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

Not Applicable

• Conditions: Competence; Cardiac Disease; Valvular Heart Disease; Nurse's Role
• Interventions: Other: Common Practice; Other: STAR Nurse

• Registration Number: NCT04301648
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 cardiology's 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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-10
• Last Update Submitted: 2020-03-21
• Last Update Posted: 2020-03-24
• Study Start: 2021-11-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Common Practice	Common Practice	Patients included in the phase before will receive common practice.
STAR Nurse	STAR Nurse	Patients included in the phase after will receive care by a STAR Nurse.

Primary Outcome Measures

Name	Time	Method
Structural Quality Indicators	30 days	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.
Process Quality Indicators	30 days	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.
Outcome Quality Indicators	30 days	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.

Trial Locations

Locations (1)

FGS Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain