Self-assessment Tool for Implementing the ESCNH

NCT06379828 | Not Yet Recruiting

• 1 other identifier: 2024-0140
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

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

Keywords

ESCNH; EFCNI; eDlephi method; Pilot-testing; Implementation; Self-assessment; Tool; Neonatal care standards

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Response rates

  15.10.2024 - 30.06.2025

• Demographics and characteristics

  15.10.2024 - 30.06.2025

• User-friendliness score of the self-assessment tool

  15.10.2024 - 30.06.2025

• Applicability score of the formulation of the questions

  15.10.2024 - 30.06.2025

• Qualitative feedback on illustration of output

  15.10.2024 - 30.06.2025

Study Arms (2)

eDelphi panel/participants

The eDelphi panels will consist of approximately 100 healthcare professionals from various European countries from the following fields: neonatology, midwifery, (neonatal) care, obstetrics, parent representing institutions, psychology, and physiotherapy. 20-30 of them will be invited for a final consensus workshop.

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

Pilot hospitals

10 hospitals with neonatal units from Germany, UK, France, Italy, Sweden, Portugal, and Spain.

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

Interventions

Please note that this is an observational study; not applicable OTHER

Please note that this is an observational study; not applicable

Pilot hospitals; eDelphi panel/participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The PEG consists of 8 renowned experts of multidisciplinary professions: neonatologists, a (neonatal) nurses, an obstetrician, a parent representative, a public health expert, and a statistician and is completed by members of the EFCNI study team. The eDelphi panels will consist of experts from various European countries from the following fields: neonatology, midwifery, (neonatal) care, obstetrics, parent representing institutions, psychology, and physiotherapy. Participants for the pilot-testing will be healthcare professionals with varying professional backgrounds in pilot hospitals across Europe.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global Foundation for the Care of Newborn Infants: lead

Study Sites (1)

European Foundation for the Care of Newborn Infants (EFCNI)

Munich, Bavaria, 81379, Germany

Location

Related Publications (2)

• 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 BACKGROUND

• 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-2024-003008.

  PMID: 39837587 DERIVED

Related Links

• Related Info

Study Officials

• Silke Mader

  Global Foundation for the Care of Newborn Infants

  STUDY DIRECTOR

• Julia Hoffmann, Dr.

  Global Foundation for the Care of Newborn Infants

  STUDY DIRECTOR

Central Study Contacts

Isabel Geiger, Dr.

CONTACT

+49 (0) 89 89 0 83 26-0; isabel.geiger@efcni.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Director

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: June 3, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

DE (1)