concluded.
Because outcomes for heart failure patients have not improved, remote monitoring seems like a promising strategy. The researchers pointed to a recent study in the Cochrane Systematic Review, which found a 44 percent reduced rate of death from any cause and a 21 percent reduced rate of heart-failure–related hospitalizations when telemonitoring was used. However, "the quality of the methods used in the studies was variable, and many of the studies were small."
To help clarify the issue, Sarwat Chaudhry, MD, from the Yale University School of Medicine, and colleagues conducted the Tele-HF (Telemonitoring to Improve Heart Failure Outcomes) study from 2006 through 2009 at 33 U.S. practices.
In the multicenter, randomized, controlled trial, researchers randomly assigned 1,653 heart failure patients to undergo either telemonitoring or usual care. A total of 79 percent of the patients completed the six-month interview.
Investigators said the rate of completed responses was not surprising given the severity of illness in the study population. They also noted that the missing data should have minimal influence on the study outcomes.
At each practice, a site coordinator was assigned responsibility for overseeing implementation of and adherence to the protocol. Site coordinators identified patients hospitalized for heart failure in the previous 30 days.
The telemonitoring group was instructed to make daily, toll-free calls to the telephone-based interactive voice-response system (Pharos Innovations). During each call, patients heard a series of questions about general health and heart failure symptoms, and they entered responses using the telephone keypad. All questions had predetermined responses that triggered variances to flag clinicians' attention.
If patients did not use the system for two consecutive days, they received a system-generated reminder call; after that, they were contacted by site staff to encourage participation. Only 14 percent of the telemonitoring group had never used the system.
About 85 percent of patients in the telemonitoring group made at least one call; among these patients, adherence (at least three calls per week) to the intervention was highest, 90.2 percent during the first week of the study period and decreased to 55 percent by week 26.
Researchers, led by senior author Harlan Krumholz, MD, pointed out that "considerable resources, which would be difficult to leverage outside a clinical trial, were directed toward optimizing patients' engagement with the system."
In that regard, "adherence rates in this trial most likely represent the best-case scenario and are in fact similar to previously documented rates of medication adherence."
The primary endpoint was readmission for any reason or death from any cause within 180 days after enrollment. Secondary endpoints included hospitalization for heart failure, number of days in the hospital and number of hospitalizations.
There were 29,163 variances generated during the study period, with a median of 21 (interquartile range, 5 to 54) per patient.
Researchers found no significant differences in the primary endpoint between the two groups. which occurred in 52.3 percent (telemonitoring) and 51.5 percent (usual-care groups) of patients.
Readmission for any reason occurred in 49.3 percent of patients in the telemonitoring group and 47.4 percent of patients in the usual-care group. About 11 percent of patients in both groups died.
Researchers also found no significant differences between the two groups with respect to the secondary endpoints.
In the subgroup analyses, researchers found no baseline characteristics—including age, sex, race, left ventricular ejection fraction and heart failure class—that identified a group in which telemonitoring was effective.
"In interpreting our results, it is important to recognize that automated telemonitoring represents a single, focused approach to disease management," the authors wrote.
They added that perhaps more formal instructions to clinicians on patient and medication management could have influenced results.
They suggested that disease-management systems need rigorous evaluation before their adoption and they also questioned the value of findings based on systematic review of low-quality studies.
"Why was no benefit seen with the telemonitoring intervention studied in this trial?" asked Akshay S. Desai, MD, and Lynne Warner Stevenson, MD, from Brigham and Women's Hospital, in Boston, in a NEJM accompanying editorial. One possibility, they suggested, is that signals of weight and symptoms are not adequate and are in fact poor surrogates for filling pressures.
They also said that a physician who is empowered to contact the patient directly with a treatment plan, rather than a nurse intermediary, should review the remotely gathered data.
They said that some form of home surveillance is needed to reduce HF readmissions and that such a strategy does not "necessarily diminish the number of personnel required to provide effective disease management."
In the current study, each site had an average of 884 variances requiring a response. "Managing this volume of information may actually enhance the need for midlevel personnel specialized in heart failure management and may also create new concerns about liability for unread transmissions."
Desai and Stevenson concluded that it might be wise to "design training, reimbursement and a hub-and-spoke regional system incorporating a personnel force on the order of 10,000 nurses, nurse practitioners and physician assistants to offer heart failure management to the two million patients with advanced heart failure."
They added that this goal "might be achievable for less than a third of the cost associated with the number of cardioverter–defibrillators implanted annually."
"In an environment in which vendors promote their products to health systems that are under increasing pressure to reduce readmission rates, the knowledge that telemonitoring is ineffective suggests the need to consider alternative approaches to improving care," researchers concluded.
Because outcomes for heart failure patients have not improved, remote monitoring seems like a promising strategy. The researchers pointed to a recent study in the Cochrane Systematic Review, which found a 44 percent reduced rate of death from any cause and a 21 percent reduced rate of heart-failure–related hospitalizations when telemonitoring was used. However, "the quality of the methods used in the studies was variable, and many of the studies were small."
To help clarify the issue, Sarwat Chaudhry, MD, from the Yale University School of Medicine, and colleagues conducted the Tele-HF (Telemonitoring to Improve Heart Failure Outcomes) study from 2006 through 2009 at 33 U.S. practices.
In the multicenter, randomized, controlled trial, researchers randomly assigned 1,653 heart failure patients to undergo either telemonitoring or usual care. A total of 79 percent of the patients completed the six-month interview.
Investigators said the rate of completed responses was not surprising given the severity of illness in the study population. They also noted that the missing data should have minimal influence on the study outcomes.
At each practice, a site coordinator was assigned responsibility for overseeing implementation of and adherence to the protocol. Site coordinators identified patients hospitalized for heart failure in the previous 30 days.
The telemonitoring group was instructed to make daily, toll-free calls to the telephone-based interactive voice-response system (Pharos Innovations). During each call, patients heard a series of questions about general health and heart failure symptoms, and they entered responses using the telephone keypad. All questions had predetermined responses that triggered variances to flag clinicians' attention.
If patients did not use the system for two consecutive days, they received a system-generated reminder call; after that, they were contacted by site staff to encourage participation. Only 14 percent of the telemonitoring group had never used the system.
About 85 percent of patients in the telemonitoring group made at least one call; among these patients, adherence (at least three calls per week) to the intervention was highest, 90.2 percent during the first week of the study period and decreased to 55 percent by week 26.
Researchers, led by senior author Harlan Krumholz, MD, pointed out that "considerable resources, which would be difficult to leverage outside a clinical trial, were directed toward optimizing patients' engagement with the system."
In that regard, "adherence rates in this trial most likely represent the best-case scenario and are in fact similar to previously documented rates of medication adherence."
The primary endpoint was readmission for any reason or death from any cause within 180 days after enrollment. Secondary endpoints included hospitalization for heart failure, number of days in the hospital and number of hospitalizations.
There were 29,163 variances generated during the study period, with a median of 21 (interquartile range, 5 to 54) per patient.
Researchers found no significant differences in the primary endpoint between the two groups. which occurred in 52.3 percent (telemonitoring) and 51.5 percent (usual-care groups) of patients.
Readmission for any reason occurred in 49.3 percent of patients in the telemonitoring group and 47.4 percent of patients in the usual-care group. About 11 percent of patients in both groups died.
Researchers also found no significant differences between the two groups with respect to the secondary endpoints.
In the subgroup analyses, researchers found no baseline characteristics—including age, sex, race, left ventricular ejection fraction and heart failure class—that identified a group in which telemonitoring was effective.
"In interpreting our results, it is important to recognize that automated telemonitoring represents a single, focused approach to disease management," the authors wrote.
They added that perhaps more formal instructions to clinicians on patient and medication management could have influenced results.
They suggested that disease-management systems need rigorous evaluation before their adoption and they also questioned the value of findings based on systematic review of low-quality studies.
"Why was no benefit seen with the telemonitoring intervention studied in this trial?" asked Akshay S. Desai, MD, and Lynne Warner Stevenson, MD, from Brigham and Women's Hospital, in Boston, in a NEJM accompanying editorial. One possibility, they suggested, is that signals of weight and symptoms are not adequate and are in fact poor surrogates for filling pressures.
They also said that a physician who is empowered to contact the patient directly with a treatment plan, rather than a nurse intermediary, should review the remotely gathered data.
They said that some form of home surveillance is needed to reduce HF readmissions and that such a strategy does not "necessarily diminish the number of personnel required to provide effective disease management."
In the current study, each site had an average of 884 variances requiring a response. "Managing this volume of information may actually enhance the need for midlevel personnel specialized in heart failure management and may also create new concerns about liability for unread transmissions."
Desai and Stevenson concluded that it might be wise to "design training, reimbursement and a hub-and-spoke regional system incorporating a personnel force on the order of 10,000 nurses, nurse practitioners and physician assistants to offer heart failure management to the two million patients with advanced heart failure."
They added that this goal "might be achievable for less than a third of the cost associated with the number of cardioverter–defibrillators implanted annually."