Appendix C.1. Of the. Evaluation of Lifestyle Modification and Cardiac Rehabilitation in Medicare Beneficiaries*

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The Centers for Medicare & Medicaid Services' Office of Research, Development, and Information (ORDI) strives to make information available to all. Nevertheless, portions of our files including charts,
The Centers for Medicare & Medicaid Services' Office of Research, Development, and Information (ORDI) strives to make information available to all. Nevertheless, portions of our files including charts, tables, and graphics may be difficult to read using assistive technology. In some cases due to size or complexity, we were not able to make files fully accessible using assistive technology. Persons with disabilities experiencing problems accessing portions of any file should contact ORDI through at Appendix C.1 Of the Evaluation of Lifestyle Modification and Cardiac Rehabilitation in Medicare Beneficiaries* The Economics of Cardiac Rehabilitation: A Review of Literature A. James Lee, PhD Gail K. Strickler, PhD, MS Donald S. Shepard, PhD Schneider Institute for Health Policy Heller School, MS 035 Brandeis, University Waltham, MA April 30, 2009 *Supported by the Centers for Medicare & Medicaid Services under contract number , Task Order 02 to Brandeis University and number MDBU to the Delmarva Foundation for Medical Care + Citation for published version: Lee AJ, Strickler GK, Shepard DS (2007). The economics of cardiac rehabilitation: a review of literature. Journal of Cardiopulmonary Rehabilitation and Prevention 27(3): Reprinted by permission of Wolters Kluwer Lippincott Williams & Wilkins, Baltimore, MD, Table of Contents Introduction and Statement of Purpose...1 Review of Relevant Literature...1 Cost Analysis of a Five-Year Non-Randomized Trial of Exercise-Only Cardiac Rehabilitation...5 Differences in Rehospitalization Charges for Self-Selected Cardiac Rehabilitation Patients...6 A Meta-Analysis Based Cost-Effectiveness Estimate...6 The Costs of Hospital vs. Home-Based Rehabilitation...7 Economic Evaluation of a Randomized Trial...8 Exercise vs. Stress Management Training...9 Effects on Health Care Utilization in Patients Aged 65 and Older...10 Traditional vs. Modified Cardiac Rehabilitation...11 A Limited Trial of Lifestyle Interventions in General Practice...12 The Estimated Costs and Savings of Medical Nutrition Therapy...12 Discussion and Application to Practice...13 Summary and Conclusions...14 References...15 List of Tables Table 4.1. Summary of Study Findings, Strengths and Weaknesses...2 ii Introduction and Statement of Purpose The goal of this review is to identify, review and rate all available credible evidence on the costs and cost effectiveness of cardiac lifestyle modification and related modalities, reflecting information as reported on all such modalities in the scientific literature. Unfortunately, the available literature in this area is both extraordinarily thin and highly variable in research integrity. While we felt obliged to be comprehensive in our review of this limited literature, we nevertheless thought it important to highlight the variable quality of this literature and explicitly acknowledge our lesser confidence in the findings from some studies. Heterogeneity of study methods precluded formal meta-analysis. Review of Relevant Literature One truly excellent literature review (Oldridge 1997) provided an invaluable point of departure and foundation for this report. In further searching the literature, we used MEDLINE and NLM Gateway to identify published articles with various subsets of keywords, including heart, cardiac rehabilitation, diet, exercise, lifestyle, cost and cost-effectiveness. We considered only those studies published in English, and reporting original empirical findings focused on cardiac rehabilitation (CR)-type programs and related interventions. Based on the abstracts, case-control and other very small-scale comparisons were eliminated, as were studies that reported only pre-post comparisons with no control group. We then obtained full text documents for studies remaining and eliminated those with manifest methodological flaws (e.g., using only a demographically-matched control group). Additional, generally older studies were identified from the literature reviews and bibliographies included in newer studies. Cost-related studies identified by the authors of other chapters were also referred to our attention. No meta-analyses were found. The studies described below are loosely organized in order of usefulness and quality. Their key findings, strengths and weaknesses are summarized in Table Table 4.1. Summary of Study Findings, Strengths and Weaknesses Study Key Finding Strength(s) Weakness(es) Cost Analysis of a Five-Year Non- Randomized Trial of Exercise-Only Cardiac Rehabilitation (Levin et al. 1991) Savings in health treatment expense nearly five times as large as the cost of this exercise-only program. Five-year followup; wellmatched comparison group. Comparatively small sample sizes (about 150 each); program conducted more than 25 years ago; exercise only program. Differences in Rehospitalization Charges for Self-Selected Cardiac Rehabilitation Patients (Ades et al. 1992) Short-term savings in rehospitalization charges amounts to two-thirds of cost for traditional cardiac rehabilitation program. Modern cardiac rehabilitation program; supporting analysis of covariance. Entry into cardiac rehabilitation self-selected; physician charges not monitored; charges rather than cost; only 21-month followup. A Meta-Analysis Based Cost- Effectiveness Estimate (Ades et al. 1997) Incremental life expectancy of years for cardiac rehabilitation participants; net cost (in 2003 dollars) of a cardiac rehabilitation program amounts to approximately $6,000 per life-year saved. Meta-analysis of 22 randomized trials of cardiac rehabilitation; involving total of 2,200 patients. Meta-analysis data reflect experience of mostly male, non-elderly populations who underwent rehabilitation prior to availability of thrombolytic therapy and lipid-lowering drugs; health care cost savings estimate based on single study (Ades et al. 1992). 2 Study Key Finding Strength(s) Weakness(es) The Costs of Hospital vs. Home- Based Rehabilitation (Marchionni et al. 2003) Home-based program costing less than a fifth of hospitalbased program; notably lower health care costs in the homebased program. Randomized trial with three groups: hospitalbased, home-based and control; 12-month followup; supporting evidence from total work capacity and healthrelated quality of life measurements. Small sample sizes (90 each); statistical significance of cost differences not reported (but evidently not significant). Economic Evaluation of a Randomized Trial (Oldridge et al. 1993) Estimated cost per qualityadjusted life-year gained of nearly $12,000 in 2003 dollars. Randomized trial; 12- month followup; modern cardiac rehabilitation program. Small sample sizes (about 100 each); includes only AMI patients with anxiety or depression; reflects only three-year survival difference. Exercise vs. Stress Management Training (Blumenthal et al. 2002) Compared to exercise-only program, significantly lower cardiac rehospitalization costs for participants in stress management-only program. Randomized assignment to two treatment arms; five-year followup. Very small sample sizes (ranging from 26 to 37); nonequivalent control group; primitive and incomplete costing methodology. Effects on Health Care Utilization in Patients Aged 65 and Older (Bondestam et al. 1995) Rehospitalization and emergency visit rates significantly lower in aged AMI patients receiving two home visits by a specially trained nurse and encouraged to exercise. 12-month followup. Modest treatment; small sample sizes (less than 100 each); questionable control group. 3 Study Key Finding Strength(s) Weakness(es) Traditional vs. Modified Cardiac Rehabilitation (Carlson et al. 2000) Compared to traditional cardiac rehabilitation, cost of modified protocol program emphasizing off-site exercise about a third less. Examined a less expensive version of cardiac rehabilitation. Very small sample sizes (about 40); only six-month observational interval; questionable cost measures. A Limited Trial of Lifestyle Interventions in General Practice (Salkeld et al. 1997) General practice-based educational interventions (videos and self-help booklets) directed at high risk males costing about $40,000 (2003 dollars) per life-year saved, based on associated cardiovascular risk factor improvements. Randomized design. Modest interventions; extraordinary patient attrition (36 percent); insignificant risk factor differences; authors concede insufficient evidence. The Estimated Costs and Savings of Medical Nutrition Therapy (Sheils et al. 1999) Providing medical nutrition therapy to aged cardiac patients associated with significant reduction in hospital use and physician visits. Large sample of HMO claims data. Apparent reductions in health care use and expense improbably large for an illdefined, brief intervention; questionable control for regression to the mean after expensive inpatient episode; concerned that results reflecting non-causal correlation. 4 Cost Analysis of a Five-Year Non-Randomized Trial of Exercise-Only Cardiac Rehabilitation In Sweden, Levin et al. (1991) monitored the direct and indirect costs of CR following acute myocardial infarction (AMI), comparing the five-year experience of 147 post-ami patients under age 65 (124 males, 23 females) who received CR to the experience of 158 similar patients (134 males, 24 females) who received standard care. Between August 1977 and December 1980, all these eligible AMI patients discharged from a district hospital in Sweden were invited to participate in a medically supervised, hospital-based physical training program. Beginning six weeks after AMI, patients were to exercise (cycling, jogging and calisthenics) twice weekly at the hospital for three months. After this initial training interval, hospital-based training was phased out over a two-year interval, and patients were encouraged to continue with home-based training. The control group includes all similarly eligible patients discharged from a neighboring district hospital between 1978 and These patients received standard care, consisting of one post-ami visit to the hospital clinic, followed by referral to primary health care. The two hospitals offered comparable treatment for AMI patients, with similar lengths of stay. The two geographically defined catchment areas are similar, and the baseline demographic and clinical characteristics of the two study cohorts are remarkably similar. Some 82 of the 147 patients included in the treatment group (56%) completed the first three months of physical training, and 72 patients (49%) continued training after two years. Reflecting the perspective of intention to treat, the cost analysis includes all treatment group patients not only those who participated in the training program, but also those who chose not to participate. The mean training cost per patient was Swedish Kroner (SEK) 1,530 ($805 in 2003 US dollars). Although treatment group patients visited the clinic more often 14.0 visits vs visits for the control group they were hospitalized less frequently for cardiovascular diseases over the five-year interval 1.6 admissions vs. 2.2 admissions for the control group and the lengths of stay for cardiac admissions were shorter 10.7 days vs days for the control group. The two groups did not differ with respect to frequency or length of stay for non-cardiac admissions. Over the five-year interval of follow-up, the mean treatment cost of intervention patients was SEK 7,370 ($3,876 in 2003 US dollars) less than the mean treatment cost of control patients SEK 36,030 for the intervention group and SEK 43,000 for the control group ($18,949 and $22,824 in 2003 US dollars, respectively). Taking account only of this difference in health care treatment expense, we calculate a benefit-cost ratio for this exercise-only CR program of 4.8 to 1 for health costs alone. At the end of five years, 52% of treatment group patients were actively employed, compared to just 27% of control group patients. Over the five-year follow up, the authors project an average savings on sick 5 leave cost of SEK 70,610. Adding this productivity-type gain to the savings on treatment expense, the review authors calculate a total benefit-cost ratio of 51 to 1. That is, their results indicate that the benefits are 51 times as large as the costs. Differences in Rehospitalization Charges for Self-Selected Cardiac Rehabilitation Patients Ades et al. (1992) compare the rehospitalization experience of 230 post-coronary event patients who enter a traditional CR program to the experience of 350 patients who did not enter the program. All patients who survived AMI or coronary artery bypass graft (CABG) at the Medical Center Hospital of Vermont from October 1983 to January 1987 and lived within a one-hour drive of the medical center were included in the study. Entry into CR was self-selected. Baseline left ventricular ejection fraction was virtually identical in the two groups. Patients began CR four to eight weeks after the cardiac event. They exercised three hours per week for 12 weeks, and attended a weekly one-hour educational class. This risk factor teaching component included five sessions on stress management, two sessions on diet, three sessions on specific cardiac risk factors, and one session each on cardiac symptoms and cardiac medications. On completion of the program, patients underwent repeat stress testing on the treadmill and were encouraged to continue exercising. Some 179 of the 230 program entrants completed the entire program. Following cardiac readmissions for an average of 21 months, program entrants were significantly less likely to be rehospitalized and their per-admission charges when hospitalized were significantly less. On average, the cardiac rehospitalization charges of program entrants were $739 ($1,739 in 2003 US dollars) lower. Because physician charges were not available, the total charge differential is understated. During the study interval, the per-participant cost of the cardiac program was $32 ($75 in 2003 US dollars) per session, or a total $1,142 ($2,688 in 2003 US dollars) per patient for those attending all 36 sessions. Analysis of covariance was used to adjust for differences between the two groups at baseline, and rehospitalization costs remained significantly higher in the group that did not enter CR. However, no estimate of the adjusted hospital charge differential is provided. A Meta-Analysis Based Cost-Effectiveness Estimate Using meta-analytic findings drawn from 22 randomized trials of CR involving 2,200 patients in each group, Ades et al. (1997) estimate that participants have an incremental life expectancy of years 6 over the 15-year interval following program completion. Based on survey reports from 626 CR programs, the authors estimate that CR programs cost an average of $1,280 per patient in the mid-1980s ($3,671 in 2003 US dollars). Adding a 15% increment for physician services to their estimate that CR saves $739 ($2,120 in 2003 US dollars) in hospital charges, they consider that CR saves an average of $850 ($2,438 in 2003 US dollars) per patient on medical expense. On this assumption, the net cost of a CR program in the mid-1980s is calculated to be $430 ($1,233 in 2003 US dollars), and the authors find that it costs just $2,130 ($6,109 in 2003 US dollars) per year of life saved. The authors conclude that, Compared with other post-ami treatment interventions, CR is more cost-effective than thrombolytic therapy, coronary bypass surgery, and cholesterol lowering drugs, though less cost-effective than smoking cessation programs. (Ades et al. 1997). Sensitivity analysis provides additional support for this statement. The authors, caution, however, that, Limitations of this study include the use of primary mortality data obtained in a mostly male, non-elderly population who underwent rehabilitation before the introduction of valuable interventions that are now commonplace, such as thrombolytic therapy and lipid-lowering drugs. (Ades et al. 1997). The Costs of Hospital vs. Home-Based Rehabilitation Marchionni et al. (2003) report a randomized, controlled trial conducted in Florence, Italy around the year Post-AMI patients were randomized into three treatment arms of 90 each (1) hospital-based CR (2) home-based CR and (3) a no-cr control group. Each treatment arm was stratified into three age groups of 30 middle-aged (45 to 65 years old), old (66 to 75 years old) and very old ( 75 years old) patients. The hospital-based CR program consisted of 40 exercise sessions, 24 sessions (three per week) of endurance training plus 16 sessions (two per week) of stretching and flexibility exercises. Patients received cardiovascular risk factor management counseling twice per week and were invited to join a monthly support group together with family members. The home-based patients first participated in four to eight hospital-based exercise sessions. They also received risk factor counseling at these sessions and were similarly invited to join a monthly support group. After this instructional phase, the home-based patients received an exercise prescription and were loaned a cycle ergometer for the two-month training program. A physical therapist made home visits every other week to collect data and adjust the prescription as needed. Patients randomized to the no-cr group attended a single educational session on risk-factor management and were referred back to their family physician. Within each age group, total work capacity (TWC) as measured by a symptom-limited cycle ergometer test at the conclusion of the training program improved significantly in both CR groups but was unchanged in the control group. The improvements were similar in the two younger-aged cohorts, while improvement in the oldest cohort was smaller, yet still significant. At the 12-month follow-up, TWC 7 remained significantly higher than baseline for all age cohorts within the home-based CR group. By comparison, TWC had returned to baseline for the two older-aged cohorts in the hospital-based rehabilitation group. Health-related qualify-of-life (HRQL), a scale based on self-reported activities and social interactions, improved significantly over the study interval for very old patients in both rehabilitation groups, and it did not improve for those in the control group. In the two younger-aged cohorts, HRQL improved consistently over the study interval, independent of treatment assignment. The per-patient cost of the hospital-based program was about five times the cost of the home-based program $10,170 vs. $1,898 in 2003 US dollars. Although the home-based rehabilitation group also had notably lower healthcare utilization costs than either the hospital-based rehabilitation group or the control group over the 12-month follow-up interval (due to fewer medical visits and lower rehospitalization rates), the differences do not appear to be statistically significant. Economic Evaluation of a Randomized Trial Oldridge et al. (1993) report a 1987 randomized, controlled trial conducted in Hamilton, Ontario hospitals. Patients with AMI and mild to moderate anxiety or depression while still hospitalized (about 70 % of AMI patients screened) were randomized into either an eight-week rehabilitation intervention (n=99) or usual care (n=102). The rehabilitation program consisted of twice-weekly, low-level supervised exercise, as well as group behavioral and risk factor management counseling focused on coping strategies, and individual counseling as needed. Data were collected at baseline, upon completion of the intervention, and at four, eight and 12 months from hospital discharge. In 1991 US dollars, Oldridge et al. (1993) estimate that the gross cost of the intervention program averaged $790 ($1,365 in 2003 US dollars) per patient. However, since usual care control patients utilized $310 (in 1991 US dollars) more services in community-based rehabilitation programs,
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