Clinical trial NCT04301648: Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain.
Official title: Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain. STAR Nurse Project.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valvular Heart Disease
Nurse's Role
Competence
Cardiac Disease
Keywords: Quality of Health Care/organization & administration
Advanced Practice Nursing/trends
Quality Improvement/organization & administration
Quality of Health Care/standards
Professional Role
Structural Heart Disease
Nurse's Role
Valvular Heart Disease
Nurse's Competences
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental design study, pre-post intervention type.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Structural Quality Indicators
timeFrame: 30 days
measure: Process Quality Indicators
timeFrame: 30 days
measure: Outcome Quality Indicators
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: FGS Hospital de la Santa Creu i Sant Pau
Study officials:
References: