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A multicenter disease management program for hospitalized patients with heart failure |
Tsuyuki R T, Fradette M, Johnson J A, Bungard T J, Eurich D T, Ashton T, Gordon W, Ikuta R, Kornder J, MacKay E, Manyari D, O'Reilly K, Semchuk W |
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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 two-stage programme for the management of patients hospitalised with heart failure (HF) was examined. In stage 1, a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme (ACE) inhibitors and other HF medications. In stage 2, patients were given a patient support programme (PSP), consisting of education on HF, self-monitoring, adherence aids, newsletters and telephone hotline, and were followed for 6 months after discharge.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients older than age 18 years, admitted to a hospital with a most responsible, primary, secondary, or complicating diagnosis of HF.
In stage 1, patients were excluded if they had known secondary causes of HF (i.e. correctable causes such as anaemia or hyperthyroidism), preserved systolic function, or were taking an angiotensin-II antagonist because of known intolerance or contraindication to ACE inhibitors. They were also excluded if they had a terminal illness with a life expectancy less than 6 months, cognitive impairment, or were attending a specialised HF clinic for medical management.
In stage 2, additional exclusion criteria were applied. More specifically, absolute contraindication to ACE inhibitors, and those discharged to a setting where patients were not responsible for administration of their own medication.
Setting The setting was both a hospital and the community. The economic study was carried out in Canada.
Dates to which data relate The assessment of clinical and economic data started between September 1999 and April 2000 and continued for 6 months. The price year appears to have been 2000.
Source of effectiveness data The effectiveness evidence was derived from a single study.
Link between effectiveness and cost data The costing was carried out prospectively on the same sample of patients as that used in the clinical study.
Study sample Power calculations were performed in the preliminary phase of the study for both stage 1 and stage 2. For stage 1, assuming 60% utilisation of ACE inhibitors at admission (based on previous studies) and an anticipated increase to 70% at hospital discharge, a sample of 300 patients would provide 95% power to detect this difference at a 5% significance level. For stage 2, assuming a 50% adherence rate in the usual care group and an anticipated increase to 70% in the patient support programme group at 6 months after discharge, a sample of 250 patients (125 per group) would be required for 90% power to detect this difference at a 5% level of significance. However, a sample of 750 patients was required in stage 1 because the recruitment of patients for stage 2 was dependent on stage 1.
Of the 2,310 consecutive patients screened, 1,544 patients were excluded because of cognitive impairment (24%), preserved systolic dysfunction (23%), or an inability to communicate (19%). Thus, a sample of 766 patients (55% men) was enrolled in stage 1. The mean age of these patients was 74 (+/- 12) years. Of these patients, 490 were further excluded because they were unwilling to participate in stage 2 (58%) or were not responsible for their own medication (30%). Thus, 276 patients were included in stage 2, of which 140 patients (58% men) were in the programme group and 136 (58% men) in the usual care group. The mean age of the patients was 71 (+/- 12) years in the programme group and 72 (+/- 12) years in the usual care group.
Study design Two different designs were used for the two phases of the study. A within-group comparative study was used in stage 1, while a prospective, randomised clinical trial was used in stage 2 when patients were allocated to the programme or usual care groups. The study was carried out in ten hospitals across Canada.
Randomisation was carried out via a telephone call by a computer-generated sequence using block randomisation (block size of 4), stratified by study site (hospital). The patients were followed for 6 months. The final outcomes could not be measured in 24 patients in the programme group (5 withdrew, 3 were lost to follow-up and 16 died) and 18 patients in the usual care group (2 withdrew, 4 were lost to follow-up and 12 died). Blinding was not used in the assessment of the outcome measures.
Analysis of effectiveness It was not stated whether the analysis of the clinical study was conducted on an intention to treat basis or on treatment completers only.
The primary outcome measure in stage 1 was the proportion of patients receiving ACE inhibitors at hospital admission compared with that at hospital discharge. The secondary outcome measure was the dosage of ACE inhibitor at hospital admission compared with that at discharge. For the purposes of this end point, all ACE inhibitor doses were converted to enalapril equivalents.
The primary outcome measure in stage 2 was medication adherence, as measured by pharmacy records. The secondary outcomes were clinical events, such as physician visits, emergency room (ER) visits, hospital readmissions, total length of stay (LOS), the proportion of patients with at least one ER visit, and the proportion of patients with at least one hospital readmission. Clinical events were grouped as all-causes or cardiovascular-related, and were recorded by patient report and through examination of the hospital records.
The authors stated that the baseline characteristics of patients in stage 2 were comparable with those of patients enrolled in stage 1. However, in stage 2, a significantly higher proportion of patients in the programme group had an ischaemic etiology compared with those in the usual care group.
Effectiveness results In the whole group during stage 1, ACE inhibitor use increased from 58% of patients on admission to 83% of patients on discharge, (p<0.0001). The average daily ACE inhibitor dose at hospital admission or drug initiation was 11.3 (+/- 8.8) mg enalapril equivalents. This increased to 14.5 (+/- 8.8) mg at hospital discharge, (p<0.0001).
ACE inhibitor adherence was 86.2% (+/- 29.0) with usual care and 83.5% (+/- 31.2) with the programme, (p=0.691).
Among secondary outcome measures, the following were significantly different and favoured the programme group:
all-cause total LOS (1,082 versus 627 days),
cardiovascular-related ER visits (49 versus 20),
cardiovascular-related total LOS (812 versus 341),
cardiovascular-related average LOS (11.6 +/- 10.3 versus 6.4 +/- 6.0 days), and
cardiovascular-related proportion of patients with at least one ER visit (21.3% versus 12.1%).
Clinical conclusions The effectiveness analysis showed that the programme did not significantly improve ACE inhibitor use, but it did reduce hospital stay in comparison with usual care for patients with HF.
Measure of benefits used in the economic analysis The health outcomes were left disaggregated and no summary benefit measure was used in the economic evaluation. In effect, a cost-consequences analysis was performed.
Direct costs The cost analysis was carried out from the perspective of a Canadian provincial health care system. The health services included in the economic evaluation were ACE inhibitors (including mark-up and dispensing fees), hospital stay during readmission, ER visit, general practitioner visit and specialist visit. Medications other than ACE inhibitors were assumed to have been comparable and were not considered in the analysis. The unit costs were presented separately from the quantities of resources used for most cost items. Resource use was based on patients' self-reported data. The costs were estimated using provincial costs for health care. Since three provinces were involved, average values were estimated. Discounting was not relevant, as the costs were incurred during 6 months, and was not applied. The price year appears to have been 2000.
Statistical analysis of costs The costs were treated deterministically.
Indirect Costs The indirect costs were not considered in the economic evaluation.
Sensitivity analysis Sensitivity analyses were not performed.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The estimated cardiovascular-related costs per patient were Can$4,548 with usual care and Can$2,017 with the intervention (difference Can$2,531).
The estimated all-cause costs per patient were Can$6,154 with usual care and Can$3,691 with the intervention (difference Can$2,463).
Synthesis of costs and benefits A synthesis of the costs and benefits was not relevant since a cost-consequences analysis was carried out.
Authors' conclusions The dedicated heart failure (HF) programme using hospital pharmacists and nurses led to a non significant improvement in ACE inhibitor usage and dosing, with significant reductions in clinical events. The reduction in costs has substantial implications in terms of cost-savings associated with the high prevalence of HF.
CRD COMMENTARY - Selection of comparators The selection of the comparator was appropriate as it reflected usual care in the authors' setting. The programme examined in the study was extensively described. You should decide whether this is a valid comparator in your own setting.
Validity of estimate of measure of effectiveness The effectiveness evidence came from a study that used two different designs. A within-group comparison study was used in stage 1 and a clinical trial in stage 2.
The use of a before-and-after design for stage 1 was justified on the grounds of practical and ethical reasons. Patients participating in the stage 1 were identified from several participating centres, and extensive details on the selection of the sample were reported. In general, the study sample appears to have been representative of the patient population. The patients in stage 1 were treated as a whole group, with a comparison of baseline characteristics being undertaken. A high proportion of patients refused to participate to the second stage of the programme, which might limit how representative the study sample was.
The use of a clinical trial was appropriate for the study question. Details on the random allocation of patients to the study groups were provided. The use of a random design limits the potential impact of selection bias and confounding factors. The two groups of patients were well matched at baseline, although the proportion of patients who had an ischaemic etiology was slightly different between groups.
A further strength of the study was the appropriateness of the sample size, which was based on statistical calculations. The authors stated that a longer follow-up period would probably allow better measurement of drug adherence. Further, the authors noted that patients in the control group were aware of participating in an "adherence study", which might have biased the results of the analysis. The reasons for loss to follow-up were reported, although this concerned only a small fraction of the patients. These issues tend to enhance the internal validity of the study.
Validity of estimate of measure of benefit No summary benefit measure was used in the analysis because a cost-consequences analysis was conducted. Please refer to the comments in the 'Validity of estimate of measure of effectiveness' field (above).
Validity of estimate of costs The perspective adopted in the study was explicitly stated and the costs included were consistent with such a perspective. The costs were estimated from typical Canadian sources using a common methodology. The unit costs were reported for some items and information on the quantities of resources used was provided for most services. This enhances the possibility of replicating the analysis in other settings. The cost estimates were treated deterministically and the use of alternative estimates was not investigated in the sensitivity analysis. The price year was reported, which aids reflation exercises in other time periods.
Other issues The authors pointed out that their study was the largest multi-centre trial conducted to date, in both academic and community centres, demonstrating the improved outcomes that could be obtained using a simple patient support programme. It was also noted that the dosage improvement observed in the current study was comparable with that reported in other published clinical trials. The authors noted that the use of a multi-centre design increased the external validity. Further, the programme could be readily adaptable to other settings because the intervention was less resource intensive, in terms of manpower and follow-up procedures, than other disease management programmes. However, the generalisability of the study results to hospitals outside Canada is limited. In addition, sensitivity analyses were not carried out. The authors noted some limitations of their study, which have been highlighted already.
Implications of the study The study results strongly support the implementation of the 6-month patient education and support programme for outpatients with HF. The authors stated that further research by their group would be directed to assess which aspects of the programme are the most important.
Source of funding Funded by an unrestricted educational grant from Parke Davis Canada (now Pfizer Canada) and the University of Alberta Hospital Foundation.
Bibliographic details Tsuyuki R T, Fradette M, Johnson J A, Bungard T J, Eurich D T, Ashton T, Gordon W, Ikuta R, Kornder J, MacKay E, Manyari D, O'Reilly K, Semchuk W. A multicenter disease management program for hospitalized patients with heart failure. Journal of Cardiac Failure 2004; 10(6): 473-480 Other publications of related interest Krumholz HN, Amatruda J, Smith GL, et al. Randomized trial of an education and support intervention to prevent readmission of patients with heart failure. Journal of the American College of Cardiology 2002;39:83-9.
Kasper EK, Gerstenblith G, Hefter G, et al. A randomized trial of the efficacy of multidisciplinary care in heart failure outpatients at high risk of hospital readmission. Journal of the American College of Cardiology 2002;38:471-80.
Bungard TJ, McAlister FA, Johnson JA, et al. Underutilisation of ACE inhibitors in patients with congestive heart failure. Drugs 2001;61:2021-33.
McAlister FA, Lawson FM, Teo KK, et al. A systematic review of randomized trials of disease management programs in heart failure. American Journal of Medicine 2001;110:378-84.
Indexing Status Subject indexing assigned by NLM MeSH Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors /therapeutic use; Canada; Counseling; Disease Management; Female; Heart Failure /drug therapy /therapy; Hospitalization /economics; Humans; Inpatients /education /psychology; Male; Middle Aged; Patient Care Team; Patient Compliance; Patient Education as Topic AccessionNumber 22005000004 Date bibliographic record published 31/01/2006 Date abstract record published 31/01/2006 |
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