Self-assessment Tool for Implementing the ESCNH

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGlobal Foundation for the Care of Newborn Infants

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    Please note that this is an observational study; not applicable

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: eDelphi panel/participants1 intervention
Group B: Pilot hospitals1 intervention

Trial outcomes

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.

Time frame
15.06.2024 - 15.07.2025

Secondary outcomes

1

Response rates

Number of participants completing the first and second eDelphi round, number of hospitals joining the pilot-testing phase

Time frame
15.10.2024 - 30.06.2025
2

Demographics and characteristics

A summary of demographic information and the participants characteristics will be presented

Time frame
15.10.2024 - 30.06.2025
3

User-friendliness score of the self-assessment tool

Time taken to fill in, illustration on screen, understandability

Time frame
15.10.2024 - 30.06.2025
4

Applicability score of the formulation of the questions

Evaluation data on formulation of the questions and understandability

Time frame
15.10.2024 - 30.06.2025

Other outcomes

Sponsors and contacts

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