[Development and evaluation of complex interventions in nursing : Application of the medical research council's framework using the example of interventions to prevent physical restraints]. / Entwicklung und Evaluation komplexer Interventionen in der Pflege : Anwendung des Rahmenmodells des Medical Research Council am Beispiel von Interventionen zur Vermeidung freiheitsentziehender Maßnahmen.

Many nursing interventions are complex. They comprise different intervention elements (components) and aim to change processes or behaviours of individuals or groups. A framework of the British Medical Research Council comprises methodological recommendations for the development and evaluation of complex interventions. This narrative review describes the framework's methodological recommendations using an example of interventions to reduce physical restraints in hospital and long-term care settings, such as bedrails or belts in chairs and beds. In addition to the characteristics of the complex interventions, the development and theoretical foundation of the interventions as well as the feasibility test and evaluation is described.

Family Conferences to Facilitate Deprescribing in Older Outpatients With Frailty and With Polypharmacy: The COFRAIL Cluster Randomized Trial.

Importance: For older adults with frailty syndrome, reducing polypharmacy may have utility as a safety-promoting treatment option. Objective: To investigate the effects of family conferences on medication and clinical outcomes in community-dwelling older adults with frailty receiving polypharmacy. Design, Setting, and Participants: This cluster randomized clinical trial was conducted from April 30, 2019, to June 30, 221, at 110 primary care practices in Germany. The study included community-dwelling adults aged 70 years or older with frailty syndrome, daily use of at least 5 different medications, a life expectancy of at least 6 months, and no moderate or severe dementia. Interventions: General practitioners (GPs) in the intervention group received 3 training sessions on family conferences, a deprescribing guideline, and a toolkit with relevant nonpharmacologic interventions. Three GP-led family conferences for shared decision-making involving the participants and family caregivers and/or nursing services were subsequently held per patient at home over a period of 9 months. Patients in the control group received care as usual. Main Outcomes and Measures: The primary outcome was the number of hospitalizations within 12 months, as assessed by nurses during home visits or telephone interviews. Secondary outcomes included the number of medications, the number of European Union list of the number of potentially inappropriate medication (EU[7]-PIM) for older people, and geriatric assessment parameters. Both per-protocol and intention-to-treat analyses were conducted. Results: The baseline assessment included 521 individuals (356 women [68.3%]; mean [SD] age, 83.5 [6.17] years). The intention-to-treat analysis with 510 patients showed no significant difference in the adjusted mean (SD) number of hospitalizations between the intervention group (0.98 [1.72]) and the control group (0.99 [1.53]). In the per-protocol analysis including 385 individuals, the mean (SD) number of medications decreased from 8.98 (3.56) to 8.11 (3.21) at 6 months and to 8.49 (3.63) at 12 months in the intervention group and from 9.24 (3.44) to 9.32 (3.59) at 6 months and to 9.16 (3.42) at 12 months in the control group, with a statistically significant difference at 6 months in the mixed-effect Poisson regression model (P = .001). After 6 months, the mean (SD) number of EU(7)-PIMs was significantly lower in the intervention group (1.30 [1.05]) than in the control group (1.71 [1.25]; P = .04). There was no significant difference in the mean number of EU(7)-PIMs after 12 months. Conclusions and Relevance: In this cluster randomized clinical trial with older adults taking 5 or more medications, the intervention consisting of GP-led family conferences did not achieve sustainable effects in reducing the number of hospitalizations or the number of medications and EU(7)-PIMs after 12 months. Trial Registration: German Clinical Trials Register: DRKS00015055.

Prevention of physical restraints in the acute care setting (PROTECT): study protocol for a cluster-randomised controlled pilot study.

INTRODUCTION: Physical restraints (PR) are regularly used in acute care settings, although evidence for their effectiveness and safety (eg, for prevention of falls) is lacking. Their use is associated with adverse events, such as decreased mobility and injuries for patients. We developed a complex intervention to prevent PR in acute care settings according to the UK Medical Research Council Framework, and investigated the feasibility. The intervention comprised the qualification of key nurses as multipliers and a short interprofessional information session. The intervention has proven to be feasible. It also became apparent that further development of the intervention and the study procedures is necessary. Therefore, this study aims to refine and pilot the complex intervention. Furthermore, the objective of this pilot study is to improve study procedures. METHODS AND ANALYSIS: In a preparatory phase, we will conduct focus groups and individual interviews with the target groups to explore the possibilities for adaption of the intervention and implementation strategies. Subsequently, a cluster-randomised controlled trial with a 6-month follow-up period will be conducted. It is planned to recruit eight general hospitals in Germany (area of Halle (Saale) and Leipzig) with 28 wards and 924 patients per observation period (2772 overall). Primary outcome is the proportion of patients with at least one PR after 6 months. Data will be collected by direct observation over a period of seven consecutive days and three times a day. Secondary outcomes are falls, interruptions in therapy and prescription of psychotropic medication. A comprehensive process evaluation will accompany the study. ETHICS AND DISSEMINATION: The Ethics committee of the Medical Faculty of the University of Halle (Saale) approved the study protocol. Results will be published in a peer-reviewed journal and presented at conferences. Study information and additional material will be freely available on an already existing website. TRIAL REGISTRATION NUMBER: DRKS00027989.

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

BACKGROUND: Physical restraints, such as bedrails, belts in chairs or beds, and fixed tables, are commonly used for older people in general hospital settings. Reasons given for using physical restraints are to prevent falls and fall-related injuries, to control challenging behavior (such as agitation or wandering), and to ensure the delivery of medical treatments. Clear evidence of their effectiveness is lacking, and potential harms are recognised, including injuries associated with the use of physical restraints and a negative impact on people's well-being. There are widespread recommendations that their use should be reduced or eliminated. OBJECTIVES: To assess the best evidence for the effects and safety of interventions aimed at preventing and reducing the use of physical restraint of older people in general hospital settings. To describe the content, components and processes of these interventions. SEARCH METHODS: We searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register the International Clinical Trials Registry Portal on 20 April 2022. SELECTION CRITERIA: We included randomised controlled trials and controlled clinical trials that investigated the effects of interventions that aimed to prevent or reduce the use of physical restraints in general hospital settings. Eligible settings were acute care and rehabilitation wards. We excluded emergency departments, intensive care and psychiatric units, as well as the use of restrictive measures for penal reasons (e.g. prisoners in general medical wards). We included studies with a mean age of study participants of at least 65 years. Control groups received usual care or active control interventions that were ineligible for inclusion as experimental interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the articles for inclusion, extracted data, and assessed the risk of bias of all included studies. Data were unsuitable for meta-analysis, and we reported results narratively. We used GRADE methods to describe our certainty in the results. MAIN RESULTS: We included four studies: two randomised controlled trials (one individually-randomised, parallel-group trial and one clustered, stepped-wedge trial) and two controlled clinical trials (both with a clustered design). One study was conducted in general medical wards in Canada and three studies were conducted in rehabilitation hospitals in Hong Kong. A total of 1709 participants were included in three studies; in the fourth study the number of participants was not reported. The mean age ranged from 67 years to 84 years. The duration of follow-up covered the period of patients' hospitalisation in one study (21 days average length of stay) and ranged from 4 to 11 months in the other studies. The definition of physical restraints differed slightly, and one study did not include bedrails. Three studies investigated organisational interventions aimed at implementing a least-restraint policy to reduce physical restraints. The theoretical approach of the interventions and the content of the educational components was comparable across studies. The fourth study investigated the use of pressure sensors for participants with an increased falls risk, which gave an alarm if the participant left the bed or chair. Control groups in all studies received usual care. Three studies were at high risk of selection bias and risk of detection bias was unclear in all studies. Because of very low-certainty evidence, we are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on our primary efficacy outcome: the use of physical restraints in general hospital settings. One study found an increase in the number of participants with at least one physical restraint in the intervention and control groups, one study found a small reduction in both groups, and in the third study (the stepped-wedge study), the number of participants with at least one physical restraint decreased in all clusters after implementation of the intervention but no detailed information was reported. For the use of bed or chair pressure sensor alarms for people with an increased fall risk, we found moderate-certainty evidence of little to no effect of the intervention on the number of participants with at least one physical restraint compared with usual care. None of the studies systematically assessed adverse events related to use of physical restraint use, e.g. direct injuries, or reported such events. We are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on the number of participants with at least one fall (very low-certainty evidence), and there was no evidence that organisational interventions or the use of bed or chair pressure sensor alarms for people with an increased fall risk reduce the number of falls (low-certainty evidence from one study each). None of the studies reported fall-related injuries. We found low-certainty evidence that organisational interventions may result in little to no difference in functioning (including mobility), and moderate-certainty evidence that the use of bed or chair pressure sensor alarms has little to no effect on mobility. We are uncertain about the effect of organisational interventions on the use of psychotropic medication; one study found no difference in the prescription of psychotropic medication. We are uncertain about the effect of organisational interventions on nurses' attitudes and knowledge about the use of physical restraints (very low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain whether organisational interventions aimed at implementing a least-restraint policy can reduce physical restraints in general hospital settings. The use of pressure sensor alarms in beds or chairs for people with an increased fall risk has probably little to no effect on the use of physical restraints. Because of the small number of studies and the study limitations, the results should be interpreted with caution. Further research on effective strategies to implement a least-restraint policy and to overcome barriers to physical restraint reduction in general hospital settings is needed.

Health policy analysis on barriers and facilitators for better oral health in German care homes: a qualitative study.

OBJECTIVES: To assess possible health policy interventions derived from the theoretical domains framework (TDF) by studying barriers and facilitators on the delivery of oral healthcare and oral hygiene in German care homes using a behavioural change framework. DESIGN: Qualitative correlational study to evaluate a national intervention programme. SETTING: Primary healthcare in two care homes in rural Germany. PARTICIPANTS: Eleven stakeholders participating in the delivery of oral healthcare (hygiene, treatment) to older people, including two care home managers, four section managers, two nurses/carers and three dentists. INTERVENTIONS: Semistructured interviews conducted in person in the care homes or by phone. A questionnaire developed along the domains of the TDF and the Capabilities, Opportunities and Motivations influencing Behaviours model was used to guide the interviews. Interviews were transcribed and systematised using Mayring's content analysis along the TDF. RESULTS: 860 statements were collected. We identified 19 barriers, facilitators and conflicting themes related to capabilities, 34 to opportunities and 24 to motivation. The lack of access to professional dental care was confirmed by all stakeholders as a major limitation hampering better oral health. PRIMARY OUTCOME: A range of interventions can be discussed with the methodology we utilised. In our interviews, lack of dentists willing to treat patients at these facilities was the most discussed barrier for improving oral health of nursing home residents. SECONDARY OUTCOMES: Dentists highlighted the need for better incentives and facilities to deliver oral healthcare in these institutions. Differences with urban settings regarding access to healthcare were frequently discussed by our study participants. CONCLUSIONS: Within our sample, greater capacitation of care home staff, better financial incentives for dentists and increased cooperation between the two stakeholders should be considered when designing interventions to tackle oral health of care home residents in Germany.

[Development and feasibility of an intervention to reduce physical restraints in hospitals: A mixed methods study]. / Entwicklung und Machbarkeit einer Intervention zur Vermeidung freiheitsentziehender Maßnahmen im Krankenhaus.

Development and feasibility of an intervention to reduce physical restraints in hospitals: A mixed methods study Abstract. Background: Physical restraints (PR) are regularly used in people with dementia or delirium in general hospital settings. There is no clear evidence for the effectiveness of PR, but their use is associated with an increased risk for harm. Therefore, a restraint-free care is recommended. Aim: Development and feasibility test of an intervention to reduce PR in general hospital settings. Methods: Systematic literature reviews and theory-guided modelling of an intervention involving relevant clinical stakeholders and mixed methods study in two wards of a university hospital (geriatric traumatology and neurology). Results: The complex intervention comprises the following components: qualification of multipliers, interprofessional education about PR reduction, regular audit and feedback meetings, and the support regarding the aim of the intervention from nursing and medical leaders. The results of the feasibility test indicate that the intervention is feasible and helpful, but the interprofessional approach was not implemented as planned. An important barrier hampering PR reduction was the high workload. The results on the prevalence of PR could not be interpreted due to a very low number of measures applied. Conclusion: The complex intervention with a multiplier approach for preventing PR use was judged as feasible, but there is a need for further development to strengthen interprofessional cooperation. The feasibility of the intervention should also be tested in other departments.

Process evaluation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A mixed methods study.

AIMS: To describe the implementation process and fidelity of two versions of a guideline-based, multicomponent intervention to reduce physical restraints in nursing homes and to identify factors that might explain the heterogeneity of effects between different clusters. DESIGN: Mixed methods evaluation of the implementation process (dose delivered, dose received, response, and adaption) alongside a pragmatic three-arm cluster randomized controlled trial. METHODS: Quantitative and qualitative process data were collected during the study period (February 2015-February 2017). Quantitative data from questionnaires and short surveys were analysed by descriptive statistics. Qualitative data from focus groups and semi-structured interviews were analysed using content analysis. An in-depth analysis was conducted by contrasting responding and non-responding clusters regarding the intervention goal and primary outcome. RESULTS: Both interventions were implemented as planned in all clusters: we found no deviations from the protocol regarding the dose delivered to and received by the clusters. Satisfaction of staff targeted by the interventions was high. The in-depth analysis did not reveal any pronounced variation in the degree of implementation or adoption in clusters with a good or nearly no response to the interventions or factors explaining different study effects. CONCLUSION: Although both versions of a guideline-based multicomponent intervention to prevent physical restraints in nursing homes were implemented as planned and the response was generally acceptable, the interventions' goal to change nursing practice towards a least-restraint policy was not achieved by the entire nursing staff in all of the clusters. No factors could be identified that might explain the different effects of the interventions. IMPACT: For some nursing homes, different approaches than addressing nurses' attitudes and institutional policies might be needed to sustainably reduce the use of physical restraints; however, the process evaluation did not reveal characteristics that might have hampered or facilitated the effectiveness of the intervention.

Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial.

INTRODUCTION: Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor. We will develop an evidence-based catalogue of interventions ('Oral Health Toolbox') and provide care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA). We hypothesise that such intervention will significantly improve OHrQL, daily oral hygiene/care behaviour and is cost-effective. METHODS AND ANALYSIS: A scoping review will be used to identify possible intervention components. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German LRC. The result will be the 'Oral Health Toolbox', a two-phased instrument supporting both initial intervention allocation to improve oral health/hygiene and reinstruction/remotivation. A two-arm clustered, randomised controlled trial (ratio of 1:1 via block randomisation) will be performed in LRC in Rhineland-Palatinate, Germany. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, we aim at recruiting 618 residents in 18 clusters. In the intervention group, dentists will assign one or more intervention component from the box (phase 1). During follow-up, nursing staff will be reinstructed and remotivated by DA, who use the box to decide how to maintain the intervention (phase 2). In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the General Oral Health Assessment Index. Secondary outcomes include pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For our primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial. ETHICS AND DISSEMINATION: Ethical approval by the University of Kiel was granted (D480/18). TRIAL REGISTRATION NUMBER: NCT04140929.

Interventions to improve oral health of older people: A scoping review.

OBJECTIVES: A range of interventions have been tested to improve oral health of older people. We performed a scoping review to map interventions' aims, outcome measures and findings, and to locate them on different levels of care. DATA: We systematically screened for (1) controlled studies on (2) people over 65 years of age, (3) comparing at least two interventions to improve oral health. Interventions were summarized according to their aims and the employed intervention type, mapped on their level of action, and classified as primary/secondary/tertiary prevention. SOURCES: Studies retrieved via MEDLINE, EMBASE, CINAHL. STUDY SELECTION: Eighty-one studies (published 1997-2019, conducted mainly in high-income countries) were included. Sample sizes varied (n = 24-1987). Follow-up was 0.25-60 months. Most studies (64/81) found a statistically significant benefit of the intervention. A total of 13 different aims were identified, and a range of intervention types employed (e.g. educational interventions, professional oral healthcare, restorative treatment, fluoride application and, generally, dentifrices, mouthwashes, chewing gums/food supplements). Most studies were located on the carer/patient level (56/81 studies) or the system/policy-maker level (44/81). The majority of studies aimed for primary prevention (64/81). CONCLUSIONS: Oral health improvement interventions are widely studied. However, study aims, methods and outcome measures are highly heterogeneous, which limits the ability for robust conclusions. Current research focusses on primary prevention on the level of patients/carers or system/policy-maker level. Future studies may want to consider interventions on dentists' level focussing on secondary prevention. These studies should rely on a core set of comprehensive, standardized set of outcome measures. CLINICAL SIGNIFICANCE: While specific interventions seem efficacious to improve older people's oral health, the current body of evidence is neither comprehensive (significant gaps exists in relevant levels of the care process) nor comparable enough to draw robust conclusions.

Interventions to reduce physical restraints in general hospital settings: A scoping review of components and characteristics.

AIMS AND OBJECTIVES: To describe the characteristics of interventions for reducing physical restraints in general hospital settings. BACKGROUND: Physical restraints, such as bedrails and belts in beds and chairs, are commonly used in general hospital settings. However, there is no clear evidence on their effectiveness but some evidence on potential risks for harm. DESIGN: Scoping review. METHODS: We conducted a systematic database search (MEDLINE via PubMed, CINAHL, Cochrane Library; March 2020) and snowballing techniques. We included both interventional studies and quality improvement projects conducted in general hospital settings and published in English or German language. Two reviewers independently performed the study selection and data extraction. The Scoping Reviews (PRISMA-ScR) Checklist was used. RESULTS: We included 31 articles (published between 1989 and 2018), 15 quality improvement projects and 16 intervention studies. Only five studies used a controlled design. Most studies and quality improvement projects investigated multicomponent interventions including education (predominantly for nursing staff) and additional components (e.g. case conferences). Three studies examined simple educational programmes without additional components. CONCLUSIONS: A large number of multicomponent interventions for preventing and reducing physical restraints in general hospital settings have been developed. The interventions differed widely regarding the components, contents and settings. Well-designed evaluation studies investigating the effects of such interventions are lacking. RELEVANCE TO CLINICAL PRACTICE: Multicomponent educational interventions might be one approach to change clinical practice, but only insufficient information is available about potential effects of these approaches.

[Database indexing of health science journals from the German-speaking area: A journal analysis]. / Datenbankindexierung von gesundheitswissenschaftlichen Fachzeitschriften aus dem deutschsprachigen Raum: eine Zeitschriftenanalyse.

BACKGROUND: Journal hand searching offers the possibility to complement a literature search as part of systematic reviews and other evidence syntheses. Hand searching is indicated in cases where scientific journals with potentially relevant publications addressing the research question are not indexed in a literature database. However, it is often unclear whether these journals are actually indexed, and when they are, in which literature databases. In many cases, it is also unknown which journals should be searched by hand in addition to systematic literature search after databases to be searched have been specified. Therefore, the project aimed to investigate the indexation of selected scientific health science journals and to provide an overview of indexation in order to facilitate the hand search planning process. METHODS: Journals from German-speaking countries covering eight professional fields (medical laboratory assistance, occupational therapy, midwifery, logopedics, nursing, physiotherapy, public health and rehabilitation) were considered that publish original research papers or systematic reviews or other review types in German and/or English. Two researchers per field identified relevant journals and independently analyzed the indexing locations using the journal websites. In case of missing information, we contacted the editors. RESULTS: A total of 70 journals were included: from 1 to 17 journals per field. These journals are indexed in 1 to 29 databases. Twelve journals are not indexed or do not offer information concerning indexation. Indexation is distributed across n=74 different literature databases. Most journals are indexed in LIVIVO (n=55) and bibnet.org (n=33). Other common indexing databases are Scopus (n=18), Web of Science Core Collection (n=16), PSYNDEX (n=13), and Embase (n=10). CONCLUSIONS: The results indicate a heterogeneous indexation of the included journals. Only a small number is indexed in common international literature databases such as MEDLINE or CINAHL. On the other hand, only a few journals are not indexed in any database. The results can be used as a basis to define databases for literature searches as part of systematic reviews. In addition, the findings might guide the selection of journals for hand searching after literature databases have been defined.

Family conferences and shared prioritisation to improve patient safety in the frail elderly (COFRAIL): study protocol of a cluster randomised intervention trial in primary care.

BACKGROUND: Frailty in elderly patients is associated with an increased risk of poor health outcomes, including falls, delirium, malnutrition, hospitalisation, and mortality. Because polypharmacy is recognised as a possible major contributor to the pathogenesis of geriatric frailty, reducing inappropriate medication exposure is supposed to be a promising approach to improve health-related quality of life and prevent adverse outcomes. A major challenge for the process of deprescribing of inappropriate polypharmacy is to improve the communication between general practitioner (GPs), patient and family carer. This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home. METHODS: This is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70 years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing guideline and providing information on how to conduct a family conference focussing on prioritisation of treatment goals concerning drug therapy. During the 1-year intervention, GPs are expected to perform a total of three family conferences, each including a structured medication review with patients and their family carers. GPs of the control group will receive no training and will deliver care as usual. Geriatric assessment of all patients will be performed by study nurses during home visits at baseline and after 6 and 12 months. The primary outcome is the hospitalisation rate during the observation period of 12 months. Secondary outcomes are number and appropriateness of medications, mobility, weakness, cognition, depressive disorder, health-related quality of life, activities of daily living, weight, and costs of health care use. DISCUSSION: This study will provide evidence for a pragmatic co-operative and patient-centred educational intervention using family conferences to improve patient safety in frail elderly patients with polypharmacy. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00015055 (WHO International Clinical Trials Registry Platform [ICTRP]). Registered on 6 February 2019.

Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial.

BACKGROUND: Despite clear evidence for the lack of effectiveness and safety, physical restraints are frequently applied in nursing homes. Multicomponent interventions addressing nurses' attitudes and organizational culture have been effective in reducing physical restraints. OBJECTIVE: To evaluate the effectiveness of two versions of a guideline and theory-based multicomponent intervention to reduce physical restraints in nursing homes. DESIGN: Pragmatic cluster randomized controlled trial. SETTING: The study was conducted in 120 nursing homes in four regions in Germany. PARTICIPANTS: All residents living in the participating nursing home during follow-up, newly admitted residents were also included. A total of 12,245 residents included in the primary analysis (4126 and 3547 residents in intervention group 1 and 2 and 4572 residents in the control group). METHODS: Intervention group 1 received an updated version of a successfully tested guideline-based multicomponent intervention (comprising brief education for the nursing staff, intensive training of nominated key nurses in each cluster, introduction of a least-restraint policy and supportive material), intervention group 2 received a concise version of the original program and the control group received optimized usual care (i.e. supportive materials only). Primary outcome was physical restraint prevalence at twelve months, assessed through direct observation by blinded investigators. Intervention and control groups were compared using baseline-adjusted linear regression on cluster level, Bonferroni-adjusted for double testing. Secondary outcomes included falls, fall-related fractures, and quality of life. We also described intervention costs and performed a comprehensive process analysis. RESULTS: At baseline, mean physical restraint prevalence was 17.4% and 19.6% in intervention groups 1 and 2, and 18.8% in the control group. After twelve months, mean prevalence was 14.6%, 15.7%, and 17.6%. Baseline-adjusted differences between mean prevalences were 2.0% (97.5% CI, -5.8 to 1.9) lower in intervention group 1 and 2.5% (97.5% CI, -6.4 to 1.4) lower in intervention group 2 compared to controls. Physical restraint prevalence showed a pronounced variation between the different clusters in all study groups. We found no significant differences in the secondary outcomes. According to the process evaluation, the intervention was mainly implemented as planned, but the expected change towards a least restraint culture of care was not achieved in all clusters. CONCLUSIONS: Neither intervention showed a clear advantage compared to control. The pronounced center variation in physical restraint prevalence indicates that other approaches like governmental policies are needed to sustainably change physical restraint practice and reduce center variations in nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02341898.

[Physical restraints from the perspective of advocates of nursing home residents - a qualitative Study]. / Freiheitseinschränkung aus Sicht der Interessenvertretungen von Pflegeheimbewohnerinnen und -bewohnern − eine qualitative Studie.

Physical restraints from the perspective of advocates of nursing home residents - a qualitative Study Abstract. Background: Physical restraints are commonly used in nursing homes despite clear evidence of the lack of effectiveness and a high risk of negative consequences. Beside nurses, other persons acting as advocates of nursing home residents like relatives, legal guardians and members of the resident council, could also influence the use of physical restraints. OBJECTIVE: To describe the perceptions and attitudes of advocates of nursing home residents regarding the use and reduction of physical restraints. METHODS: Four semi-structured interviews and four focus groups with a total of 22 participants (five relatives, one legal guardian, 16 members of resident councils) were conducted for the process evaluation of a pragmatic cluster-randomised controlled trial and analysed through qualitative content analysis. RESULTS: Five categories regarding physical restraints were identified: 1. Use in nursing home setting; 2. Evaluation of use and reduction; 3. Information on use and reduction; 4. Decision about use and reduction; 5. Effects of use and reduction. Overall, the three groups of advocates describe physical restraints as necessary to prevent falls and to control challenging behaviour and have little knowledge regarding alternatives. CONCLUSIONS: Relatives, legal guardians and members of the nursing home resident council showed uncritical attitudes and a lack of knowledge towards physical restraints. Addressing these groups through information and education in interventions aiming to avoid physical restraints in nursing homes could be supportive.

Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial.

BACKGROUND: Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomised controlled trial, the efficacy and safety of a guideline-based multicomponent intervention programme has been proven. The present study aims to evaluate the effectiveness of two different versions of the original intervention in nursing home residents in four different regions throughout Germany. METHODS/DESIGN: The study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care. The first intervention group receives an educational programme for all nurses, additional training and structured support for nominated key nurses, printed study material and other supportive material. In the second intervention group, nurses do not receive education as part of the intervention, but may be trained by nominated key nurses who have received a short train-the-trainer module. All other components are similar to the first intervention group. The control group receives the printed study material only. Overall, 120 nursing homes including approximately 10,800 residents will be recruited and randomly assigned to one of the three groups. The primary outcome is defined as the proportion of residents with at least one physical restraint after 12 months follow-up. The use of physical restraints will be assessed by direct observation. Secondary outcomes are the residents' quality of life and safety parameters, e.g. falls and fall-related fractures. In addition, comprehensive process and economic evaluations will be performed. CONCLUSIONS: We expect a clinically relevant reduction in the proportion of residents with physical restraints. It is also expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02341898.