Report of the Council on Scientific Affairs
Use of Restraints for Patients in Nursing Homes
Rosalie Guttman, PhD; Roy D. Altman, MD; Mitchell S. Karlan, MD;
for the Council on Scientific Affairs, American Medical Association
Arch Fam Med. 1999;8:101105
Objective: To examine issues related to the use of re
straints on nursing home patients, including regula tions and guidelines,
risks and benefits of restraint use, system problems, and measures to
reduce restraint use, to determine when the use of restraints results
in clini cally desirable outcomes.
Methods: Sources of information included a review of
published articles and reports, a survey of federal and state regulations
and guidelines relating to restraint use in nurs ing homes, review of
current legislative initiatives, and consultation with experts in the
field.
Results: The data reveal that restraint use imposes
more risk of falls and other undesirable outcomes than it prevents. In
response to legislative initiatives and regulatory activities and by
implementing alternatives, the prevalence of restraint use has decreased
by 20% in recent years. In many states, facilities have created restraintfree
environments or restraintfree policies and goals. The Council on Scientific
Affairs finds that current federal and state regulations on the use of
restraints have benefited the vast majority of nursing home patients.
Conclusions: While guidelines are in place for the use
of restraints when clinically necessary, the Council on Scientific Affairs
recommends increased research to de termine when the use of restraints
results in desirable out comes. Extraregulatory initiatives, such as
widespread educational programs, are needed for professionals and consumers
to improve awareness of the risks and ben efits of restraints, as well
as the rights of residents with respect to restraint use.
In June 1989, the Council on Ethical and Judicial Affairs of the American
Medical Association (AMA) published a report,
"Guidelines for the Use of Restraints in Longterm Care Facilities." [1]
Among the ethical and legal issues addressed were the right of the nursing
home resident to be free from needless bodily restraint and to informed
consent when restraints are deemed medically necessary. The Council on
Ethical and Judicial Affairs report included recommendations that advocate
judicious caution in the use of restraints, which should only be applied
when explicitly ordered by physicians, that restraints not be used as
punishment or for the convenience of staff, that the right to informed
consent be incorporated into institutional policy, that maximum bodily
mobility be permitted whenever restraints are applied, and that restraints
be used only in accordance with appropriate clinical indications. In
light of recent changes in the regulations governing restraint use, there
is a need for an updated report.
This Council on Scientific Affairs report reviews subsequent policy or
regulations and research findings relative to restraint use in nursing
homes and proposes additional AMA policy on this subject.
METHODS
Published studies from the years 1990 to 1997 were identified through
a MEDLINE search of Englishlanguage articles, using the key phrase "physical
restraints or chemical restraints and nursing homes." Additional
publications were identified by review of references cited in the above
noted articles and in textbooks and by consultation with experts in the
field. Approximately 120 articles from the medical or scientific literature
and other documents on the subjects of restraints and nursing homeswere
analyzed and the most relevant were selected; secondary sources and metaanalyses
were excluded. In addition, existing federal and state regulations and
guidelines relating to restraint use in nursing homes and current legislative
initiatives were reviewed. The report underwent peer review by experts
and by the AMA Council on Scientific Affairs. This report was transmitted
by the AMA Board of Trustees to the House of Delegates, where the recommendations
were adopted as AMA policy in June 1997.
BACKGROUND
Among the legal changes incorporated into the Omnibus Budget Reconciliation
Provisions of 1987 (OBRA) were strict controls governing the use of restraints
in nursing facilities and the communication of rights of nursing home
residents to be free from restraints. The Nursing Home Reform Provisions
[2] were included in OBRA and implemented in 1990, and
it stipulated that restraints were to be imposed only to ensure the physical
safety of the resident or that of other residents and only on the written
order of a physician. Moreover, physician orders for restraints were
required to be specific with regard to the duration and circumstances
of their use.
Since the implementation of the Nursing Home Reform Provisions, the prevalence
of restraint use in the United States decreased from an estimated 41%
nationwide to about 20%. [3] Despite this reduction,
one fifth, or more than 300,000 of the elderly population in nursing
homes remain physically restrained. Although the actual law did not change,
the policy of the Health Care Financing Administration toward restraints
continued to evolve, as what was considered "medically necessary" restraint
use became more narrowly defined by medical professionals.
Research findings suggest that the prevalence rates for restraint use
of 0% to 5% are achievable for the proper care of the nursing home population.
[4,5] Based on these conclusions, the
Health Care Financing Administration, while not committing to a given
percentage of restraint use as a criterion, has agreed that the standard
of care that is currently widely accepted in the medical community permits
less justification for restraint use than was foreseen whenOBRAwas enacted
in 1987. It is also likely that the scope of what is currently considered
to be medically appropriate use of restraints will continue to narrow
even further in the future. [6]
UPDATE OF OBRA
Regulations contained in the OBRA governing requirements of participation
for longterm care facilities were revised in 1996. The modifications
included operational instructions to state surveyors. The Interpretive
Guidelines, [7] the primary federal guide to surveyors
on the application of the regulations, were expanded to help eliminate
some of the confusion that persists regarding the definition of a restraint
and the contexts in which restraints may and may not be used.
The restraint and seclusion standards issued by the Joint Commission
on Accreditation of Healthcare Organizations require facilities to limit
and, if feasible, reduce the use of restraints and seclusion. Additionally,
they encourage administrators to actively take steps toward using preventive
strategies, develop protocols for consistency, and institute timelimited
orders for all residents so as to permit more frequent assessments and
early release from restraints when they are used in cases of clinical
necessity. [8]
Physical restraint is defined 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. [9]
Chemical restraint is defined as any psychopharmacologic drug
that is used for convenience or to control undesirable behaviors and
not required to treat medical symptoms. [9]
ACCORDING TO THE INTERPRETIVE GUIDELINES
Physical restraints include, but are not limited to, leg restraints,
arm restraints, hand mitts, soft ties or vests, lap cushions, and lap
trays the resident cannot remove. Also included as restraints are facility
practices that meet the definition of a restraint, such as using bed
rails to keep a resident from voluntarily getting out of bed as opposed
to enhancing mobility while in bed; tucking in a sheet so tightly that
a bedbound resident cannot move; using wheelchair safety bars to prevent
a resident from rising out of a chair; placing a resident in a chair
that prevents rising; and placing a resident who uses a wheelchair so
close to a wall that the wall prevents the resident from rising. [7 (p53)]
Orthotic body devices are to be used only for therapeutic purposes to
enhance overall functional capacity of the patient.
When a restraint is used, it must serve as an enabler (ie, to increase
functional ability) and it must be the least restrictive alternative.
For example, bed rails may be used as restraints (to prevent residents
from getting out of bed) or they may be used to assist in mobility and
transfer. Thus, the use of bed rails as restraints is prohibited unless
they are necessary to treat a resident's medical symptoms. Bed rails
used as restraints add risk to the resident by increasing the possibility
of more significant injury caused by a fall from a bed with bed rails
as opposed to a fall from a bed without rails. [7]
The standards are based on the goals of preserving and protecting residents'
rights, dignity, and physical and emotional wellbeing when restraints
are applied. To this end, the resident has the right to participate in
the plan of care and to refuse or accept restraints. So the resident
can make an informed choice about the use of restraints, the facility
is required to explain the negative outcomes of restraint use. Potential
and multiple undesirable outcomes include incontinence, decreased range
of motion and ability to ambulate, symptoms of withdrawal or depression,
or reduced social contact. [10]
If a resident is not competent to make a decision, a surrogate or agent
may exercise this right based on the same information that would have
been given to the resident. However, the regulation that restraints may
be used only to treat the resident's medical condition applies even when
permission is given for restraint use by a representative or surrogate.
Restraint use is never justifiable solely for the convenience of facility
staff, for disciplinary purposes, or because a surrogate requests them.
[9]
All restraint use must be justified: that is, the facility must demonstrate
the presence of medical symptom(s) and a written explanation of how the
restraint would treat the cause of the symptom(s) and assist the resident
in reaching his or her highest level of physical and psychosocial wellbeing
must be provided. [7]
RISKS AND BENEFITS OF RESTRAINT USE
Evans and Strumpf [11] pointed out the paradox in the
willingness of health professionals to use restraints on the elderly,
given the existing knowledge about the range of serious effects and consequences
related to restraint and immobility in this population. Among the consequences
of restraint application are physical risks, such as avoidable decline
in the ability to ambulate, contractures, decreased muscle tone, increased
risk of pressure sores and infections, constipation, and urinary incontinence
or retention, and psychological risks, such as agitation, increase in
disorganized behavior, depression, humiliation, fear of being abandoned,
impaired selfimage, and (in the presence of dementia) catastrophic reaction.
[1113]
Other undesirable outcomes associated with restraint use are falls and
injuries that ensue when individual residents attempt to personally remove
restraints or try to climb over bed rails. It is estimated that as many
as 200 deaths occur annually as a result of strangulation or suffocation
caused by restraints, even when t hey are correctly applied. [1418]
Several recent studies [13,15,1921]
found that serious fall-related injuries were much more common in restrained
residents than in those who were not restrained (17% vs 5%, respectively).
Tinetti et al [15] found that among residents of skilled
nursing facilities residents who were restrained were 3 times as likely
to sustain an injury in a fall or related incident than those who were
not restrained. In their study of 397 nursing home residents, Schnelle
and Smith [19] noted that 10% of the falls occurred
while the individual was restrained or immediately after restraints were
removed. Many falls occur after restraints are removed, which suggests
that if restraints cause falls and related injuries they do so indirectly.
The authors [13,15,19]
believed that restraints worsen deconditioning and gait and balance abnormalities,
thereby increasing the risk of falls and injuries. Other studies comparing
fall rates i n restra i ned and unrestrained residents of nursing homes
showed similar results: the authors [20,21]
reported a lack of association between restraint use and a decrease in
falls.
Similar risks also are associated with the use of psychoactive drugs
as chemical restraints. Toxic reactions to these drugs, especially in
the elderly, are well documented in the literature. Examples of these
reactions are dizziness, tremors, tardive dyskinesia, increased agitation
and confusion, dehydration, constipation, and urinary incontinence. In
addition, studies [22,23] showed
that an increased risk for falls and hip fractures is associated with
psychoactive drug use among the elderly. Moreover, the results of research
showed that the sequelae of psychotropic drug use (dizziness, agitation,
and confusion, for example) lead to further restraint with mechanical
appliances. [24]
The benefits of using restraints, according to facility personnel, are
the prevention of falls and fallrelated injuries, better management
of therapeutic regimens and difficult behaviors, aid in maintenance of
body alignment , increased resident feeling of security and safety, and
the prevention of wandering. [11,15]
The perceived benefits of restraints are anecdotal, and no clinical trials
or outcome studies have been conducted yet to assess the efficacy of
physical or chemical restraint interventions.
At present, there is no scientific basis of support that demonstrates
the efficacy of restraints in preventing injury to nursing home patients.
Rather, the scientific literature overwhelmingly demonstrates the disproportionate
risk-benefit ratio in the use of restraints.
SYSTEM PROBLEMS ASSOCIATED WITH RESTRAINTS
Several factors contribute to the problems associated with restraint
use in longterm care facilities. Providers indicate that there is a
lack of congruence between surveyors' and providers' use of restraints
and/or alternatives. Additionally, providers cite family pressure for
restraint use as a majorbarrier to developing care plans in some cases.
Some family members believe that a person has to be restrained to prevent
a fall, and providers are concerned about litigation if they do not comply
with family demands. However, providers have been successfully sued when
injury or death has resulted from restraint application. [14]
Conversely, according to findings from a national project, more than
90% of families find the use of restraints acceptable. [25]
Furthermore, the rights of residents are often perceived to be antithetical
to the rights of professionals. Thus, a tension or adversarial relationship
is created between residents and families and health care professionals,
which intensifies concerns about malpractice suits. [26,27]
There is an additional relationship between the propensity of nursing
home staff to use restraints and the level of education and employment
characteristics. There is a greater reluctance on the part of less welltrained
staff to try alternatives; their attitudes and beliefs favor restraint
use. [28] Other burdens imposed on facilities are financial
concerns. Many administrators perceive that alternatives to restraint
use are costly and timeconsuming and that they haveneither the financial
nor the personnel resources to implement less restrictive interventions.
[29,30]
System factors that create dilemmas with regard to restraint use can
be summarized as follows: administrative pressure to avoid litigation,
family demands, the availability of restraint devices, staff attitudes,
and insufficient staffing.
MEASURES TO REDUCE THE USE OF RESTRAINTS
The extent to which nursing home residents require restraints to prevent
or control accidental falls and other injuries has not been established.
Because of the known undesirable effects of restraint use and its limitations
as a preventive strategy, in conformity with federal and state regulations,
there has been a nationwide endeavor to reduce restraint use in longterm
care facilities. Several prospective randomized trials have been conducted
using alternatives to both physical and chemical restraints, with salutary
outcomes. These studies [3135] demonstrated that effective
programming can eliminate a need for restraints.
Cohen and colleagues [25] developed the national demonstration
and research project to determine whether physical restraints could be
safely removed from nursing home residents. They studied a random sample
of facilities with a high level of restraint use. The intervention emphasized
individualized care, multidisciplinary team assessment, and rehabilitation
to enhance functional independence and education of staff and families.
The goal was to teach a process that would reduce restraint use to 5%
or less. Restraints were classified into categories, and alternatives
were developed for each category. At the end of 2 years, restraint use
decreased from 41% (858 restrained residents) to 4.05% (89). Ultimately,
13 of 16 facilities had achieved a restraint rate of 5%or less. The remainder
achieved a reduction to more than 5% but less than 10%. [25]
Neufeld et al [36] reported that, in their restraint
reduction study of 16 facilities with 2075 beds and a high level of restraint
use, their educational intervention effected a decrease in restraint
use to 5%. A major finding was an increase in staff morale associated
with the reduction in restraint use.
Other studies [37,38] similarly demonstrated
the effectiveness of education and expert nurse consultation on the reduction
of restraint use. Reduction was achieved without increasing falls or
the use of psychotropic medications or chemical restraints.
It is estimated that 20% or more of nursing home residents receive antipsychotic
drugs, primarily for the behavioral manifestations of dementia. Many
of these drugs have high toxic effects, especially in the elderly. By
teaching the use of behavioral techniques to physicians, nurses, and
other nursing home personnel for the management of behavioral symptoms
and encouraging the withdrawal of psychoactive drugs, drug use decreased
by 72% in an intervention sample vs 13% in nursing homes serving as controls.
[30]
In response to the federal regulations on the use of psychotropic drugs,
nursing homes in many states have been successful in decreasing the rates
of antipsychotic drug use. A survey [23] of all nursing
homes in Minnesota found that antipsychotic drug use had decreased by
33% during the 4year study period. Similar studies [39,40]
in Baltimore, Md, and Tennessee reported decreases of 37% and 27%, respectively,
in antipsychotic drug use. Finally, Rader and Donius [41]
describe a 3level restraint reduction intervention in Oregon. These
researchers found that multiple factors, including resident characteristics,
staff education, and environmental manipulation, affect restraint use.
The care of level 1 residents is easily maintained without the use of
restraint with alternatives. Level 2 residents have more complex problems
and require structural changes in the environment and specialized equipment
to facilitate restraint release. For level 3 residents, who are the most
difficult to manage and who generally do not do well without restraints
(they may be receiving life-sustaining treatment, fall on every attempt
to stand or walk, or engage in harmful behaviors), the goal is to provide
maximum freedom by using the least restrictive devices and minimizing
the time they are used. [41]
Numerous restraint reduction initiatives and alternatives to restraints
have been described in the literature. These include educational programs
for facility staff and families, involving residents in activities and
exercise, low beds and chairs and recliners, pillows and positioning
aids, monitoring caffeine and sugar intake, behavioral mapping as an
aid in assessment of new residents and those with dementia, alarm devices,
and the establishment of timely toileting schedules and regular rest
periods. As Schnelle and Smith [19] pointed out, restraint
alternatives need to be described with sufficient specificity for them
to be more readily implemented.
Overall, the restraint reduction movement and the implementation of alternative
strategies have been beneficial with regard to decreasing the risks inherent
in restraint use. Perceived benefits of restraint removal are improvement
in quality of life, enhanced functional status, fewer falls and other
injuries, decreased use of antipsychotic medications, fewer behavioral
symptoms, and increased staff morale. [33,34]
CONCLUSIONS
Most study findings indicate that the use of restraints does not reduce
the risk or incidence of falls, other accidents, or disruption of medical
care when appropriate alternative interventions are provided. In fact,
research suggests that the use of restraints causes more problems than
it prevents. The existing regulations governing the use of restraints
in longterm care facilities, while encouraging providers to use alternatives
to the extent possible in an attempt to reduce restraint use, are quite
explicit in permitting their use in cases of documented medical necessity.
However, the regulations are subject to variable interpretation by surveyors
and providers. When restraints are used, there must be ongoing assessment,
intermittent relief from use, and conformity to the resident's (or surrogate's)
right to informed consent and selfdetermination. Because of the constraints
and limitations imposed on facilities, as well as the nonspecific guidelines
and fear of penalty related to disjunction between some surveyor expectations
and family practices, there has been an exaggeration toward nonuse of
restraints.
Thus, there is a need for more effective education about the use of restraints
for families, patients, and professionals, as well as better outcome
studies on restraint use that meets regulatory requirements. Ultimately,
there needs to be a satisfactory resolution of the ethical dilemma of
beneficence vs autonomy and consonance with the uppermost goal of all
AMA policy, delivery of care that is in the best interest of the patient's
or resident's quality of life provided within the least restrictive environment.
RECOMMENDATIONS
The following statements, recommended by the Council on Scientific Affairs,
were adopted by the AMA House of Delegates as AMA policy in June 1997.
-
The AMA reaffirms the opinion of the Council on Ethical and Judicial
Affairs "that all individuals have a fundamental right to
be free from unreasonable bodily restraint" (Policy 280.987).
[42]
-
The AMA recommends further research to support or refute the findings
that physical restraints in nursing homes tend to be more harmful
than beneficial.
-
The AMA supports the position that there must be compelling reasons
to justify the use of restraints.
-
The AMA encourages widespread dissemination of information and educational
initiatives for the public as well as health care professionals
on the risks and uncertain benefits of restraints.
-
The AMA encourages physicians to communicate the consequences, risks,
and potential benefits of restraint use with family members of
residents who ask for restraints.
-
The AMA encourages research to determine precisely when the use of
restraints results in improved outcomes.
-
The AMA encourages the longterm evaluation of effects of the restraint
regulations on the health and wellbeing of nursing home residents.
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