Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379828
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-18
Brief Title:
Self-assessment Tool for Implementing the ESCNH
Sponsor:
European Foundation for the Care of Newborn Infants
Organization:
European Foundation for the Care of Newborn Infants
Study Overview
Official Title:
Hospital Self-assessment Tool for the Implementation of the European Standards of Care for Newborn Health ESCNH
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None