Expanded nursing roles to promote person-centred care for people with cognitive impairment in acute care (ENROLE-acute): study protocol for a controlled clinical trial, process and economic evaluation.

BACKGROUND: For people with cognitive impairment, hospitalisation is challenging and associated with adverse events as well as negative outcomes resulting in a prolonged hospital stay. Person-centred care can improve the quality of care and the experience of people with cognitive impairment during hospitalisation. However, current care processes in German hospitals are rarely person-centred. To enable successful implementation of person-centred care on hospital wards, change agents within the interprofessional team are key. The aim of this study is to test the feasibility and initial effects of a newly developed complex person-centred care intervention for people with cognitive impairment provided by expanded practice nurses in acute care. METHODS: We will conduct an exploratory non-randomised controlled clinical trial with accompanying process and cost evaluation with three intervention and three control wards at one university hospital. The person-centred care intervention consists of 14 components reflecting the activities of expanded practice nurses within the interprofessional team on the intervention wards. The intervention will be implemented over a six-month period and compared with optimised care on the control wards. We will include people aged 65 years and older with existing cognitive impairment and/or at risk of delirium. The estimated sample size is 720 participants. The primary outcome is length of hospital stay. Secondary outcomes include prevalence of delirium, prevalence of agitation, sleep quality, and person-centred care. We will collect patient level data at six time points (t1 admission, t2 day 3, t3 day 7, t4 day 14, t5 discharge, t6 30 days after discharge). For secondary outcomes at staff level, we will collect data before and after the intervention period. The process evaluation will examine degree and quality of implementation, mechanisms of change, and the context of the complex intervention. The economic evaluation will focus on costs from the hospital's perspective. DISCUSSION: The ENROLE-acute study will provide insights into the effectiveness and underlying processes of a person-centred care intervention for people with cognitive impairment provided by expanded practice nurses on acute hospitals wards. Results may contribute to intervention refinement and evidence-based decision making. TRIAL REGISTRATION: Current controlled trials: ISRCTN81391868. Date of registration: 12/06/2023. URL: https://doi.org/10.1186/ISRCTN81391868.

Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1).

INTRODUCTION: Multiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1-2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS. METHODS AND ANALYSIS: A web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03968172); Pre-results.

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)-study protocol for a randomised controlled trial.

INTRODUCTION: Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. METHODS: The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. DISCUSSION: We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients' relapse management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04233970 . Registered on 18 January 2020.

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.

BACKGROUND: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. METHODS: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. DISCUSSION: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

Reducing waste in evaluation studies on fall risk assessment tools for older people.

OBJECTIVES: To critically appraise the recognition of methodological challenges in evaluation studies on assessment tools and nurses' clinical judgment on fall risk in older people and suggest how to reduce respective research waste. STUDY DESIGN AND SETTING: Opinion article and narrative review covering systematic reviews on studies assessing diagnostic accuracy and impact of assessment tools and/or nurses' clinical judgment. RESULTS: Eighteen reviews published in the last 15 years were analyzed. Only one reflects potentially important factors threatening the accuracy of assessments using delayed verification with fall events as reference after a certain period of time, that is, natural course, preventive measures, and treatment paradox where accurate assessment leads to prevention of falls, that is, influencing the reference standard and falsely indicating low diagnostic accuracy. In addition, only one review mentions randomized controlled trials as appropriate study design for the investigation of the impact of fall risk assessment tools on patient-important outcomes. Until now, only one randomized controlled trial dealing with this question has been performed showing no effect on falls and injuries. Instead of investigating the diagnostic accuracy of fall assessment tools, the focus of future research should be on the effectiveness of the implementation of fall assessment tools at reducing falls and injuries.

[Deliberations of the expert advisory council on innovation fund applications]. / Überlegungen des Expertenbeirats zu Anträgen im Rahmen des Innovationsfonds.

The "Innovation Fund" provides incentives for the development and testing of healthcare innovations in the area of the statutory health insurance with the aim to improve the quality of care in Germany. Over a period of initially four years (2016-19), 300 million Euro will be allocated annually to projects on "innovative forms of healthcare provision" and "health services research". Using a formalized procedure, the ten-member expert advisory board appointed by the German Federal Ministry of Health (BMG) assess all applications on the basis of various criteria for scientific quality, potential of innovation, relevance for health service delivery, and implementability. The present discussion paper sets out important considerations for submission and assessment and puts them up for discussion. (As supplied by the authors).

Managing the transition (ManTra): a resource for persons with secondary progressive multiple sclerosis and their health professionals: protocol for a mixed-methods study in Italy.

INTRODUCTION: 15 years after clinical onset, about 50% of patients with relapsing-remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS). Notwithstanding the importance of this transition, knowledge of the experiences and needs of patients and carers is fragmentary, and targeted interventions are not available. Managing the Transition to SPMS (ManTra) is a mixed methodology project to develop and test a user-led resource for newly diagnosed patients with SPMS. Here, we describe the developmental phase, consisting of a literature review and a new research study involving key stakeholders, in which we construct the resource. METHODS AND ANALYSIS: Round 1: The literature review and study will be conducted in parallel. The latter will identify patient needs using a qualitative approach consisting of: personal semistructured interviews with >15 recently diagnosed patients with SPMS; three focus group meetings (one with significant others of patients, one with neurologists and one with other health professionals caring for patients with SPMS). An online survey (>200 recently diagnosed Italian patients with SPMS) will follow to verify needs in a larger independent sample. An expert panel will outline a set of candidate resources/interventions that aim to satisfy the needs thus identified. Round 2: Consensus on the final resource will be obtained in a 1-day meeting of recently diagnosed patients with SPMS, significant others, health professionals and other stakeholders, using the nominal group technique. The expert panel will refine the resource, identify the outcome measures to assess its efficacy and ascertain the most suitable comparator (ManTra Phase 2, not part of this protocol). ETHICS AND DISSEMINATION: The study protocol was approved by the ethics committees of each of the involved centres: Foundation IRCCS Neurological Institute C Besta, Milan ; G D'Annunzio University of Chieti-Pescara and the Aldo Moro University of Bari. The results will be published in peer-reviewed journals, presented at conferences and a lay summary sent to participants.

Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients.

BACKGROUND: Natalizumab (NAT) is associated with the risk of progressive multifocal leukoencephalopathy (PML). Risk stratification algorithms have been developed, however, without detectable reduction of PML incidence. OBJECTIVE: To evaluate to which extent patients and physicians understand and accept risks associated with NAT treatment. METHODS: Prospective observational cohort study in German MS centers (n=73) among NAT-treated MS patients (n=801) and their neurologists (n=99). Patients included in this study had mean disease duration of 10.2years and a mean NAT treatment duration of 24months. RESULTS: More than 90% of patients and physicians voted for shared decision making or an informed choice decision making approach. Patients and physicians perceived a similar threat from MS as serious disease and both overestimated treatment benefits from NAT based on trial data. Men perceived MS more severe than women and perception of seriousness increased with age in both groups and in patients as well with increasing disability. Although patients evaluated their PML risk higher, their risk acceptance was significantly higher than of their neurologists. Risk stratification knowledge was good among neurologists and significantly lower among patients. CONCLUSION: While patients and physicians seem to have realistic risk perception of PML and knowledge of risk stratification concepts, the threat of MS and the perception of treatment benefits may explain the ongoing high acceptance of PML risk.

Systematic literature review on effectiveness of self-management support interventions in patients with chronic conditions and low socio-economic status.

AIM: To assess the quality of evidence and determine the effect of patient-related and economic outcomes of self-management support interventions in chronically ill patients with a low socio-economic status. BACKGROUND: Integrated evidence on self-management support interventions in chronically ill people with low socio-economic status is lacking. DESIGN: Systematic literature review. DATA SOURCES: Cochrane database of trials, PubMed, CINAHL, Web of Science, PsycINFO and Joanna Briggs Institute Library were searched (2000-2013). Randomized controlled trials addressing self-management support interventions for patients with cardiovascular disease, stroke, cancer, diabetes and/or chronic respiratory disease were included. REVIEW METHODS: Data extraction and quality assessment were performed by independent researchers using a data extraction form. RESULTS: Studies (n = 27) focused mainly on diabetes. Fourteen studies cited an underlying theoretical basis. Most frequently used self-management support components were lifestyle advice, information provision and symptom management. Problem-solving and goal-setting strategies were frequently integrated. Eleven studies adapted interventions to the needs of patients with a low socio-economic status. No differences were found for interventions developed based on health behaviour theoretical models. CONCLUSION: Limited evidence was found for self-management support interventions in chronically ill patients with low socio-economic status. Essential characteristics and component(s) of effective self-management support interventions for these patients could not be detected. Rigorous reporting on development and underlying theories in the intervention is recommended.

[Nursing and industry relations: literature review and conflicts of interest survey]. / Pflege und Industriekontakte: Eine Literaturübersicht und eine Befragung zu Interessenkonflikten.

BACKGROUND: Advanced competencies and tasks of nurses go along with an increasing interest of pharmaceutical companies and manufacturers in nurses as a marketing target. OBJECTIVE: To identify nurses' attitudes, perceptions and behavior regarding industry and marketing strategies. METHODS: 1) Systematic literature search in Medline via PubMed and CINAHL for international studies on nurses' conflict of interests towards pharmaceutical companies; 2) analysis of a survey with PhD students from two Nursing Science doctoral programs. RESULTS: The review including 16 publications published between 1999 and 2014 and the survey among 82 PhD students revealed comparable results. The majority of nurses already had contact with pharmaceutical companies. Nurses are often uncritical in their attitudes, and suggestibility is claimed to be low. The majority of nurses were not - or at least not sufficiently - provided with conflict of interest training, neither as part of their vocational training nor their continuing education. CONCLUSION: Conflict of interest seems to be an important topic for nurses. Increasing relevance in the future underpins the need for making nurses more sensitive towards this issue, especially through professional training programs.

Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.

BACKGROUND: The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions. METHODS/DESIGN: The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study. DISCUSSION: To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02295462.

[Conflict of interest with industry--a survey of nurses in the field of wound care in Germany, Australia and Switzerland]. / Interessenkonflikte mit der Industrie--eine Befragung von Pflegenden im Bereich der Wundversorgung in Deutschland, Österreich und der Schweiz.

BACKGROUND: Nurses in the field of wound care are increasingly being courted by the wound industry. OBJECTIVES: A survey regarding nurses' perceptions and participation in pharmaceutical marketing was conducted. METHODS: Based on existing instruments, a standardized questionnaire (39 items, 5-point Likert scale) was developed. It was sent electronically and by mail to all nursing members of the Austrian Society for Vascular Care (ÖGvP), the German Wound Healing Society (DGfW e. V.) and the Swiss Association for Wound Care (SAfW). RESULTS: 178 nurses participated in the survey (75 % women; aged 27 - 70 years [median 45], 0 - 40 years [median 9] practice in the area of the wound care). Only about one fourth of the respondents (23,0 %) did not participate in pharmaceutical marketing last year. Generally small gifts were more frequently received than expensive gifts. Most of the nurses valued inexpensive gifts, educational gifts and gifts with patient benefit as appropriate. The majority of respondents consider themselves as less influenceable in decision making, compared to physicians. CONCLUSIONS: The behavior and attitude of nurses are ambivalent. The occurrence of conflict of interest is partly justified by perceived patient benefit. Lack of knowledge about the topic and social desirability could be the cause of an uncritical attitude. For a more critical approach education and ethical standards are necessary.

Comparison of a fall risk assessment tool with nurses' judgement alone: a cluster-randomised controlled trial.

BACKGROUND: the impact of fall risk assessment tools on clinical endpoints is unknown. OBJECTIVE: we compared a standardised fall risk assessment tool alongside nurses' clinical judgement with nurses' judgement alone. DESIGN: a 12-month cluster-randomised controlled trial. SETTING: nursing homes in Hamburg (29 per study group). SUBJECTS: 1,125 residents (n = 574 intervention group, IG; n = 551 control group, CG). INTERVENTIONS: all homes received structured information on fall prevention before randomisation. The IG monthly administered the Downton Index, and the CG did not use a tool. Measurements were number of participants with at least one fall, falls, fall-related injuries and medical attention, fall preventive measures, physical restraints. RESULTS: the mean follow-up was 10.8 +/- 2.9 months in both groups: 105 (IG) and 114 (CG) residents died or moved away. There was no difference between the groups concerning the number of residents with at least one fall (IG: 52%, CG: 53%, mean difference -0.7, 95% confidence interval -10.3 to 8.9, P = 0.88) and the number of falls (n = 1,016 and n = 1,014). All other outcomes were also comparable between the IG and CG. CONCLUSIONS: application of a fall risk assessment tool in nursing homes does not result in the better clinical outcome than reliance on nurses' clinical judgement alone.

The Tinetti test: Babylon in geriatric assessment.

The Tinetti test has been recommended and widely used in the elderly to assess mobility, balance and gait, and predict falls. Different versions can be found. A systematic literature search identified 37 publications on the Tinetti test and falls. Wide variations were found concerning name of the instrument, test items, scoring, and cut-off values. This heterogeneity interferes with evaluations of the test's validity, reliability and generalisability. Researcher and clinicians should be aware of this fact, when dealing with the Tinetti test.

Predicting the risk of falling--efficacy of a risk assessment tool compared to nurses' judgement: a cluster-randomised controlled trial [ISRCTN37794278].

BACKGROUND: Older people living in nursing homes are at high risk of falling because of their general frailty and multiple pathologies. Prediction of falls might lead to an efficient allocation of preventive measures. Although several tools to assess the risk of falling have been developed, their impact on clinically relevant endpoints has never been investigated. The present study will evaluate the clinical efficacy and consequences of different fall risk assessment strategies. STUDY DESIGN: Cluster-randomised controlled trial with nursing home clusters randomised either to the use of a standard fall risk assessment tool alongside nurses' clinical judgement or to nurses' clinical judgement alone. Standard care of all clusters will be optimised by structured education on best evidence strategies to prevent falls and fall related injuries. 54 nursing home clusters including 1,080 residents will be recruited. Residents must be > or = 70 years, not bedridden, and living in the nursing home for more than three months. The primary endpoint is the number of participants with at least one fall at 12 months. Secondary outcome measures are the number of falls, clinical consequences including side effects of the two risk assessment strategies. Other measures are fall related injuries, hospital admissions and consultations with a physician, and costs.