Health care workers have been taught for decades that restraint and bed rail use translates to safe patient care. However, recent literature has shown that bed rails may cause significant injury and death resulting from entrapments (Todd, Ruhl, & Gross, 1997). Between 1985 and 1999, 371 entrapments involving hospital beds, mattresses, and rails were reported to the Food and Drug Administration (FDA). Of these, 228 resulted in deaths, 56 resulted in non-fatal injury, and 56 resulted in no injury because of effective caregiver intervention (Hospital Bed Safety Workgroup, 2000). Anecdotal evidence indicates that rails may also contribute to serious injury and death caused by falls over, under, between, and around bed rails (Braun & Capezuti, 2000).
Many factors are associated with resident safety in nursing homes including frailty, agitation, depression, incontinence, polypharmacy, pain, involuntary movements, gait or balance disorders, dizziness, confusion, and accidents or environmental hazards (Capezuti, Talerico, Strumpf, & Evans, 1998; Rubenstein, Josephson, & Robbins, 1994). Because staff is concerned with patient safety and reduction of falls and injuries, they may use restraints and bed rails to keep patients from trying to get out of bed independently (Bryant & Fernald, 1997; Werner, Cohen-Mansfield, Koroknay, & Braun, 1994). Rubenstein and Robbins (1984) described this phenomenon as an example of "defensive medicine," a standard of practice based on consensus rather than scientific evidence. As a result, "routine use of bed rails" became the standard of effective nursing practice (Braun & Capezuti, 2000). The common sense notion that rails were safety devices and their incorporation into standard hospital bed design deterred nurses from questioning the efficacy of bed rails in falls prevention. Nursing home residents spend a great deal of time in bed (Ancoli-Israel, Parker, & Since, 1989; Bliwise, Carroll, &: Dement, 1990); therefore, their exposure to the risks of entrapment is increased compared to patients who spend little time in bed.
The Health Care Financing Administration (2000) defined restraints in nursing homes as "any manual method or physical or mechanical device, material, or equipment attached or adjacent to the individual's body that the individual cannot remove easily, which restricts freedom of movement or normal access to one's body." Under this functional definition, a bed rail is a restraint if it prohibits freedom of movement within one's environment or normal access to one's body.
Picture 1. Body pillows used as an alternative to bed rails.
Picture 2. A floor mat provides additional protection.
For providers, reducing the use of bed rails is similar to experiences in 1990 when nursing homes were directed to reduce the use of physical restraints and psychoactive drugs with little empirical evidence to guide such a change in practice. As nursing homes have reduced use of physical restraints, research-based alternative interventions have been tested and reported in the literature (Capezuti, Strumph, Evans, & Maisiin, 1999; Cohen, Neufeld, Dunbar, Pflug, & Breuer, 1996; Ejaz, Jones, & Rose, 1994; Evans et al., 1997; Strumpf, Evans, Wagner, & Patterson, 1992; Werner et al., 1994). Some have documented reduced bed rail use as a result of a restraint reduction program Levine, Hammond, Marchello, & Breuer, 2000).
Myint, Neufeld, and Dunbar (1999) found that through a planned intervention to reduce bed rails in a short-term nursing home rehabilitation unit, 80% of residents were free of bed rails. This decrease in bed rail use did not result in increases in serious injury. Systematic interventions to reduce bed rail use while addressing related clinical problems are needed to guide practice. In this study, the approach is consistent with other fall research projects using multifactorial interventions targeting several domains (Gerson, Blanda, & Janakiram, 2001; Yates & Dunnagan, 2001) and using foundational work of others (Capezuti, Talerico, et al., 1999; Myint et al., 1999; "Untie the Elderly," 2001). Thus, this project contributes to a small, but growing, body of work addressing the gap in knowledge concerning safe reduction of bed rail use.
The Veterans' Integrated Service Network (VISN) 8 Patient Safety Center of Inquiry has been working with the FDA and representatives from regulatory agencies, consumers, health care providers, manufacturers, and others to form an interdisciplinary coalition called The Hospital Bed Safety Work Group (www.fda. gov/cdrh/beds/). The purpose is to raise awareness of hospital bed system entrapment hazards, educate caregivers and family members on the
Figure. BedSAFE Bed Rail Rounds Observational Checklist *Note: TBI = traumatic brain injury.
problems associated with bed rail use, and develop manufacturing standards for new hospital bed systems (e.g., bed frames, mattresses, transfer devices, bed rails). As pan of this national entrapment reduction effort, this quality improvement project was undertaken to reduce the inappropriate use of bed rails in a long-term care facility without increasing the risk of injuries caused by falls out of bed. Bed Safety Alternatives for Frail Elderly (BedSAFE) was funded by the VISN 8 Patient Safety Center of Inquiry in 1999 as a continuous quality improvement project.
DESCRIPTION OF THE BEDSAFE PROGRAM
The three long-term care units in this program have a varied population. Approximately one-third of the residents have Alzheimer's disease with severe dementia as their admitting diagnosis, one-third of the residents are admitted for long-term rehabilitation or skilled nursing care, and onethird are hospice or respite residents. The units have beds with two fulllength bed rails, and occasionally four half or split rails are attached to the beds. All 180-beds in the long-term care facility were included in the study. Although a key feature of BedSAFE was compliance monitoring, the mission was much broader and included education, awareness, assessment of changing needs, communication of creative solutions, and the provision of economical alternatives.
Program components included an interdisciplinary team, alternatives to bed rail use, the art of persuasion, and audit and feedback.
An Interdisciplinary Team. The interdisciplinary team consisted of the team leader (a member of the hospital's restraint reduction committee), representatives from nursing staff and resident families, nurse managers, a hospital engineer, and representatives from other departments who worked with the residents in areas such as kinesiotherapy, occupational therapy, and social work. The interdisciplinary nature of the team helped identify a broad range of barriers and safety concerns and solutions. Nursing and rehabilitation staff brought critical knowledge of residents' medical conditions and recent changes in functional status, as well as resident and family preferences. Direct care providers with established relationships with residents often were effective in persuading them to lower bed rails. The engineer's input was very different from clinicians'; he identified safety concerns sometimes overlooked by staff. His input was critical and added a unique perspective to the group by identifying equipment solutions (e.g., a urinal, a remote control holder). The team also included a family advocate who understood the reason for reducing bed rail use and who had good communication skills. This individual attended rounds, talked to residents and family members, and discussed bed rails at monthly family meetings using a patient education brochure. During the course of BedSAFE, advice was sought from Elizabeth Capezuti and other nationally known experts in restraint reduction.
The team conducted walking rounds monthly on each nursing home care unit and performed individual patient and environmental assessments, determined risk, and identified and provided alternatives to bed rails. To remind all staff after rounds, signs were posted at bedsides to indicate which, if any, bed rails should be in the raised position and which alternatives should be used.
Alternatives to Bed Rail Use. Individual patient assessment was the basis of decision-making concerning lowering bed rails. Nurse-perceived reasons for bed rail use such as history of falls, confusion, and degree of disability were discussed (Figure). Based on this patient-specific assessment, and resident and family input, the team decided on appropriate alternatives to bed rails, such as environmental modifications, equipment, and accessories (Table 1 and Picture 1). These alternatives became concrete symbols of safety that were hoped to replace the symbolic meaning of bed rails as safety devices. Accessories and height-adjustable beds were pilot tested for effectiveness and acceptability to residents and staff. These product evaluations guided purchase decisions.
The Art of Persuasion. During the course of the intervention, the team became adept at using techniques of persuasion combined with resident and family education to convince residents and families of the advantages of lower bed rails. Quite often, residents or family members insisted on using bed rails because it was a symbol of safety, particularly if they had used rails for a long period of time. The team had to explain why for years health care providers recommended the use of bed rails for safety, but, in light of new information, it was believed that the disadvantages of bed rails outweighed the advantages. "Weaning" was the term used to describe a gradual process of reducing the length of time bed rails were in the raised position for residents or families who were skeptical. If the residents were willing, they were asked if the rail could be lowered for 5 minutes. After 5 minutes the team returned, reassured the resident, and decided with the resident how quickly to proceed. Sometimes this process occurred over a period of days to weeks. The team and unit staff conducted one-on-one and group-level education to residents, students, and families. Group-level education and discussion were used for family members during monthly caregjver support group meetings. An educational brochure and slide show were used as teaching aids. A similar brochure is available at www.fda.gov/cdrh/beds/ bed brochure.html.
PRIMARY ALTERNATIVES TO BED RAILS USED IN BEDSAFE PROGRAM
Audit and Feedback. During bed rail rounds, a researcher collected observational data on use of bed rails, bed safety features, and bed rail alternatives using a checklist (Figure). Monthly data were compiled for each unit, trended by month and unit, and presented in graphic format. The BedSAFE coordinator chaired a monthly meeting during which bed rail use rates and other data were presented to staff and management from each unit. The reasons for trends and deviations from expected results were discussed. Through discussion, the team determined barriers and identified best practices for implementation across units. Audit and feedback were used to stimulate the interest of staff, to reinforce the positive outcomes of their bed rail reduction efforts, and to stimulate "friendly competition" across the three units. During the course of the intervention, nurse managers conducted independent activities to transfer bed rail knowledge among staff. For example, nurse managers developed a tracking form to verify that staff nurses implemented BedSAFE recommendations. Nurse managers also began reviewing bed rail compliance on the night shift each morning.
A data collector recorded use of bed rails each month using the BedSAFE Checklist. An occurrence of bed rail use was defined as a rail in a raised position at the time of data collection. Because all beds on each of the 60-bed units had full-length bed rails, each unit could have a range of 0 to 120 occurrences of bed rail use. To capture bed-related falls pre- and post-BedSAFE, 2 years of incident reports were reviewed - 1 year prior to the implementation of BedSAFE and the first year of BedSAFE. Only incident reports of falls from bed were analyzed. Information regarding the circumstances of the fall, the prevalence and type of injury, environmental characteristics, and risk factors were analyzed. Descriptive statistics and chi square analysis were used.
Measures Demonstrating Improved Patient Care
Bed Rail Use. Comparing rail use pre- and post-BedSAFE, a point prevalence analysis showed a decrease in rail use of 27% across all three units (Table 2). Greatest gains reductions occurred in the hospice unit. Remaining rail use was attributed to mobility and transfer needs; falls precautions for residents with neurological disorders, blindness, or severe coughing; and patient or family preference. Moreover, the use of no rails improved with a decrease in the use of two rails per bed (Table 3).
PREVALENCE OF BED RAIL USE BY UNIT
Falls from Bed. The effect of BedSAFE on falls was positive. The number of falls from bed in the year preceding BedSAFE was 142 compared to 126 falls from bed in the year following the BedSAFE intervention - an 11% reduction. The rate of falls from bed per 1,000 patient days in the year preceding BedSAFE compared to the year of BedSAFE was 2.28 and 2.13, respectively (chi square not significant [NS]). The effect of the program on fall-related injuries was also positive. The frequency of injuries caused by falls from bed decreased slightly between pre- and post-intervention (Table 4). The percent of falls resulting in injury decreased from 30% to 28% (chi square NS). The most common injuries resulting from falls from bed in this long-term care facility's units, before and after BedSAFE intervention, are listed in Table 5. The most frequent bed-related fall injuries occurring among residents in the three nursing home care units were lacerations, scrapes, and bruises.
Circumstances Surrounding Falls from Bed. Using incident report data, the team collected specific information surrounding the circumstances of patient falls from bed that occurred 1 year before and 1 year after the BedSAFE intervention. Although the overall frequency of injuries decreased only slightly from pre- to post-intervention, a marked difference in postintervention injuries was found when falls were categorized into those resulting in a fall from bed onto a floor mat and those resulting in a fall from bed with no floor mat. Only 11% of post-intervention injuries occurred when residents fell from bed and landed on a floor mat. The remaining 89% of injuries occurred when the floor mat was not in use.
Results of this quality improvement project were important in understanding the effect of lowering bed rails on falls from bed and related injuries in a nursing home setting. Results were reassuring because not only did falls from bed decrease as a result of this program, but also for the most part, residents did not experience serious injuries from their falls. The results were similar to outcomes of another program examining the effects of introducing a bed rail policy and an educational program on patient falls and fall-related injuries (Hanger, Ball, & Wood, 1999). This information can be conveyed to reassure staff, families, and residents that lowering bed rails, Jf performed systematically using accessories, such as floor mats, will not increase harm to patients.
Results of this program demonstrated that proper assessment and intervention may lead to an increased health benefit by lowering risk of entrapment and fall-related injuries, improved dignity for the resident by being in bed without rails, and improved quality of life as noted in the restraint reduction literature (Capezuti, Strumph, Evans, Grisso, & Maislin, 1998; Cohen et al, 1996; Meyer, Kraenzle, Gettman, & Morley, 1994; Neufeld et al., 1999). However, it should be noted that this quality improvement project was a natural experiment with inherent weaknesses. An experimental research design, with random assignment of facilities or units to usual care versus BedSAFE, would provide more generalizable results. Because of the naturalistic perspective, limitations included changes in patient mix and acuity across the three units and use of incident report data to capture the major outcomes of bed-related falls and bed-related fall injuries.
Incident report data is notoriously flawed. It is generally assumed that adverse events are under-reported (Institute of Medicine, 1999). In a culture of safety that reinforces blame and punishment, employees are reluctant to file a report that may implicate their own behavior in contributing to an adverse event. Furthermore, because falls are often not witnessed, staff reports may not accurately reflect what really happened. It was also found that medical follow up of an incident, though mandatory, is inconsistently documented on the incident forms. The medical record was often used to verify data.
PERCENTAGE OF BEDS WITH ONE RAIL UP, TWO RAILS UP, OR NO RAILS UP BY UNIT
FREQUENCY OF FALLS FROM BED WITHOUT AND WITH INJURY
FREQUENCY AND PERCENTAGE OF INJURY TYPE FROM BEDRELATED FALLS PRE AND POST BEDSAFE
Despite research design limitations, these authors believe that the systematic approach to bed rail reduction is a best practice model that could be adapted to suit the needs of long-term care units at other facilities. An underlying reason for the success in safely reducing bed rails was strong administrative support at all levels, including the Veterans Health Affairs (VHA), the Veterans Integrated Service Network of which this facility is a part, the VHA-funded Patient Safety Center of Inquiry, the local faculty, and the nursing home administration and unit management. The VHA has taken a national leadership role in promoting patient safety and changing the culture of safety by funding four patient safety centers, spearheading Veterans Affairs-wide root cause analysis and issuing research requests for proposals targeting patient safety (Weeks & Bagian, 2000).
This soiid national leadership has filtered through the network director, facility director, and managers. This strong and consistent leadership set the stage for the bed rail reduction program and increased the probability of success. According to the Institute of Medicine report (1999), a major force in improving patient safety is strong leadership for safety within health care organizations. Leadership and commitment of nursing administrators has been shown to be important in minimizing the use of restraints and maintaining a restraintfree environment (Dunbar, Neufeld, Libow, Cohen, & Foley, 1997).
During the course of a year, staff became increasingly sensitized to patient safety from a variety of sources, began to analyze errors from a systems perspective, became less reluctant to report errors, including bed-related adverse events, and began to view reporting adverse events as a means toward preventing future adverse events. An important unintended benefit of BedSAFE was that, over time, the team began to notice other safety hazards, such as broken wheel locks, spills, and broken equipment. BedSAFE helped to further sensitize the staff to thinking of safety first and to reduce environmental hazards. Strong leadership support translated into resources for the interdisciplinary team, including release time for staff participation and funds to purchase safety equipment, floor mats, and height-adjustable beds. The sustained effort of the interdisciplinary team on a unit-based program supported by administration kept the momentum of the program strong.
Despite strong leadership support, several barriers were identified. The use of rails during the course of the intervention year was somewhat variable and depended on staff turnover, patient census, patient acuity, patient transfers, staff training, and historical events such as an unforeseen unit closure. Rail use tended to decrease during periods of stability in patient and staff turnover, low patient acuity, and immediately after intense feedback and monitoring by the BedSAFE team and clinical managers. To address high staff turnover, bed rail safety was incorporated into new nursing staff orientation.
A major condition underlying many of the barriers was related to the fact that multiple individuals and groups within a hospital believed they were responsible for beds and often these groups did not interact on a regular basis. Nursing staff, physicians, engineers, purchasers, environmental management, residents, families, rehabilitation therapists, and skin care committee members all had a stake in nursing home beds. Additionally, anyone who entered a resident's room could raise or lower a bed rail, including staff, visitors, roommates, and residents themselves. Based on the authors' experiences, thoughtful, timely, and tactful communication among multiple individuals across multiple departments will maximize the success of any bed rail reduction program. Additionally, the authors learned that for most newly admitted residents, the default position of bed rails was raised. Staff reported wanting to keep the bed rails raised until they could get to know the resident well enough to be sure of bed-related needs. The authors were not able to affect this practice of raising bed rails by default.
During the year of BedSAFE, there was high staff turnover - a condition not expected to change because of the current nursing shortage and the emotionally and physically demanding nature of nursing home care work. New staff did not always receive the BedSAFE training in a timely manner. Moreover, staff recently graduating from nursing schools often did not learn the newest information about bed rail risks and continued to raise bed rails, mistakenly believing they were enforcing safety standards. Thus, to make a lasting effect on bed rail use, schools of nursing and training programs for nursing assistants must be encouraged to integrate the newest advances in this area into existing curricula.
Another challenge was in overcoming initial defensiveness when the team entered the nursing home care units as outsiders. The team was better accepted after recruiting the support of nurse managers, advanced registered nurse practitioners, and front line staff. Front line staff acknowledged the clinical expertise of the nurse practitioners and were likely to follow through on recommendations made by them. The sustained nature of the intervention during 1 year helped to convince staff of the team's commitment to making a difference for patient safety. During that year, we, as consultants, gradually retreated and transferred responsibility for the program to unit staff. Staff members from different units were encouraged to work together. When nurses made rounds on each other's units, a productive synergy resulted from sharing of the best practices and resources and seeing each other's commitment to patient safety.
Nurses in the units where this project was conducted tended to view themselves as patient advocates. They had strong ethics about doing what the patient wanted, and used this as justification for having rails up. This stance was evidenced in situations in which the patient or family resisted lowering of bed rails. Staff found the ethical conflicts arising from trying to abide by patient preferences problematic when implementing a new safety intervention for which strong scientific evidence (as the case in bed rail lowering) did not exist. One nurse told us, "Advocating for the patient is never wrong." However, in areas in which knowledge is developing rapidly and conflicts with conventional wisdom, this view becomes particularly problematic. Open and frequent discussions among residents, families, and staff about bed rail use must occur to solve the difficult ethical issues that surface during bed rail reduction projects.
Safe reduction of bed rail use in long term care was achieved by interdisciplinary involvement (including residents and families), careful patient assessment, alternatives matched to the specific needs of each resident, and VHA leadership in patient safety. Results of BedSAFE reinforce that staff cannot just take away rails without the infrastructure in place including resources, alternatives, and equipment. This is similar to Untie the Elderly Resource Manual ("Untie the Elderly," 2001), which emphasized a planned change process involving resources and staff, resident, and family education.
The reassuring 1-year outcome of reduced patient falls from bed with no increase in injuries should encourage staff, residents, and families to reduce bed rail use. BedSAFE is currently a purely unit staff-driven endeavor. Until new bed designs significantly reduce the risk of entrapment and are in use in all facilities, staff plan to continue the BedSAFE process. The BedSAFE process includes ongoing development of sound alternatives and creative problem solving until definitive equipment solutions are in place. Until that time, the authors will advocate for the increased use of floor mats next to beds to reduce the severity of fall-related injuries from bed. This team found bedside floor mats were a low cost solution; were easy to use and store; and were readily accepted by staff, patients, and families (Picture 2 on page 35). Mats were not only a practical solution, but also a visible proactive intervention that showed staff, residents, and families that patient safety was being taken seriously and that it was okay to lower rails.
As in any patient safety initiative, one must be mindful that any positive change could result in an unintended increased safety risk in another area. For example, some experts are reluctant to suggest the use of floor mats because they can pose a risk of tripping and falling for both residents and staff. In this program, no resident or nursing injuries occurred as a result the mats. However, further monitoring of unintended consequences of bed rail reduction programs is warranted.
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PRIMARY ALTERNATIVES TO BED RAILS USED IN BEDSAFE PROGRAM
PREVALENCE OF BED RAIL USE BY UNIT
PERCENTAGE OF BEDS WITH ONE RAIL UP, TWO RAILS UP, OR NO RAILS UP BY UNIT
FREQUENCY OF FALLS FROM BED WITHOUT AND WITH INJURY
FREQUENCY AND PERCENTAGE OF INJURY TYPE FROM BEDRELATED FALLS PRE AND POST BEDSAFE