Falls Prevention Interventions in the Medicare Population
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EVIDENCEEVIDENCE REPORTREPORT ANDAND EVIDENCE-BASEDEVIDENCE-BASED RECOMMENDATIONSRECOMMENDATIONS FallsFalls PreventionPrevention InterventionsInterventions inin thethe MedicareMedicare PopulationPopulation Southern California Evidence-Based Practice Center SantaSanta Monica LosLos Angeles SanSan Diego PREPARED FOR: U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services 7500 Security Blvd. Baltimore, MD 21244-1850 PREPARED BY: RAND CONTRACT NUMBER: 500-98-0281 CONTRACT PERIOD: September 30, 1998 to September 29, 2003 Project Staff Principal Investigator Paul Shekelle, M.D., Ph.D. Project Manager Margaret Maglione, M.P.P. Article Screening/Review John Chang, M.D., M.P.H. Walter Mojica, M.D., M.P.H. Senior Statistician Sally C. Morton, Ph.D. Quantitative Analyst Marika J. Suttorp, M.S. Senior Programmer/Analyst Elizabeth A. Roth, M.A. Staff Assistant/ Database Manager Shannon Rhodes, M.F.A. Cost Analyst Shin-Yi Wu, Ph.D. Medical Editor Sydne Newberry, Ph.D. Principal Investigator Laurence Rubenstein, M.D., M.P.H. Healthy Aging Project CMS Project Officer Pauline Lapin, M.H.S. i TABLE OF CONTENTS EXECUTIVE SUMMARY ............................................................................................IV INTRODUCTION............................................................................................................. 1 METHODS ........................................................................................................................ 3 IDENTIFICATION OF LITERATURE SOURCES ............................................................... 6 EVALUATION OF POTENTIAL EVIDENCE ................................................................... 13 EXTRACTION OF STUDY-LEVEL VARIABLES AND RESULTS ..................................... 15 STATISTICAL METHODS ............................................................................................. 24 COST EFFECTIVENESS ................................................................................................ 27 RESULTS ........................................................................................................................ 28 IDENTIFICATION OF EVIDENCE.................................................................................. 28 SELECTION OF STUDIES FOR THE META-REGRESSION ANALYSES........................... 30 CONTROLLED TRIALS EXCLUDED FROM THE META-REGRESSION ANALYSES ....... 35 RESPONSES TO QUESTIONS SPECIFIED BY CMS ....................................................... 42 LIMITATIONS............................................................................................................... 69 CONCLUSIONS ............................................................................................................. 71 RECOMMENDATIONS................................................................................................ 72 REFERENCES CITED ................................................................................................... 73 ACCEPTED ARTICLES - FALLS EVIDENCE REPORT................................................... 80 REJECTED ARTICLES - FALLS EVIDENCE REPORT ................................................... 86 EXPERT PANEL MEMBERS ....................................................................................... 118 EVIDENCE TABLES ................................................................................................... 119 ii TABLES TABLE 1. LITERATURE SEARCH TERMS .............................................................................7 TABLE 2. REVIEW AND BACKGROUND ARTICLES ..............................................................8 TABLE 3. FOLLOW-UP PERIODS FOR ARTICLES WITH FALLS OUTCOMES......................30 TABLE 4. STUDIES WITH MULTIPLE TIME POINT MEASURES .........................................33 TABLE 5. STUDIES EXCLUDED FROM META-REGRESSION ANALYSES ............................38 TABLE 6. RCT STUDIES INCLUDED IN META-REGRESSION ANALYSES ..........................39 TABLE 7. POOLED ANALYSES ...........................................................................................45 TABLE 8. META-REGRESSION ESTIMATES OF THE EFFECT OF INDIVIDUAL INTERVENTION COMPONENTS..........................................................................46 TABLE 9. COMPONENTS OF A MULTIFACTORIAL FALLS RISK ASSESSMENT..................47 TABLE 10. EXERCISE COMPONENTS.................................................................................48 TABLE 11. SETTING TYPES................................................................................................51 TABLE 12. COST EFFECTIVENESS ARTICLES ...................................................................53 TABLE 13. COST ANALYSIS BASE CASE ESTIMATION......................................................63 TABLE 14. COST ANALYSIS SENSITIVITY ANALYSIS 1 .....................................................63 TABLE 15. COST ANALYSIS SENSITIVITY ANALYSIS 2 .....................................................63 TABLE 16. COST ANALYSIS SENSITIVITY ANALYSIS 3 .....................................................64 TABLE 17. COST ANALYSIS SENSITIVITY ANALYSIS 4 .....................................................64 TABLE 18. COST ANALYSIS SENSITIVITY ANALYSIS 5 .....................................................64 TABLE 19. INTERVENTION BY POPULATION TYPE ...........................................................65 TABLE 20. REFUSAL RATE OF PERSONS ELIGIBLE TO PARTICIPATE IN RANDOMIZED CLINICAL TRIALS OF FALLS PREVENTION INTERVENTIONS...........................67 FIGURES FIGURE 1. CONCEPTUAL MODEL........................................................................................5 FIGURE 2. FALLS PREVENTION ARTICLE SCREENING FORM ..........................................14 FIGURE 3. FALLS PREVENTION ARTICLE QUALITY REVIEW FORM ...............................16 FIGURE 4. ARTICLE FLOW ................................................................................................29 FIGURE 5. SHRINKAGE PLOT OF CLINICAL TRIALS OF FALLS PREVENTION INTERVENTIONS ASSESSING THE OUTCOME "SUBJECTS WHO FELL AT LEAST ONCE"...............................................................................................................42 FIGURE 6. SHRINKAGE PLOT OF CLINICAL TRIALS OF FALLS PREVENTION INTERVENTIONS ASSESSING THE OUTCOME "MONTHLY RATE OF FALLING"44 FIGURE 7. FUNNEL PLOT OF STUDIES ASSESSING RISK OF FALLING AT LEAST ONCE .....49 FIGURE 8. FUNNEL PLOT OF STUDIES ASSESSING RATE OF FALLS....................................49 iii EXECUTIVE SUMMARY Introduction Falls are a major health problem among older adults in the United States. One of every three people over the age of 65 years living in the community falls each year, and this proportion increases to one in two by the age of 80 years.1-3 Fall-related injuries in older adults often reduce mobility and independence, and are often serious enough to result in a hospitalization and an increased risk of premature death.4 Studies among older persons in the community have found that about 10 percent of the fallers have a serious fall-related injury, including fractures, joint dislocations, or severe head injuries.5-7 Falling has also been found to be associated with subsequent admission to a nursing home.8 The costs of health care associated with fall-related injuries and fractures, including hip fractures, are staggering. The total direct cost of all fall injuries in older adults in 1994 was $20.2 billion and is estimated to reach $32.4 billion by 2020.9 Medicare costs for hip fractures were estimated in 1991 to be $2.9 billion.10 With an aging population and a growing number of hip fractures, these cost estimates are projected to rise to as high as $240 billion by the year 2040.11 Clearly, the prevention of falls is an important issue if it can prevent significant declines in function and independence, and the associated increase in costs of complications. The major risk factors for falling are diverse, and many of them--such as balance impairment, muscle weakness, polypharmacy, and environmental hazards-- are potentially modifiable.3 However, the interventions designed to address these risk factors share the same diversity. Likewise, the evidence for the effectiveness of a single intervention in preventing falls has been inadequate.12 Since the risk of falling appears to increase with the number of risk factors,3 multifactorial interventions have been suggested as the most effective strategy to reduce falling. Heretofore, numerous interventions have been studied in the prevention of falls. Results have been mixed, yielding uncertainty as to which interventions are most clinically effective or cost-effective, or what kind or combination of interventions should be included in a program to prevent falls. To gain a better understanding of which interventions may be beneficial in the Medicare population, the Centers for Medicare and Medicaid Services (CMS), as part of its Healthy Aging Project, commissioned an evidence-based systematic review of interventions in the prevention of falls, the results of which are detailed in this report. For this report, CMS asked us to provide evidence in response to the following questions: 1. Are falls prevention programs effective? What are the key components that should be included in a falls prevention intervention? Are multifactorial iv approaches more effective than single intervention approaches? 2. Are public information or education campaigns alone effective in reducing or preventing falls?