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Design and rationale of the EFFORTII project: a multicentric randomised-controlled trial on the impact of continued nutritional therapy at hospital discharge

Por: Wunderle · C. · Tribolet · P. · Kaegi-Braun · N. · Haller · V. · Escher · R. · Aujesky · D. · Trennepohl Da Costa Heinen · G. · Brändle · M. · Bregenzer · T. · Henzen · C. · Zehnder · T. · Schait · S. · Gassmann · C. · Dorfschmid · M. · Ballesteros-Pomar · M. D. · Cuerda · C. · Burgo
Introduction

Malnutrition is a highly prevalent chronic condition that contributes to higher morbidity and mortality in patients with multiple comorbidities. While positive effects of nutritional therapy in the in-hospital setting have recently been demonstrated, the benefits of long-term nutritional therapy after hospital discharge remain uncertain. Herein, we outline the design and rationale of the EFFORTII trial, the largest nutritional trial to date to assess the effects of continued nutritional support after hospital discharge in medical patients, with particular attention to key design decisions regarding nutritional strategy, patient selection criteria and study endpoints.

Methods and analysis

The Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery (EFFORTII) is an investigator-initiated, non-commercial randomised controlled trial designed to evaluate whether ongoing, individualised nutritional therapy after hospital discharge—targeted to meet specific energy and protein requirements—offers a cost-effective approach to lowering mortality, minimising complications and maintaining functional status compared with standard care. Eligible participants are adult, chronically ill medical inpatients at risk of malnutrition. Patients in the intervention group receive individualised nutritional therapy delivered by an experienced dietitian through a combination of telemedicine and in-person consultations. The intervention aims to meet personalised nutritional targets, supported by a trained dietitian. Control group patients receive nutritional counselling at discharge, but no structured nutritional management during follow-up. We designed the trial as an event-driven trial with a target of 247 mortality events (primary endpoint), which will be assessed over approximately 5 years until event-driven endpoint is met. The minimum total sample size is at least 802 participants, based on the assumed treatment HR of 0.70. The main trial is enrolling patients across multiple sites in Switzerland. During the trial, additional sites in Spain joined the study, and their data will be analysed using a patient-level pooled approach.

Ethics and dissemination

This study involves human participants and was first granted ethical approval by the Ethics Committee Northwest- and Central Switzerland and then by all participating local ethics committees. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.

Trial registration number

NCT04926597.

Strategies to Position the Clinical Academic Nurse in University, Teaching and General Hospitals

ABSTRACT

Aim

Explore the perspectives of Clinical Academic Nurses and stakeholders on strategies for positioning Clinical Academic Nurses in Dutch hospitals.

Design

A descriptive qualitative study.

Methods

Semi-structured interviews and focus groups were conducted with Clinical Academic Nurses and stakeholders from five hospitals involved in the positioning of Clinical Academic Nurses. Data was analysed using thematic analysis to identify strategies for positioning these nurses.

Results

Four themes emerged: (1) ‘Supportive vision and culture’ is crucial for a shared vision and enables a culture for consistent support in the positioning, (2) A clear defined and strategic ‘Position of Clinical Academic Nurses’ is needed for uniform positioning, (3) ‘Research infrastructure’ describes the important supportive elements, and (4) ‘Leadership’ describes Clinical Academic Nurses' pioneering role in aligning research with organisational goals which strengthens their position.

Conclusion

Positioning Clinical Academic Nurses in hospitals requires a vision, well-defined positions, a research infrastructure, and leadership support. Long-term strategic investments are needed to integrate research into clinical nursing practice and recognise Clinical Academic Nurses as strategic assets.

Implications for Policy and Practice

Positioning Clinical Academic Nurses requires visionary leadership, institutional commitment and investment in research infrastructure. The Nurse Advisory Board should support this by aligning positioning, support and evaluation with strategic policies. Strategic hospital-academic partnerships foster research, education, mentorship and grant support. Clinical Academic Nurses should set measurable goals, proactively align research with clinical priorities and increase visibility to advance nursing practice.

Impact

This study identifies empirically grounded insights into strategies to position Clinical Academic Nurses and offers actionable insights for management, policymakers and Clinical Academic Nurses to strengthen knowledge infrastructure and improve patient care.

Reporting Method

COREQ.

Patient or Public Contribution

Limited patient and public involvement, focusing on feedback on preliminary results.

Determinants and implementation strategies to implement a reflection method for guideline-based informal caregiving in community nursing in the Netherlands: a mixed-method study

Por: Vullings · N. · Maas · M. · Adriaansen · M. · Vermeulen · H. · Van der Wees · P. · Heinen · M.
Aim

This study aims to identify key determinants and strategies for effectively implementing a reflection method to support adequate use of the ‘Informal Care’ guideline within community nursing. The SPARK (Self & Peer Assessment to Reflect on Quality Standards) reflection method, developed in an earlier participatory design-based study, is a structured group reflection approach designed to help nurses and nursing assistants reflect on and apply guideline recommendations in daily practice.

Design

A mixed method study.

Setting

Six community care organisations in the Netherlands.

Participants and interventions

This mixed-method study collected qualitative data through observations and video recordings of group meetings with community nurses, nursing assistants and a patient representative, alongside quantitative questionnaires. This project included design and test group meetings to develop and evaluate prototypes of the reflection method. Observations were discussed, and video recordings were thematically analysed. The Measurement Instrument for Determinants of Innovations questionnaire was used to identify key determinants for effective implementation. The questionnaire results were analysed descriptively, using the Tailored Implementation in Chronic Diseases (TICD) framework to present preliminary determinants for validation. Implementation strategies were then selected in a group meeting. Based on this input, the research group operationalised the selected implementation strategies.

Results

Twenty-nine determinants for implementing the reflection method were identified across seven TICD domains, including barriers such as limited support, knowledge and time, and facilitators such as team collaboration and prevention of caregiver overload. Based on these findings, three implementation strategies, namely knowledge enhancement, coaching development and leadership strengthening, were formulated to support integration into community nursing practice.

Conclusion

This study identified key determinants and strategies for implementing a reflection method in community nursing. While several determinants align with existing literature, context-specific determinants related to the heterogeneous group of registered nurses and certified nursing assistants also emerged. Strengthening guideline knowledge, coaching competencies and leadership is essential for sustainable, guideline-based reflection in practice.

Developing and testing a reflection method for implementation of the informal care guideline in community nursing: Design‐based research

Abstract

Aim

To develop a reflection method for community nurses and certified nursing assistants to support the implementation of the Dutch Informal Care guideline in daily care.

Design

Design-based research.

Methods

A design group and four test groups of community nurses and nursing assistants were formed to develop a reflection method that aligns with the needs and preferences of its end-users. The design and test group meetings were video recorded. The video data were iteratively discussed and analysed thematically to adapt and refine the method and to identify its key features.

Results

A final reflection method was developed. Five main themes were identified from the analysis: the group, reflective triggers, knowledge about the guidelines, the coach and preconditions. The themes are linked to nine key features representing the building blocks of the reflection method. The key features are group size, participants with different (educational) backgrounds, pairs of participants, expressing thoughts, video feedback, reflection game, making the connection with the guideline, coaching as a process facilitator and meeting organizational and contextual conditions for implementation.

Conclusion

An evidence- and practice-based reflection method for community nurses and certified nursing assistants is developed to support the implementation. By involving community nurses and certified nursing assistants, the method closely matches their needs and preferences. Critical elements of the reflection method are a game element, video feedback and working in pairs in a group of participants from different (educational) backgrounds. Guidance is needed to make the transfer from theory to practice.

Impact

A reflection method for community nurses and certified nursing assistants was developed to enhance care work according to guideline recommendations, aiming to improve the care provided by informal caregivers.

Report Method

The COREQ guideline was used.

Patient or Public Contribution

This reflection method was developed in close collaboration with all stakeholders during the entire study.

Developing and Testing a Reflection Method for Implementation of a Professional Reporting Guideline in Community Nursing: Design‐Based Research

ABSTRACT

Aim

To develop a reflection method for community nurses and certified nursing assistants to support the implementation of a professional reporting guideline for nurses and certified nursing assistants in daily care and to identify its key features.

Design

Design-based research.

Methods

This study was conducted in the Netherlands from February 2021 to April 2022. The reflection method was developed by a design group (community nurses, certified nursing assistants and a patient representative) and four test groups of nurses. Experiences of participants were explored with video recordings and observational notes from test group meetings. The data were thematically analysed to refine the reflection method and identify key features.

Results

A final reflection method was developed. We identified three main themes: (1) Impact on behaviour change, (2) group learning and (3) conditional factors for critical reflection. Seven key features emerged as essential, forming the building blocks of the reflection method: focus on critical reflection, allocate time to formulate themes, include participants from various backgrounds and organisations, ensure the group is appropriately sized, allow for sufficient time, keep it simple and attractive and stimulate the group to make the transfer of learning to their clinical practice.

Conclusions

The final method included two 2 h meetings with up to six participants and a coach. Participants learned from critical reflection and feedback to improve the reporting quality and critical assessment of daily practices, especially from colleagues with varying team affiliations and educational backgrounds.

Impact

This reflection method enables community nurses and certified nursing assistants to learn collaboratively, aligning with the ‘Nursing and Caring Reporting’ guideline and bridging the gap between research and clinical practice.

Report Method

The COREQ guideline was used.

Patient or Public Contribution

The study design facilitated close collaboration among researchers, community nurses, certified nursing assistants and clients.

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