Evaluation of a nurse-led falls prevention programme versus usual care: a randomized controlled trial
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1 Age and Ageing 2002; 31: # 2002, British Geriatrics Society Evaluation of a nurse-led falls prevention programme versus usual care: a randomized controlled trial ELIZABETH LIGHTBODY 2,CAROLINE WATKINS 2,MICHAEL LEATHLEY 2,ANIL SHARMA 1,MICHAEL LYE 3 1 Department of Medicine for the Elderly, University Hospital Aintree, Liverpool, UK 2 Department of Nursing, University of Central Lancashire, Preston PR1 2HE, UK 3 University Clinical Departments, The Duncan Building, Liverpool, UK Address correspondence to: E. Lightbody. Fax: (q44) elightbody@uclan.ac.uk Abstract Objective: to evaluate a nurse-led management plan and care pathway for older people discharged from an Accident and Emergency Department after a fall. Design: randomized controlled trial. Setting: a large teaching hospital. Subjects: 348 consecutive patients aged 65 or over attending the Accident and Emergency Department with a fall. Interventions: we randomized patients to falls nurse intervention or usual care. Within 4 weeks, the intervention group received a home assessment to address easily modifiable risk factors for falls. This included assessments of medication, ECG, blood pressure, cognition, visual acuity, hearing, vestibular dysfunction, balance, mobility, feet and footwear. All patients were given advice and education about general safety in the home. Main outcome measures: Further falls, functional ability, re-attendance at the Accident and Emergency Department and admission to hospital. Results: at 6 months post-index fall, 36 patients in the intervention group and 39 patients in the control group had had 89 and 145 falls respectively. Although the intervention group had less falls, this was not significant (P)0.05). Similarly, the intervention group had fewer fall-related admissions and bed days (8 and 69 respectively) than the control group (10 and 233 respectively). The intervention group scored significantly higher in indicators of function (P-0.05) and mobility within the community (P-0.02). Conclusions: although the differences were not significant, patients in the intervention group had fewer falls, less hospital attendances and spent less time in hospital. Moreover, patients in the intervention group were more functionally independent at 6 months post-index fall. Keywords: older people, fall prevention Introduction Falls are common and debilitating, affecting about a third of those aged 65 and over [1 4], in whom they are a leading cause of mortality and morbidity [4 8]. In Britain, over older people attend Accident and Emergency Departments after falling at home, and of these 1500 die as a direct result of falling. Falls in older people cause major injuries, long lie complications, functional decline and fear of falling [9 14]. Costs are substantial in terms of functional loss and use of healthcare services. Hip fractures cost an estimated 160 million a year and account for 20% of orthopaedic bed occupancy [15]. The multifactorial aetiology of falls and heterogeneity of those at risk make assessment and treatment difficult. Knowledge of risk factors [16 22] has led to development of community falls prevention programmes [23 35]. Study results conflict and use a variety of interventions including exercise and postural control [23 27], education programmes [28, 29] and multifactorial assessment [19, 30 34]. Few studies have significantly reduced falls [23, 25, 28, 30, 33], despite using complex intervention programs. Reasons for previous negative studies may include differences in intensity and duration of interventions, length of follow-up and, most critically, the definition and measurement of a fall. Even the populations studied 203
2 E. Lightbody et al. have shown great variability in terms of sex, age group and risk factors [23]. In Tinetti s study [30], subjects were assessed by a nurse and a physiotherapist. Intervention subjects were visited on average eight times in 3 months. A 6-month maintenance phase followed. At one year, 35% of the intervention group fell compared with 47% of controls. Interventions using existing resources and mechanisms are likely to be implemented and be sustainable. This study assessed a nurse-led intervention for older people discharged from the Accident and Emergency Department, requiring a single visit, where action on falls risk factor modification could be taken through usual channels. Methods Design A randomized controlled trial of usual care versus a falls nurse intervention. Patients were block-randomized consecutively to groups. We obtained ethical approval from the appropriate ethics committees. Setting and subjects University Hospital Aintree, Liverpool is a teaching hospital with a catchment population of Between July and December 1997, we recorded consecutive patients aged 65 or over attending the Accident and Emergency Department with a primary diagnosis of fall. Patients were excluded if they were admitted to hospital as a result of the Index fall (see below), lived in institutional care, if they refused or were unable to consent, or were out of the area. Definition of a fall: Patient failing to maintain a stable position and inadvertently coming to rest on the ground or lower level, with or without loss of consciousness, but not as the result of acute medical events (e.g. stroke) or extraordinary environmental factors (e.g. traffic accident). Coming to rest against furniture or a wall was not deemed a fall [3]. The current fall was termed the Index fall. Baseline measurement Eligible patients were identified, gave consent and were randomized. We collected baseline data in the Accident and Emergency Departments, including demographic details, pre-fall independence ( Barthel [36]) and pre-fall handicap ( Rankin [37]). We developed a scaled version of the Life Space Diameter [38, 39], indicating the area through which people habitually move (Appendix 1). We recorded current cognitive function (Abbreviated Mental Test Score [40]), mood (Yale [41]) and medication. We noted falls in the previous year and severity of Index fall. Index falls were coded a priori (to allow post hoc testing of randomization) using a simple classification: mild, no treatment; moderate, required simple dressing; severe, required X-ray, sutures or sustained a fracture; or head injury. Intervention Following some basic training, therapists and clinicians agreed about the nurse s initial assessment and criteria for onward referral, as some areas require specialist assessment, e.g. provision of aids and adaptations. The intervention group was assessed for risk factors for falls [2, 9, 14, 16 21, 42, 43] at home by the falls nurse 2 4 weeks following the Index fall. Medication, ECG, blood pressure, cognition, visual acuity, hearing, vestibular dysfunction, balance, mobility, feet and footwear were assessed using adapted versions of the falls checklist (Appendix 2) and s test [44, 45]. The environmental assessment identified inadequate lighting, tripping hazards and unsuitable furniture. Patients were given advice and education about safety in the home, and simple modifications were made with consent (e.g. mat removal). Risk factors requiring further action were referred to relatives, community therapy services, social services and/or the primary care team. Direct referrals were not made to hospital outpatients or day hospital. At randomization, patients were given a diary to complete daily for up to 6 months after the Index fall. Further falls, consequent injury and subsequent place of treatment (i.e., hospital) were recorded. At 6 months, postal questionnaires asked about the number of falls, functional ability, mood and social support. records were reviewed and hospital databases interrogated for attendances and admissions. Sample size and analysis The power calculation estimated that 168 patients per group were required to detect a 35% reduction in number of falls by 6 months after the Index fall (a=5%, 90% power, chi-square). We compared frequency data using chi-square or Fisher s exact test, ordinal using the Mann Whitney U-test, interval using Student s t-test (for all tests a=0.05). Results Patient demographics Of 863 patients who matched the inclusion criteria, 348 (40.3%) were recruited, 171 to falls nurse intervention and 177 to usual care (Figure 1). There was no difference 204
3 Efficacy of a falls nurse intervention in preventing falls Table 2. Baseline data N Intervention 171 Control 177 P value Demographics Median age (IQR) 75 (70 82) 75 (70 81) 0.85 Women 131 (77%) 128 (72%) 0.43 Lived alone 79 (46%) 74 (42%) 0.47 Fall-related variables Falls in previous 12 months 72 (42%) 74 (42%) 0.96 Falls outside 107 (63%) 101 (57%) 0.34 Injuries sustained in index fall Mild no treatment 21 (12%) 21 (12%) ns Moderate dressing 17 (10%) 25 (14%) ns Severe medical treatment 112 (66%) 117 (66%) ns Head injury head injury 21 (12%) 14 (8%) ns Mean Barthel Index (SD) 19 (2.0) 19 (2.3) 0.42 Rankin)1 66 (39%) 77 (44%) 0.41 Median Life Space Diameter 6 (5 7) 6 (5 7) 0.08 (IQR) Positive response to Yale 37 (21%) 38 (22%) 0.83 Medications Number of daily medications Patients on more than 3 69 (40%) 101 (59%) 0.53 Number on target medications 123 (72%) 126 (71%) 0.97 IQR=Inter quartile range. Figure 1. Trial profile. Table 1. Sex and age of patients aged 65 and over attending the Accident and Emergency Department with a fall n Women Men Age (median, IQR) Included (74.4%) 89 (25.6%) 75 (70 81) Refused (71.4%) 53 (28.6%) 75.5 ( ) a Retrospective (62.6%) 82 (36.9%) b 74 ( ) c Other not (55.4%) 41 (44.6%) 75.5 ( ) d included Withdrew (68.8%) 5 (31.3%) 77 ( ) Admitted (69.2%) 121 (30.8%) 80 (74 86) a Institution (78.8%) 43 (21.2%) 84.5 (77 90) a For 4 patients, no age or date of birth recorded. b For 1 patient, no name or sex recorded. c For 2 patients, no age or date of birth recorded. d For 3 patients, no age or date of birth recorded. IQR= Inter quartile range. in age (P)0.05) between those recruited and those not (retrospectively identified and refused consent) (Table 1). There were no differences between intervention and usual care groups in baseline characteristics, except total number of medications (Table 2). Intervention by Falls Of those in the intervention group, 170 had a home visit. Problem areas identified (not mutually exclusive) are shown in Table 3. Referrals to community services are shown in Table 4. The falls nurse referred target medications for review in 125 (74%) patients and thirteen (8%) orthopaedic footwear referrals. Twenty-three (14%) patients had Social Services referrals for assessment for aids or adaptations. Outcome data At 6 months, 314 patients remained in the study, 155 in the intervention group and 159 in usual care. Eighteen patients had died (11 intervention, 7 usual care), 12 had withdrawn (2 intervention, 10 usual care) and 4 were lost to follow up (3 intervention, 1 usual care). There were no significant group differences in mortality or withdrawal rates. A review of the falls diaries revealed that in the intervention group, 43 patients fell a total of 141 times and with usual care, 44 patients fell a total of 171 times. These differences were not significant. Table 5 shows the main outcomes. From postal questionnaires: 35 (23%) patients in the intervention group fell a total of 89 times, with usual care, 39 (25%) patients fell a total of 145 times. Although there were 205
4 E. Lightbody et al. Table 3. Problems identified by the falls nurse during the home visit Problem areas N % affected Target medication Abnormal ECG Postural hypotension 1-1 Cognition Visual acuity Hearing Dizziness Balance Mobility Foot and footwear Environment See Appendix 2 for definitions of abnormalities. Table 4. Referrals by the falls nurse Chiropody Physiotherapy Occupational therapy Directly Referred Seen 20 (74%) 5 (56%) 2 (33%) Not seen 7 (26%) 4 (44%) 4 (67%) Died/lost Primary care Referred 8 50 Seen 1 (17%) 9 (20%) Not seen 5 (83%) 35 (80%) Died/lost 2 6 more falls in the usual care group, this was not significant. There was no significant difference in the number of falls recorded in diaries compared with postal questionnaires. Although the Barthel index was lower in both groups, there was no apparent deterioration in Life Space Diameter. Table 5 shows that at 6 months the intervention group were significantly more independent (P-0.04) and more mobile in the community (P-0.02). In the 6 months after their Index fall, 39 (13%) patients not previously requiring support were now receiving it, 24 (62%) in the usual care group and 15 (38%) in the intervention group. Fewer patients (trend only) in the intervention group re-attended the Accident and Emergency Department or were admitted with a new fall or a falls-related problem (Table 5). The intervention group presented with fewer major injuries (2 head injuries and 1 fractured femur) than the usual care group (2 head injuries, 2 fractured femurs and 2 wrists) and had fewer falls-related days in hospital. More of the patients (P-0.05) directly referred for community services by the falls nurse received treatment (physiotherapy 5/10 : chiropody 20/30) than those referred via the primary care team (physiotherapy 9/50 : chiropody 1/8) (Table 5). In addition, 23 patients were referred to Social Services by the falls nurse and of these, 2 were lost to follow-up, 12 (57%) had been contacted, 10 (48%) had been assessed and 5 (24%) had received an aid or adaptation by 6 months (data not in table). There was little overall difference between intervention and usual care patients in terms of target medications at 6 months, compared with baseline. However, the numbers of patients in the intervention group taking anti-hypertensives and diuretics were markedly reduced. Conversely, there were increases in the number of patients on benzodiazepines, vasodilators, anti-convulsants and anti-parkinsonian drugs. When comparing target medication at baseline (Table 2) with subsequent falls by 6 months, patients on more than three target medications were significantly more likely to fall than those on three or less (P-0.005, odds ratio 3.31, 95% confidence intervals ). Discussion This study demonstrates the effectiveness of a nurse-led intervention in reducing dependence and maintaining mobility in the community by 6 months after the Index fall. The numbers of subsequent falls were lower in the intervention group and there were less falls-related hospital admissions and bed days in the intervention group. The intervention group were significantly more independent in activities of daily living and were more mobile within the community than the control group. These findings reinforce those of Close and colleagues [33] where there was a significant difference in Barthel scores between groups at 12 months (though patients in both groups had deteriorated). Despite finding that more of the intervention group were able to go out alone at 12 months, this effect was not apparent after adjustment for initial Barthel score and ability to go out alone at baseline [33]. In this study, there were fewer falls (non-significant) in the intervention group. Previous studies suggest that increasing activity results in more falls and injuries [46, 47]. In maintaining activity, our intervention may have increased opportunities for falling. When considering the overall faller rate in the 6 month follow-up period (23% of the intervention and 25% of the control) the study in retrospect was under-powered; the sample size was based on previous studies with an estimated proportion of fallers of up to 52% [19, 23, 30, 33] and aimed to reduce the number of fallers by 35%. For other outcome indicators, the intervention group re-attended the Accident and Emergency Department less often, had fewer hospital admissions and bed days, and were less likely to require additional social support. Our results reflect those of Close et al. [33] and Tinetti et al. [30] who found that subjects in the intervention group required fewer hospital admissions. It is beyond the remit of this paper to present detailed cost analyses. 206
5 Table 5. Outcome data at 6 months Efficacy of a falls nurse intervention in preventing falls Intervention Control P value Number of fallers a 36 (23%) 39 (25%) 0.89 Number of falls a Number of fallers b 39 (25%) 41 (26%) 1.00 Number of falls b Mean Barthel Index (SD) a 18.5 (2.37) 17.8 (3.6) Median Life Space Diameter (IQR) a 7 (5 7) 6 (4 7) Resource use AED new fall or problem c Falls-related attendance d Falls-related Hospital admissions c Total number of bed days with a fall or fall related problem c Total number of bed days Medications Number of daily medications Patients on more than 3 79 (49%) 94 (57%) 0.21 Number on target medications 130 (81%) 132 (80%) 0.88 Source of information: a Questionnaire. b Diary. c Hospital database. d questionnaire. However, if we consider falls-related bed days, it is apparent that cost savings could be made (total cost of bed days and in the intervention and usual care groups respectively). This suggests that the falls nurse intervention might lessen the need for formal care and reduce the economic burden of falls. The intervention aimed to use existing resources and referral mechanisms. Where the falls nurse could take action on interventions directly, e.g. by removing mats or social service referrals, risk factors were modified by 6 months in most cases. However, where interventions had to be taken indirectly, risk factors were less likely to have been addressed. For example, as polypharmacy increases falls liability [6, 16, 20, 48 53], it was imperative for the falls nurse to facilitate modification of target medications. However, this could only be achieved indirectly through primary care. Unfortunately, the proportion of those on three or more medications actually increased, despite this risk factor being easily modifiable. The falls nurse in this study was unknown to many s and contact was generally by letter. The intervention may be improved if the falls nurse worked directly with a primary care trust and had close liaison with Accident and Emergency Departments and older peoples services e.g. geriatricians, and existing falls clinics. Successful implementation of such a service depends on developing acute and primary care-based multidisciplinary pathways. Non-intervention by a second party in this study may also have been compounded by the short timeframe to identify, implement and effect change. Other studies with positive outcomes have used a year follow-up period [30, 33]. The efficacy of this intervention has been demonstrated and the intervention s acceptability to patients is evidenced by low withdrawal rates. It has proved feasible with this nurse-led intervention to effect positive changes in function and mobility, number of falls-related hospital bed days, Accident and Emergency Department attendances and new falls. Key points. A fifth of those aged 65 and over attending Accident and Emergency Departments, do so with a fall.. A single assessment of risk factors for falls with appropriate intervention increased long term independence.. Effective mechanisms for actioning interventions through primary care should be agreed.. Falls prevention programmes should focus not only on falls but also on independence. Acknowledgements This study was grant funded by North West Region NHS Executive and supported by Liverpool and Wirral Research and Development Liaison Group. We wish to thank Kevin McDonald for the design of the database and cleaning the data. 207
6 E. Lightbody et al. References 1. McVey LJ, Studenski SA. Falls in the elderly. Adv Clin Rehab 1988; 2: Blake AJ, Morgan K, Bendall MJ et al. Falls by elderly people at home: prevalence and associated factors. Age Ageing 1988; 17: Campbell AJ, Reinken J, Allan BC, Martinez GS. Falls in old age: a study of frequency and related clinical factors. Age Ageing 1981; 10: Sattin RW. Falls among older persons: a public health perspective. Ann Rev Pub Health 1992; 13: Baker SP, Harvey AH. Fall injuries in the elderly. Clin Geriat Med 1985; 1: Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. New Eng J Med 1988; 319: Gryfe CI, Amies A, Ashley MJ. A longitudinal study of falls in an elderly population. Age Ageing 1977; 6: Lilley JM, Arie T, Chilvers CED. Accidents involving older people: a review of the literature. Age Ageing 1995; 24: Prudham D, Evans JG. Factors associated with falls in the elderly: a community study. 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7 Efficacy of a falls nurse intervention in preventing falls 38. May D, Mayak USL, Isaacs B. The life-space diary: a measure of mobility in old people at home. Int Rehabil Medicine 1985; 7: Isaacs B. The Challenge of Geriatric Medicine. Oxford: Oxford University Press, Hodkinson HM. Evaluation of a mental test score for assessment of mental impairment in the elderly. Age Ageing 1972; 1: Mahoney J, Drinka TJK, Abler R et al. Screening for depression: single question versus GDS. J Am Geriatr Soc 1994; 9: Jack CIA, Smith T, Neoh C, Lye M, McGalliard JN. Prevalence of low vision in elderly patients admitted to an acute geriatric unit in Liverpool: elderly people who fall are more likely to have low vision. Gerontology 1995; 41: Kwok T. A survey of in-patients footwear. Care of the Elderly 1994; March: Dyer CAE, Watkins C, Rowe J. Multiple risk factor assessment for falls: from a written checklist to the penless clinic. Age Ageing 1998; 27: Prajapati C, Watkins C, Cullen H et al. The S test a preliminary study of an instrument for selecting the most appropriate mobility aid. Clin Rehab 1996; 10: Speechley M, Tinetti M. Falls and injuries in frail and vigorous community elderly persons. J Am Geriatr Soc 1991; 39: O Loughlin JL, Robitaille Y, Boivin JF, Suissa S. Incidence of and risk of fractures for falls and injurious falls among the community dwelling elderly persons. Am J Epidemiol 1993; 137: Sorock GS, Shimkin EE. Benzodiazepine sedatives and the risk of falling in a community-dwelling elderly cohort. Arch Int Med 1988; 148: Granek E, Baker SP, Abbey H et al. Medications and diagnoses in relation to falls in a long-term care facility. J Am Geriatr Soc 1987; 35: Ray WA, Griffin MR, Schaffner W et al. Psychotropic drug use and the risk of hip fracture. New Eng J Med 1987; 316: Ballinger BR, Ramsay AC. Accidents and drug treatment in a psychiatric hospital. Br J Psychiatry 1975; 126: Ray WA, Griffin MR, Downey W. Benzodiazepines of long and short elimination half-life and the risk of hip fracture. JAMA 1989; 262: Campbell AJ. Drug treatment as a cause of falls in old age: a review of the offending agents. Drugs Aging 1991; 1: Received 13 May 2001; accepted in revised form 23 January 2002 Appendix 1. Life space diameter Please tick the statement which best applies to you I am unable to walk or bedbound I am unable to walk without help I can only get around one room in the house I can get around all the rooms in the house I can get around the house and garden/back yard I am able to go to the local shops I am able to go to the town/city centre I am able to travel outside town/city including daytrips/ holidays 209
8 E. Lightbody et al. Appendix 2. Patient assessment checklist Risk factor Test If abnormality/problem intervention/action Action taken by Target medication Psychoactive Anti-depressants, -hypertensives, -arrhythmics, -convulsants, -Parkinsonian, -histamines Vasodilators Diuretics Hypoglycaemics Discussed side effects Letter to requesting review ECG abnormalities 5 minutes supine ECG Rate, rhythm & conduction abnormalities Letter to Postural hypotension Cognition Visual acuity Hearing Dizziness Balance & or mobility Feet Footwear 5 minutes supine BP done 2 minutes standing BP repeated Drop 3 20 mm Hg systolic = postural hypotension Postural/positional symptoms Abbreviated Mental Test Score Cognitively impaired -7 3 metre Snellen chart, with & without glasses, lowest line correctly read (2 attempts) Vision impaired if (3/18 Visual field assessment Patient reported s subjective assessment Questioned regarding unsteadiness, spinning Positional & displacement stress Romberg s & S-test Foot pathology, corns, calluses, bunions & deformities Vascular, neurological & nail assessment Footwear appraisal, type, fit, grip, heels, support Advised on symptom management, rise slowly, exercises before getting up, caution after meals, avoid prolonged standing Letter to to review target medication Letter to Advised to see optician Advised on home safety, lighting & obstructions Hearing aid training Letter to re audiological evaluation Letter to to review target medication Advised on symptom management Housebound, referred to physiotherapy Not housebound, letter to Advised on simple exercises Not housebound, referred to chiropody Housebound, letter to re chiropody Deformities, letter to Advised on footwear Deformities, letter to re Appliances Inappropriate prosthetic footwear, referred back to Appliances Physician /Patient /Patient 210
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