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Open AccessReview

The Effectiveness of Educational Training or Multicomponent Programs to Prevent the Use of Physical Restraints in Nursing Home Settings: A Systematic Review and Meta-Analysis of Experimental Studies

1
Centre of Higher Education for Health Sciences, 38122 Trento, Italy
2
Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy
3
Department of Human Sciences, University of Verona, 37134 Verona, Italy
*
Author to whom correspondence should be addressed.
Int. J. Environ. Res. Public Health 2020, 17(18), 6738; https://doi.org/10.3390/ijerph17186738
Received: 21 July 2020 / Revised: 2 September 2020 / Accepted: 14 September 2020 / Published: 16 September 2020
(This article belongs to the Special Issue The Use of Physical Restraints in Clinical Practice)

Abstract

This review assesses the effectiveness of interventions to reduce physical restraint (PR) use in older people living in nursing homes or residential care facilities. A systematic search of studies published in four electronic databases (MEDLINE, CINHAL, PsycINFO, Cochrane Central Register of Controlled Trials). The review included individual and cluster randomized controlled trials that compared educational training and multicomponent programs to avoid PR use. Risk bias of randomized controlled trials (RCTs) was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions. This review includes 16 studies in a qualitative synthesis that met the inclusion criteria, nine of them offered a multicomponent program and seven offered only educational training. The results of the 12 studies included in the meta-analysis showed a significant trend in favor of intervention over time and intensity of PR use tends to decrease. The review indicates that educational programs and other supplementary interventions should be effective, but the heterogeneous operative definition of physical restraints can make difficult data generalization.
Keywords: nursing homes; older people; physical restraint; systematic review; meta-analysis nursing homes; older people; physical restraint; systematic review; meta-analysis

1. Literature Review

Physical restraints (PR) are still commonly used worldwide in nursing homes and in residential care facilities, even if previous epidemiological studies showed wide differences between and within countries [1,2]. The main predictors of physical restraint use are patient’s impaired mobility, impaired cognitive status, and risk of falls; organizational policies can also determine their use. Health care professionals declared, as reported in different qualitative studies, that they use PR not only for preventing falls and injuries but also for controlling dangerous behaviors and for preventing interference with medical devices, such as urinary catheter and nasogastric tubes [3,4,5,6,7,8]. However, current evidence does not support PR effectiveness in reducing and preventing falls and fall-related injuries and questions their safety [3,9,10]. In the last years, a restraint-free nursing care environment has been recommended as a standard of care; therefore, policies and regulations aiming at reducing PR use have been implemented in many countries [11]. This topic is articulated and full of conceptual and operative details. An international consensus statement defines physical restraint as “any device, material or equipment attached to or near a person’s body and which cannot be controlled or easily removed by the person, and which deliberately prevents or is deliberately intended to prevent a person’s free body movement to a position of choice and/or a person’s normal access to their body” [12]. The most commonly methods used are bilateral bed rails, limb or trunk belts, fixed tables on a chair or chairs which prevent patients getting up on their own, and containment sheets and pajamas [3]. A European study conducted on nursing home residents suffering from dementia revealed a prevalence of physical restraints of 31.4%, with a country variation ranging from 6.1% to 83.2% [13]. However, in USA the prevalence ranged from 6.9% to 36.8% [7]; it was estimated at 31.4% in Canada and at 20.2% in China [1]. The differences in the observed occurrence of PR use are influenced by a variety of factors, such as population studied, clinical context, definition of PR and study design [14]. In recent years, restraint-free care has focused on what interventions or strategies can be employed to promote the reduction of physical restraint [15,16,17]. The use of PR is not without risks; adverse effects can be observed ranging from bodily injuries, decreased mobility, and reduced physiological well-being and up to death [3,18,19,20]. Morover PR use raises ethical issues affecting human rights and indeed several authors consider this practice as an approach that violates the freedom and dignity of restrained residents [15,21,22,23]. The persistent use of physical restraints in nursing homes requires effective interventions for educating nursing staff as well as all persons involved in healthcare, for example residents, relatives, nursing experts and nursing homes directors. Several and articulate interventions aimed to address nursing care and institution’s organizational culture about physical restraint use have been studied. However, previous systematic reviews have shown inconclusive evidence about the effectiveness of educational or multicomponent interventions for preventing and reducing the use of physical restraints in long term geriatric care [2,24]. Therefore, it is important to analyze the effectiveness of specific interventions, such as educational programs and consultation or guidance by an expert nurse, to reduce the use of PR in nursing home settings. The challenge of clinicians and researchers remains to find the ideal mix of interventions to avoid the use of physical restraints from clinical practice.

2. Materials and Methods

2.1. Aims

The aims of this systematic review are to assess the effectiveness of an educational training or multicomponent program: (1) in preventing the use of PR in nursing home, and (2) in changing (increasing or decreasing) the rate of patient falls and fall-related injuries.

2.2. Design

A systematic review with meta-analysis was conducted based on the Cochrane Handbook for Systematic Review for Intervention [25] and performed following the Guidelines for reporting Systematic Reviews and Meta-Analyses (PRISMA checklist criteria, see Supplementary File S1). This review protocol has been registered on the PROSPERO International prospective register of systematic reviews (PROSPERO 2018: CRD42019127963).

2.3. Search Methods

Studies published from 1996 to September 2019 were searched using four electronic databases (MEDLINE, CINAHL, the Cochrane Library, and PsycINFO). Other databases, such as www.ClinicalTrials.gov, EU Clinical Trial register, PROSPERO, and Cochrane Library, were searched for unpublished or ongoing studies, as well as reference lists of other studies, all of which were included in this study, were checked. The search strategy used is reported in Appendix A. The following word and MeSH terms were used: Restraint, Physical [Mesh]; Nursing Homes [Mesh] Residential Facilities [Mesh], “bed rail”, “side rail”, “coercion”, and “education”. Inclusion criteria were (a) published and unpublished studies that used cluster and individually randomized controlled trials and quasi-experimental research designs, (b) studies that compare educational training and multicomponent programs to avoid the use of PR on residents in nursing home settings were included in this study, (c) studies written in Italian and English language. The primary outcome was the status of PR as defined by Bleijlevens et al. [12] measured by number of patients who were physically restrained at the studies endpoint, assessed either by direct observation or from clinical documentation, or calculating restraint prevalence (number of restraints/number of residents × 100). Moreover, falls rate and falls- related-injuries) were assessed as secondary outcomes. Studies excluded were those that referred to psychiatric and critical populations in acute ward or home care.

2.4. Search Outcome

The electronic and manual reference list search revealed 418 publications. A total of 122 references that could meet the inclusion criteria were screened, and 222 publications were excluded; another 82 were excluded for outcomes other than “physical restraint rate”, incomplete data and being written in other languages (German and French). The full texts of the remaining 40 articles were reviewed, and of these, 16 were included in qualitative synthesis and 12 in meta-analysis (Figure 1. PRISMA Flow Diagram).

2.5. Quality Appraisal

Two reviewers (Anna Brugnolli and Martina Debiasi) independently screened the title and abstracts that met the inclusion criteria, and then screened the full text of potentially included studies. The citations in full-text articles marked as included were retrieved and those citations that the reviewers were unsure of were excluded. Disagreements and discrepancies were resolved by consensus, and when necessary, by consultation and discussion within the reviewer teams during all stages of the review process (Federica Canzan, Luigina Mortari, Luisa Saiani and Elisa Ambrosi). Risk bias of randomized controlled trials (RCTs) was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions [24]. For RCTs, we considered random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective outcome reporting, and other bias. For cluster randomized trials we evaluated recruitment bias, baseline imbalance, loss of clusters, incorrect analysis, and comparability with individually RCTs.

2.6. Data Abstractions

For each included study data were extracted by two independent reviewers using a standardized form and checked for accuracy by a third reviewer. The results were discussed within the reviewers’ team. A descriptive summary of the included studies was created by drawing on two tables of evidence: a general Characteristics table that includes details about the study type, interventions, characteristics of the population, type of intervention and primary and secondary outcome measures with a parallel definition and measurement of restraint status in the studies included (Supplementary File S2), and a Results table that classified the results for each outcomes.

2.7. Synthesis and Supplementary Statistical Analysis

We conducted a meta-analysis using random or fixed effect model where possible, a narrative synthesis was conducted where there was insufficient data. We performed analysis at the level of cluster RCTs. For one study further detail have been requested about the data and effect size about PR used [26]. To assess statistical heterogeneity, we calculated the I2 using Review Manager 5.3 (RevMan, Copenhagen, Denmark); the primary analysis used a random-effects model (risk ratio, RR), which had the highest generalizability in our empirical examination of summary effect measures for meta-analyses [24]. If the heterogeneity with random-effect model was I2 < 50% we used fixed model to estimate the intervention effects, in contrast, if I2 > 50% we used random-effect model.

3. Results

3.1. Study Characteristics

Sixteen studies met the inclusion criteria as described in Table 1. Eleven were cluster RCTs [9,15,26,27,28,29,30,31,32,33,34]; one individual RCT [35]; three quasi-experimental design studies [36,37,38]; and one pre-posttest [39]. Twelve studies were conducted in nursing homes [15,28,30,31,32,33,34,35,36,37,38,39]; four of these had psychogeriatric units/wards dedicated to residents with dementia and behavioral disorders [29,30,31,37]. One study had a unit for people with dementia [9] and one unit in a care home for people with dementia was included because of its close similarities to a residential care facility [26].

3.2. Risk of Bias Assessment of the Included Studies

The quality of RCTs was moderate, while it was low for quasi-experimental studies. Of the 16 included studies, nine had adequate sequence generation. Only three reported allocation concealment [15,27,32], blinding of participants and personnel were not possible in any included studies. Ten studies had blinding of outcome assessment [15,26,27,28,30,31,33,34,37,38].
Two of the included studies were assessed as having addressed incomplete data reporting (high risk of bias) [26,34] and lacked an explanation of the choices that underlined the recruitment of the participants [33,34]. Four studies were high risk for baseline imbalance [26,28,32,34], and in one study this issue was not clear [9]. In half of the studies, the analyses were correctly performed, although in some studies, the modalities were not described in detail [28,30,31,33,34]. Methodological quality assessment of the meta-analysis included studies is reported in Figure 2 and Figure 3, and Appendix B.

3.3. Types of Interventions

The characteristics of the intervention group are described in Table 1. Six studies offered only educational training [9,26,33,34,35,39]; and multicomponent programs were performed in ten studies [15,27,28,29,30,31,32,36,37,38]. There were seminars focusing on different topics and based on guideline or best practice followed by guidance or consultation [9,15,26,27]. Educational program changed in time from a minimum of six hours training course to a maximum of 6 months guidance and covering different themes about PR avoiding strategies. The arguments covered by the educational programs addressed the following topics:
-
Information on dementia, aggression, and challenging behavior (delirium), falls and fall prevention, care of people with dementia, complications in dementia, decision-making processes and alternatives [8,33];
-
Strategies for analyzing and managing aggression or challenging behaviors [9,28,30,32];
-
Information about legal implications, adverse effects, experience of feelings of being restrained [9,27,28,30,32];
-
Alternative strategies to the use of PR and decision-making processes [9,26,27,30,33,36];
-
Falls and fall prevention [9,28,32]; and
-
Overview of the current evidence about PR and summary of the guideline recommendations [27].
The multicomponent interventions included educational training and guide or consultation by a nurse specialist at the registered nurse level [30,31,36,37,38]; a master’s—prepared gerontological nurse such as an opinion leader [28]; an Advanced Practice nurse [39]; or a trained nurse with specific education (at least a Bachelor’s in Nursing) [27]. The consultations were structured as a monthly session supervision (from one hour to 12 h) or on demand. The multicomponent intervention in several studies provided for dissemination of the guideline’s content in clinical practice, availability of alternative interventions and/or introduction of at least a restraint policy [15,27,36,37,38].

3.4. Outcome Measures

Eight of the sixteen included studies had as the primary outcome the use of any PR [9,15,26,28,29,30,31,32,33,34,35]. Follow-up ranged from one to 24 months. Most of the studies provided a conceptual definition of PR (Supplementary File S2): fourteen studies used a comparable definition of PR even if incomplete; three of these studies did not define the devices of restraint [9,28,32] and other two reported only methods [29,39]. Two studies have not reported any definition [33,35]. Eight studies explored falls and injuries related falls; six studies evaluated the impact of a change in prescription of antipsychotic drugs [9,26,34,37,38]. This review analyzed the prevalence of restraint, but it would be relevant to break it down into time of permanence, duration (continuous/discontinuous) and type of restraints used.

3.5. Effect of Interventions

The overall results of the qualitative synthesis (16 studies), reported in Table 2, showed a significant trend in favor of interventions over time and intensity of PR use, except for Testad et al. (2016) [26], which found an increase in the use of containments over time in the intervention group and a tendency for a greater reduction in the control group. In contrast, in some RCTs [30,31], both groups, control and intervention, showed an increase in restraint intensity and multiple restraints over time. 12 RCTs of 16 studies were included in the meta-analysis and including 11 cluster-RCTs and 1 individual RCT [35]. The effects of interventions on the primary outcome were presented according to the type of intervention. The overall effect of the educational program (at study endpoint) in reducing PR use were analyzed a total of 1.186 patients (596 intervention and 590 control group) [9,26,28,33,34].
The combined estimated risk ratio (RR) of use of PR with an educational program was statistically significant (Figure 4a: 0.56, 95% CI 0.45–0.69). There was moderate overall heterogeneity (I2 = 40%). At medium term (6–8 months), RR of use of physical restraint is RR 0.74 (95% CI 0.39–1.43), and long term (12–24 months), RR 0.67 (95% CI 0.26–1.75). In both subgroups a substantial heterogeneity emerged (Figure 4b).
The overall effect of the multicomponent program (at endpoint studies) in reducing PR use were analyzed in a total of 16.937 patients (8.002 intervention vs. 8.935 control) [15,27,28,29,30,31,32]. The combined estimated RR of use of PR with a multicomponent program was statistically significant (Figure 5a: RR 0.83, 95% CI 0.73–0.94). There was an effect and statistically significant overall high heterogeneity (I2 = 80%). The results at short-term (1–4 months) and medium-term (6–8 months) were slightly statistically significant (Figure 5b). At short-term the RR of use of physical restraint is RR 0.86 (95% CI 0.73–1.02), and medium-term (RR 0.82, 95% CI 0.69–0.98). In both subgroups a substantial heterogeneity emerged (I2 = 75% and 84%).

3.6. Secondary Outcome Results

The results of secondary outcomes are reported in Table 2. The introduction of an educational or multicomponent intervention does not lead to a statistically significant increase in the rate of falls and fall-related injuries [32,33,36,37,38].

4. Discussion

This meta-analysis summarizes the evidence regarding the effectiveness of educational programs and multicomponent interventions on the use of mechanical restraints without an increase in falls, behavioral symptoms, or medication. The studies included in this review were adequate and had from low to moderate risk of bias; many of them demonstrated differences regarding the type of interventions and also most of the studies did not have an unvarying definition of physical restraint and methodologies for data collection. A previous Cochrane review underlines that there were insufficient evidence supporting the effectiveness of educational interventions for preventing or reducing the use of PR in geriatric long-term care [2]. In this systematic review emerged the effectiveness of the educational interventions at the endpoint study, and of the multicomponent program all the follow-up time (from 6 to 24 months), in reducing or preventing the use of PR in nursing home settings. More recent evidence of successful reduction efforts in use of restraints is evident from several countries, which used a multicomponent approach [15,27]. This approach demonstrated a reduction in physical restraint use within nursing home after 6- and 12-months post implementing both a detailed guideline and theory-based multicomponent interventions. Multicomponent educational interventions are designed to change the organizational culture towards a least-restraint policy. It is believed that leadership could essentially contribute to restraint-free nursing care by sensitizing nurses and creating optimal working conditions; nursing home staff profile and competencies are appropriate to meet the increasingly complex needs of residents with dementia [40,41]. Knowing that decision-making is mainly based on individual’s experiences and often is ambiguous, the development of evidence-based guidelines to support decision-making regarding the (non)-use of physical restraints is highly recommended [40]. The decision-making process concerning the application of physical restraints has always to respect the resident’s situation as well as nurse- and organization-related factors. The core educational component addresses the attitudes of nurses, physicians and other healthcare professionals who are involved in making decisions and conceiving policies about PR use. Additional components might target the care environment (e.g., environmental changes, adjustment of staff-patient ratios or staff skill mix, involvement of family members, advocacy), or the organizational culture (e.g., attitudes of the opinion leaders or the management), and may support the implementation of change in other ways (e.g., by providing supervision or guidance for healthcare professionals). Protection is a common reason for the use of PR, and the objective is to reduce the use of this method, while employing educational programs and consultation as strategies. In different countries these includes legislation and attention to creating or revising guidelines for nurses and institutions. In addition, it is important to pay attention to the barriers within long-term contexts that do not allow the reduction of PR; educational support is only a starting point and other interventions are needed. This is sure enough, as the results of the analyzed studies support the implementation of educational programs, even alone or with an expert in advanced clinical nursing capable to give consultation and to endorse changes. It is also important to underline that the effectiveness could be decrease in both approaches and is important a re-training to keep knowledge alive.

5. Study Limitations

Several limitations of this review have to be considered. The results have limited validity, transferability and generalizability due to the wide range of definitions of physical restraints, the variability of elements that performed a multicomponent program (guidance, consultation, policy or guideline) and/or different measurements in outcomes. Furthermore, the variability of the sample, in terms of baseline characteristics, high turnover, mortality and transfer drop-out or other factors led to an imbalance in the data when comparing the baseline with the data at the follow-up. Finally, there was a lack of data on the proportion of patients with dementia in most of the included studies.

6. Relevance to Clinical Practice

The results of this review will be highly relevant for clinical practice and help nurses’ decision-making. Information about effective interventions for preventing and reducing the use of PR in nursing homes may promote care with less or even without PR use which might increase the quality of care of older people. Nursing homes have an important role in the care of older people; the trajectory leading to use of restraint is complex, and the context and nursing factors could affect nurses’ decision-making [42]; further research is thus needed exploring how nurses can be empowered to deal more effectively with this important care issue. Future research is necessary to investigate the feelings and attitudes of healthcare professionals about PR and explore their knowledge of alternatives to PR use. Basic and continuous staff training is a key element in that it allows you to increase knowledge, change attitudes in favor of reducing restraint. This training should include legal, ethical and clinical aspects, with reference to possible alternative ways to avoid restraint in vulnerable people. However, based on the results, training represents a necessary but not enough element, on its own, to create a restraint free culture. In the future, multicomponent programs involving the whole team are needed; and create a multidimensional approach according to professionalism to provide the best patient assistance. Nursing home had to stimulate changes in policy and organizational procedure to reduce or prevent the use of physical restraints. In the included studies definitions of PR are inconclusive and unclear for example, bedside-rails were considered PR in some studies but not in others. Similarly, the educational programs are not always the same and have different elements and components and for these reasons, difficulties arise in comparing the results of the various studies and therefore results are not easy generalizable.

7. Conclusions

The results of this review underline that educational training and multicomponent programs could be effective in reducing the use of PR in nursing home settings. At the least, additional studies implementing an educational program alone or with consultation or guidance might provide further evidence of the effectiveness of these approaches on the reduction in the use of PR. The number of older patients with temporary or permanent cognitive impairment in general hospital settings will increase due to demographic change and medical progress. These patients have a higher risk of being restrained [43,44], and PR use may be associated with negative effects that may hamper recovery and rehabilitation. In contrast to geriatric long-term care settings, there is no high-quality systematic review about the effects of interventions intended to prevent or reduce PR use in older people in nursing home settings.

Supplementary Materials

The following are available online at https://www.mdpi.com/1660-4601/17/18/6738/s1, Figure S1: Prisma check list, Table S1: Definition and measured status of restraint in included study.

Author Contributions

Conceptualization, A.B., M.D. and F.C.; methodology, A.B., M.D. and F.C.; software, M.D.; formal analysis, A.B., M.D. and F.C.; investigation, A.B., M.D., F.C., L.M., L.S. and E.A.; resources, A.B., L.M., L.S.; data curation, A.B., M.D. and F.C.; writing—original draft preparation, A.B., M.D. and F.C.; writing—review and editing, L.M., L.S. and E.A.; visualization, A.B., M.D., F.C., L.M., L.S. and E.A.; project administration, M.D., A.B. All authors have read and agreed to the published version of the manuscript.

Funding

This research received no external funding.

Acknowledgments

Chiara Gastaldon and Corrado Barbui given technical support in using Review Manager.

Conflicts of Interest

The authors declare no conflict of interest.

Appendix A

Table A1. Search strategy.
Table A1. Search strategy.
Research QuestionElements of PICOSKeywords
PRestrained residents in nursing homeResidents in nursing home /Long term setting, residential care facilities
IEducational or multicomponent program Educational training or multicomponent program
CUsual care
OStatus of physical restraintPhysical restraints or coercion
SExperimental studiesRandomized controlled trials, clinical trials, quasi experimental studies
  • Search physical restraint (14,942)
  • Search “Restraint, Physical” [Mesh] (13,532)
  • Search nursing home (86,313)
  • Search “Nursing Homes” [Mesh] (37,522)
  • Search residential care facilities (4956)
  • Search “Residential Facilities” [Mesh] (50,272)
  • Search containment measure (393)
  • Search coercion (6417)
  • Search seat belt (4812)
  • Search side rail (74)
  • Search bedrail (41)
  • Search clinical trial (1,125,519)
  • Search randomized controlled trial (623,325)
  • Search quasi experimental (15,240)
  • Search (physical restraint) OR “Restraint, Physical” [Mesh] (14,942)
  • Search (((physical restraint) OR “Restraint, Physical” [Mesh])) AND “Nursing Homes” [Mesh] (490)
  • Search ((((physical restraint) OR “Restraint, Physical” [Mesh])) AND “Nursing Homes” [Mesh]) AND “Residential Facilities” [Mesh] (490)
  • Search (“Restraint, Physical” [Mesh]) AND “Residential Facilities” [Mesh] (517)
  • Search ((((((physical restraint) OR “Restraint, Physical” [Mesh])) OR bedrail) OR side rail) OR coercion) OR seat belt (25,952)
  • Search ((((((((physical restraint) OR “Restraint, Physical” [Mesh])) OR bedrail) OR side rail) OR coercion) OR seat belt)) AND ((“Restraint, Physical” [Mesh]) AND “Residential Facilities” [Mesh]) (517)
  • Search (((((((((((physical restraint) OR “Restraint, Physical” [Mesh])) OR bedrail) OR side rail) OR coercion) OR seat belt)) AND ((“Restraint, Physical” [Mesh]) AND “Residential Facilities” [Mesh]))) AND clinical trial) OR randomized controlled trial (623,335)
  • Search ((((((((((physical restraint) OR “Restraint, Physical” [Mesh])) OR bedrail) OR side rail) OR coercion) OR seat belt)) AND ((“Restraint, Physical” [Mesh]) AND “Residential Facilities” [Mesh]))) AND clinical trial (37)
  • Search ((((((((((physical restraint) OR “Restraint, Physical” [Mesh])) OR bedrail) OR side rail) OR coercion) OR seat belt)) AND ((“Restraint, Physical” [Mesh]) AND “Residential Facilities” [Mesh]))) AND randomized controlled trial (28)

Appendix B

Table A2. Risk of bias of included studies.
Table A2. Risk of bias of included studies.
Abraham et al. (2019) [27] (Cluster Clinical Trial)
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low risk One cluster was inadvertently allocated to another group as randomized but a sensitivity-analysis of the primary outcomes showed comparable results and we did not expect that this introduced a risk of bias.
Allocation concealment (selection bias)Low risk Clusters were randomly assigned to study groups by a person affiliated to the study center in Hamburg, but not involved in the study, using a computer-generated randomization list stratified by region with blocks of six, nine, and twelve nursing homes (generated by an independent external biometrician (BH)). One cluster at the study center Halle (Saale) that had been randomized to intervention group 1 was erroneously allocated to the control group due to miscommunication.
Blinding of participants and personnel (performance bias)High risk Not possible
Blinding of outcome assessment (detection bias)Low risk[…] raters blinded to group allocation. Raters were trained using a standardized list of measures to be rated as physical restraints. We assessed blinding of research assistants at T2 with 53.7% (95% CI, 45.5 to 63.6) of correct ratings indicating successful blinding
Incomplete outcome data (attrition bias)Low risk
Selective reporting (reporting bias)Low risk
Recruitment biasLow risk Recruitment lasted from February to November 2015. All residents that were present in the nursing home on the day of data collection were included. Residents newly admitted during follow-up were also included
Baseline imbalanceLow risk
Loss of clusterLow risk The interventions were implemented as planned with excep- tion of the one cluster discussed above.
Incorrect analysis Low risk
Evans et al., 1997 [28] (Cluster Clinical Trial)
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)High risk“Interventions were randomized to site using the sealed envelope technique”
Allocation concealment (selection bias)High risk Not done
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low risk“Observer nurses were unaware of the exact study design, interventions,
and nursing home’s group assignment”
Incomplete outcome data (attrition bias)Unclear riskNot reported flow of study design and participants
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biaslow risk
Baseline imbalancehigh risk statistically significant differences in baseline characteristics emerged concerning the prevalence of PR and the dependency level of participants
Loss of clusterLow risk no loss of cluster
Incorrect analysis high risk
Huizing et al., 2006 [29] (Cluster Randomized Controlled Trial)
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskDone “wards were assigned at random to either educational intervention (3 wards) or control status (2 wards)
Allocation concealment (selection bias)Unclear risk Not reported method of concealment
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low risk“The observers (two nurses, one occupational therapist and one member of management) were not told to the exact design of the study, the intervention and the division into experimental and control wards”
Incomplete outcome data (attrition bias)Low riskDuring the study there were newly admitted patients both in control and intervention group. Dropped out 19 residents, new admitted 18 residents
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biasLow riskThe wards were assigned at random to either educational intervention or control
Baseline imbalanceLow riskbaseline characteristics are quite similar, excepted in depression (statistically significant difference)
Loss of clusterLow riskno loss of cluster
Incorrect analysis Low risk Descriptive statistics were computed for the characteristics of the residents. Logistic regression analysis was used to compare restraint use post-intervention, controlling for characteristics of residents
Huizing et al., 2009a [30] (Cluster Randomized Study (RCT))
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskNot report methods of randomization
Allocation concealment (selection bias)Unclear risk Not reported method of concealment
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low riskTrained observers (n511) blinded to the experimental and control conditions measured the use of physical restraints
Incomplete outcome data (attrition bias)Low riskDuring the study, 130 dropped out, mainly because of death (75%). The dropout rate includes that of one ward (n = 529 residents) whose staff was unable to attend the educational intervention because of lack of time.
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biasLow risk The wards were assigned at random to either educational intervention or control
Baseline imbalancelow risk Baseline characteristic comparisons between residents who completed all four measurements and dropouts showed that these groups differed on most characteristics and is not use stratified or pair matched randomization
Loss of clusterUnclearOne out of 15 clusters was lost to follow-up
Incorrect analysis high risk
Huizing et al., 2009b [31] (Cluster Randomized Study (RCT))
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskThe 14 psycho-geriatric nursing home wards were randomly assigned to (..)
Allocation concealment (selection bias)Unclear risk Not reported method of concealment in report and protocol n. ISRCTN10117742.
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low riskThe observers were blinded to the experimental and control conditions. To measure the inter rater reliability, two of the eight observers were selected and they scored the same residents with restraints (k = 1.0).
Incomplete outcome data (attrition bias)Low risk33 residents were not included in the analyses, mainly because these residents died or informed consent had not been obtained. A total of 105 residents were included in the analyses.
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biaslow risknursing home wards were randomly assigned to either educational intervention or control status.
Baseline imbalancelow riskNot use stratified or pair matched randomization
Loss of clusterunclear “The study was part of a larger study focusing on the use of physical restraints on psychogeriatric
nursing home residents (15 Dutch nursing home)”. One out of 15 clusters was lost to follow-up (Huizing et al., 2009a)
Incorrect analysis high risk
Koczy et al., 2011 [32] (Cluster Randomized Controlled Trial (RCT))
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskDespite the randomization, there were differences in baseline characteristics of participants between the two groups.
Allocation concealment (selection bias)Low risk An independent organization performed randomization according to nursing home after baseline assessment of all restrained residents.
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)High riskNot done: “Data collection was, therefore, unblended”
Incomplete outcome data (attrition bias)Low riskDrop out 52 GI (19.4%), 30 GC (18.5%)
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biasLow risk Individual were not recruited after randomized cluster
Baseline imbalanceHigh risk“Despite the randomization, there were differences in baseline characteristics of participants between the two groups. The sex ratio was unbalanced, and the number of restrained residents differed between the IG and the CG”
Loss of clusterLow risk No loss of cluster during study
Incorrect analysis low risk Before definitive analyses, potential cluster effects were estimated for all models. For all analyses, cluster (nursing home) effects of nursing homes accounted for approximately 1.5% of the total variance and individual effects for more than 98%, so clusters were not considered in the final analysis.
Kopke et al., 2012 (Cluster Randomized Study (RCT))
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskComputer generated randomization lists will be used for allocation of clusters in blocks of four, six and eight nursing homes. Randomization will be stratified by region
Allocation concealment (selection bias)Low risk Paper and Protocol ISRCTN 34974819: “Clusters will be allocated after collection of baseline and prevalence data by an external researcher, not involved in the study. The external researcher informs each cluster about its group assignment
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low riskThe primary outcome of this study is obtained by trined external investigators.
Incomplete outcome data (attrition bias)Low riskNo nursing home dropped from the study
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes like in Protocol.
Recruitment biaslow risk Newly admitted patients in cluster during study, but individuals were not informed about the intervention or control group.
Baseline imbalanceLow risk Randomized stratification
Loss of clusterLow risk No loss of cluster
Incorrect analysis Low risk Cluster adjusted 95% confidence intervals of prevalence data were estimated corresponding to the cluster size weighted prevalence estimation from cluster means taking into account variance of cluster means.
Pellfolk et al., 2010 [9] (Cluster Randomized Controlled Trial)
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low risk“The randomization was based on a lottery system using identification codes”
Allocation concealment (selection bias)High risk Not done
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)High riskNot done
Incomplete outcome data (attrition bias)low risk
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biasLow risk
Baseline imbalanceunclear At baseline, only age, sex, and wandering behavior differed between the groups, whereas at follow-up age, sex, and cognitive level were all significantly different.
Loss of clusterLow risk No loss of cluster
Incorrect analysis Low risk The difference between IG and CG was analyzed by incorporating potential confounders into a multiple logistic regression analyses with a backward selection algorithm and adjusted for the cluster effect
Rovner et al., 1996 [35] (Randomized Controlled Trial, RCT)—NOT Cluster
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskDone “The allocation procedure was a fixed, uniform randomization scheme by computer algorithm”.
Allocation concealment (selection bias)Unclear risk Unclear
Blinding of participants and personnel (performance bias)High riskNot blinding
Blinding of outcome assessment (detection bias)High risk Not blind “nursing staff (nonblind) reported two or more behaviors on the PGDRS that were
severe enough to require restraints on the nursing unit”
Incomplete outcome data (attrition bias)Low risk
Selective reporting (reporting bias)Low riskReport included primary and secondary outcomes.
Recruitment biasLow risk
Baseline imbalanceLow riskno difference except for number of females in the intervention group
Testad et al., 2005 [33] (a Single-Blind Cluster Randomized Controlled Trial)
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskThe nursing homes were randomly assigned to the treatment intervention or control condition, two in each group, after stratification for size.
Allocation concealment (selection bias)Unclear risk Not reported in paper
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low riskData were collected immediately before and after the intervention period by a trained rater who was blind to the study hypothesis and to treatment allocation.
Incomplete outcome data (attrition bias)low riskDrop out only 9 patient in control group for death
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biasUnclear unclear methods. Not report CONSORT flow diagram
Baseline imbalanceLow risk At baseline, the number of restraint and BARS scores did not differ between the groups
Loss of clusterLow risk No loss of cluster
Incorrect analysis high risk
Testad et al., 2010 [34] (Cluster Randomized Controlled Trial)
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)UnclearNot described
Allocation concealment (selection bias)UnclearNot reported in paper
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low risk“The administration of the outcome measures and drug recording were done by a trained research nurse who was uninformed”
Incomplete outcome data (attrition bias)High riskDrop out 61.1% in intervention group and 53.1% in usual care group.
Reasons for drop-out were similar in both groups and mostly due to death and discharge
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biasunclear not described
Baseline imbalancehigh risk “were differences in proportion of using physical restraint, antipsychotics, and total CMAI score between the groups”.
Loss of clusterlow risk
Incorrect analysis high risk
Testad et al., 2016 [26] (a Single-Blind Cluster Randomized Controlled Trial)
BiasAuthors’ JudgmentSupport for Judgment
Random sequence generation (selection bias)Low riskDone “All homes in the geographical area were invited to participate following a list in randomized Order”
Allocation concealment (selection bias)unclear risk Not reported in paper and in protocol Clinical Trials NCT01715506
Blinding of participants and personnel (performance bias)High riskBlinding of participants was not possible. Personnel were not blinded
Blinding of outcome assessment (detection bias)Low risk“All data in the 24 care homes were collected within 1 week by research assistants blind to the study
Incomplete outcome data (attrition bias)High riskDropout from baseline to follow-up was 35 (30%) in the intervention group and
42 (26%) in the control group. Reasons unknown
Selective reporting (reporting bias)Low riskReports included results both primary and secondary outcomes.
Recruitment biasLow risk Treatment allocation was revealed to the facilitating teams by the principal investigator, when baseline was completed.
Baseline imbalanceHigh risk ”There were statistically significant differences between the intervention group and control
group for age, ADL score, CMAI score, and NPI sum score”. “These confounders were included in a regression analysis to identify any impact on outcomes, which showed that difference in changes in agitation represented regression to the mean”.
Loss of clusterLow risk Not loss cluster
Incorrect analysis Low risk “The effect of clustering was taken into account and adjusted for when if the ICC had a value greater than 5%. Logistical regressions were performed to detect differences between groups and adjust for possible confounders”

References

  1. Feng, Z.; Hirdes, J.P.; Smith, T.F.; Finne-Soveri, H.; Chi, I.; Du Pasquier, J.-N.; Gilgen, R.; Ikegami, N.; Mor, V. Use of physical restraints and antipsychotic medications in nursing homes: A cross-national study. Int. J. Geriatr. Psychiatry 2009, 24, 1110–1118. [Google Scholar] [CrossRef] [PubMed]
  2. Richter, T.; Köpke, S.; Meyer, G. Interventions for preventing and reducing the use of physical restraints in long-term geriatric care. Cochrane Database Syst. Rev. 2011, 16, CD007546. [Google Scholar] [CrossRef]
  3. Evans, D.; FitzGerald, M. The experience of physical restraint: A systematic review of qualitative research. Contemp. Nurse 2002, 13, 126–135. [Google Scholar] [CrossRef] [PubMed]
  4. Hamers, J.P.; Huizing, A.R. Why do we use physical restraints in the elderly? Z. Gerontol. Geriatr. 2005, 38, 19–25. [Google Scholar] [CrossRef] [PubMed]
  5. Heeren, P.; Van De Water, G.; De Paepe, L.; Boonen, S.; Vleugels, A.; Milisen, K. Staffing levels and the use of physical restraints in nursing homes: A multicenter study. J. Gerontol. Nurs. 2014, 40, 48–54. [Google Scholar] [CrossRef]
  6. Hofmann, H.; Schorro, E.; Haastert, B.; Meyer, G. Use of physical restraints in nursing homes: A multicentre cross-sectional study. BMC Geriatr. 2015, 15, 1–8. [Google Scholar] [CrossRef]
  7. Luo, H.; Lin, M.; Castle, N. Physical restraint use and falls in nursing homes: A comparison between residents with and without dementia. Am. J. Alzheimer’s Dis. Other Dement. 2011, 26, 44–50. [Google Scholar] [CrossRef]
  8. Meyer, G.; Köpke, S.; Haastert, B.; Mühlhauser, I. Restraint use among nursing home residents: Cross-sectional study and prospective cohort study. J. Clin. Nurs. 2009, 18, 981–990. [Google Scholar] [CrossRef]
  9. Pellfolk, T.J.-E.; Gustafson, Y.; Bucht, G.; Karlsson, S. Effects of a restraint minimization program on staff knowledge, attitudes, and practice: A cluster randomized trial. J. Am. Geriatr. Soc. 2010, 58, 62–69. [Google Scholar] [CrossRef]
  10. Sze, T.W.; Leng, C.Y.; Lin, S.K.S. The effectiveness of physical restraints in reducing falls among adults in acute care hospitals and nursing homes: A systematic review. JBI Libr. Syst. Rev. 2012, 10, 307–351. [Google Scholar] [CrossRef]
  11. Kong, E.-H.; Choi, H.; Evans, L.K. Staff perceptions of barriers to physical restraint-reduction in long-term care: A meta-synthesis. J. Clin. Nurs. 2016, 26, 49–60. [Google Scholar] [CrossRef]
  12. Bleijlevens, M.H.C.; Wagner, L.M.; Capezuti, E.A.; Hamers, J.P.H. The international physical restraint workgroup physical restraints: Consensus of a research definition using a modified delphi technique. J. Am. Geriatr. Soc. 2016, 64, 2307–2310. [Google Scholar] [CrossRef] [PubMed]
  13. Hofmann, H.; Hahn, S. Characteristics of nursing home residents and physical restraint: A systematic literature review. J. Clin. Nurs. 2013, 23, 3012–3024. [Google Scholar] [CrossRef]
  14. Beerens, H.C.; Sutcliffe, C.; Renom-Guiteras, A.; Soto, M.E.; Suhonen, R.; Zabalegui, A.; Bökberg, C.; Saks, K.; Hamers, J.P. Quality of life and quality of care for people with dementia receiving long term institutional care or professional home care: The european RightTimePlaceCare Study. J. Am. Med. Dir. Assoc. 2014, 15, 54–61. [Google Scholar] [CrossRef] [PubMed]
  15. Köpke, S.; Mühlhauser, I.; Gerlach, A.; Haut, A.; Haastert, B.; Möhler, R.; Meyer, G. Effect of a Guideline-Based Multicomponent Intervention on Use of Physical Restraints in Nursing Homes. JAMA 2012, 307, 2177–2184. [Google Scholar] [CrossRef]
  16. Registered Nurses’ Association of Ontario. Promoting Safety: Alternative Approaches to the Use of Restraints. Available online: http://rnao.ca/bpg/guidelines/promoting-safety-alternative-approaches-use-restraints (accessed on 14 September 2020).
  17. Royal College of Nursing (RCN). Use of Restrictive Practices in Health and Adult Social Care and Special Schools; RCN: London, UK, 19 December 2013. [Google Scholar]
  18. Bellenger, E.; Ibrahim, J.E.; Bugeja, L.; Kennedy, B. Physical restraint deaths in a 13-year national cohort of nursing home residents. Age Ageing 2017, 46, 688–693. [Google Scholar] [CrossRef]
  19. Berzlanovich, A.; Schöpfer, J.; Keil, W. Deaths Due to Physical Restraint. Dtsch. Arztebl. Int. 2012, 109, 27–32. [Google Scholar] [CrossRef]
  20. Cadore, E.L.; Moneo, A.B.B.; Mensat, M.M.; Muñoz, A.R.; Casas-Herrero, A.; Rodríguez-Mañas, L.; Izquierdo, M. Positive effects of resistance training in frail elderly patients with dementia after long-term physical restraint. Age 2013, 36, 801–811. [Google Scholar] [CrossRef]
  21. Gastmans, C.; Milisen, K. Use of physical restraint in nursing homes: Clinical-ethical considerations. J. Med. Ethics 2006, 32, 148–152. [Google Scholar] [CrossRef]
  22. Möhler, R.; Meyer, G. Attitudes of nurses towards the use of physical restraints in geriatric care: A systematic review of qualitative and quantitative studies. Int. J. Nurs. Stud. 2014, 51, 274–288. [Google Scholar] [CrossRef] [PubMed]
  23. Goethals, S.; De Casterlé, B.D.; Gastmans, C. Nurses’ ethical reasoning in cases of physical restraint in acute elderly care: A qualitative study. Med. Health Care Philos. 2012, 16, 983–991. [Google Scholar] [CrossRef]
  24. Lan, S.-H.; Lu, L.-C.; Lan, A.S.-J.; Chen, J.-C.; Wu, W.-J.; Chang, S.-P.; Lin, L.-Y. Educational intervention on physical restraint use in long-term care facilities—Systematic review and meta-analysis. Kaohsiung J. Med. Sci. 2017, 33, 411–421. [Google Scholar] [CrossRef] [PubMed]
  25. Higgins, J.P.; Green, S. Cochrane Handbook for Systematic Reviews of Interventions; John Wiley & Sons: Hoboken, NJ, USA, 2011. [Google Scholar]
  26. Testad, I.; Mekki, T.E.; Førland, O.; Øye, C.; Tveit, E.M.; Jacobsen, F.; Kirkevold, O. Modeling and evaluating evidence-based continuing education program in nursing home dementia care (MEDCED)-training of care home staff to reduce use of restraint in care home residents with dementia. A cluster randomized controlled trial. Int. J. Geriatr. Psychiatry 2016, 31, 24–32. [Google Scholar] [CrossRef] [PubMed]
  27. Abraham, J.; Kupfer, R.; Behncke, A.; Berger-Höger, B.; Icks, A.; Haastert, B.; Meyer, G.; Köpke, S.; Möhler, R. Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial. Int. J. Nurs. Stud. 2019, 96, 27–34. [Google Scholar] [CrossRef]
  28. Evans, L.K.; Strumpf, N.E.; Allen-Taylor, S.L.; Capezuti, E.A.; Maislin, G.; Jacobsen, B. A clinical trial to reduce restraints in nursing homes. J. Am. Geriatr. Soc. 1997, 45, 675–681. [Google Scholar] [CrossRef]
  29. Huizing, A.R.; Hamers, J.P.; Gulpers, M.J.M.; Berger, M.P.F. Short-term effects of an educational intervention on physical restraint use: A cluster randomized trial. BMC Geriatr. 2006, 6, 17. [Google Scholar] [CrossRef] [PubMed]
  30. Huizing, A.R.; Hamers, J.P.H.; Gulpers, M.J.M.; Berger, M.P.F. A Cluster-Randomized Trial of an Educational Intervention to Reduce the Use of Physical Restraints with Psychogeriatric Nursing Home Residents. J. Am. Geriatr. Soc. 2009, 57, 1139–1148. [Google Scholar] [CrossRef]
  31. Huizing, A.R.; Hamers, J.P.; Gulpers, M.J.; Berger, M.P.F. Preventing the use of physical restraints on residents newly admitted to psycho-geriatric nursing home wards: A cluster-randomized trial. Int. J. Nurs. Stud. 2009, 46, 459–469. [Google Scholar] [CrossRef]
  32. Koczy, P.; Becker, C.; Rapp, K.; Klie, T.; Beische, D.; Büchele, G.; Kleiner, A.; Guerra, V.; Rißmann, U.; Kurrle, S.; et al. Effectiveness of a Multifactorial Intervention to Reduce Physical Restraints in Nursing Home Residents. J. Am. Geriatr. Soc. 2011, 59, 333–339. [Google Scholar] [CrossRef]
  33. Testad, I.; Aasland, A.M.; Aarsland, D. The effect of staff training on the use of restraint in dementia: A single-blind randomised controlled trial. Int. J. Geriatr. Psychiatry 2005, 20, 587–590. [Google Scholar] [CrossRef]
  34. Testad, I.; Ballard, C.; Brønnick, K.; Aarsland, D. The Effect of Staff Training on Agitation and Use of Restraint in Nursing Home Residents with Dementia. J. Clin. Psychiatry 2010, 71, 80–86. [Google Scholar] [CrossRef] [PubMed]
  35. Rovner, B.W.; Steele, C.D.; Shmuely, Y.; Folstein, M.F. A Randomized Trial of Dementia Care in Nursing Homes. J. Am. Geriatr. Soc. 1996, 44, 7–13. [Google Scholar] [CrossRef] [PubMed]
  36. Gulpers, M.J.; Bleijlevens, M.H.C.; Ambergen, T.; Capezuti, E.A.; Van Rossum, E.; Hamers, J.P. Reduction of Belt Restraint Use: Long-Term Effects of the EXBELT Intervention. J. Am. Geriatr. Soc. 2013, 61, 107–112. [Google Scholar] [CrossRef] [PubMed]
  37. Gulpers, M.J.; Bleijlevens, M.H.C.; Ambergen, T.; Capezuti, E.A.; Van Rossum, E.; Hamers, J.P.H. Belt Restraint Reduction in Nursing Homes: Effects of a Multicomponent Intervention Program. J. Am. Geriatr. Soc. 2011, 59, 2029–2036. [Google Scholar] [CrossRef] [PubMed]
  38. Gulpers, M.J.; Bleijlevens, M.H.; Capezuti, E.A.; Van Rossum, E.; Ambergen, T.; Hamers, J.P. Preventing belt restraint use in newly admitted residents in nursing homes: A quasi-experimental study. Int. J. Nurs. Stud. 2012, 49, 1473–1479. [Google Scholar] [CrossRef] [PubMed]
  39. Capezuti, E.A.; Maislin, G.; Strumpf, N.; Evans, L.K. Side Rail Use and Bed-Related Fall Outcomes among Nursing Home Residents. J. Am. Geriatr. Soc. 2002, 50, 90–96. [Google Scholar] [CrossRef]
  40. Bellenger, E.N.; Ibrahim, J.E.; Kennedy, B.; Bugeja, L. Prevention of physical restraint use among nursing home residents in Australia: The top three recommendations from experts and stakeholders. Int. J. Older People Nurs. 2019, 14, e12218. [Google Scholar] [CrossRef]
  41. Bellenger, E.N.; Ibrahim, J.E.; Lovell, J.J.; Bugeja, L. The Nature and Extent of Physical Restraint–Related Deaths in Nursing Homes: A Systematic Review. J. Aging Health 2017, 30, 1042–1061. [Google Scholar] [CrossRef]
  42. Goethals, S.; De Casterlé, B.D.; Gastmans, C. Nurses’ decision-making in cases of physical restraint: A synthesis of qualitative evidence. J. Adv. Nurs. 2011, 68, 1198–1210. [Google Scholar] [CrossRef]
  43. Heinze, C.; Dassen, T.; Grittner, U. Use of physical restraints in nursing homes and hospitals and related factors: A cross-sectional study. J. Clin. Nurs. 2011, 21, 1033–1040. [Google Scholar] [CrossRef]
  44. Minnick, A.F.; Mion, L.C.; Johnson, M.E.; Catrambone, C.; Leipzig, R. Prevalence and Variation of Physical Restraint Use in Acute Care Settings in the US. J. Nurs. Sch. 2007, 39, 30–37. [Google Scholar] [CrossRef] [PubMed]
Figure 1. PRISMA Flow Diagram.
Figure 1. PRISMA Flow Diagram.
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Figure 2. Risk of bias summary.
Figure 2. Risk of bias summary.
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Figure 3. Risk of bias graph: review authors’ judgements about each risk of bias item presented as percentages across all included studies.
Figure 3. Risk of bias graph: review authors’ judgements about each risk of bias item presented as percentages across all included studies.
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Figure 4. (a) Effect of educational program at endpoint study on reducing PR use; (b) Effect of educational program at different follow-up on reducing PR use.
Figure 4. (a) Effect of educational program at endpoint study on reducing PR use; (b) Effect of educational program at different follow-up on reducing PR use.
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Figure 5. (a) Effect of a multicomponent program at endpoint study on reducing PR use; (b) Effect of a multicomponent program at different follow-up on reducing PR use.
Figure 5. (a) Effect of a multicomponent program at endpoint study on reducing PR use; (b) Effect of a multicomponent program at different follow-up on reducing PR use.
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Table 1. Characteristics of included studies.
Table 1. Characteristics of included studies.
Authors (Year) Study Design [Ref]Country SettingSampleInterventionsControlFollow-Up PeriodPrimary and Secondary Outcome
Education TrainingConsultation (APN) and GuidanceChange Policy Implementation GuidelineAvailability Alternative Intervention
Abraham et al. (2019) [27]
Pragmatic RCT
Germany
120 NH
N = 12,245 residents
IG 1: 4126
IG 2: 3547
CG: 4572
Usual care6–12 monthsPhysical restraint use
Falls
Fall -related fractures
Quality of life
Capezuti et al. (2002) [39]
Pre- and posttest design
USA
4NH
N = 251 residents (side rail use)
IG: N = 130 Discontinued Side Rail Use
IG: N = 121 Continued Side Rail Use
Usual care1–12 monthsSide rail use
Incidence of falls
Evans et al. (1997) [28]
Cluster randomized trial
USA
3 NH
N = 643 residents
N = 463 complete data
IGa: 152
IGb: 127
CG: 184
Usual care6–9–12 monthsPhysical restraint use
Restraint intensity
Fall rate
Gulpers et al. (2011) [37]
Quasi-experimental longitudinal design
Netherlands
26 psycho-geriatric NH
N = 420 residents
N = 405 complete data
IG: 250
CG:155
Usual care4–8 monthsBelt restraint use
Other types of physical restraint use
Use of Psychoactive drugs f
Falls
Fall-related injuries
Gulpers et al. (2012) [38]
Quasi-experimental longitudinal study
Netherlands
13 NH
N = 104 newly admitted residents
N = 82 complete data base line
IG: t0 43–t1 29
CG: t0 39–t1 20
Usual Care4–8 monthsBelt restraints use e
Other types of physical restrains use
Use of psychoactive medication
Falls
Fall-related injuries
Gulpers et al. (2013) [36]
Quasi-experimental longitudinal study
Netherlands
13 NH
N = 225 panel group
IG: N = 134
CG: N = 91
Usual care24 monthsbelt restraints use
Use of at least one physical restraint device
Huizing et al. (2006) [29]
Cluster randomized trial
Netherlands
5 psycho-geriatric
NH
N = 145 residents with dementia
N = 126 complete data
IG: t0 83–t1 86
CG: t0 62–t1 58
Usual care1 monthPhysical restraint use
Restraint intensity
Restraint type
Huizing et al. (2009a) [30]
Cluster randomized trial
Dutch
7 psycho-geriatric NH
N = 432 psycho geriatric residents
N = 241 complete data
IG: N = 125
CG: N = 115
Usual Care
1–4–8 monthsPhysical restraint status, intensity
Multiple restraint use
Huizing et al. (2009b) [31]
Cluster randomized trial
Dutch
14 psycho-geriatric NH
N = 138 newly admitted psychogeriatric residents
N = 90 complete data base line
IG: 53
CG: 37
Usual Care1–4–8 monthsPhysical restraint status, intensity
Multiple restraint use
Koczy et al. (2011) [32]
Cluster randomized trial
Germany
45 NH
N = 430 restrained residents
N = 333 complete data
IG: N = 208
CG: N = 125
Usual care3 monthsCessation of physical restraints (100%)–bed rails were not included
Falls
Use of psychoactive medication
Köpke et el. (2012) [15]
Cluster randomized trial
Germany
18 NH
N = 4449 residents
IG: N = 2283
CG: N = 2166
Standard information3–6 monthsPhysical restraint use (6 month)
Physical restraint use (3 month)
Falls
Fall-related fractures
Use of antipsychotropic therapy
Pellfolk et al. (2010) [9]
Cluster-randomized controlled trial
Sweden
40 Units for people dementia
N = 355 residents
N = 350 residents complete data
IG: Residents, N = 192
CG: Residents, N = 163
Usual care6 monthsPhysical restraint use
Falls (1 months)
Use of antipsychotic therapy (Benzodiazepines–Narcoleptics)
Rovner et al. (1996) [35]
Randomized controlled Trial (RCT)
Baltimore (USA)
A 250-bed community NH
N = 89 residents randomized
N = 81 complete data (91%)
IG: N = 42
CG: N = 39
Usual care6 monthsBehavioral disorders
Use of antipsychotic drugs
Physical restraint use
Cognition and level of nursing care
Testad
(2005) [33]
single-blind cluster Randomised controlled trial
Norway
4NH
N = 151 residents
IG: N = 55 residents
All complete data
CG: N = 96 residents
N = 87 complete data
Usual care7 monthsPhysical restraint use
Agitation
Testad et al. (2010) [34]
Single blind cluster randomized controlled trial
Norway
4NH
N = 211 residents
IG: N = 113 residents
N = 76–44 complete data
CG: N = 98 residents
N = 46 complete data
Usual care6–12 monthsStructural restraint
Interactional restraint (treatment and care giving activity such as force and pressure)
Agitation
Use of antipsychotic drugs
Testad et al. (2016) [26]
Single-blind cluster randomized controlled trial
Norway
24 care homes
(citated by authors as NH)
N = 274 residents
IG: N = 118 residents with dementia
N = 85 complete data
CG: N = 156 residents
N = 116 complete data
Usual care7 monthsPhysical restraint use
Agitation
Use of antipsychotic drugs
N = number of residents recruited at baseline; Complete data = residents at study endpoint; NH = nursing home; IG = intervention group; CG = control group.
Table 2. Results of included studies.
Table 2. Results of included studies.
Author (Year) [Ref]MA *Results on Physical Restraint UseResults on Fall Rate–Fall-Related Injuries
Abraham et al. (2019) [27]
A pragmatic cluster of randomized controlled trial
YChange in any physical restraint prevalence from baseline to follow-up
CG −1.2; 95% CI −0.04 to 0.11; p = 0.294
IG 1 update version: −2.8; 95% CI −5.5 to −0.01; p = 0.042
IG 2 concise version: −3.9; 95% CI −6.8 to −1.0; p = 0.009
≥1 Fall 12 months
OR (95% CI) IG1 vs. CG: 1.17 (0.89–1.53)
OR (95% CI) IG2 vs. CG: 1.03 (0.79–1.35)
≥1 Fall- related fractures
OR (95% CI) IG1 vs. CG: 1.31 (0.87–1.97)
OR (95% CI) IG2 vs. CG: 1.11 (0.73–1.71)
Capezuti et al. (2002) [39]
Pre-Post test design
NSide rail use immediately post (1 month) e 12 months
Statistically significant effects of time and site, indicating a change over time Only one NH Site 3 showed a statistically significant decrease in the rate of restrictive side rail use over time (p = 0.01)
Fall rate 12 months
reduced discontinue restrictive side rail group
−0.053; 95% CI (−0.083 to −0.024)
p-value < 0.001
continued restrictive side rail group
−0,013; 95% CI (−0.056 to 0.030)
p-value = 0.17
Evans et al. (1997) [28]
Cluster RCT
YPrevalence restraint use (Individual as units of analysis)
6 month CG:45% (83/184); IG: RE: 18% (27/152); REC: 16% (20/127)
9 month CG: 42% (77/184); IG: RE: 16% (24/152); REC: 12% (15/127)
12 month CG: 43% (79/184);IG: RE: 19% (29/152);REC: 14% (18/127)
Nursing home as units of analysis
6 month CG:40%; IG: RE: 19%; REC: 18%
9 month CG: 40%; IG: RE: 17%; REC: 14%
12 month CG: 42%; IG: RE: 19%; REC: 16%
Fall rate
3 months
GC vs. RE or REC (64.7% vs. 41.5% or 42.5%) p < 0.001
6 months
GC vs. RE or REC (53.3% vs. 32.2% or 37.8%)
p-value < 0.001
Gulpers et al. (2011) [37]
Quasi Experimental
NAt least one physical restraint device
4 months CG 64%; IG 54%; p-value 0.06
8 months CG 69%; IG 54%; p-value 0.003
Falls
4 months GC 14%; GI 20%; p-value 0.10
8 months GC 16%; GI 16%; p-value 0.98
Fall-related injuries
4 months GC 8%; GI10%; p-value 0.44
8 months GC 11%; GI 10%; p-value 0.66
Gulpers et al. (2012) [38]
Quasi Experimental
NAt least one physical restraint device
4 months CG 31%; IG 30%; p-value 1.00
8 months CG 36%; IG 21%; p-value 0.15
Falls
4 months GC 40%; GI 38%; p-value 1.00
8 months GC 30%; GI 21%; p-value 0.51
Fall-related injuries
4 months GC 10%; GI 24%; p-value 0.28
8 months GC 10%; GI 14%; p-value 1.00
Gulpers et al. (2013) [36]
Quasi experimental
NAt least one physical restraint 24 months
IG: 80/134 (60%); CG: 68/91 (75%)
OR 0.50, 95% CI 0.28 to 0.90, p-value = 0.020
Huizing et al. (2006) [29]
Cluster RCT
YRestraint use (prevalence)
CG 40/58; IG: 45/86
OR 0.50, 95% CI 0.24 to 0.99 p-value = 0.048
Restraint intensity over time
CG t0 56% t1 70%; IG t0 54%–t1 56% p-value > 0.05
Huizing et al. (2009a) [30]
cluster RCT
YChange in restrain status
CG 69/115 (60%); IG: 81/126(64%)
IG change t0 54% vs. t3 (8 months) 64% (p = 0.02)—at post-test 2 there were no differences
CG: t0 49% vs. t2 (4 months) 57% (p = 0.02); t3 60% (p = 0.007)
Huizing et al.(2009b) [31]
cluster RCT
YNot restrained vs. restraint
1 month
CG: 70% (14/20)–IG: 61.8% (21/34) vs. CG 30% (6/20)–IG 38,2% (13/34); p-value 0.541
4 months
CG: 67.7% (21/31) – IG: 48.8% (21/43) vs. CG 32.3% (10/31) vs. IG: 51.2% (22/43) p-value 0.105
8 months
GC 59.5% (22/37)–IG: 52.8% (28/53) vs. CG 40.5% (15/37)–IG 47.2% (25/53) p-value 0.53
Koczy et al. (2011) [32]
cluster RCT
Y100% not restrained (free) 3 months
CG 8.8% vs. IG 16.8% OR 2.16 (IC 95% 1.05–4.46)
Restraint 3 months
CG: 114/125 (91.2%); IG: 173/208 (83.2%)
Falls 3 months
GI 16.3% vs. GC 8.0%; OR 2.08 (IC 95% 0.98–4.40)
Köpke et al. (2012) [15]
RCT
YAny physical restraint
3 months
CG 30.5 (26.6–34.4) vs. IG 23.9 (19.3–28.5)
MD 6.6%; 95% CI (0.6–12.6)
Cluster adjusted OR 0.72; 95% CI (0.53–0.97) p-value 0.03; ICCC 0.029
6 months
Difference 6.5%; 95% CI (0.6–12.4)
Cluster adjusted OR 0.71; 95% CI (0.52–0.97) p-value 0.03; ICCC 0.029
Residents ≥1 fall during period study
Difference 3%; 95% CI (−3.5 to 9.4)
Cluster adjustice OR 0.85; 95% CI (0.60 to 1.21)
Fractures during period study
Difference 0.5%; 95% CI (−0.5 to 1.4)
OR (95% CI) = 0.76 (0.42 to 1.38)
Pellfolk et al. (2010) [9]
cluster RCT
YPhysical restraint 6 months
CG 38.1% (53/139); IG 20.1% (30/149)
p-Value baseline/ 6 months: 0.78/0.001
OR 0.21, 95% CI 0.08–0.57, p-value 0.002
restrained baseline vs. unrestraint 6 months
CG 3.6% (n = 1/28) vs. IG 31.3% (n = 10/32)
(p = 0.007).
unrestrained baseline vs. restrained 6 months
CG 23.4% (n26/111) vs. IG 6.8% (n8/117)
(p-value 0.001).
Falls 6 months
IG 10.1% vs. CG 8.6%
p-Value baseline/ Follow-Up: 0.45/0.68
Rovner et al. (1996) [35]
RCT
YPhysical restraint 6 months
CG 20/38 (52.6%) vs. IG 14/41 (34.1%)
OR 0.47 [95% CI 0.19 to 1.16] p-value = 0.10
Testad et al. (2005) [33]
RCT
YFrequency of use of restraint–mean (range)
7 months
CG 4/55; IG 2/96
CG 3.7 (0–25); GI 1.5 (0–10); p-value = 0.016
Testad et al. (2010) [34]
RCT
YStructural restraint
6 months CG 23/70 (33%); IG 48/75 (64%)
12 months CG 6/70 (13%) IG 8/75 (18%)
Testad et al. (2016) [26]
cluster RCT
YChange in any physical restraint physical restraint prevalence from baseline to /7months
CG t0 10.5% vs. t1 6.1% p < 0.001; IG t0 14.5% vs. t1 10.5% p-value 0.007
* MA, meta-analysis; Y, yes: studies included in meta-analysis; N, Not included; CG, control group; IC, intervention group; RE, educational rehabilitation; REC, educational rehabilitation with consultation.
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