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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Pilot hospitals | 10 hospitals with neonatal units from Germany, UK, France, Italy, Sweden, Portugal, and Spain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Please note that this is an observational study; not applicable | Other | Please note that this is an observational study; not applicable |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Demographics and characteristics |
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Inclusion criteria Participants will be eligible if they are
Exclusion Criteria Participants will be excluded if they
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabel Geiger, Dr. | Contact | +49 (0) 89 89 0 83 26-0 | isabel.geiger@efcni.org |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Foundation for the Care of Newborn Infants (EFCNI) | Munich | Bavaria | 81379 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33290600 | Background | 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. | |
| 39837587 |
| Label | URL |
|---|---|
| Related Info | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2024 |
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A summary of demographic information and the participants characteristics will be presented
| 15.10.2024 - 30.06.2025 |
| User-friendliness score of the self-assessment tool | Time taken to fill in, illustration on screen, understandability | 15.10.2024 - 30.06.2025 |
| Applicability score of the formulation of the questions | Evaluation data on formulation of the questions and understandability | 15.10.2024 - 30.06.2025 |
| Qualitative feedback on illustration of output | Evaluation data on illustration of questionnaire on the screen | 15.10.2024 - 30.06.2025 |
| 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 |
| Scalability of the self-assessment tool and dissemination | Evaluation data on the usage and outreach | 15.10.2024 - 30.06.2025 |
| 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. |
| Apr 17, 2024 |
| Prot_SAP_000.pdf |