No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .
Care Management for Low-Risk Patients with Heart Failure
Context Case management by nurses improves outcomes for patients with heart failure , but studies have targeted patients at high risk for poor outcomes because of sociodemographic or clinical factors . Whether such programs benefit low-risk patients with heart failure is unknown . Contribution Among 462 patients in 1 staff-model health maintenance organization who were hospitalized with heart failure , those r and omly assigned to nurse care management  had rates of rehospitalization and death similar to rates in those who received usual care . Implication s Care management for heart failure may offer limited benefit for patients with clinical and sociodemographic characteristics that put them at low risk for hospitalization or death . The Editors The societal and personal burden of heart failure is large and is growing apace with the aging of the population ( 1 ) . Heart failure is the largest Medicare expenditure and is the leading cause of hospitalization for persons 65 years of age or older ( 2 ) . Rates of hospital readmission within 6 months range from 25 % to 50 % ( 3 ) . Moreover , behavioral factors , such as nonadherence to diet and medications , and social factors , such as social isolation and indigence , frequently contribute to early rehospitalizations ( 3 - 4 ) . Previous studies of specialized treatment programs for heart failure have targeted clinical ly high-risk , medically underserved population s. These studies demonstrated reductions in rehospitalization for heart failure and , to a lesser extent , rehospitalization for all causes ( 4 - 6 ) . In a pilot study conducted at a single Kaiser Permanente medical center in 1994 to 1995 , we found a statistically significant reduction in rehospitalization rates during a 3-month period among low-risk patients with heart failure who received nurse care management over a 6-month period ( 7 ) . The present study evaluated nurse care management for heart failure in a low-risk population of patients selected from several medical centers in the same large health maintenance organization ( HMO ) . Methods Design This was a r and omized , controlled trial of a nurse care management system for heart failure . Patient Sample We selected patients who were hospitalized with a provisional diagnosis of heart failure from Kaiser Permanente medical centers located in San Francisco , Vallejo , Walnut Creek , Sacramento , and Roseville , California , between May 1998 and October 2000 .  Hospital-based project nurses review ed hospital charts to screen for patients with new-onset or worsening heart failure on the basis of 1 ) shortness of breath ( dyspnea at rest , including orthopnea or paroxysmal nocturnal dyspnea ) and 2 ) at least 1 corroborating clinical sign ( pulmonary congestion on examination , including rales , crackles , or wheezes ) or radiologic abnormality ( pulmonary congestion on chest radiograph ) consistent with heart failure . We excluded patients who were scheduled for coronary artery bypass or valvular surgery ; had undergone cardiac surgery in the preceding 8 weeks ; had a serum creatinine value of 13.26 mol/L ( 5 mg/dL ) or greater ; were receiving dialysis or awaiting renal transplantation ; had a history of severe pulmonary disease requiring home oxygen ; had 1 or more additional diseases that were expected to result in death within 1 year ; had cognitive mental deficits , substance abuse , or severe psychiatric disorders ; or were expected to move from the area within 1 year . We did not use measurements of left ventricular function by echocardiography , radionuclide angiography , or contrast angiography as selection criteria . Among the 59 % of patients who had left ventricular ejection fraction measured , 28 % had an ejection fraction less than 0.40 and 31 % had an ejection fraction of 0.40 or greater . Study nurses interviewed patients during hospitalization or by telephone within 2 weeks after discharge , explained the purpose of the study , and obtained written informed consent . Research staff who were not associated with delivering the intervention r and omly assigned patients to treatment conditions by using sealed assignments . Equal numbers of patients were allocated to the 2 groups in each medical center by using the Efron procedure ( 8) . Physicians were notified of r and omization assignment by letter . The institutional review boards at Stanford University and Kaiser Permanente approved the study . Baseline Data Collection Baseline data , recorded by staff nurses on st and ardized forms , included sociodemographic characteristics , self-reported illnesses , medications , and results of st and ard diagnostic studies and laboratory tests . Treatment Environment Before the study , the investigators met with the medical staffs of the 5 participating hospitals to present and discuss the research protocol , including detailed descriptions of the planned interactions between the nurse care managers and the medical staff . The medical staffs were multispecialty groups of 20 to 60 physiciansapproximately 480 physicians total . After r and omization , all patients continued to receive usual care , including instruction on diet , drug adherence , physical activity , and response to changing symptoms .  Intervention In addition to usual care , patients in the intervention group received a physician-directed , nurse-managed , home-based program for heart failure developed by the investigators ( 9 ) . Originally design ed for coronary risk factor management , this program was exp and ed to encompass heart failure . It incorporated the features of best practice design ated by Rich ( 10 ) : coordination of care across disciplines , patient and caregiver education , enhancement of self-management skills , effective follow-up , and guidelines -based medications for heart failure . Our system also incorporated the principles of heart failure management developed by the Cardiovascular Nursing Council of the American Heart Association ( 11 ) . The st and ardized , telephone-mediated intervention included the following elements : initial educational session , including a videotape ; baseline telephone counseling session ; nurse-initiated follow-up telephone contacts ; pharmacologic management ; and nurse-initiated communication with physicians . The initial 1-hour educational session with a nurse occurred in the patient 's medical center . Patients received printed educational material s , including methods for self-monitoring of symptoms , body weight , and medications ; a dietary management workbook ; food-frequency question naires ; and instructions on how to access emergency care in case symptoms abruptly worsened . Patients viewed a videotape portraying the treatment process . Two experienced Stanford-based nurse care managers provided a 45-minute baseline telephone counseling session within 1 week of r and omization ; subsequent nurse contacts were tailored to the needs of the individual patients . Nurse-initiated follow-up telephone contacts with patients during daytime weekday hours were scheduled at weekly intervals for 6 weeks ; biweekly for 8 weeks ; monthly for 3 months ; bimonthly for 6 months ; and as needed to monitor patients ' medications , laboratory assessment s , symptoms , and other medical problems . We based pharmacologic management for heart failure on published treatment guidelines ( 12 , 13 ) . The nurse care managers obtained permission from physicians to initiate and regulate pharmacologic therapy for heart failure according to study protocol . Nurse-initiated communication with physicians about patients ' current medical status was maintained and specific management problems were addressed . Nurse care managers spent an average of 9 hours per patient coordinating the treatment plan with patients and physicians during the first year . The intervention did not include consultation with social services to facilitate discharge planning or home visits after discharge . Measurement Research staff who were not associated with , and were blinded to , the intervention conditions measured health outcomes at 12 months . On the basis of review of the Kaiser Permanente medical records , project nurses used st and ardized forms to record the cause , number , and duration of hospitalizations and emergency department visits during the 12-month follow-up period . Kaiser Permanente provided more than 90 % of all care . Two cardiologists who were not associated with implementing the intervention review ed medical records on deaths , rehospitalizations , and emergency department visits to determine whether these events were primarily due to heart failure or due to other causes . They did not use discharge diagnoses recorded in the medical record to make these judgments . Rehospitalizations and emergency department visits were classified as either due to heart failure or due to other causes ; the latter were classified as cardiac or noncardiac . Outcomes The primary outcome of the study was the time to first rehospitalization for heart failure or for any cause . In our analysis , we treated deaths occurring before rehospitalization as censored data . However , analysis in which we classified deaths occurring before rehospitalization as outcome events result ed in similar conclusions , primarily because most observed deaths occurred after a rehospitalization . Secondary outcomes were the time to a composite outcome of death , rehospitalization , or emergency department visits for cardiac cause or for any cause , the proportion of patients receiving recommended pharmacotherapy , and the rate of outpatient clinic and emergency department visits . We based the study 's power on a proposed reduction in the risk for rehospitalization for heart failure from 21 % to 13 % , corresponding to a number needed to treat for benefit of 12.5 . We expected that the actual number needed to treat for benefit would be less than 12.5 . Statistical Analysis We evaluated the effect of care management on rehospitalization rates by using KaplanMeier survival curves and Cox proportional hazards regression models . We compared nominal variables by using chi-square tests , ordered variables by
No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .