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Enhancing palliative care in intensive care units: protocol of EPIC, a controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase

Por: Mentzelopoulos · S. D. · Hartog · C. S. · Tenge · T. · Schwenkglenks · M. · Piper · S. K. · Barbier · M. · Rusinova · K. · Neukirchen · M. · Schüürhuis · S. · Jensen · H. I. · van Heerden · V. · Dutzmann · J. · Drescher · D. · Zvara · M. · Metaxa · V. · Nachshon · A. · De Robertis
Introduction

Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.

Methods and analysis

This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.

The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.

Ethics and dissemination

EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.

Trial registration number

NCT06605079.

Nursing Literature Mapping in Neurodegenerative Diseases: A Scoping Review

ABSTRACT

Aim

To explore the topics and themes covered in published research studies in nursing about neurodegenerative disease, synthesise the available evidence, and discuss future directions.

Design

Scoping review following the Joanna Briggs Institute guidelines.

Methods

A multi-step search strategy was applied across different databases to identify studies published in English or Italian up to September 2023. Data were analysed using a Nursing Data Matrix based on the nursing meta-paradigm and the Child Health and Nutrition Research Initiative (CHNRI) 4D-framework. Screening and data extraction were performed independently by pairs of reviewers; data were extracted and thematically analysed to identify existing research questions and potential priorities.

Data Sources

Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, and Embase databases were searched for studies published from 2013 to 2023.

Results

A total of 351 studies met inclusion criteria. The majority of studies originated from the United States (35%). Parkinson's disease and Alzheimer's disease were the most studied conditions, while rare diseases were scarcely represented. Most studies focused on nursing care (39%), with limited attention to rehabilitation (0.8%) and cost-effectiveness (1%). Although 70% of articles included at least one nurse author, 22% lacked any nursing authorship despite addressing nursing-related topics. Thematic and matrix analyses revealed an uneven distribution of research, with a predominance of descriptive studies and limited work in discovery-oriented research.

Conclusion

This review provides a comprehensive overview of nursing research in neurodegenerative diseases, highlighting key themes and gaps. The findings informed the preliminary identification of new nursing research priorities in neurodegenerative diseases to guide future studies and enhance evidence-based nursing care.

Implications for the Profession and/or Patient Care

The study highlights key trends and gaps in nursing research on neurodegenerative diseases, calling for a more inclusive, equitable, and comprehensive research agenda.

Reporting Method

PRISMA-ScR guidelines.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct or reporting.

Trial and Protocol Registration

Review registration was done on Open Science Framework, and can be viewed at https://osf.io/tn5v9 (https://doi.org/10.17605/OSF.IO/TN5V9)

Topical medications for moderate-to-severe rosacea: protocol for a living systematic review and network meta-analysis

Por: Amstutz · A. V. · Fladger · A. · Sanchez-Feliciano · A. · Barbieri · J. S.
Introduction

Rosacea is a chronic skin condition characterised by papules, pustules, transient erythema (flushing), persistent erythema, telangiectasia and phymatous changes. Rosacea can be associated with substantial effects on quality of life. Rosacea is most commonly treated with topical therapy, but little is known about the relative efficacy of these treatment options.

Since most randomised controlled trials of topical rosacea therapies do not include active comparators (ie, head-to-head comparisons), indirect comparisons must be made to understand the relative efficacy, safety and tolerability of these treatment options. The aim of this study is to conduct a living network meta-analysis evaluating topical therapies for moderate to severe rosacea. The results of this study can guide clinical decision-making and improve patient outcomes.

Methods and analysis

Data search will be conducted in the Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Web of Science and Embase. Screening of titles, abstracts and full papers, as well as data extraction, will be conducted by two independent researchers in duplicate. Primary outcomes will include mean change in absolute lesion count, Investigator Global Assessment (IGA) and treatment discontinuation for adverse events or side effects. Secondary outcomes will include percentage change in lesion count, changes in quality of life, Patient Global Assessment, Clinician Erythema Assessment (CEA) and change in rosacea facial redness. For each outcome with enough qualified data, a network meta-analysis using a random-effects model will be carried out. We plan for a living review with continuous updating of the analysis as new treatments become available.

Ethics and dissemination

Dissemination in a peer-reviewed scientific journal is planned.

PROSPERO registration number

CRD420251103231.

Interventions to Prevent Patient‐ and Visitor‐Perpetrated Violence Against Nurses in the Emergency Department: A Scoping Review

ABSTRACT

Aim

To identify interventions and strategies to prevent patient- and visitor-perpetrated violence against nurses working in acute hospital Emergency Departments. Design Scoping review following the Joanna Briggs Institute guidelines.

Methods

A comprehensive literature search was conducted in PubMed and CINAHL to identify relevant studies published up to June 2024. The review included primary research studies employing quantitative, qualitative, and mixed-method approaches. Eligibility criteria focused on interventions aimed at preventing physical and verbal violence in acute hospital emergency settings, explicitly targeting nurses. The selection process followed PRISMA-ScR guidelines, with independent screening and data extraction by two reviewer pairs. Data Sources PubMed and CINAHL databases were searched for studies published up to June 2024.

Results

A total of 40 studies were included, covering interventions across 11 countries, mostly from the United States. Interventions were categorised as organisational, environmental, or individual-focused. Training programs were the most common strategy, followed by risk assessment tools, defense strategies, multidisciplinary briefings, and technology-assisted interventions. Most interventions (73%) were implemented before violent incidents, 23% during, and 5% after. Healthcare workers, particularly nurses, were the primary target group, highlighting the need for effective preventive strategies.

Conclusion

Violence prevention interventions in Emergency Departments focus on pre-incident strategies, mainly organisational and individual-focused. Limited attention has been given to environmental interventions despite their role in mitigating workplace violence. Further research is needed to assess the long-term effectiveness of these strategies.

Implications for the Profession and/or Patient Care

Addressing workplace violence in EDs ensures a safer work environment, improves staff retention, and enhances patient care quality.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct, or reporting.

Care accessibility and reasons for non-urgent emergency department visits in South Tyrol (Italy): protocol of the multicentre cross-sectional CARES study

Por: Ausserhofer · D. · Zaboli · A. · Mahlknecht · A. · Plagg · B. · Barbieri · V. · Marino · P. · Piccoliori · G. · Engl · A. · Wiedermann · C. J.
Introduction

Emergency departments (EDs) suffer from crowding due to patients with low urgency whose treatment is often inappropriate in many cases. Crowding in the ED may indicate inefficiencies in the primary care infrastructure. According to the literature, it is associated with individual and system-related factors, such as younger age, convenience of visiting the ED and a negative perception of care outside the hospital. However, patients’ motives driving decision-making for non-urgent visits to the ED in this post-pandemic period require further exploration. Therefore, this study aims to describe the proportion of potentially avoidable, non-urgent ED visits and to explore the associations between socio-demographic and clinical characteristics, patients’ motives, and potentially avoidable, non-urgent visits to the ED.

Methods and analysis

This multicentre cross-sectional study will be conducted in the ED of seven public hospitals in the South Tyrolean Health Service in the northern Italian Province of Bolzano-Bozen. A consecutive sample of 1000 adult patients (≥18 years) with clinical conditions that are triaged as ‘non-urgent’ (ie, Manchester Triage System priority level ‘blue’ or ‘green’) and consent to participate in the study will be included. Data will be collected in each ED over two full working weeks (24 hours, weekdays and weekends) between 1 September 2024 and 30 November 2024. For each patient, triage nurses and medical doctors will fill out a data collection sheet, including the triage code, diagnosis at discharge and avoidability of the ED visit. Patients will be surveyed using a structured questionnaire with standardised instruments (eg, the Patient Activation Measure and Mental Health Inventory) and self-developed items (eg, motives for ED visits and previous use of community care services). Data analysis will involve descriptive and inferential analyses (ie, 2 tests) to determine group differences. Multivariate multilevel modelling will be applied to explore the associations between individual, system and cultural factors and potentially avoidable, non-urgent visits.

Ethics and dissemination

Ethical approval for this study was obtained from the Medical Ethics Committee of the South Tyrolean Health Service (Nr. 41-2024). The results will be published in relevant scientific journals and communicated to the public and relevant institutions through dissemination activities, including press releases and stakeholder meetings. The findings will inform recommendations aimed at refining health policies and optimising access to primary and emergency care services.

Registration details

ISRCTN registry (ISRCTN17355506).

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