What was studied in this review?
Physical restraints (PR) are devices that prevent a person moving their body freely to a position of their choice. Examples are bedrails, belts and fixed tables, which prevent people from getting out of bed or a chair. PR use for older people who have dementia or who cannot walk well is used quite commonly when they are being looked after in care institutions or even in their own homes. The main reason given for using PR is to try to prevent accidental falls and fall-related injuries, or to prevent people from walking into other people's rooms or generally walking around unobserved and putting themselves or others at risk.
It is questioned that PR use is an effective way of preventing falls or fall-related injuries. In fact, by making people spend more time immobile, they may worsen walking problems and actually increase the risk of falling. They may also increase feelings of fear, anger and discomfort, and decrease well-being. Other unintended consequences include an increased risk of pressure ulcers and incontinence, and injuries directly related to the use of PR. In some countries, the use of PR is illegal in most circumstances and guidelines recommend that its use should be reduced or stopped.
What did we want to find out?
We wanted to know which interventions are most effective for preventing or reducing the use of PR for older people receiving long-term care either in care institutions or at home. Interventions for preventing and reducing the use of PR typically include education and training for nursing staff and may also include changes to policies and the way care is organised.
What did we do?
We updated a review that was last published in 2011. We searched for trials that investigated interventions intended to reduce or prevent the use of PR in older people receiving long-term care. The trials had to include a comparison group of people who did not get the intervention (a control group). We included eleven studies. All of them were conducted in long-term care facilities (residential and nursing homes). The average age of the people in the studies was about 85 years. In most studies, the intervention being tested was compared with treatment-as-usual although, in two studies, managers of nursing homes in the control group also received some additional information about PR.
Four studies tested organisational interventions, which aimed to change policy and practice so that nursing staff would use PR less often or not at all. An important part of these interventions was training 'champions' to support the rest of the staff in avoiding the use of PR. Six studies tested less complex interventions that offered education directly to nursing staff. One study provided nursing staff with specific assessments of the fall risk of individual residents.
What did we find?
Our main outcome of interest was the number of people who were restrained at least once during the period of the study. We found that organisational interventions probably lead to a reduction in the number of people restrained and a large reduction in the number of people restrained with a belt. One study reported whether the residents came to any harm during the study period and it reported no harmful events. We did not find any evidence that the interventions made a difference to the number of people with at least one fall or at least one fall-related injury, or the number of people prescribed medication to modify behaviour. These studies were mainly well conducted and reported.
For simple educational interventions, the quality of the studies and how well they were reported varied, and this affected our confidence in the results. The results of the studies were inconsistent, so we could not draw any conclusion about the effect of this type of intervention on the use of PR. None of these studies reported harmful events. Again, we did not find any evidence that the interventions made a difference to the number of people with at least one fall or at least one fall-related injury, and we could not be sure of the effect on prescription of medication.
Based on one study, informing nursing staff about residents' individual risk of falling may not lead to any reduction of PR use compared with the control group.
What is the conclusion?
Organisational interventions aimed at reducing use of PR through changing policy and practice in care homes are probably effective at reducing the number of people restrained overall and especially with belts. Reducing restraints did no lead to a higher number of people with falls. We are uncertain whether simple educational interventions reduce the use of PR, and interventions providing information about residents' fall risk may have little or no effect on the use of PR. All the evidence came from studies in institutions and it may not apply to care in people's own homes.
How up-to-date is this evidence?
The evidence is up-to-date to 4 August 2022.
Organisational interventions aimed to implement a least-restraint policy probably reduce the number of residents with at least one PR and probably largely reduce the number of residents with at least one belt. We are uncertain whether simple educational interventions reduce the use of physical restraints, and interventions providing information about residents' fall risk may result in little to no difference in the use of physical restraints. These results apply to long-term care institutions; we found no studies from community settings.
Physical restraints (PR), such as bedrails and belts in chairs or beds, are commonly used for older people receiving long-term care, despite clear evidence for the lack of effectiveness and safety, and widespread recommendations that their use should be avoided. This systematic review of the efficacy and safety of interventions to prevent and reduce the use of physical restraints outside hospital settings, i.e. in care homes and the community, updates our previous review published in 2011.
To evaluate the effects of interventions to prevent and reduce the use of physical restraints for older people who require long-term care (either at home or in residential care facilities)
We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid Sp), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register, the International Clinical Trials Registry Portal, on 3 August 2022.
We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that investigated the effects of interventions intended to prevent or reduce the use of physical restraints in older people who require long-term care. Studies conducted in residential care institutions or in the community, including patients' homes, were eligible for inclusion. We assigned all included interventions to categories based on their mechanisms and components.
Two review authors independently selected the publications for inclusion, extracted study data, and assessed the risk of bias of all included studies. Primary outcomes were the number or proportion of people with at least one physical restraint, and serious adverse events related to PR use, such as death or serious injuries. We performed meta-analyses if necessary data were available. If meta-analyses were not feasible, we reported results narratively. We used GRADE methods to describe the certainty of the evidence.
We identified six new studies and included 11 studies with 19,003 participants in this review update. All studies were conducted in long-term residential care facilities. Ten studies were RCTs and one study a CCT. All studies included people with dementia. The mean age of the participants was approximately 85 years.
Four studies investigated organisational interventions aiming to implement a least-restraint policy; six studies investigated simple educational interventions; and one study tested an intervention that provided staff with information about residents' fall risk. The control groups received usual care only in most studies although, in two studies, additional information materials about physical restraint reduction were provided.
We judged the risk of selection bias to be high or unclear in eight studies. Risk of reporting bias was high in one study and unclear in eight studies.
The organisational interventions intended to promote a least-restraint policy included a variety of components, such as education of staff, training of 'champions' of low-restraint practice, and components which aimed to facilitate a change in institutional policies and culture of care. We found moderate-certainty evidence that organisational interventions aimed at implementation of a least-restraint policy probably lead to a reduction in the number of residents with at least one use of PR (RR 0.86, 95% CI 0.78 to 0.94; 3849 participants, 4 studies) and a large reduction in the number of residents with at least one use of a belt for restraint (RR 0.54, 95% CI 0.40 to 0.73; 2711 participants, 3 studies). No adverse events occurred in the one study which reported this outcome. There was evidence from one study that organisational interventions probably reduce the duration of physical restraint use. We found that the interventions may have little or no effect on the number of falls or fall-related injuries (low-certainty evidence) and probably have little or no effect on the number of prescribed psychotropic medications (moderate-certainty evidence). One study found that organisational interventions result in little or no difference in quality of life (high-certainty evidence) and another study found that they may make little or no difference to agitation (low-certainty evidence).
The simple educational interventions were intended to increase knowledge and change staff attitudes towards PR. As well as providing education, some interventions included further components to support change, such as ward-based guidance. We found pronounced between-group baseline imbalances in PR prevalence in some of the studies, which might have occurred because of the small number of clusters in the intervention and control groups. One study did not assess bedrails, which is the most commonly used method of restraint in nursing homes. Regarding the number of residents with at least one restraint, the results were inconsistent. We found very-low certainty evidence and we are uncertain about the effects of simple educational interventions on the number of residents with PR. None of the studies assessed or reported any serious adverse events. We found moderate-certainty evidence that simple educational interventions probably result in little or no difference in restraint intensity and may have little or no effect on falls, fall-related injuries, or agitation (low-certainty evidence each). Based on very low-certainty evidence we are uncertain about the effects of simple educational interventions on the number of participants with a prescription of at least one psychotropic medication.
One study investigated an intervention that provided information about residents' fall risk to the nursing staff. We found low-certainty evidence that providing information about residents' fall risk may result in little or no difference in the mean number of PR or the number of falls. The study did not assess overall adverse events.