Reducing Physical Restraints By Older Adults In Home Care .

Scheepmans et al. BMC Geriatrics(2020) 20:169home care? (4) What ethical and legal framework cansupport healthcare providers in decisions about the useof physical restraint in home care? (5) How can healthcare workers reduce physical restraint use in home care?(6) What steps and persons need to be involved in thedecision-making process regarding and application ofphysical restraints in home care? The first five questionsaim to increase awareness and knowledge of the problem of restraint use in home care. These insights andknowledge are required to understand the flowchart andhow to deal with complex situations where the use of restraints is considered, requested or already present(question 6).The research team recruited a multidisciplinary working group (n 7) comprising home nurses (n 2), domestic aides (n 2), a general practitioner (n 1) andrepresentatives of patients and informal caregivers (n 2). Members were selected to match the expertise of theresearch team (n 4), consisting of persons with expertise in home care (n 2); physical restraints, delirium,and falls (n 1); and the ethics of care (n 1). Inaddition, 2 lawyers and an ethicist were consulted to explain the legal and ethical frameworks for restraint usein home care.Stage 2: Literature searchThe availability of existing national and internationalguidelines on physical restraint use in home care was determined by conducting a literature search. Because ofthe absence of available guidelines in this setting, thesearch was expanded to include research involving residential settings. Publications were considered if they metthe following criteria: (1) reporting on older persons, restraint use, chronic care and (practice) guidelines and(2) written in English, French or Dutch. Guidelines onrestraint use related to children; schools; psychiatry; seclusion; acute, emergency or intensive care; or dentistrywere excluded. Five databases (i.e., PubMed, Embase,Psych Info, Cinahl and Invert) and online (inter)nationalguideline databases (including New Zealand GuidelinesGroups, National Clearinghouse, Guideline Finder UK,SIGN [Scottish Intercollegiate Guidelines Network],NICE [National Institute for Health and Care Excellence], World Health Organization [WHO] guidelines,Canadian Medical Association InfoBase Clinical PracticeGuidelines, Haut Autorité de Santé, Agency for Healthcare Research and Quality, KCE [Federaal kenniscentrum voor Gezondheidszorg], Domus Medica and‘Société Scientifique de Médecine Générale’) weresearched from March 2013. Five guidelines [23–28] werefound and assessed using AGREE II (Table 1). Based onthe AGREE II results, two of them were retained [23,28]. A third guideline [24] scored almost equally well onthe quality assessment as the clinical guideline of MilisenPage 3 of 14et al. [28]. Because the content of the RCN guidelinewas based mainly on legislation in the UK, which wasnot the primary focus of the study and not applicable tothe Belgian context, we excluded this guideline.Next, a literature search (July 2015) focused on theaforementioned six predetermined clinical practice questions. For each question, the literature search consistedof two phases. First, the articles were checked for relevance to the topic of home care, and articles of any design written in English, Dutch or French were eligiblefor inclusion. Second, this review was supplemented by asearch of review articles related to the residential settingpublished in the last 5 years, with the same language criteria as for home care.PubMed and Cinahl were the databases consulted forboth searches. For only the first clinical question in thehome care setting, an additional database (i.e., Embase)was consulted. To construct the search string, medicalsubject headings were combined with free search termsusing Boolean operators (AND / OR). The same groupsof search terms (i.e., restraints and aged) were used forboth searches and combined with search terms in function of the subject of the clinical question and setting.The search string of the home care setting was completed with variations on the term ‘home care’. For theresidential setting, combinations of key words for reviewwere added (see Additional file 1: overview of all searchstrategies per clinical question (home care and residential setting)).One author (KS) conducted the guideline and literature search, removed duplicate publications and madefirst selection of articles based on titles and abstracts.The methodological quality of the articles was assessedby two authors (KS, LP). Differences between theirscores were discussed within the research team.Various tools were used to assess the quality of the articles according to the study design: VAKS (Danish acronym for Appraisal of Qualitative Studies) [29], MINORS(Methodological Index for Non-Randomized Studies) [30]and AMSTAR (Assessing the Methodological Quality ofSystematic Reviews) [31]. Table 2 gives an overview of theretained articles and the quality assessment by clinicalquestion and setting. Using the snowball method, reference lists were checked, which resulted in the inclusion ofthree additional articles [14, 39, 40]. Four articles [14, 39,41, 42] and one chapter from the book of Gastmans andVanlaere [43] contained important background information drawing upon expert opinion while not reporting primary research. As a consequence, there was no qualityassessment for those items.Stage 3: Development of the practice guidelineThe literature search confirmed that no guidelines specific to restraint use in home care and that research on

Scheepmans et al. BMC Geriatrics(2020) 20:169Page 4 of 14Table 1 Quality appraisal of existing guidelines according to Agree IIJBI, 2002 (Pt1 & 2) [25,26]Irish NursesOrganisation,2003 [27]Anaes, 2000 [23]Royal College ofNursing, 2008[24]Milisen et al.,2006 [28]Domain 1: Scope and Purpose1. The overall objective(s) of the guideline is (are)specifically described.577772. The health question(s) covered by the guidelineis (are) specifically described.426543. The population (patients, public, etc.) to whomthe guideline is meant to apply is n 2: Stakeholder Involvement4. The guideline development group includesindividuals from all the relevant professionalgroups.426665. The views and preferences of the targetpopulation (patients, public, etc.) have been sought.214336. The target users of the guideline are clearlydefined.24554871514137. Systematic methods were used to search forevidence.115118. The criteria for selecting the evidence are clearlydescribed.111119. The strengths and limitations of the body ofevidence are clearly described.1121110. The methods for formulating therecommendations are clearly described.1111111. The health benefits, side effects and risks havebeen considered in formulating therecommendations.3222212. There is an explicit link between therecommendations and the supporting evidence.2353313. The guideline has been externally reviewed byexperts prior to its publication.5163214. A procedure for updating the guideline isprovided.11111Subtotal151123131215. The recommendations are specific andunambiguous.6665716. The different options for management of thecondition or health issue are clearly presented.4334417. Key recommendations are easily identifiable.5335618. The guideline describes facilitators and barriersto its main 3: MethodologyDomain 4: Clarity of PresentationDomain 5: Applicability19. The guideline provides advice and/or tools onhow the recommendations can be put intopractice.

Scheepmans et al. BMC Geriatrics(2020) 20:169Page 5 of 14Table 1 Quality appraisal of existing guidelines according to Agree II (Continued)JBI, 2002 (Pt1 & 2) [25,26]Irish NursesOrganisation,2003 [27]Anaes, 2000 [23]Royal College ofNursing, 2008[24]Milisen et al.,2006 [28]20. The potential resource implications of applyingthe recommendations have been considered.1111121. The guideline presents monitoring and/ orauditing criteria.11111Subtotal5785622. The views of the funding body have notinfluenced the content of the guideline.3111123. Competing interests of guideline developmentgroup members have been recorded andaddressed.21111Subtotal52222- Rate the overall quality of this guideline: 1 (lowest 3possible quality) – 7 (highest possible quality)4545 Implemen-tationschedule ( )Overview by behaviourand scores ofalternativesLegislation of UK( )Examples forclarification ( )Employersinvolved ( )Ethical aspects( )Belgiancontextflowchart52806869Domain 6: Editorial IndependenceOverall guideline assessment- I would recommend this guideline for useYesYes, with modifications NoNotesTotal61The quality appraisal according to Agree II consists of 23 items divided over 6 domains. Each item is rated on a 7-point scale ranging from strongly disagree (1) tostrongly agree (7). The assessment is based on the total score of the 23 items and whether the user wants to recommend the guideline for use. Because there isnot a set of minimum scores to judge the quality, the decision is made by the user and the context in which AGREE II is used [22]restraint use in home care settings was scarce. For thisreason, the multidisciplinary working group used a consensus procedure to develop the practice guideline [32,44]. Our consensus method existed of different steps.First, once the clinical practice questions were decidedby the working group, one member of the research teamprepared the responses to the different questions basedon the literature search. Second, the content was firstdiscussed by the entire research team. Third, theadapted version was presented to and discussed with themultidisciplinary working group. Special attention wasgiven to translate the residential setting literature to thehome care setting. Feedback was used by the membersof the research team to refine the content. The adaptedtext was then again discussed with the multidisciplinaryworking group. This process was repeated until consensus was reached.The development of the practice guideline resultedin ten recommendations in response to the six clinical practice questions and a flowchart to support thedecision-making process when the use of physical restraints is requested or considered. To indicate thequality of evidence and strength of the recommendations, we used the methodology based on GRADE(Grading of Recommendations Assessment, Development and Evaluation system), which was required bythe validation committee [34].A preliminary version of the guideline was read by theorganizations to which the members of the multidisciplinary working group belonged. They checked whether thecontent of the guideline was applicable to theirorganization. The guideline was revised based on the experience of and feedback from these organizations. Furthermore, the revised version of the guideline wasdiscussed with the multidisciplinary working group usingclinical cases. Based on this feedback, a penultimate versionwas developed by the research team and presented to anddiscussed with a group of clinical practitioners (i.e., nurses,occupational therapists, general practitioners, and physiotherapists). The text was again adapted one last time.

Scheepmans et al. BMC Geriatrics(2020) 20:169Page 6 of 14Table 2 Overview of articles by clinical question, setting and quality AddressedQuality appraisalAMSTARaVAKSbMINORScBeerens et al., 2014 [2]HCSurvey110/10de Veer et al., 2009 [13]HCSurvey19/10Evans and FitzGerald, 2002 [40]ResReview26/10Evans and Cotter, 2008 [39]HCPaper5, 6NANANAEvans et al., 2003 [46]ResReview34.5/10Gastmans and Milisen, 2006 [14]ResPaper1,2, 4–6NANANAGastmans and Vanlaere, 2005 [43]ResBook2–4NANANAGoethals et al., 2012 [15]ResReview2–46/10Goethals et al., 2013 [35]ResQualitative study4Hamers and Huizing, 2005 [41]HC, ResPaper1–3NANA14.6NANANAHellwig, 2000 [42]HCPaper1, 3, 5, 6NAHofmann and Hahn, 2014 [12]ResReview1–36/10Köpke et al., 2012 [51]ResRCT5, 610/10Kurata and Ojima, 2014 [48]HCSurvey19/10Lane and Harrington, 2011 [49]ResReview15/10Möhler et al., 2012 [52]Res, HCReview1, 5, 67/107/10Möhler et al., 2014 [19]ResReview1, 3, 4Scheepmans et al., 2014 [10]HCQualitative study115NA not applicable, HC home care, Res residentialaShea et al., 2007. AMSTAR is a validated instrument and consists of 11 items with 4 answer possibilities [31]bThe assessment tool VAKS consists of 30 questions related to 5 criteria (i.e. formal requirements, credibility, transferability, dependability and confirmability).Based on the total score an article is ‘recommended’ ( 15), ‘recommended with reservations’ ( 10 15) or ‘not recommended’ ( 10) [29]cThe MINORS consists of 12 items, the first 8 items are for non-comparable studies. The scores for the individual items can be 0 (not reported), 1 (reported butinadequate) or 2 (reported and adequate) [30]Stage 4: Validation of the practice guidelineThe resultant practice guideline was presented to theBelgian Centre for Evidence-Based Medicine (CEBAM)for validation. The aim of this independent validationwas to guarantee the methodological quality of theguideline. A validation committee was formed consisting of one methodological expert, one content expert, achair (president of CEBAM and a general practitioner)and three experienced clinicians representing the disciplines for which the guideline was developed (onehome care nurse, one occupational therapist, and onegeneral practitioner). The validators assessed the guideline using the AGREE II instrument [22], and they discussed the criteria for which the validators haddivergent scores. Next, the validation committee cameto a final judgement, for which there were three possible final decisions: the guideline is validated as such,possibly with minor comments (1); the guideline is validated, provided that the authors meet the major comments (2); or the guideline cannot be validated in itscurrent state (3). Next, the validation committee discussed all their remarks with the researchers (KS, KM).The most important comments related to the focus ofthe guideline (application rather than prevention of restraints in home care), some aspects of the method(more specification requested) and the recommendations (clear delimitations of the key recommendations).The commission decided that the guideline could bevalidated provided that the major comments were addressed. The guideline was again revised by the research team in response to the comments of thevalidation commission and finally approved in itscurrent form by CEBAM on 15 December 2015.ResultsThe current article provides only a summary of the results. The full guideline has been published in book format [33] and a summary of the guideline is available onthe website www.fixatiearmethuiszorg.be. The practiceguideline answers six clinical questions, makes 10 recommendations (Table 3), and is accompanied by aflowchart that illustrates the steps to be taken and thepersons to involve in the decision-making process forthe application of physical restraints in home care(sixth question).

Scheepmans et al. BMC Geriatrics(2020) 20:169Page 7 of 14Table 3 Overview of the six clinical questions, ten recommendations, quality of the evidence and strength of the recommendationsaccording to GRADEClinical Practice QuestionNo. RecommendationsGRADE1. What is meant by physical restraint use in home care?1.A definition of physical restraint should be used in home care. Thefollowing definition is suggested: as ‘Physical restraint is any device,material or equipment, attached to or near a person’s body and whichcannot be controlled or easily removed by the person and which (is)deliberately (intended to) prevent(s) a person’s free body movement toa position of choice and\or a person’s normal access to their body’(Retsas, 1998). (e.g. bedrails, bed-against-the-wall (positioned in a waythat the person will not fall out of bed), locked room or house doors,deep chair that prevents rising and restrictive clotting and belts).1C2.Healthcare providers should be aware that the application of anymeasure that limits free movement of the patient, regardless of itspurpose, is a form of restraints.1C3.Healthcare providers should take the complex set of risk factors intoaccount that affect the probability of physical restraint use in homecare:1B2. What factors affect the probability of physical restraint use in homecare?- personal (e.g., poor mobility) and contextual factors- knowledge and attitudes of healthcare providers- culture of home care organisation- legislation3. What are the consequences and the impact of physical restraint usein home care?4. What ethical and legal framework can support healthcare providersin decisions about the use of physical restraint in home care?4.The use of physical restraints should be avoided as much as possibledue to the negative physical and psychosocial consequences for thepatient.1A5.Healthcare providers should be aware of the negative impact ofphysical restraints on the informal caregiver and should pay attentionto support them.1C6.Healthcare organizations should be aware of the impact of usingphysical restraints on the involved healthcare providers.1B7.Consider carefully the different values, norms and reasons in thecontext of humane care.1C8.Physical restraints may only be used as a last resort and exception. Aclear reporting of the careful decision-making process in the patientrecord is necessary.1** No strength of evidence because it is based on legal texts5. How can healthcare workers reduce physical restraint use in homecare?9.Healthcare providers should reduce restraint use in home care. Thefollowing elements should be considered:1B1. Gain insight into personal and contextual factors: thoroughassessment2, Collaborate with interdisciplinary team (including patient andfamily) and take personal responsibility.3. Communicatie proactively and transparently with all involvedpersons.4. Develop a care plan with the involved persons (formal andinformal caregivers) to determine the aims and preventive actions.6. What steps and persons need to be involved in the decision-making 10.process regarding and the application of physical restraints in homecare? (see flowchart Fig. 1)A successful decision-making process to reduce physical restraints inhome care should consists of the following components:1C- carefully and consciously dealing with situations where means ofphysical restraints are considered, requested or already used;- taking the preferences of the patient into account;- involving the patient and the family and all other involvedhealthcare providers from the beginning of the process.Physical restraint is a last resort and should only be used after firstconsidering alternatives, over a short period of time, with carefulsupervision and with materials that are in proportion to the patient’sbehaviour.GRADE: The strength of the recommendation is based on the GRADE methodology expressed in a number (1 strong; 2 weak). The quality of theevidence is classified into high (A), moderate (B) or low (C) (Van Royen et al., 2008 [34])

Scheepmans et al. BMC Geriatrics(2020) 20:169What is meant by physical restraint use in home care?Given the absence of a clear consensus on the definitionof physical restraints when the guideline was developed,the definition of Retsas (1998) [45] was used [recommendation 1]. This comprehensive definition is widelyused in the residential setting and seems to be useful forhome care. The use of psychoactive drug, electronicsupervision or prescribed orthopaedic devices that arepart of a treatment process are not considered physicalrestraints. Examples of physical restraints in home careare bedrails, bed-against-the-wall (positioned in a waythat the person will not fall out of bed), locked room orhouse doors, deep chair that prevents rising, and restrictive clothing and belts [3].What factors affect the probability of physical restraintsbeing used in home care?Physical restraints were often considered by nurses and informal caregivers to be safety measures [10]. For this reason, the second recommendation of the guidelineemphasized that healthcare providers must be aware thatthe application of any measure that limits the free movement of the patient – regardless of its purpose – is a formof restraint because of the possible negative impact of itsuse and the lived experience of the patient (see question 3)[recommendation 2]. A combination of factors

A multicomponent intervention to support healthcare workers in implementing the guideline in clinical practice needs to be developed. Keywords: Evidence based, Home care, Physical restraints, Practice guideline, Reduction, Nurses, Nursing . The practice guideline was developed according to the framework of the Belgian Centre for Evidence-Based