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NCT Number: NCT06379828

Self-assessment Tool for Implementing the ESCNH

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Please note that this is an observational study; not applicable

Other

Please note that this is an observational study; not applicable

Primary outcomes

  1. Online self-assessment tool (including statements and questions)

    Time frame: 15.06.2024 - 15.07.2025

    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.

Secondary outcomes

  1. Response rates

    Time frame: 15.10.2024 - 30.06.2025

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

  2. Demographics and characteristics

    Time frame: 15.10.2024 - 30.06.2025

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

  3. User-friendliness score of the self-assessment tool

    Time frame: 15.10.2024 - 30.06.2025

    Time taken to fill in, illustration on screen, understandability

  4. Applicability score of the formulation of the questions

    Time frame: 15.10.2024 - 30.06.2025

    Evaluation data on formulation of the questions and understandability

  5. Qualitative feedback on illustration of output

    Time frame: 15.10.2024 - 30.06.2025

    Evaluation data on illustration of questionnaire on the screen

  6. Appraisal on the utilisation of the self-assessment tool

    Time frame: 15.10.2024 - 30.06.2025

    Evaluation data on the utilisation of the self-assessment tool

  7. Scalability of the self-assessment tool and dissemination

    Time frame: 15.10.2024 - 30.06.2025

    Evaluation data on the usage and outreach

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Geiger, Dr.

CONTACT

[email protected]

+49 (0) 89 89 0 83 26-0

Sponsors and collaborators

Lead sponsor

Global Foundation for the Care of Newborn Infants

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 23, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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