Chapter 26. Prevention of Falls in Hospitalized and Institutionalized Older People (continued)

Subchapter 26.2. Interventions that Decrease the Use of Physical Restraints

Background

The Health Care Financing Administration (HCFA) defines physical restraints as "any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient that the individual cannot remove easily which restricts freedom of movement or normal access to one's body."¹ Physical restraints have been used in nursing homes and hospitals both as a safety device and as a falls prevention tool. Because restrained patients cannot arise from a chair or transfer out of bed, they theoretically will not fall or, in the case of bedrails, will not roll out of bed. However, the use of physical restraints may lead to substantial adverse outcomes. In fact, serious injuries and even death have been reported with use of these devices.^2,3 This chapter examines interventions to reduce use of physical restraints and the concomitant effect on fall rates.

Practice Description

Studies examining the use physical restraints have considered 2 types of interventions in hospital or nursing home settings: bedrails and other mechanical restraints designed to restrict mobility. These interventions usually begin with either a physician or nurse making an assessment that a patient is at risk for falls, elopement, or other adverse outcomes. Thereafter, use of a restraint is initiated, with periodic reassessment of the ongoing need for the device. Safety practices to reduce restraint use in nursing home patients have included nursing education strategies focusing on assessment/reassessment of the need for restraints and the use of alternatives to restraints.

Prevalence and Severity of the Target Safety Problem

See Introduction to Chapter 26.

Opportunities for Impact

Federal guidelines now discourage all but the limited, appropriate use of physical restraints and bedrails. Legislation adopted as part of the Omnibus Budget Reconciliation Act of 1987 directed nursing homes to limit physical restraints, and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) has adopted similar guidelines. Several statewide initiatives (e.g., the Pennsylvania Restraint Reduction Initiative, begun in 1996) have been implemented under HCFA's National Restraint Reduction Initiative, resulting in notable reductions in restraint usage.⁴ The Food and Drug Administration's Hospital Bed Safety Work Group has likewise actively raised awareness of the risks and benefits of bedrail use.⁵ Based on an annual HCFA survey, the national restraint rate was approximately 13.5% in 1999, down from approximately 20% in 1996 when HCFA's Restraint Reduction Initiative began.⁶ Nonetheless, data from selected states reveals that the rate was still as high as 26% as of 1998.⁷

Study Designs and Outcomes

Six studies were identified: 2 concerning bedrail interventions^8,9 and 4 describing mechanical restraints interventions (Table 26.2.1).^7,10-12 Most studies compare interventions with historical control or baseline rates using a before-after study design. Morbidity data on falls are reported in all studies.

Evidence for Effectiveness of the Practice

The studies reveal no statistically significant difference in falls compared with historical controls when bedrails are removed. In fact, restrained patients appear to have a modest increase in fall risk or fall injuries based on several studies. Weaknesses in study design for some of these studies preclude a final conclusion.

Potential for Harm

The potential for harm with use of bedrails is well-documented, including death from a variety of mechanisms, including death and strangulation.¹³ Mechanical restraints likewise carry a risk of severe injury, strangulation, and mobility limitations that may predispose patients to other adverse outcomes (pressure ulcers, incontinence, acute confusion). Limits to patient freedom, dignity, and quality of life also contribute to the potential for harm. A potential harm of interventions to decrease restraint use is that there may be an increase in other adverse events (e.g., elopement) if appropriate alternative preventive measures are not in place.

Costs and Implementation

The costs associated with interventions to reduce the use of restraints have not been described. Nonetheless, reduction in the use of physical restraints will require resources to pay for alternative interventions and rehabilitative measures and will increase labor costs.¹⁴ Compliance with interventions to reduce bedrail rates and to decrease mechanical restraint use has been good. In fact, given adequate alternatives to the use of these devices, hospital and nursing staffs have decreased their usage significantly. In the Neufeld study,⁷ for example, restraint use fell from 41% to 4%.

Comment

There is growing evidence that physical restraints have a limited role in medical care. Restraints limit mobility, a shared risk factor for a number of adverse geriatric outcomes, and increase the risk of iatrogenic events. They certainly do not eliminate falls, and decreasing their use can be accomplished without increasing fall rates. In some instances reducing the use of restraints may actually decrease the risk of falling. Incorporating changes into physician and staff behavior may be easier if large, multicenter trials are successful in identifying safe alternatives to restraints that effectively limit falls risks for patients.

Table 26.2.1. Studies of physical restraints and fall risk*

Study	Participants and Setting	Design, Outcomes	Results
Hanger, 19999	1968 hospital patients in New Zealand, 1994; formal bedrail policy and educational program to reduce bedrail use, historical controls	Level 3, Level 1	No significant difference in overall fall rate: 164.8 falls/10,000 bed days before and 191.7 falls/10,000 bed days after the intervention (p=0.18) Fewer serious falls occurred after the intervention (p=0.008)
Si, 19998	246 patients in a teaching nursing home, 1993-94; interdisciplinary team assessment and removal of bedrails with provision of bedrail alternatives, historical controls	Level 3, Level 1	No significant difference in fall rates: 2/116 (1.7%) patients before and 2/130 (1.5%) patients after the intervention
Capezuti, 199611	322 nursing home residents; subgroup of confused patients examined for mechanical restraint use	Level 3, Level 1	Confused patients who were restrained had increased odds of falling (OR 1.65, 95% CI: 0.69-3.98) and recurrent falls (OR 2.46, 95% CI: 1.03-5.88)
Capezuti, 199812	633 nursing home residents in 3 nursing homes, 1990-1991; restraint education and consultation interventions compared with baseline rates	Level 3, Level 1	No significant increase in fall rates in the restraint-free group Decreased odds of minor injury after restraint removal, adjusted OR 0.3 (95% CI: 0.1-0.9)
Neufeld, 19997	2075 nursing home beds in 16 nursing homes, 1991-1993; educational intervention to decrease mechanical restraints compared with baseline rates	Level 3, Level 1	Moderate/severe injuries decreased from 7.4% to 4.4% (p=0.0004) after educational intervention
Tinetti, 199110	397 elderly patients at 12 skilled nursing facilities; observational cohort study of mechanical restraint use	Level 3, Level 1	15/275 (5%) of unrestrained patients compared to 21/122 (17%) experienced a serious fall-related injury (p<0.001) Restraint use was significantly associated with a serious fall, adjusted OR 10.2 (95% CI: 2.8-36.9)

* CI indicates confidence interval; OR, odds ratio.

References

1. Health Care Financing Administration. FY 2001 Annual Performance Plan. Available at: http://www.hcfa.gov/stats/2001.htm. Accessed June 13, 2001.

2. FDA Center for Devices and Radiological Health. FDA safety alert: entrapment hazards with hospital bed side rails. August 1995. Available at: http://www.fda.gov/cdrh/ bedrails.html. Accessed June 12, 2001.

3. Miles SH, Irvine P. Deaths caused by physical restraints. Gerontologist 1992;32:762-766.

4. Health Care Financing Administration. National restraint reduction newsletter. Summer 2000. Available at: http://www.hcfa.gov/publications/newsletters/restraint/2000/rr0600.asp. Accessed June 12, 2001.

5. FDA Center for Devices and Radiological Health. A guide to bed safety. Available at: http://www.fda.gov/cdrh/beds/bedrail.pdf. Accessed June 12, 2001.

6. Health Care Financing Administration. National restraint reduction newsletter. Winter 1999. Available at: http://www.hcfa.gov/publications/newsletters/restraint/1999/rrwin99.htm. Accessed June 12, 2001.

7. Neufeld RR, Libow LS, Foley WJ, Dunbar JM, Cohen C, Breuer B. Restraint reduction reduces serious injuries among nursing home residents. J Am Geriatr Soc 1999;47:1202-1207.

8. Si M, Neufeld RR, Dunbar J. Removal of bedrails on a short-term nursing home rehabilitation unit. Gerontologist 1999;39:611-614.

9. Hanger HC, Ball MC, Wood LA. An analysis of falls in the hospital: can we do without bedrails? J Am Geriatr Soc 1999;47:529-531.

10. Tinetti ME, Liu YB, Ginter S. Mechanical restraint use and fall related injuries among residents of skilled nursing facilities. Ann Intern Med 1992;116:369-374.

11. Capezuti E, Evans L, Strumpf N, Maislin G. Physical restraint use and falls in nursing home residents. J Am Geriatr Soc 1996;44:627-633.

12. Capezuti E, Strumpf NE, Evans LK, Grisso JA, Maislin G. The relationship between physical restraint removal and falls and injuries among nursing home residents. J Gerontol A Biol Sci Med Sci 1998;53:M47-M52.

13. Parker K, Miles SH. Deaths caused by bedrails. J Am Geriatr Soc 1997;45:797-802.

14. Schnelle JF, Smith RL. To use physical restraints or not? [editorial]. J Am Geriatr Soc 1996;44:727-728.

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Subchapter 26.3. Bed Alarms

Background

Epidemiologic studies reveal that falls occur commonly in and around bed areas.^1,2 Decreasing the risk of falls when patients attempt to transfer into and out of bed without assistance is a potentially important target safety goal. This chapter examines the use of a bed alarm system that alerts hospital staff to patient movement out of bed as a strategy to reduce falls. General principles of alarm use in healthcare settings can be found in Chapter 8.

Practice Description

A sensor device is placed on the bed, under a sitting or reclining patient. When the patient changes position, it detects movement and/or absence of weight. An audible alarm is triggered at the nurses' station and, with some devices, in the patient's room. The alarm alerts nurses when patients attempt to leave the bed without assistance and may alert a patient to remain in bed if the alarm is audible in the patient's room.

Evidence for Effectiveness of the Practice

Several studies have included bed alarms as part of a multifaceted intervention.^3-6 However, the study designs do not allow calculation of the effect attributable to the bed alarm component or were not controlled. A recent, unpublished before-after study was identified in a Web search but the full report could not be obtained before completion of this chapter.⁷ Tideiksaar et al randomized elderly patients at "high risk" for falls to either a group that received an alarm system (the RN+ OnCall bed monitoring system) or to a control group that did not (Table 26.3.1)⁸. The groups were similar in age and gender. No other baseline comparisons were reported. There were fewer falls in the study group but the difference failed to reach statistical significance. However, the total number of falls was low (n=17) and had there been one less fall in the alarm group or one more fall in the control group, the difference would have been statistically significant.

Potential for Harm

No harm was identified. There are theoretical electrical risks if the sensor devices are internally compromised due to bending of the sensor mats and exposure to fluids, but such events have not been reported in the literature.

Costs and Implementation

Costs of the devices vary by manufacturer, the type of bed monitoring system used, and the number of beds to be monitored. Manufacturers' charges range from several hundred to several thousand dollars for the receiving equipment. Individual sensors require replacement after pre-specified periods of use or, in some cases, can be cleaned between patients, which incurs additional hospital costs. Implementation requires adequate staffing to respond in a timely manner to the audible alarms.

Comment

At this time, there is insufficient evidence regarding the effectiveness of bed alarms in preventing falls in elderly patients to recommend the practice. Additional research sufficiently powered to identify meaningful differences, coupled with a formal economic analysis, would be useful.

Table 26.3.1. Study of bed alarms for fall prevention

Study	Participants and Setting	Study Design, Outcomes	Results (95% Confidence Interval)
Tideiksaar, 19938	70 patients on a geriatric unit in a university hospital, 1992	Level 1, Level 1	Odds ratio for prevention of falls: 0.32 (0.10-1.03)

References

1. Vassallo M, Amersey RA, Sharma JC, Allen SC. Falls on integrated medical wards. Gerontology 2000;46:158-162.

2. Sutton J, Standan P, Wallace A. Incidence and documentation of patient accidents in hospital. Nurs Times 1994;90:29-35.

3. Schmid NA. Reducing patient falls: a research-based comprehensive fall prevention program. Mil Med 1990;155:202-207.

4. Widder B. A new device to decrease falls. Geriatr Nurs 1985;6:287-288.

5. Morton D. Five years of fewer falls. Am J Nurs 1989;89:204-205.

6. Innes E. Maintaining fall prevention. QRB 1985;11:217-221.

7. Bed-Check Corporation. Fall prevention study: bed alarms, investigating their impact on fall prevention and restraint use. Available at: http://www.bedcheck.com/fall-prevention-study.html. Accessed June 6, 2001.

8. Tideiksaar R, Feiner CF, Maby J. Falls prevention: the efficacy of a bed alarm system in an acute-care setting. Mt Sinai J Med 1993;60:522-527.

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Subchapter 26.4. Special Hospital Flooring Materials to Reduce Injuries from Patient Falls

Background

One proposed practice to prevent injury due to falls is to alter flooring material on hospital wards or in nursing homes. Carpeting, vinyl, or other biomedically-engineered materials could potentially improve falls outcomes. The use of special flooring materials has been shown to influence specific gait characteristics in hospitalized elders.¹ A recent study described the Penn State Safety Floor, which is designed to remain relatively rigid under normal walking conditions but to deform elastically to absorb impact forces during a fall.² The efficacy of this floor is still being tested outside the laboratory environment among nursing home residents.³

Practice Description

As data on the efficiency of the Penn State Safety Floor² are not yet available, we restrict our review to the use of hospital-duty carpeting compared with "usual" vinyl flooring.

Study Designs and Outcomes

We identified 2 studies of the effect of flooring type (carpet vs. "usual" vinyl flooring) on falls: a randomized controlled trial in an inpatient rehabilitation unit⁴ and a retrospective study of accidents reported in a care of the elderly unit (Table 26.4.1).⁵ Both studies reported Level 1 outcomes. The randomized trial measured the rate of falls. The retrospective analysis studied fall-related injury, defined as any graze, bruise, laceration, fracture or pain.

Evidence for Effectiveness of the Practice

The randomized trial by Donald et al found more falls in the group housed in rooms with carpeted flooring, although the difference barely failed to achieve statistical significance. The earlier retrospective analysis by Healey found that the rate of injury was significantly lower for patients who fell on carpet rather than vinyl flooring.⁵ The severity of injuries was not reported and it was not possible to determine whether the rate of falls differed according to flooring material.

Potential for Harm

No harm was identified, although it is possible that asthmatic patients might react to increased levels of dust-mite allergens in carpeted wards.⁶

Costs and Implementation

No cost estimates for changes in flooring were reported in the literature. Implementation of this practice would require a large expenditure for facilities upgrades nationwide. Likewise, the costs associated with keeping various floor surfaces clean in the hospital or nursing home environment would also be high.

Comment

Advances in biomedical engineering could result in potentially significant redesign of the physical environment in hospitals and nursing facilities. The primary aim of specialized flooring could be either to reduce the risk of falling or to reduce the risk of an injury once a fall has occurred, or both. The two studies analyzed seem to indicate that carpeted floors may increase fall rates but decrease fall injuries; it is possible that other surfaces would yield better results. Further study of this area is warranted.

Table 26.4. Study of special flooring for falls prevention

Study	Participants and Setting	Study Design, Outcomes	Results
Donald, 20004	32 patients in an elderly care rehabilitation ward in the United Kingdom in 1996	Level 2, Level 1	Rate of falls: Carpet, 10/16 (63%); vinyl, 1/16 (6%) RR 8.3 (95% CI: 0.95-73; p=0.05)
Healey, 19945	Random sample of accident forms (n=213) from care of elderly unit over 4 years	Level 3, Level 1	Falls resulting in injury: Carpet, 15%; vinyl, 91% (p<0.001)

* CI indicates confidence interval; RR, relative risk.

References

1. Wilmott M. The effect of a vinyl floor surface and a carpeted floor surface upon walking in elderly hospital in-patients. Age Ageing 1986;15:119-120.

2. Casalena JA, Badre-Alam A, Ovaert TC, Cavanagh PR, Streit DA. The Penn State safety floor. Part II: reduction of fall-related peak impact forces on the femur. J Biomech Eng 1998;120:527-532.

3. Stevens JA, Olson S. Reducing falls and resulting hip fractures among older women. MMWR Morb Mortal Wkly Rep 2000; 49(RR02):1-12.

4. Donald IP, Pitt K, Armstrong E, Shuttleworth H. Preventing falls on an elderly care rehabilitation ward. Clin Rehabil 2000;14:178-185.

5. Healey F. Does flooring type affect risk of injury in older patients? Nurs Times 1994;90:40-41.

6. Sadler C. Floored thinking. Nurs Times 1993;89:20-21.

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Subchapter 26.5. Hip Protectors to Prevent Hip Fracture

Background

cHip fractures are an important cause of morbidity and mortality, resulting in about 340,000 hospitalizations in 1996 in the United States for those aged 65 years and older.¹ Six months after hospitalization for hip fracture, 12.8% of patients require total assistance to ambulate according to a recent prospective study.² New dependency in physical and instrumental activities of daily living is also considerable. For those independent prior to a hip fracture, 20% of patients require assistance putting on pants, 66% require assistance in getting on or off the toilet, and 90% require assistance climbing 5 stairs after a hip fracture.³ Mortality rates range between 18-33% within the first year post-fracture.³ One proposed prevention measure is for a patient to wear a protective pad around the hip to absorb the impact of a fall and to reduce the risk of fracture by "shunting" energy away from the hip region.

Practice Description

External hip protectors are usually made with plastic pads or shields that are padded or constructed with foam-type materials. They fit into specially-designed pockets in undergarments or pants. They are designed to be worn during the day for people who are out of bed, walking or engaged in activities that place them at higher risk for falls. Ideally, they would be worn all the time to protect individuals from nighttime falls.

Prevalence and Severity of the Target Safety Problem

See Introduction to Chapter 26.

Opportunities for Impact

No data on the nationwide use of hip protectors in the hospital or nursing home are available. A small minority of institutions are in the process of evaluating them, and a few may have begun to use them.

Study Designs

Five relevant randomized controlled trials^4-8 were identified from a literature search and from a Cochrane systematic review.⁹ The Cochrane review cites 2 additional abstracts^10,11 not included here. Four of the trials evaluate effectiveness of the devices and one study⁸ examines compliance rates of wearing hip protectors as part of a pilot study. Two studies were cluster-randomized and 2 were randomized by individual patient.

Study Outcomes

Studies reported hip fractures as an outcome, although compliance with the intervention was the primary outcome in one study. Additional outcomes reported were mortality, falls, and non-hip fractures.

Evidence for Effectiveness of the Practice

External hip protectors appear to be an effective means to reduce the risk of a hip fracture in older persons aged 65 and over who fall. Table 26.5.1 lists the abstracted studies and outlines their pertinent features. The generalizability of these results to wider audiences and to lower risk populations has not been demonstrated, nor has the potential benefit for hospitalized patients been reported. Concerns with compliance could hinder their effectiveness on a population-wide level.

Potential for Harm

Discomfort from wearing the device, difficulty managing the garment while dealing with continence, and the potential for skin irritation and breakdown are causes for concern if fragile older people were to wear hip protectors. Because long-term compliance is low, it is unclear how many people would experience such problems if the devices were worn for longer periods during the day or for long-term use.

Costs and Implementation

An Australian study published in 2000 quoted a cost of A$10 per pair (approximately $5.25US).⁴ The retail price quoted by one US manufacturer of a different hip protector is approximately $90 per pair. The lycra-containing undergarment used by some manufacturers to keep the hip pads in place requires special laundering and would require a tracking system similar to that used for other specialized garments or medical devices assigned to patients within a facility. Once provided, if devices can be put on and taken off by individual users, implementation is straightforward. The cost-effectiveness of the devices has not been formally reported.

Comment

One of the main philosophical concerns raised by these studies is the change in emphasis from primary prevention of the underlying cause of hip fractures (i.e., falls) to an emphasis on methods of protecting patients from the deleterious consequences of falls. However, a strategy for addressing the multiple risk factor model for falls is still warranted for primary falls prevention. With this caveat in mind, there is strong evidence to support the ability of hip protectors to prevent hip fractures. This evidence, in addition to their high face validity, may encourage their rapid adoption. Further evaluation of their costs, acceptability to patients, and effectiveness in hospitalized patients (versus nursing home residents) is needed.

Table 26.5.1. Hip protectors to prevent hip fracture*

Study	Participants and Setting	Design, Outcomes	Results
Parker, 20009	1752 nursing home or rest home residents in 5 countries	Level 1A, Level 1	Peto OR 0.44 (95% CI: 0.26-0.75) of hip fracture in the intervention group in cluster-randomized studies Peto OR 0.22 (95% CI: 0.09-0.57) in patient-randomized studies
Chan, 20004	71 nursing home residents in Australia, year not stated	Level 1, Level 1	RR of hip fracture in the intervention group 0.264 (95% CI: 0.073-0.959)
Ekman, 19925	746 nursing home residents in Sweden, year not stated	Level 1, Level 1	RR of hip fracture in the intervention group 0.33 (95% CI: 0.11-1.00)
Kannus, 20006	1801 community based elderly in Finland, 1996-1997	Level 1, Level 1	RR of hip fracture in the intervention group 0.4 (95% CI: 0.2-0.8; p=0.008)
Lauritzen, 19937	665 nursing home residents in Denmark, 1991-1992	Level 1, Level 1	RR of hip fracture in the intervention group 0.44 (95% CI: 0.21-0.94)
Villar, 19988	141 rest home residents in the UK, year not stated	Level 1, Level 3	30% compliance over 3 months (hip fracture outcomes not assessed)

* CI indicates confidence interval; OR, odds ratio; and RR, relative risk.

References

1. Stevens JA, Olson S. Reducing falls and resulting hip fractures among older women. MMWR Morb Mortal Wkly Rep 2000;49:1-12.

2. Hannan EL, Magaziner J, Wang JJ, et al. Mortality and locomotion 6 months after hospitalization for hip fracture. JAMA 2001;285:2736-2742.

3. Magaziner J, Hawkes W, Hebel JR, et al. Recovery from hip fracture in eight areas of function. J Gerontol Medical Sciences 2000;55A:M498-M507.

4. Chan DK, Hillier G, Coore M, et al. Effectiveness and acceptability of a newly designed hip protector: a pilot study. Arch Gerontol Geriatr 2000;30:25-34.

5. Ekman A, Mallmin H, Michaelsson K, Ljunghall S. External hip protectors to prevent osteoporotic hip fractures. Lancet 1997;350:563-564.

6. Kannus P, Parkkari J, Niemi S, et al. Prevention of hip fracture in elderly people with use of a hip protector. N Engl J Med 2000;343:1506-1513.

7. Lauritzen JB, Petersen MM, Lund B. Effect of external hip protectors on hip fractures. Lancet 1993;341:11-13.

8. Villar MTA, Hill P, Inskip H, Thompson P, Cooper C. Will elderly rest home residents wear hip protectors? Age Ageing 1998;27:195-198.

9. Parker MJ, Gillespie LD, Gillespie WJ. Hip protectors for preventing hip fractures in the elderly. In: The Cochrane Library, Issue 2, 2001. Oxford: Update Software.

10. Harada A, Okulzumi H. Hip fracture prevention trial using hip protector in Japanese elderly. Osteoporos Int 1998;8(Suppl 3):121.

11. Heikinheimo R, Jantti PL, Aho HJ, Maki-Jokela PL. To fall but not to break—safety pants. Proceedings of the Third International Conference on Injury Prevention and Control, Melborne 1996;1996:576-578.

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