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Cost effective management programme for heart failure reduces hospitalisation |
Cline C M J, Israelsson B Y A, Willenheimer R B, Broms K, Erhardt L R |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology A nurse-led education and management programme was compared to routine clinical practice for the care of patients following hospitalisation for heart failure.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients aged 65 to 84 years who were hospitalised primarily because of heart failure. Heart failure was diagnosed on the basis of characteristic signs and symptoms and was supported by at least one objective sign present on admission, such as pulmonary rates, peripheral oedema, congestion in a chest radiograph, or a third heart sound. Exclusion criteria for the study were as follows: the presence of other serious diseases that either prevented participation or were expected significantly to influence quality-of-life, morbidity, or mortality in the following year; predictable follow-up problems such as residence outside the hospital catchment area, serious alcohol or drug abuse, or psychiatric disease; inability to understand or answer the study questionnaires; participation in another trial; and discretion of the treating physician.
Setting The study was based in primary and secondary care in Sweden.
Dates to which data relate The effectiveness evidence and resource use data were collected between December 1991 and October 1993. The price year was not reported.
Source of effectiveness data Effectiveness data were derived from a single study.
Link between effectiveness and cost data Prospective costing was carried out on the same patient sample as that used in the effectiveness study.
Study sample No power calculations were reported. Eligible patients were randomised by computer generated allocation to the intervention or control group. Patients were then invited to participate on the basis of information relevant to the allocated study group (intervention or control).
The authors stated that one limitation of this study was that the study population specifically selected patients who were free from other serious diseases. However, concomitant disease is common in patients with heart failure. So, the initial study sample may not have been appropriate for the clinical study question. The authors did not report any further details about patients excluded from the initial study sample. A total of 206 patients were randomised. Informed consent following randomisation was withheld by 16 of the patients (intervention group). The authors reported that there were no significant differences between those patients who participated, and those who refused to participate in the trial. 190 patients were included in the final analysis, 80 patients were randomised to the intervention group, and 110 to the control group.
Study design This was a single-centre, prospective, randomised, controlled trial. Patients were followed-up for one-year. A total of 55 patients were lost to follow-up (24 in the intervention group and 31 in the control group) because they died. No blinding method for the assessment of outcomes was reported.
Analysis of effectiveness The analysis presented was for survivors at 1 year follow up (i.e. treatment completers) only. The primary health outcomes used in the analysis were: mortality at one-year; (quality-of-life in heart failure; Nottingham Health Profile; and patients global assessment of health related quality of life. The two patient groups were comparable in terms of age, gender, degree of heart failure (moderately severe), and cause of heart failure (ischaemic heart disease). The two groups differed significantly with respect to the baseline left ventricular ejection fraction, which was lower in the intervention group.
Effectiveness results There were no statistically significant differences between the intervention and control groups at 1-year follow up in mortality (30%, n=24 versus 28%, n=31 respectively), quality-of-life in heart failure (3.5 versus 3.5 respectively), Nottingham Health Profile (25.3 versus 23.4 respectively), or patients global assessment of health related quality of life (3.3 versus 3.2 respectively).
Clinical conclusions The authors concluded that the management programme for patients with heart failure could reduce hospital readmission and costs without impairing quality of life.
Modelling A Kaplan-Meier survival curve was used to estimate survival.
Measure of benefits used in the economic analysis The clinical outcomes were reported in a disaggregated fashion and, as such, the study should be regarded as a cost-consequences analysis.
Direct costs Quantities and costs were not analysed separately. The direct costs for the hospital were included in this analysis. The costs identified and measured were those associated with: the intervention (group information visit; telephone contact with study nurse; out-patient contact with study nurse including administrative costs, nurses' salaries and overheads; doctors visits; and re-admissions (in-patient costs). The estimation of the quantities of doctors' visits and re-admissions was collected from patients and hospital records. All unit costs were based on charges from the hospital to patients not covered by Swedish Health Insurance. No unit costs were available for telephone calls or in-hospital visits. The cost of an in-patient visit by a study nurse was estimated to be 50% of an out-patient visit ($20). The data on resources used were collected between December 1991 and October 1993. The price year was not reported. The time horizon was one-year from the time the patient was randomised and received the intervention or control group care, or until the patient died. Discounting was not carried out because of the short time frame of the study (one-year).
Statistical analysis of costs The Mann-Whitney U test was used to analyse the costs because it was continuous non-normally distributed data.
Indirect Costs No indirect costs were included in this analysis because they were not consistent with the study perspective.
Currency Costs were valued in Swedish kroner (Sek) and were reported in US dollars ($). The conversion rate used in this study was US$1 = Sek7.76. The date for this conversion rate was not reported.
Sensitivity analysis No sensitivity analysis was reported.
Estimated benefits used in the economic analysis See effectiveness results above.
Cost results There was no significant difference between the number of days hospitalised in the intervention group (4.2 days, SD: 7.8) and the control group (8.2 days, SD: 14.3, p<0.07). The mean time to re-admission was longer in the intervention group (141 days, SD: 87) than in the control group (106 days SD: 100, p<0.05). The total annual costs per patient for the intervention group were $3,594. The total annual costs per patient for the control group were $2,294. The mean net saving of the intervention group was -US$1,300, (p=0.07).
Synthesis of costs and benefits The estimated benefits and costs were not combined. The intervention group was similar in terms of effectiveness and less costly than the control group.
Authors' conclusions The authors concluded that the management programme for patients with heart failure discharged after hospitalisation reduces health care costs and the need for readmission with no impairment to quality of life.
CRD COMMENTARY - Selection of comparators The authors stated that the treatment for the control group (comparator) reflected routine clinic care in the study setting. They did not, however, define or describe routine clinical care for the study population or study sample. The authors noted that the care providers for the control group were familiar with the intervention, so that the control treatment may have included some of the elements of the intervention treatment. In addition, a heart failure unit, opened toward the end of the study, provided patient self-management and education, and nurse directed follow-up as part of routine care. This may also have influenced the content of routine clinical practice in the study. You, as a user of this database, should consider whether the two alternatives compared in this study are relevant to practice in your own setting.
Validity of estimate of measure of effectiveness The analysis was based on data collected in a prospective randomised trial. The authors did not report procedures to mask the patients, care providers and investigators to treatment allocation. In addition, a higher proportion of patients allocated to the intervention group refused to participate than those allocated to the control group. Only patients who completed the 1-year follow-up were included in the analysis of effectiveness and cost data. These factors may bias the analysis. The study sample excluded all patients with disease states in addition to heart failure and was selected from hospitalised patients only. The authors note that the study sample may not reflect the actual patient population who would require the intervention in clinical practice. The intervention and control groups were comparable at baseline in all but 1 factor (left ventricular fraction).
The authors did not report whether the study had sufficient power to detect statistically significant differences. It is not possible to determine whether the similar mortality and quality-of-life results were due to therapeutic equivalence of the intervention and control or to the fact that there was insufficient power to detect a statistically significant difference. As noted above the treatment given to the control group may have been contaminated by knowledge of the intervention on the part of local health care providers. This confounding factor may reduce the power to detect statistically significant differences between the groups. The authors did not report any statistical analyses to take account of these potential biases and confounding factors.
Validity of estimate of measure of benefit The authors did not define a measure of health benefit for the economic analysis. The authors hypothesised that there would be no difference in quality-of-life, but did not demonstrate this. The analysis was categorised as a cost consequences analysis.
Validity of estimate of costs The authors did not explicitly report the study perspective. Only the direct costs of hospital care services were included. These appeared to include the key items for the limited hospital perspective. The costs were based on charges by a University teaching hospital (the study centre) to patients not covered by Swedish healthcare insurance. The authors reported that these charges included hospital costs only and excluded profits and other costs. The authors reported numbers of hospital admissions and hospital days but did not report the quantities and unit costs for other resources used. The resource use data were collected prospectively from patients and hospital records. It is not possible directly to extrapolate the results of this Swedish based study to UK clinical practice. The authors conducted a statistical analysis of the differences in hospitalisation and length of stay and hospital costs.
Other issues The authors compared the results of the study with other published studies of education and management programmes for heart failure and chronic obstructive disease. The authors discussed the generalisability of the results to other patient groups, but not to other settings.
Implications of the study The authors reported that the management programme for patients with heart failure, that included patient education, self-management, and follow-up at an easy access, nurse directed out-patient clinic for one-year after hospitalisation can reduce subsequent readmission and health care costs without impairing quality of life. The authors noted that another study would be required to assess the effect of the intervention on an out-patient population rather than a population of patients who were initially hospitalised.
Source of funding Supported by grants from the Swedish Heart and Lung Foundation, the research foundation administered by Malmo University Hospital, and the Council for Health Care Research, Lund University.
Bibliographic details Cline C M J, Israelsson B Y A, Willenheimer R B, Broms K, Erhardt L R. Cost effective management programme for heart failure reduces hospitalisation. Heart 1998; 80(5): 442-446 Other publications of related interest Comment in: Heart 1998;80(5):430-1.
Indexing Status Subject indexing assigned by NLM MeSH Aged; Aged, 80 and over; Cost-Benefit Analysis; Female; Follow-Up Studies; Heart Failure /economics /mortality /therapy; Hospitalization /economics /statistics & Hospitals, University /economics /utilization; Humans; Male; Patient Care Planning /economics /organization & Program Evaluation; Prospective Studies; Recurrence; Statistics, Nonparametric; Survival Rate; Treatment Outcome; administration; numerical data AccessionNumber 21998001740 Date bibliographic record published 31/01/2002 Date abstract record published 31/01/2002 |
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