Around 30% of all hip fractures in the community occur in residential aged care, representing a substantial cost to the health care system. Evidence from overseas on calcium and vitamin D supplementation and hip protectors suggests these strategies could reduce hip fractures in aged care facilities by up to 50%.1-3
We undertook a cluster randomised controlled trial. All residential aged care facilities with at least 20 beds in the Hunter and Lower Mid North Coast areas of New South Wales were invited to participate in the study. Of the 92 eligible facilities, 88 took part. Consenting facilities were stratified according to mix of bed type (high-care, low-care and dementia-specific) and randomly allocated within strata into intervention or control groups by the statistician (R E G) using the procedure “surveyselect” in SAS statistical software, version 9.1 (SAS Institute Inc, Cary, NC, USA). Forty-six facilities were allocated to the intervention group and 42 to the control group. Facility staff were not blinded as to whether they were in the intervention or control group. Data collection commenced in July 2005 and concluded in June 2007. Ethics approval was obtained from the Hunter New England Area Health Service Human Research Ethics Committee.
The intervention involved employment of a project nurse to encourage a range of best-practice strategies at the facilities during the 17-month intervention period. The strategies promoted were: falls risk assessment; mobility assessment; use of hip protectors; calcium and vitamin D supplementation; continence management; exercise programs; appropriate footwear; medication review; and post-fall management review.
The project nurse provided link people from each intervention facility with information and resources to assist with preventing falls and fractures. An initial training session was held in November 2005. A set of resources was developed to support the 2005 falls prevention guidelines (known as the “Big Green Box”).4 The implementation of these resources was further encouraged during 3-monthly network meetings, held from February 2006 to June 2007 (six meetings in total), convened by the project nurse and attended by the link people. Intervention facility staff were also invited to attend a workshop to learn how to plan and run exercise programs. Support for the intervention was obtained from Divisions of General Practice.
Staff from facilities allocated to the control (usual care) group attended a workshop where data collection procedures were explained, and they were prompted to submit monthly data.
The main outcomes of interest were change in use of vitamin D supplements and hip protectors, and change in the rate of fall events. Measurement and comparison of outcomes were undertaken at two levels.
Facility-level data were investigated to determine change in the rate of events per 100 beds. A two-piece mixed (both fixed and random effects) model was fitted to the data for each outcome of interest, adjusting for bed type (low-care, high-care and mixed low- and high-care). The first piece of the model estimated the baseline rate (intercept) and change (slope) in the 7 months before the intervention commenced (pre-intervention period), and the second piece estimated change (second slope) for the duration of the intervention.
At the time of the census, there were 5391 permanent residents. Box 1 shows that randomisation produced reasonably similar characteristics for residents in the control and intervention groups.
Monthly falls data collection forms were returned by 76%–97% of facilities for each month from July 2005 to June 2007. There was no systematic bias in returns according to type of facility or phase of the study (pre-intervention or intervention). Overall, six facilities withdrew from the project during the intervention. All withdrawing facilities provided sufficient data to allow retention in analyses (Box 2).
Mean use of vitamin D at baseline was 12.7 supplements per 100 beds (95% CI, 7.4 to 18.1) in the control group and was 6.7 per 100 beds (95% CI, 1.2 to 10.9) lower in the intervention group. Slope did not change during the pre-intervention period for either group (P = 0.4) but increased significantly during the intervention period, with mean slope of 2.0 supplements per 100 beds per month averaged over both groups (P < 0.001). A two-piece model with quadratic term, adjusted for bed type, showed that the intervention group had a significantly lower supplementation rate at baseline than the control group (P = 0.015). However, there were no differences in slopes, for either the first or second stage (pre-intervention and during intervention: P = 0.161 and P = 0.092, respectively), with respect to study group.
Falls events recorded by facilities are shown in Box 3. For the entire cohort (intervention and control groups), there were 13.5 fractured neck of femur events per 1000 falls. Of these events, two occurred within the first 3 months of admission (15%). The risk of death within 3 months of a fall that resulted in a neck of femur fracture was 33%. Similar rates for all events were reported during the pre-intervention and intervention periods, after accounting for high variability of fall rates within facilities per month. The two-stage longitudinal regression model showed no evidence of change in the rate of falls from 16.0 per 100 beds (95% CI, 14.2 to 17.9) for either the pre-intervention stage (0.14 falls per 100 beds per month; 95% CI, − 0.17 to 0.45; P = 0.37) or after intervention commencement (− 0.023 falls per 100 beds per month; 95% CI, − 0.14 to 0.09; P = 0.686), when averaged over both groups. There were also no significant differences between intervention and control groups at commencement, with the intervention group being 2.40 falls per 100 beds (95% CI, − 1.25 to 6.24; P = 0.198) higher than the control group (12.91 falls per 100 beds; 95% CI, 6.89 to 18.93), nor over the first slope representing the pre-intervention period (0.18 more falls per 100 beds per month; 95% CI, − 0.39 to 0.76; P = 0.532) or over the second slope representing the intervention period (0.13 fewer falls per 100 beds per month; 95% CI, − 0.36 to 0.10; P = 0.259).
A sensitivity analysis excluding facilities that withdrew indicated no change in results.
Our trial tested the hypothesis that a full-time project nurse could assist a large number of aged care facilities to implement best-practice strategies to reduce hip fractures. However, there was no reduction in hip fractures in the intervention group compared with the control group, nor over time. A possible reason for this is that the addition of only one resource, the project nurse, was not sufficient to enable widespread uptake of best-practice strategies in the intervention facilities.
Other trials of falls injury prevention in aged care facilities have produced varied results. One trial showed a reduction in falls by repeat fallers;1 others failed to produce any reduction in falls or fractures;2,3 and one showed reduction in hospital admissions.1 The most significant results came from a French trial of vitamin D and calcium supplementation5 and a Danish trial of hip protector use,6 although the reductions in risk of hip fractures seen in these studies have not been replicated in subsequent studies. Two recent studies have used a wider range of strategies, with better results,7,8 although the short period of intervention in one trial makes the results less convincing.
Another possibility is that the intervention period was too short. A German study seems to support this possibility.8 Falls injury prevention programs may also not be effective if they involve a significant proportion of people with dementia. Subgroup analyses of an intervention trial in aged care facilities that showed an overall reduction in falls failed to show a reduction in residents with cognitive impairment.7
1 Characteristics of 5391 residents in participating facilities at the time of the census, January–February 2006
* Defined as anyone who can stand and walk with or without assistance. |
Received 20 April 2009, accepted 24 September 2009
Abstract
Objective: To test the effectiveness of using a full-time project nurse to assist residential aged care facilities in using evidence-based approaches to falls injury prevention.
Design, setting and participants: Cluster randomised controlled trial involving 5391 residents in 88 aged care facilities in the Hunter and Lower Mid North Coast areas of New South Wales. Residents were followed for 545 days or until death or discharge. Data were collected from July 2005 to June 2007.
Intervention: Employment of a project nurse to encourage best-practice falls injury prevention strategies during the 17-month intervention period.
Main outcome measures: Monthly data about falls, falls injury and falls injury prevention programs; audit of hospitalisation for fractured neck of femur.
Results: Despite significant increases in the provision of hip protectors and use of vitamin D supplementation in both intervention and control facilities, there was no difference in the number of falls or falls injuries between the intervention and control groups, nor a reduction in falls overall. There was also no difference between the 7-month pre-intervention period and the intervention period in the number of falls or falls injuries. Factors related to residents having an increased risk of falls with fractured neck of femur included being ambulant, having dementia, increasing age, and having a high falls risk assessment score.
Conclusion: It is difficult to change falls risk among high-risk populations, including people with dementia. The use of important strategies such as hip protectors and vitamin D and calcium supplementation increased during the study, probably with contamination of control facilities. Longer follow-up may be required to measure the impact on falls outcomes of the strategy of using a facilitating nurse.
Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12605000540617.