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Multifactorial intervention after a fall in older people with cognitive impairment and dementia presenting to the accident and emergency department: randomised controlled trial

Fiona E Shaw, Alzheimer's Society research fellow ^a, John Bond, professor ^b, David A Richardson, clinical research associate ^a, Pamela Dawson, senior lecturer ^c, I Nicholas Steen, statistician ^b, Ian G McKeith, professor ^d, Rose Anne Kenny, professor of cardiovascular research ^a. 

^a Cardiovascular Investigation Unit, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, ^b Centre for Health Services Research, University of Newcastle upon Tyne NE2 4AA, ^c Division of Physiotherapy and Applied Life Sciences, University of Northumbria, Newcastle upon Tyne NE7 7XA, ^d Department of Old Age Psychiatry, Newcastle General Hospital, Newcastle upon Tyne NE4 6BE

Correspondence to: Dr Shaw, Newcastle General Hospital, Newcastle upon Tyne NE4 6BE fionashaw{at}aol.com

	Abstract

Top Abstract Introduction Participants and methods Results Discussion References

Objective: To determine the effectiveness of multifactorial intervention after a fall in older patients with cognitive impairment and dementia attending the accident and emergency department.
Design: Randomised controlled trial.
Participants: 274 cognitively impaired older people (aged 65 or over) presenting to accident and emergency department after a fall: 130 were randomised to assessment and intervention and 144 were randomised to assessment followed by conventional care (control group).
Setting: Two accident and emergency departments, Newcastle upon Tyne.
Main outcome measures: Primary outcome was number of participants who fell in year after intervention. Secondary outcomes were number of falls (corrected for diary returns), time to first fall, injury rates, fall related attendances at the accident and emergency department, fall related hospital admissions, and mortality.
Results: Intention to treat analysis showed no significant difference between intervention and control groups in proportion of patients who fell during 1 year's follow up (74% (96/130) and 80% (115/144), relative risk ratio 0.92, 95% confidence interval 0.81 to 1.05). No significant differences were found between groups for secondary outcome measures.
Conclusions: Multifactorial intervention was not effective in preventing falls in older people with cognitive impairment and dementia presenting to the accident and emergency department after a fall.

What is already known on this topic Multifactorial intervention prevents falls in cognitively normal older people living in the community and in those who present to the accident and emergency department after a fall Fall prevention strategies have not been tested by controlled trials in patients with cognitive impairment and dementia who fall What this study adds No benefit was shown from multifactorial assessment and intervention after a fall in patients with cognitive impairment and dementia presenting to the accident and emergency department The intervention was less effective in these patients than in cognitively normal older people

	Introduction

Top Abstract Introduction Participants and methods Results Discussion References

Older people with cognitive impairment and dementia are at increased risk of falls, with an annual incidence of around 60% (twice that of cognitively normal older people). ^{1 2} They are also at increased risk of a major injury such as a fracture.² In the United Kingdom the national service framework for older people makes prevention of further falls in older patients who attend the accident and emergency department after a fall a priority.³

We aimed to determine the effectiveness of multifactorial assessment and intervention after a fall compared with conventional care in older people with cognitive impairment and dementia presenting to the accident and emergency department.

	Participants and methods

Top Abstract Introduction Participants and methods Results Discussion References

We recruited older people (aged 65 or over) with cognitive impairment and dementia (mini-mental state examination score <24⁴) presenting to the accident and emergency department after a fall.⁵ We excluded patients who were unable to walk, had a medical diagnosis that was a likely attributable cause of index fall (for example, cerebrovascular accident), were unfit for investigation within 4 months, were unable to communicate for reasons other than dementia, and had no major informant, defined as someone in contact with the patient at least twice a week.

Design
We conducted a prospective single centre randomised controlled trial of multifactorial assessment and intervention after a fall compared with assessment followed by conventional care. We recruited patients from two inner city accident and emergency departments, which were screened for 52 weeks.

At baseline interviews we recorded personal details, previous falls, current medical diagnoses, and research criteria for dementia.⁶ The patients underwent multifactorial clinical assessment (medical, physiotherapy, occupational therapy, and cardiovascular) at baseline. Those randomised to the intervention group received intervention for all identified risk factors for falls (see bmj.com). Participants in the control group received conventional care from all health professionals who were or became involved in their management during the year's follow up.

We collected data on falls, injuries, attendance at accident and emergency department, hospital admission, and mortality prospectively for 1 year. At 3 months we repeated physiotherapy and occupational therapy assessments and cardiovascular tests if they were abnormal. We also assessed compliance with the multifactorial intervention at 3 months (see bmj.com).

Outcome measures
The primary outcome measure was number of participants who fell at least once in the year after intervention. Secondary outcome measures were number of falls (corrected for diary returns), time to first fall, injury rates, fall related attendance at accident and emergency department, fall related hospital admissions, and mortality.

We recorded data on falls prospectively by asking informants to complete a weekly diary in the form of a postcard. We collected additional data on injuries and hospital admission at monthly intervals from computerised records.

Statistical analysis
We estimated that at the 5% level we would require 90 patients in each group to give an 80% power of detecting a reduction of 30% (from an estimated 66%¹ to 46%) in the proportion of patients who had at least one fall. We calculated the weekly rate of falls for each patient by dividing the number of recorded falls by diary returns and used this when comparing differences in number of falls between control and intervention groups. We analysed data on an intention to treat basis.

	Results

Top Abstract Introduction Participants and methods Results Discussion References

We recruited 308 patients and report on 274; data on initial multifactorial assessment or outcome of falls (diary returns) were not obtained on 34 patients who died (n=24) or withdrew (n=10) shortly after recruitment. Overall, 88% of diaries were returned (11 095/12 542).

The baseline characteristics of the patients are shown on bmj.com. Overall, 73% (n=199) of participants cooperated with multifactorial assessment (medical 86% (236), cardiovascular 73% (201), physiotherapy 78% (214), occupational therapy 79% (216)). We identified 1011 risk factors for falls (485 in intervention group, 526 in control group); for both groups, median number 4 (interquartile range 3-5). We found no significant differences in baseline characteristics or risk factors for falls between intervention and control groups (table 1).

The intervention group had 652 falls and the control group 728 falls during the year's follow up. We found no significant differences between the intervention and control groups for any study outcomes (table 2).

	Discussion

Top Abstract Introduction Participants and methods Results Discussion References

Our study is the first randomised controlled trial to evaluate multifactorial intervention to prevent falls in older patients with cognitive impairment and dementia who present to the accident and emergency department after a fall. Intention to treat analysis showed no difference between intervention and control groups for any of the outcomes we measured.

About 10% fewer patients fell in the intervention group than in the control group. As the sample size was calculated to detect a 30% difference in fall rates, similar to outcomes achieved by multifactorial intervention in cognitively normal older patients, this was not significant. ^{7 8} When calculating the sample size, we judged that routine clinical implementation of any positive findings would require us to show similar effectiveness of multifactorial intervention after a fall in older patients both with and without dementia.

Strengths and limitations
It is unlikely that contamination of the control group was a major factor in the negative outcome. The control and intervention patients lived in the same residential or nursing homes, and all received a comprehensive assessment of risk factors at baseline. However, although 14% of control patients had changes in drugs meeting criteria for compliance with intervention, for all other key risk factors less than 10% of control patients received intervention outwith the study. Fall rates in the control group were equivalent to the highest reported rates of nursing home populations including residents with dementia. ^{2 9} Poor compliance with intervention was anticipated, yet compliance with key interventions at 3 months was similar to that reported in studies where multifactorial intervention had been successful in preventing falls (see bmj.com). ^{8 10}

Our study is limited by lack of generalisabilitythere was relative under-recruitment of participants from the community, and recruitment was from a specific population in a single centre. A further limitation is that effective single blinding was feasible for only the primary outcome measure (number of participants who fell) and the secondary outcome measures of number of falls and time to first fall.

Practical implications and conclusion
The recommendations for fall prevention within the national service framework for older people are broadly similar to a guideline issued in 2001 by a joint panel of the American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons.¹¹ Implementation of these recommendations will have considerable resource implications for the NHS in the United Kingdom. It seems appropriate, particularly in areas where effective services for falls do not yet exist, to target scarce resources where benefit is proved. Research data support multifactorial intervention in cognitively normal older people living in the community with risk factors for falls and those who present to the accident and emergency department after a fall. ^{7 8} Several studies also support the use of exercise as a single intervention in cognitively normal older people living in the community. ^{12 13} Although one randomised controlled trial of multifactorial intervention showed a reduction in recurrent falls in residents of nursing homes, most studies in this setting have been unable to prevent falls. ^{5 10 14}

Our study suggests that multifactorial intervention after a fall is less effective in patients with cognitive impairment and dementia than in cognitively normal older people. Limited resources may be used more effectively if targeted towards cognitively normal older people who fall. However, as older people with cognitive impairment and dementia are at particularly high risk of falls and their associated morbidity, it is important that prevention of falls remains a research priority in this patient group. Further work is required in patients with cognitive impairment and dementia who fall to determine optimal delivery of interventions and to identify the most important modifiable risk factors.

	Acknowledgments

We thank the participants, their families and carers, local family practitioners, staff of the accident and emergency departments, research physiotherapists Ros Krys and Victoria Bowles, research occupational therapist Helen Buri, research nurses Sarah Daniel, Alison Long, Katherine Wilton, and Michelle Widdrington, accident and emergency consultants Bas Sen and Nigel Fox for cooperation with screening, Pauline Potts for coding the diaries, and Pauline Cogan for assistance with data collection and processing.

Contributors: See bmj.com

	Footnotes

Funding: Alzheimer's Society and Northern and Yorkshire NHS Executive.

Competing interests: None declared.

This is an abridged version; the full version is on bmj.com

	References

Top Abstract Introduction Participants and methods Results Discussion References

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(Accepted 7 October 2002)