Editorial

Heart failure disease management programs: efficacy and limitations

Prior studies suggest that disease management programs may be effective in improving clinical and economic outcomes in patients with heart failure. Whether these types of programs can lower health care cost and be adapted to the primary care setting is unknown. This study was designed to assess the impact of a home-based disease management program, the Alere DayLink HF Monitoring System (HFMS), on the clinical and economic outcomes of Medicare beneficiaries recently hospitalized for heart failure who received the care from a community-based primary care practitioner.

The Heart Failure Home Care trial was a multicenter, randomized, controlled trial of sophisticated, monitoring of heart failure patients with an interactive program versus standard heart failure care with enhanced patient education and follow-up (SC) in Medicare-eligible patients. The study endpoints included cardiovascular death or rehospitalization for heart failure, length of hospital stay, total patient cost, and cost to Medicare at 6 months of enrollment. A total of 315 patients age ≥65 years old were randomized: 160 to the HFMS and 155 to SC. There were no significant statistical differences between the groups in regards to 6-month cardiac mortality, rehospitalizations for heart failure, or length of hospital stay. Of those, 304 patients had their Medicare data available. The information from the Medicare claims data was used to determine the cost. Information from the trial was used to determine costs of out-patient drugs and the interventions. The 6-month mean Medicare costs were estimated to be $17,837 and $13,886 for the HFMS and the SC groups, respectively. We found that overall medical costs of medicare patients were significantly higher for patients who were randomized to the HFMS arm than they were for the patients randomized to the SC arm.

Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program and less costly in patients who are elderly and receive the care from a community-based primary care practitioner.

Disease management programs (DMPs) are developed to address the high morbi-mortality and costs of congestive heart failure (CHF). Most studies have focused on intensive programs in academic centers. Washington County Hospital (WCH) in Hagerstown, MD, the primary reference to a semirural county, established a CHF DMP in 2001 with standardized documentation of screening and participation. Linkage to electronic records and state vital statistics enabled examination of the CHF population including individuals participating and those ineligible for the program.

All WCH inpatients with CHF International Classification of Diseases, Ninth Revision code in any position of the hospital list discharged alive.

Of 4,545 consecutive CHF admissions, only 10% enrolled and of those only 52.2% made a call. Enrollment in the program was related to: age (OR 0.64 per decade older, 95% CI 0.58-0.70), CHF as the main reason for admission (OR 3.58, 95% CI 2.4-4.8), previous admission for CHF (OR 1.14, 95% CI 1.09-1.2), and shorter hospital stay (OR 0.94 per day longer, 95% CI 0.87-0.99). Among DMP participants mortality rates were lowest in the first month (80/1000 person-years) and increased subsequently. The opposite mortality trend occurred in nonenrolled groups with mortality in the first month of 814 per 1000 person-years in refusers and even higher in ineligible (1569/1000 person-years). This difference remained significant after adjustment. Re-admission rates were lower among participants who called consistently (adjusted incidence rate ratio 0.62, 95% CI 0.52-0.77).

Only a small and highly select group participated in a low-intensity DMP for CHF in a community-based hospital. Design of DMPs should incorporate these strong selective factors to maximize program impact.

Prior studies suggest that disease management programs may be effective in improving clinical outcomes in patients with heart failure (HF). However, the use of these programs in settings with limited sources and among diverse population is not know. Thus the present study was designed to assess the impact of a computer-based home disease management program (Alere DayLink HF Monitoring System [HFMS]) on the clinical outcomes of Medicare beneficiaries with HF who were elderly, women, and non-white males who received the care from a community-based primary care practitioner.

The Heart Failure Home Care (HFHC) trial was a multicenter, randomized, controlled trial of HFMS versus standard heart failure care (SC: enhanced patient education, education to clinicians, and follow-up).The primary study end point was treatment failure, defined as a composite of cardiovascular death or rehospitalization for heart failure within 6 months of enrollment. Among patients rehospitalized for HF, length of hospital stay was also considered a primary end point. A total of 315 patients were randomized: 160 to HFMS and 155 to SC. Although the incidence of the primary outcome was somewhat higher in the SC arm (28.8% versus 21.2%, P = .15), the difference was not statistically different. The length of hospital stay was also similar in both groups.

Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program in patients with HF who are elderly, women and non-Caucasian males and receive the care from a community-based primary care practitioner.

To describe the design, implementation, baseline data, and feasibility of establishing a disease management program for smoking cessation in rural primary care.

The study is a randomized clinical trial evaluating a disease management program for smoking cessation. The intervention combined pharmacotherapy, telephone counseling, and physician feedback, and repeated intervention over two years. The program began in 2004 and was implemented in 50 primary care clinics across the State of Kansas.

Of eligible patients, 73% were interested in study participation. 750 enrolled participants were predominantly Caucasian, female, employed, and averaged 47.2 years of age (SD = 13.1). In addition to smoking, 427 (57%) had at least one additional major risk factor for cardiovascular disease (diabetes, hypertension, high cholesterol, heart disease or stroke). Participants smoked on average 23.7 (SD = 10.4) cigarettes per day, were contemplating (61%) or preparing to quit (30%), were highly motivated and confident of their ability to quit smoking, and reported seeing their physicians multiple times in the past twelve months (Median = 3.50; Mean = 5.48; SD = 6.58).

Initial findings demonstrate the willingness of patients to enroll in a two-year disease management program to address nicotine dependence, even among patients not ready to make a quit attempt. These findings support the feasibility of identifying and enrolling rural smokers within the primary care setting.

Heart failure (HF) ambulatory disease management programs appear to offer the greatest benefit to HF patients at highest risk, defined as having New York Heart Association (NYHA) functional Class III or IV symptoms. The Latitude Patient Management System is the first HF management tool to use wireless telemetry present in a cardiac resynchronization therapy defibrillator (CRT-D) device that is linked to remotely collect blood pressure and weight measures, permitting a single transmission reporting device data. Potential advantages of this system include ease of data transmissions, correlation among measures of HF status, arrhythmic events, and device performance. However, the use and ultimate utility of these combined features for patient management are untested.

The Remote Active Monitoring in Patients with Heart Failure (RAPID-RF) study is a multicenter registry that will enroll up to 1000 patients on the Latitude Patient Management System from approximately 100 centers. The primary objective is to examine physician responses to Latitude Active Monitoring data alerts by assessing alert-related medical interventions. Minimum follow-up will be 3 months after implant with a maximum follow-up time of 24 months after implant.

The RAPID-RF study will provide important preliminary data on how remotely collected HF and arrhythmic surveillance data alter the management of HF patients with CRT-D devices.

Determine the effect on hospitalization cost of a heart failure disease management (HFDM) program delivered within a diverse provider network as demonstrated in the SPAN-CHF randomized controlled trial.

The SPAN-CHF trial was a prospective randomized assessment of the effectiveness of HFDM delivered for 90 days across a diverse provider network in a heterogeneous population of 200 patients. Baseline clinical and demographic data were obtained on each patient, mortality was monitored, and hospitalizations were tracked for 90 days. Cost estimates for each hospitalization were based on a subsample of patients seen at Tufts–New England Medical Center for whom hospitalization costs were calculated. Heart failure disease management program costs were estimated using a programmatic budget model. Hospital utilization and cost data were combined to estimate medical costs for intervention and control groups.

Heart failure disease management had a favorable effect on heart failure hospitalization, which was partially offset by noncardiac hospitalizations. The relative odds of at least one all-cause hospitalization during the intervention period trended less for the intervention group compared with the control group (0.76 [95% CI 0.38-1.51]). The point estimate of the differential hospitalization cost between control and intervention groups was a reduction in cost of $375 per patient. The net effect including the costs of the program was an increase of $488 per patient for the intervention group compared with the control group. The program would have been cost saving if HFDM costs had been 24% lower.

The HFDM intervention, administered over 90 days to patients hospitalized for heart failure, succeeded in reducing the rate of heart failure hospitalizations, although this effect was partially offset by an increase in non–heart failure hospitalizations. The resulting modest reduction in all-cause hospitalization costs was exceeded by the cost of the intervention. Thus, although the reduction in heart failure may be interpreted as an improvement in health status, it could not be considered cost saving.