Clinical trial NCT06379828: Self-assessment Tool for Implementing the ESCNH
Official title: Hospital Self-assessment Tool for the Implementation of the European Standards of Care for Newborn Health (ESCNH)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Global Foundation for the Care of Newborn Infants
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Online self-assessment tool (including statements and questions)
timeFrame: 15.06.2024 - 15.07.2025
Secondary outcomes:
measure: Response rates
timeFrame: 15.10.2024 - 30.06.2025
measure: Demographics and characteristics
timeFrame: 15.10.2024 - 30.06.2025
measure: User-friendliness score of the self-assessment tool
timeFrame: 15.10.2024 - 30.06.2025
measure: Applicability score of the formulation of the questions
timeFrame: 15.10.2024 - 30.06.2025
measure: Qualitative feedback on illustration of output
timeFrame: 15.10.2024 - 30.06.2025
measure: Appraisal on the utilisation of the self-assessment tool
timeFrame: 15.10.2024 - 30.06.2025
measure: Scalability of the self-assessment tool and dissemination
timeFrame: 15.10.2024 - 30.06.2025
Other outcomes:
Locations:
city: Munich
country: Germany
facility: European Foundation for the Care of Newborn Infants (EFCNI)
state: Bavaria
Study officials:
affiliation: Global Foundation for the Care of Newborn Infants
name: Silke Mader
role: STUDY_DIRECTOR
affiliation: Global Foundation for the Care of Newborn Infants
name: Julia Hoffmann, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.