Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain.

Cardiac Disease Clinical Trial

— STAR-Nurse  

Official title:

Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain. STAR Nurse Project.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04301648
• Other study ID #: IIBSP-STA-2019-123
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: ADRIAN MARQUEZ LOPEZ
• Phone: +342919000
• Email: amarquez[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 cardiology's nursing role.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (>18 years) who have been or will undergo any procedure of structural heart disease in the hemodynamic and interventional cardiology unit of the Hospital de la Santa Creu i Sant Pau.

• Patients who accept to participate in the study.

Exclusion Criteria:

• Patients with cognitive impairment, mental disability or other serious difficulty communicating.

• Patients with insufficient fluency of the main languages.

Related Conditions & MeSH terms

• Cardiac Disease
• Competence
• Heart Diseases
• Heart Valve Diseases
• Nurse's Role
• Valvular Heart Disease

Intervention

Other:
• STAR Nurse
This intervention will consist in that the nurse who is in the hemodynamic nurse's office will do the STAR Nurse's tasks and competences. Although the intervention will be detailed through phase 1 (integrative review) and 2 (Delphy methodology). It is expected that the main STAR nurse's competencies and tasks in the nurse's office will be: To guarantee a comprehensive evaluation and appropriate triage to candidates for an interventional procedure of structural heart disease, coordinating the request for complementary tests and previous visits. Make education to the patient and family. Make communication bridge with cardiologists. Establish specific patient-centered care processes. Promote continuity of care after discharge, follow up after discharge, and reevaluate quality of life and fragility.
• Common Practice
Common practice will consist in that the nurse who is in the hemodynamic nurse's office will do her usual task that is exclusively health education.

Locations

Country	Name	City	State
Spain	FGS Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural Quality Indicators	Structural quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's structural quality indicators could be some like: - Percutaneous/transcatheter treatment waiting time (days). Data will be collected by medical history review.	30 days
Primary	Process Quality Indicators	Process quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's process quality indicators could be some like: - Evaluation of procedural risk (points). The Society of Thoracic Surgery (STS) risk score will be used.; The classification of the results is: Less than or equal to 2 points means low surgical risk.; From 3 to 5 points means intermediate surgical risk.; Upper than or equal to 6 means high surgical risk.	30 days
Primary	Outcome Quality Indicators	Outcome quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's outcome quality indicators could be some like: - Mortality after Percutaneous/transcatheter treatment for any medical cause (days). Data will be collected by medical history review.	30 days