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Cochrane Database of Systematic Reviews Protocol - Intervention

Interventions for preventing and reducing the use of physical restraints of older people in general hospital settings

Authors' declarations of interest

Version published: 19 December 2016 Version history

https://doi.org/10.1002/14651858.CD012476

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view the current version 25 August 2022
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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

  1. To assess the best evidence for the effectiveness and safety of interventions aimed at preventing and reducing the use of PR of older people in general hospital settings.

  2. To describe the content, components and processes of these interventions.

Background

Description of the condition

Physical restraint (PR) is commonly used in general hospital settings in many countries (Bower 2003; Krüger 2013; Minnick 2007; O'Flatharta 2014). An international expert panel defined PR as "any action or procedure that prevents a person’s free body movement to a position of choice and/or normal access to his/her body by the use of any method that is attached or adjacent to a person’s body and that he/she cannot control or remove easily" (Bleijlevens 2016). Common types of PR include belts (e.g. at the wrist, ankle, waist or chest) in bed and chair, bedrails, geriatric chairs with fixed tables, or mitts.

Prevalence rates of PR in general hospital settings differ widely between studies and countries, ranging from no use up to 50% of patients with PR (de Vries 2004; Krüger 2013; O'Flatharta 2014). In one study the prevalence ranged from 4.7 to 94 patient days (mean 50/1000 patient days) (Minnick 2007). The variation between these different studies can be explained partly by different definitions of PR, methods of data collection and patient characteristics (Krüger 2013;Minnick 2007), however, some of the observed variation cannot be explained by patients' or institutional characteristics (de Vries 2004; Healey 2009; Minnick 2007). One explanation for these variations is the risk‐averse culture that prevails in many hospitals.

The main reasons for using PR in general hospital settings are to prevent injuries, e.g. related to falls, and to ensure delivery of medical treatment (Bower 2003; Möhler 2014). Risk of falling, agitation and wandering are often experienced as particular challenges by healthcare staff in hospitals where their numbers and their capabilities for supervising patients are often limited. When patients' mobility is already restricted, e.g. after surgical or medical procedures, agitation, wandering and difficulties with independent mobility are often perceived as risk factors for further injuries, and this may lead to the use of PR by healthcare staff (Goethals 2012; Möhler 2014). Accordingly, patients frequently at risk of being restrained in hospitals include people with permanent or temporary cognitive impairment (e.g. older people with dementia or delirium) who also exhibit challenging behaviour (e.g. behaviour that interferes with medical treatment or that might increase the risk of falling) (Bower 2003; de Vries 2004; O'Flatharta 2014). However, the evidence does not support the assumption that PR is effective in reducing falls or fall‐related injuries and there is some evidence that it has a negative effect on these outcomes in general hospital settings (Healey 2008; Tang 2012). Overall, the evidence on this point is inconclusive. One study showed an increase of falls and fall‐related injuries in restrained patients (Tan 2005), while Healey 2008 found no evidence to support an increased risk of falling. There is also inconclusive evidence about the effectiveness of PR to secure tubes or venous lines. High rates of extubation have been described for agitated or aggressive patients in intensive care units irrespective of the use of PR (da Silva 2012; Kikkas 2013), but these results have come mainly from observational studies. PR might be used as an alternative to sedation, although studies conducted in geriatric long‐term care settings found no correlation between a reduction in PR and an increase in psychotropic medication usage (Gulpers 2011; Köpke 2012).. Several adverse effects have been described for the use of PR. The experience of being restrained affects patients' well‐being negatively and can cause feelings of fear, anger and discomfort (Bower 2003; Evans 2002). The use of PR is also associated with decreased mobility, prolonged length of stay in hospital, increased risk of pressure ulcers and incontinence, and serious injuries (Bai 2014; Bower 2003; Evans 2003; Kwok 2012). Therefore, PR may hamper patients' recovery and rehabilitation, and may also increase challenging behaviour in people with dementia (Mott 2005).

As a result of the lack of evidence for the effectiveness and safety of PR, and ethical problems with its use (Gastmann 2006), the use of PR is restricted by law in many countries (Bretschneider 2012; Cleary 2015), and its reduction in general hospital settings is an accepted goal that has been recommended by healthcare authorities and nursing organisations (e.g. AAN 2015; AHRQ 2013; Lach 2016; RCN 2008; RNOA 2012). In geriatric long‐term care, several educational interventions that aim to prevent or reduce PR use have been evaluated. While a systematic review published in 2012 found inconclusive evidence for their effectiveness (Möhler 2012), two studies that were not included in the review were effective in reducing PR use in long‐term care facilities (Gulpers 2011; Köpke 2012). Both studies evaluated multicomponent interventions and included a strong focus on policy change in the use of PR by including components that addressed the organisational leadership. However, applicability of this strategy seems to be limited to the hospital setting, as both the environment and reasons for using PR differ between geriatric long‐term care and acute hospital settings. Preventing and reducing the use of physical restraints in general hospital settings requires interprofessional collaboration, and challenges nursing staff, physicians, other healthcare professionals, managers, patients and their relatives, and other stakeholders.

Description of the intervention

Interventions for preventing and reducing the use of physical restraints of older people in general hospital settings aim to support healthcare professionals (e.g. nursing staff, physiotherapists, or physicians) in the omission of PR use in clinical practice. Several important barriers that hamper the reduction of PR in clinical practice have been identified (de Casterlé 2015; Goethals 2012; Goethals 2013; Möhler 2014). These include nurses' attitudes, the care environment and/or the organisational culture (e.g. leadership and inter‐personal network of nurses and other healthcare professionals or the patients' families) focusing primarily on the prevention of potentially hazardous events (a risk‐averse culture), and the belief that PR use is effective in reducing falls or fall‐related injuries. These beliefs, attitudes and culture of care may lead to RP use being preferred to alternative strategies. In addition, the implementation of a 'least restraints' policy in clinical practice may be impeded by a lack of knowledge about effective alternatives to PR use. Therefore, there might be several different categories of interventions that aim to prevent or reduce the use of PR for older people in general hospital settings.

1. Interventions that provide alternatives to PR use

These interventions offer technical devices that target risk factors for the use of PR, e.g. sensor mats to reduce the risk of falling, or low‐low beds to reduce the risk of fall‐related injuries. The interventions might also comprise instructions about the correct use of devices.

2. Simple educational interventions

Simple educational interventions address the knowledge of healthcare professionals about PR use, e.g. on lack of evidence about PR effectiveness as well as ethical and legal aspects.

3. Multicomponent educational interventions

Multicomponent educational interventions are aimed at implementing a least‐restraint policy and changing the organisational culture of PR use. These interventions are complex in nature and comprise several interacting components (Craig 2008), with an educational core component (addressing knowledge and attitudes of healthcare professionals about PR use), and additional components designed to increase the effectiveness of the educational component. These interventions may also include the use of technical devices that target risk factors for the use of PR as a supplementary component.

We will include interventions that could fit into more than one of these groups. In these cases, we will categorise the intervention in the category which best fits the aims and theoretical approach described.

How the intervention might work

Interventions from the first group outlined above aim to reduce the perceived need for PR by providing alternative technical devices to manage the main risk factors for PR use. For example, low‐low beds or motion sensors may be offered to help prevent falls or fall‐related injuries. Low‐low beds are used to prevent injuries from bed falls and motion sensors to make nursing staff aware of patients with an increased risk of falling when getting out of bed. These interventions may provide alternative devices usually with instructions about their correct use.

Simple educational interventions mainly address the knowledge of healthcare professionals involved in the decision‐making process on PR use in order to change clinical practice. Education may cover the lack of evidence for the effectiveness of PR (e.g. to prevent falls or unplanned extubation), adverse effects, legal and ethical aspects, alternative strategies of care and use of alternative measures. Alternative strategies focus on a change in care practice regarding PR use, e.g. by avoiding PR, while the use of alternative measures refers to replacing PR with other devices. In the latter case, attitudes of nursing staff (or 'culture' of care) are not addressed.

Multicomponent educational interventions are designed to change the organisational culture towards a least‐restraint policy. The core educational component addresses the attitudes of nurses, physicians and other healthcare professionals who are involved in making decisions and devising 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 organisational 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).

Why it is important to do this review

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 (Heinze 2012; Minnick 2007), and PR use may be associated with negative effects that may hamper recovery and rehabilitation (Mott 2005). 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 general hospital settings. The results of such a review will be highly relevant for clinical practice. Information about effective interventions for preventing and reducing the use of PR in general hospital settings may promote care with less, or even without, PR use, which might increase the quality of care of older people in general hospital settings.

Objectives

  1. To assess the best evidence for the effectiveness and safety of interventions aimed at preventing and reducing the use of PR of older people in general hospital settings.

  2. To describe the content, components and processes of these interventions.

Methods

Criteria for considering studies for this review

Types of studies

We will include all individually randomized or cluster‐randomised controlled trials (RCTs) and other controlled clinical trials (CCTs) investigating the effects of interventions aimed to prevent or reduce the use of PR in general hospital settings. There will be no language restriction.

Types of participants

We will include studies conducted in general hospital settings where the mean age of the study population was at least 65 years. We expect a high prevalence of participants with temporary or permanent cognitive impairment and challenging behaviour, since these are important risk factors for being physically restrained. General hospital settings cover different acute care settings, including rehabilitation clinics. We will exclude emergency departments, intensive care and psychiatric units, since older people are not the main target group for PR use in these settings, and the rationale for and nature of PR use in them differs. We will include psychogeriatric or interdisciplinary wards offering care for people with somatic or psychiatric diagnosis, if they mainly offer acute care. The use of restrictive measures for penal reasons (e.g. prisoners in general medical wards) will not be included in this review.

Types of interventions

Interventions

We will include all non‐pharmacological interventions intended to prevent or reduce the use of PR in general hospital settings. The following different groups of interventions are anticipated:

  1. interventions that provide alternatives to PR use by offering technical devices that target risk factors for the use of PR;

  2. simple educational interventions;

  3. multicomponent educational interventions comprising education and supplemental components (including technical devices that target risk factors for the use of PR, changes to the care environment, and components that target organisational culture).

We will not include interventions that have pharmacological components, i.e. psychotropic medication, since there is no clear definition of chemical restraints and it is often unclear whether medication is used for therapeutic reasons or not.

Comparison

The control intervention may be usual care (no intervention) or optimised usual care. Studies offering alternative interventions as the control will also be included, e.g. educational approaches versus providing alternatives for PR use.

Types of outcome measures

Primary outcomes

  1. Number of patients who were physically restrained at least once, assessed either by direct observation or from the clinical documentation.

  2. Adverse events, e.g. injuries related to PR use.

Secondary outcomes

  1. Total duration of PR use

  2. Challenging behaviour, assessed by e.g. the Cohen‐Mansfield Agitation Inventory (CMAI)

  3. Quality of life

  4. Mobility

  5. Length of stay in hospital

  6. Number of falls or fall‐related injuries

  7. Incidence of pressure ulcers

  8. Use of psychotropic medication

  9. Mortality

  10. Caregiver burden (hospital staff)

  11. Nurses' or relatives' attitudes towards PR use

  12. Costs

Search methods for identification of studies

Electronic searches

We will search ALOIS, the register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG). ALOIS is maintained by the Information Specialist and contains dementia and cognitive improvement studies identified from:

  1. monthly searches of a number of major healthcare databases: MEDLINE, Embase, CINAHL, PsycINFO and LILACS;

  2. monthly searches of a number of trial registers: metaRegister of Controlled Trials; UMIN Clinical Trials Register (Japan);

  3. the World Health Organization (WHO) portal (which covers ClinicalTrials.gov; International Standard Randomised Controlled Trial Number (ISRCTN); Chinese Clinical Trials Register; German Clinical Trials Register; Iranian Registry of Clinical Trials and the Netherlands National Trials Register, and others);

  4. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  5. six‐monthly searches of a number of grey literature sources: ISI Web of Knowledge Conference Proceedings; Index to Theses; and Australasian Digital Theses.

To view a list of all sources searched for ALOIS see About ALOIS (www.medicine.ox.ac.uk/alois) on the ALOIS website.

We will use the following search terms: "physical restraint*", "bedrail*", "siderail*", "cotside*", "belt*", "containment measure*", "acute care", "hospital", and the MeSH terms "Restraint, Physical" and "Hospitals". See Appendix 1 for the MEDLINE search strategy.

Searching other resources

We will check the reference lists of included studies and relevant reviews. Also, we will perform forward citation tracking for all included studies (using google.scholar.de). Additionally, we will contact study authors and experts in the field to identify unpublished and ongoing studies.

Data collection and analysis

Selection of studies

After excluding any duplicates, two review authors will independently examine the titles and abstracts of all citations to identify potentially relevant studies. In a second step, all potentially relevant articles will be screened for inclusion and exclusion. For relevant articles not available in English or German, we will use a language translation service. Disagreement will be resolved by discussion or, if necessary, by consulting a third review author.

Data extraction and management

Independently, two reviewers will group all included studies according to the groups of interventions described (see: Types of interventions). If an intervention can be categorised in different groups, we will categorise it in the group which best fits the aims, theoretical approach and components described. In case of disagreement, a third reviewer will be consulted to reach consensus.

Independently, two authors will extract the data from the included studies using Covidence. We will check extracted data for accuracy and in case of disagreement or discrepancies a third review author will be consulted to reach consensus. The following data will be extracted: study characteristics; methods; characteristics of the participants, interventions, and comparator; outcomes; results, and adverse events. Characteristics of the interventions will be assessed based on the TIDieR criteria or the CReDECI 2‐criteria (Hoffmann 2014; Möhler 2015, respectively).

Assessment of risk of bias in included studies

We will follow the process described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Independently, two authors will assess and rate the methodological quality of included studies in order to identify any potential sources of bias. 'Risk of bias' assessment will address the following domains: sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias. We will determine study validity by categorising individual studies as being at low, high or unclear risk of bias.

Measures of treatment effect

For dichotomous data, we will calculate risk ratios (RR) with 95% confidence intervals (CI).

For continuous outcome data assessed with the same rating scale, we will calculate the mean difference with 95% CI. Where different rating scales are used, we will calculate the standardised mean difference (SMD) (absolute mean difference divided by the standard deviation) with 95% CI.

We will perform statistical analysis using Review Manager 5.3 (RevMan 2014).

Unit of analysis issues

If cluster‐randomised trials are included, we will perform analysis at the level of individual participants (patients) while accounting for cluster effects. If individual‐level data are not available, we will use the direct estimate of effect measure (odds ratio (OR) with CI) from cluster‐randomised controlled trials. If study authors failed to control for clustering effects, we will request individual patient data to calculate an estimate of the intracluster correlation coefficient (ICC). If there are no data available, we will obtain an external estimate of the ICC from similar studies and calculate `effective sample sizes' as described in the Cochrane Handbook for Systematic Reviews of Interventions to approximate analyses of cluster‐randomised trials for meta‐analyses (Higgins 2011). We will perform meta‐analyses using the generic inverse variance method in RevMan 5.3 (RevMan 2014).

If studies with more than one intervention group are included, we will split the sample size for the control group as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

If cross‐over trials are included, we will use only data from the first period (up to the first point of cross‐over) to rule out carry‐over effects.

Dealing with missing data

We will report any missing data and any cases of data imputation we use, as well as any imputation methods used in the primary studies. Where necessary, we will contact the study authors for additional information about missing data. We will use data from intention‐to‐treat analyses if available.

Assessment of heterogeneity

We will assess clinical heterogeneity separately for each group of interventions (see: Types of interventions). For all interventions within one group, we will examine extracted data about study participants, the interventions' components and outcome measurements. Two authors will discuss whether the interventions in one group are sufficiently similar in clinical and methodological characteristics to be included in a meta‐analysis.

To assess statistical heterogeneity, we will calculate the I2 and Chi2 statistics using RevMan 5.3 (RevMan 2014). If no substantial heterogeneity is found (I2 < 50%, P value > 0.05), and a sufficient number of studies are included, we will perform meta‐analyses using a random‐effects model for each group of interventions.

Assessment of reporting biases

We will include all studies in any language to minimise language bias. If there are at least 10 studies included in the meta‐analysis, we will prepare funnel plots to estimate visually small study effects that may reflect reporting bias (Higgins 2011).

Data synthesis

We will assess the quality of the evidence following the GRADE approach by rating the quality of evidence as high, moderate, low or very low (Guyatt 2011). We will perform meta‐analyses only if the included studies are sufficiently clinically homogeneous in terms of participants, interventions and outcomes. Meta‐analyses will be performed using the generic inverse variance method in RevMan 5.3 (RevMan 2014). We expect clinical heterogeneity between studies of all three groups due to variation of the interventions' components or technical devices offered. Therefore, we will use only random‐effects models for meta‐analyses.

Subgroup analysis and investigation of heterogeneity

Depending on the availability of sufficient data, we will conduct subgroup analyses according to the setting, the stage of dementia, or the different components of multicomponent educational interventions. We will also explore possible sources of heterogeneity by repeating analyses after excluding studies with non‐overlapping confidence intervals (`outliers').

Sensitivity analysis

We will use sensitivity analyses to examine the effect of studies at higher risk of bias. In particular, if we have included any CCTs in a meta‐analysis, we will perform a sensitivity analysis including only RCTs.

Presentation of results – 'Summary of findings' tables

We will assess the overall quality of the body of evidence for each outcome using the GRADE approach (Higgins 2011). GRADE defines the quality of evidence as the extent to which one can be confident that an estimate of effect is close to the true quantity of interest. It takes into account risk of bias, imprecision, inconsistency between studies, indirectness of the evidence and publication bias.

We will present the results of the following outcomes in `Summary of findings’ tables: number of participants with at least one episode of PR, adverse events, mortality, challenging behaviour, mobility, quality of life, number of fall‐related injuries. `Summary of findings’ tables offer key information concerning the best estimate of effect of the interventions included and the quantity and the quality of the evidence (Higgins 2011).