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      Effectiveness and cost-effectiveness of a multidisciplinary intervention programme to prevent new falls and functional decline among elderly persons at risk: design of a replicated randomised controlled trial [ISRCTN64716113]

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          Abstract

          Background

          Falls are common among community-dwelling elderly people and can have a considerable impact on quality of life and healthcare costs. People who have sustained a fall are at greater risk of falling again.

          We replicated a British randomised controlled trial which demonstrated the effectiveness of a multidisciplinary intervention programme to prevent falls.

          The objective is to describe the design of a replication study evaluating a multidisciplinary intervention programme on recurrent falls and functional decline among elderly persons at risk. The study consists of an effect evaluation, an economic evaluation and a process evaluation.

          Methods/design

          The programme is aimed at community-dwelling elderly people aged 65 years or over who have visited an accident and emergency department (A&E department) or a general practitioners' cooperative (GP cooperative) because of a fall.

          The design involves a two-group randomised controlled trial. Participants are followed for twelve months after baseline. The intervention programme consists of a detailed medical and occupational therapy assessment with referral to relevant services if indicated. People in the control group receive usual care.

          The main outcome measures of the effect evaluation are number of falls and daily functioning. The economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention programme.

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          A multifactorial intervention to reduce the risk of falling among elderly people living in the community.

          Since falling is associated with serious morbidity among elderly people, we investigated whether the risk of falling could be reduced by modifying known risk factors. We studied 301 men and women living in the community who were at least 70 years of age and who had at least one of the following risk factors for falling: postural hypotension; use of sedatives; use of at least four prescription medications; and impairment in arm or leg strength or range of motion, balance, ability to move safely from bed to chair or to the bathtub or toilet (transfer skills), or gait. These subjects were given either a combination of adjustment in their medications, behavioral instructions, and exercise programs aimed at modifying their risk factors (intervention group, 153 subjects) or usual health care plus social visits (control group, 148 subjects). During one year of follow-up, 35 percent of the intervention group fell, as compared with 47 percent of the control group (P = 0.04). The adjusted incidence-rate ratio for falling in the intervention group as compared with the control group was 0.69 (95 percent confidence interval, 0.52 to 0.90). Among the subjects who had a particular risk factor at base line, a smaller percentage of those in the intervention group than of those in the control group still had the risk factor at the time of reassessment, as follows: at least four prescription medications, 63 percent versus 86 percent, P = 0.009; balance impairment, 21 percent versus 46 percent, P = 0.001; impairment in toilet-transfer skills, 49 percent versus 65 percent, P = 0.05; and gait impairment, 45 percent versus 62 percent, P = 0.07. The multiple-risk-factor intervention strategy resulted in a significant reduction in the risk of falling among elderly persons in the community. In addition, the proportion of persons who had the targeted risk factors for falling was reduced in the intervention group, as compared with the control group. Thus, risk-factor modification may partially explain the reduction in the risk of falling.
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            Prevention of falls in the elderly trial (PROFET): a randomised controlled trial.

            Falls in elderly people are a common presenting complaint to accident and emergency departments. Current practice commonly focuses on the injury, with little systematic assessment of the underlying cause, functional consequences, and possibilities for future prevention. We undertook a randomised controlled study to assess the benefit of a structured inderdisciplinary assessment of people who have fallen in terms of further falls. Eligible patients were aged 65 years and older, lived in the community, and presented to an accident and emergency department with a fall. Patients assigned to the intervention group (n=184) underwent a detailed medical and occupational-therapy assessment with referral to relevant services if indicated; those assigned to the control group (n=213) received usual care only. The analyses were by intention to treat. Follow-up data were collected every 4 months for 1 year. At 12-month follow-up, 77% of both groups remained in the study. The total reported number of falls during this period was 183 in the intervention group compared with 510 in the control group (p=0.0002). The risk of falling was significantly reduced in the intervention group (odds ratio 0.39 [95% CI 0.23-0.66]) as was the risk of recurrent falls (0.33 [0.16-0.68]). In addition, the odds of admission to hospital were lower in the intervention group (0.61 [0.35-1.05]) whereas the decline in Barthel score with time was greater in the control group (p<0.00001). The study shows that an interdisciplinary approach to this high-risk population can significantly decrease the risk of further falls and limit functional impairment.
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              The cost diary: a method to measure direct and indirect costs in cost-effectiveness research.

              From a societal perspective long-term clinical trials or follow-up studies should preferably not only include an evaluation of the health effect for the patient, but also an economic evaluation. In order to yield comprehensive medical and nonmedical resource use data, we at least partly depend on respondents' recall for collecting these costing data. A patient cost diary was developed in order to estimate total resource use, expenses, and lost production due to illness and treatment. We applied the cost diary in two randomized clinical trials evaluating the cost-effectiveness of behavioral rehabilitation in 205 fibromyalgia and chronic low back pain patients. The use of the diary was evaluated, studying the feasibility, the influence of the period of data collection on the results, and some aspects of validity. Eighty-five percent of the patients completed at least one diary and in total 68% of the diaries were returned. Although the results for the three alternative periods of data collection (keeping the diary 1 week every month, 2 weeks every 2 months, or a full year) were not significantly different, they were only moderately correlated. Finally, self-reported specialist care contacts were generally in agreement with data from an insurance company. However, for physiotherapy contacts there were differences between the self-reported and insurance data. This study shows how the cost diary might be used successfully in cost-effectiveness studies.
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                Author and article information

                Journal
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                2005
                14 January 2005
                : 5
                : 6
                Affiliations
                [1 ]Department of Health Care Studies, section Medical Sociology, Faculty of Health Sciences, Maastricht University, The Netherlands
                [2 ]Department of Health Organisation Policy and Economics, Maastricht University, The Netherlands
                [3 ]Department of General Practice, Maastricht University, The Netherlands
                Article
                1471-2458-5-6
                10.1186/1471-2458-5-6
                546206
                15651990
                adeb6a41-ff2b-4d21-85cc-db4925adfe43
                Copyright © 2005 Hendriks et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 10 December 2004
                : 14 January 2005
                Categories
                Study Protocol

                Public health
                Public health

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