Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04301648
Status:
UNKNOWN
Last Update Posted:
2020-03-24
First Post:
2020-03-03
Brief Title:
Impact in Quality of Care of the STructural heARt NURSE as New Interventional Cardiology Nursing Role in Spain
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Impact in Quality of Care of the STructural heARt NURSE as New Interventional Cardiology Nursing Role in Spain STAR Nurse Project
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
NOT_YET_RECRUITING
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:
STAR-Nurse
Brief Summary:
The hypothesis is that patients with structural heart disease who are treated by STructural heARt nurses obtain better results in indicators of quality of care compared with the usual practice or not assisted by this type of new interventional cardiologys nursing role
Detailed Description:
Valvular disease is the future epidemic structural heart disease of developed countries To slow or alter the course of the disease cardiac valve repair or replacement is necessary Transcatheter treatment has become a safe alternative to surgery The United States and Canada developed the TAVI Transcather Aortic Valve Implantation program and TAVI Nurse is strongly supported by scientific societies as a key leadership role in the aortic stenosis care process This nursing role is not implemented in Spain
The objective of this study is to develop a new nursing role in interventional cardiology similar to TAVI Nurse but including all the structural heart diseases through conceptual definition and competencies and evaluate its impact on the quality of care after of its implementation
The new nursing role of a hemodynamics and interventional cardiology unit in Spain will be based on the model existing in other countries
This study consists of three phases
Phase I Integrative review to explore and identify the definition and competencies of TAVI Nurse or another similar figure outside Spain as well as identify quality of care indicators
Phase II The competences of these nurses will be contextualized in Spain and indicators of quality of care will be defined through the consensus of experts using a Delphi methodology
Phase III Quasi-experimental pre post study to assess the quality of care through the indicators developed of the implementation of the new nursing role
The objective of this study is to develop a new nursing role in interventional cardiology similar to TAVI Nurse but including all the structural heart diseases through conceptual definition and competencies and evaluate its impact on the quality of care after of its implementation
The new nursing role of a hemodynamics and interventional cardiology unit in Spain will be based on the model existing in other countries
This study consists of three phases
Phase I Integrative review to explore and identify the definition and competencies of TAVI Nurse or another similar figure outside Spain as well as identify quality of care indicators
Phase II The competences of these nurses will be contextualized in Spain and indicators of quality of care will be defined through the consensus of experts using a Delphi methodology
Phase III Quasi-experimental pre post study to assess the quality of care through the indicators developed of the implementation of the new nursing role
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