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.

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.

Oral health educational interventions for nursing home staff and residents.

BACKGROUND: Associations between nursing home residents' oral health status and quality of life, respiratory tract infections, and nutritional status have been reported. Educational interventions for nurses or residents, or both, focusing on knowledge and skills related to oral health management may have the potential to improve residents' oral health. OBJECTIVES: To assess the effects of oral health educational interventions for nursing home staff or residents, or both, to maintain or improve the oral health of nursing home residents. SEARCH METHODS: We searched the Cochrane Oral Health Trials Register (to 18 January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2015, Issue 12), MEDLINE Ovid (1946 to 18 January 2016), Embase Ovid (1980 to 18 January 2016), CINAHL EBSCO (1937 to 18 January 2016), and Web of Science Conference Proceedings (1990 to 18 January 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 18 January 2016. In addition, we searched reference lists of identified articles and contacted experts in the field. We placed no restrictions on language or date of publication when searching the electronic databases. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs comparing oral health educational programmes for nursing staff or residents, or both with usual care or any other oral healthcare intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently screened articles retrieved from the searches for relevance, extracted data from included studies, assessed risk of bias for each included study, and evaluated the overall quality of the evidence. We retrieved data about the development and evaluation processes of complex interventions on the basis of the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). We contacted authors of relevant studies for additional information. MAIN RESULTS: We included nine RCTs involving 3253 nursing home residents in this review; seven of these trials used cluster randomisation. The mean resident age ranged from 78 to 86 years across studies, and most participants were women (more than 66% in all studies). The proportion of residents with dental protheses ranged from 62% to 87%, and the proportion of edentulous residents ranged from 32% to 90% across studies.Eight studies compared educational interventions with information and practical components versus (optimised) usual care, while the ninth study compared educational interventions with information only versus usual care. All interventions included educational sessions on oral health for nursing staff (five trials) or for both staff and residents (four trials), and used more than one active component. Follow-up of included studies ranged from three months to five years.No study showed overall low risk of bias. Four studies had a high risk of bias, and the other five studies were at unclear risk of bias.None of the trials assessed our predefined primary outcomes 'oral health' and 'oral health-related quality of life'. All trials assessed our third primary outcome, 'dental or denture plaque'. Meta-analyses showed no evidence of a difference between interventions and usual care for dental plaque (mean difference -0.04, 95% confidence interval (CI) -0.26 to 0.17; six trials; 437 participants; low quality evidence) or denture plaque (standardised mean difference -0.60, 95% CI -1.25 to 0.05; five trials; 816 participants; low quality evidence). None of the studies assessed adverse events of the intervention. AUTHORS' CONCLUSIONS: We found insufficient evidence to draw robust conclusions about the effects of oral health educational interventions for nursing home staff and residents. We did not find evidence of meaningful effects of educational interventions on any measure of residents' oral health; however, the quality of the available evidence is low. More adequately powered and high-quality studies using relevant outcome measures are needed.

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.

[Preparedness - decisions in the face of uncertainty. Evaluation of nurses' response readiness in hospital emergency exercises]. / Preparedness - Entscheidungen trotz Unsicherheit. Evaluation der Reaktionsbereitschaft von Pflegepersonal in Krankenhauskrisenübungen.

Events in which the health and life of a large number of people are at stake impose particular challenges to all who are involved in healthcare. An effective response requires prompt decision-making under time pressure, in a context characterised by uncertainty and low routine. The hypothesis is that healthcare staffs' preparedness-related competency increases response quality. An evaluation tool was developed to assess response-relevant competencies of emergency nurses. Competencies relevant to the German healthcare system were systematically defined and operationalised into observable items. Multiple phases of qualitative field studies were employed to develop a conceptual guide to planning and conducting the evaluation. The usability of the evaluation tool was piloted and iteratively optimised. The resulting evaluation approach has the potential to substantiate education and training in the context of curriculum development.

[Development of a decision aid on post mortem organ donation - somewhere between evidence uncertainty, fears, and ethical and moral values]. / Entwicklung einer Entscheidungshilfe "Organspende nach dem Tod" - im Spannungsfeld zwischen Evidenz, Ungewissheit, Ängsten und ethisch-moralischen Wertvorstellungen.

The recently revised German transplantation law provides that people are to be supported to make informed decisions on post-mortem organ donation by implementing broad education campaigns. A comprehensive web-based decision aid "organ donation after death" was developed, evaluated and optimised utilising multiple methodological phases. The decision aid comprises 1) factual information in a question-answer format, 2) tools for the individual assessment of this information, and 3) narratives addressing attitudes and emotional aspects. The website content was compiled by participating experts and potential users of the decision aid. Potential users also participated in the usability evaluation. Version 1.0 was made publicly available on the Internet in April 2012. Currently, version 2.0 of the decision aid is being updated step-by-step, based on the results of the evaluation.

Decision aids for patients.

BACKGROUND: Patients want to be more involved in medical decision-making. To this end, some decision aids are now available. METHODS: We present an overview of this subject, in which we explain the terms "shared decision-making", "decision aid", and "evidence-based patient information" and survey information on the available decision aids in German and other languages on the basis of a literature search in MEDLINE, EMBASE and PsycInfo and a current Cochrane Review. We also searched the Internet for providers of decision aids in Germany. RESULTS: Decision aids exist in the form of brochures, decision tables, videos, and computer programs; they address various topics in the prevention, diagnosis, and treatment of disease. They typically contain information on the advantages and disadvantages of the available options, as well as guidance for personal decision-making. They can be used alone or as a part of structured counseling or patient education. Minimal quality standards include an adequate evidence base, completeness, absence of bias, and intelligibility. Our search revealed 12 randomized controlled trials (RCTs) of decision aids in German and 106 RCTs of decision aids in other languages. These trials studied the outcome of the use of decision aids not just with respect to clinical developments, but also with respect to patient knowledge, adherence to treatment regimens, satisfaction, involvement in decision-making, autonomy preference, and decisional conflicts. CONCLUSION: Only a small fraction of the available decision aids were systematically developed and have been subjected to systematic evaluation. Patients are still not receiving the help in decision-making to which medical ethics entitles them. Structures need to be put in place for the sustainable development, evaluation and implementation of high-quality decision aids.