Self-assessment Tool for Implementing the ESCNH

Self-Assessment Clinical Trial

Official title:

Hospital Self-assessment Tool for the Implementation of the European Standards of Care for Newborn Health (ESCNH)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379828
• Other study ID #: 2024-0140
• Status: Not yet recruiting
• Start date: June 3, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: April 2024
• Source: European Foundation for the Care of Newborn Infants
• Contact: Isabel Geiger, Dr.
• Phone: +49 (0) 89 89 0 83 26-0
• Email: isabel.geiger[@]efcni.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Self-Assessment

Intervention

Other:
• Please note that this is an observational study; not applicable
Please note that this is an observational study; not applicable

Locations

Country	Name	City	State
Germany	European Foundation for the Care of Newborn Infants (EFCNI)	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
European Foundation for the Care of Newborn Infants

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Online self-assessment tool (including statements and questions)	Within a two-round eDelphi survey, the eDelphi panel will critically appraise the first template of the self-assessment tool. If required (indicated by = 80% of participants) additional items will be added or unnecessary items will be removed. Remaining discrepancies will be discussed in a final consensus workshop and the questionnaire will be adapted based on consensus gathered within the workshop. The resulting questionnaire will be the first version of the self-assessment tool, which will be evaluated during and adapted after a pilot-testing phase.	15.06.2024 - 15.07.2025
Secondary	Response rates	Number of participants completing the first and second eDelphi round, number of hospitals joining the pilot-testing phase	15.10.2024 - 30.06.2025
Secondary	Demographics and characteristics	A summary of demographic information and the participants characteristics will be presented	15.10.2024 - 30.06.2025
Secondary	User-friendliness score of the self-assessment tool	Time taken to fill in, illustration on screen, understandability	15.10.2024 - 30.06.2025
Secondary	Applicability score of the formulation of the questions	Evaluation data on formulation of the questions and understandability	15.10.2024 - 30.06.2025
Secondary	Qualitative feedback on illustration of output	Evaluation data on illustration of questionnaire on the screen	15.10.2024 - 30.06.2025
Secondary	Appraisal on the utilisation of the self-assessment tool	Evaluation data on the utilisation of the self-assessment tool	15.10.2024 - 30.06.2025
Secondary	Scalability of the self-assessment tool and dissemination	Evaluation data on the usage and outreach	15.10.2024 - 30.06.2025

External Links

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