Self-assessment Tool for Implementing the ESCNH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Please note that this is an observational study; not applicable.
- Who it may be relevant to
- Registry conditions: Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health, Testing of the Developed Self-assessment Tool in European Hospitals, Self-Assessment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hospital Self-assessment Tool for the Implementation of the European Standards of Care for Newborn Health (ESCNH)
Overview
This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability.
Detailed description
This project aims to develop a uniformly applicable self-assessment tool in different languages with the overall goal to support care providers across Europe to measure the level of implementation of the ESCNH, to pinpoint possible inhibitors, and ultimately to increase the extent of implementation. Covering the great variety of standards in one hands-on and easy-to-use self-assessment tool requires prioritising the most important components. This has to be approached in a systematic and scientific manner. For this purpose, a two-round electronic (e) Delphi survey will be conducted followed by an expert workshop. The aim of the two-stage eDelphi process is to lay a solid ground for the self-assessment tool. Prior to the eDelphi rounds, members of the study team together with the Project Expert Group (PEG) will condense and prioritise the ESCNH into one online questionnaire and thereby elaborate the first framework of the self-assessment tool. Next to participant-related information such as profession or country of employment, the questionnaire will cover specific aspects of the eleven major topics of the ESCNH namely: Birth and transfer, medical care and clinical practice, care procedures, infant- and family-centred developmental care, neonatal intensive care unit (NICU) design, nutrition, ethical decision-making and palliative care, follow-up and continuing care, patient safety and hygiene practice, data collection and documentation, education and training. The questionnaire will subsequently, in the first eDelphi round, be evaluated by the eDelphi panel. The panel consist of approximately 100 healthcare professionals from various disciplines related to neonatal care as well as parent representatives. In the first eDelphi round, panellists will appraise the relevance of included content, the wording of questions as well as the prioritisation of content to be included in the self-assessment tool. This will be enabled through a predefined evaluation scheme as well as free-text fields. Based on feedback from panellists, the preliminary self-assessment tool will be adapted by adding additional information, removing unnecessary items and re-wording if necessary. In the subsequent (second) eDelphi round, the same panellists will receive qualitative and quantitative information on the adaptation of the first version and will have again the option to evaluate the adapted questionnaire. Remaining discrepancies will be discussed in a final consensus workshop. For this purpose, 20-30 panellists will be selected based on their level of experience and invited for participation. The result of the workshop will be the agreed-upon content for the self-assessment tool. Except for the workshop, data collection during the eDelphi rounds will be anonymous.
To ensure applicability, the self-assessment tool will be pilot tested in European hospitals. For this purpose, the self-assessment tool will be translated into 5 languages (German, French, Italian, Swedish, Portuguese, and Spanish). For the pilot-testing, healthcare professionals in 10 pilot hospitals across Europe will be invited to evaluate the self-assessment tool. Feedback of the pilot-testing will be discussed with the PEG and adapted accordingly.
Interventions
- Other Please note that this is an observational study; not applicable
Please note that this is an observational study; not applicable
Primary outcome measures
- Online self-assessment tool (including statements and questions) [Time frame: 15.06.2024 - 15.07.2025]
Secondary outcome measures (7)
- Response rates [Time frame: 15.10.2024 - 30.06.2025]
- Demographics and characteristics [Time frame: 15.10.2024 - 30.06.2025]
- User-friendliness score of the self-assessment tool [Time frame: 15.10.2024 - 30.06.2025]
- Applicability score of the formulation of the questions [Time frame: 15.10.2024 - 30.06.2025]
- Qualitative feedback on illustration of output [Time frame: 15.10.2024 - 30.06.2025]
- Appraisal on the utilisation of the self-assessment tool [Time frame: 15.10.2024 - 30.06.2025]
- Scalability of the self-assessment tool and dissemination [Time frame: 15.10.2024 - 30.06.2025]
Eligibility criteria
Inclusion criteria Participants will be eligible if they are
- parent representatives or representatives of caregivers of infants who received special/intensive care,
- healthcare professionals in the field of neonatology, midwifery, neonatal nursing care, obstetrics, psychology, health sociology, physical therapy, or
- hospital management.
Exclusion Criteria Participants will be excluded if they
- provide insufficient proficiency of English for the eDelphi questionnaires or the languages of the self-assessment tool in the pilot testing, or
- have a professional background that is not related to the ESCNH / individuals that are not parent representatives or representatives of caregiver of infants who received special/intensive care.
- primarily work in the industry.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 1 center
- European Foundation for the Care of Newborn Infants (EFCNI) — Munich
Publications
- Lindacher V, Altebaeumer P, Marlow N, Matthaeus V, Straszewski IN, Thiele N, Pfeil JM, Zimmermann LJI, Mader S; European Standards of Care for Newborn Health project members. European Standards of Care for Newborn Health-A project protocol. Acta Paediatr. 2021 May;110(5):1433-1438. doi: 10.1111/apa.15712. Epub 2020 Dec 22. PMID 33290600
- Hoffmann J, Lehmann S, Ancora G, Hummler H, Lack N, Schlembach D, Schouten E, Simonelli I, Thernstrom Blomqvist Y, Vavouraki E, Webbe J, Zimmermann LJI, Mader S, Geiger I. Study protocol for the development and pilot-testing of a Self-assessment tool for the implementation of the European Standards of Care for Newborn Health (ESCNH). BMJ Paediatr Open. 2025 Jan 20;9(1):e003008. doi: 10.1136/bmjpo- PMID 39837587
Identifiers
NCT: NCT06379828 · 2024-0140