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

NCT ID: NCT04301648

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-07-01

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.

Conditions

Valvular Heart Disease; Nurse's Role; Competence; Cardiac Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Common Practice

Patients included in the phase before will receive common practice.

Group Type: ACTIVE_COMPARATOR

Common Practice

Intervention Type: OTHER

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.

STAR Nurse

Patients included in the phase after will receive care by a STAR Nurse.

Group Type: EXPERIMENTAL

STAR Nurse

Intervention Type: OTHER

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:

1. 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.

2. Make education to the patient and family.

3. Make communication bridge with cardiologists.

4. Establish specific patient-centered care processes.

5. Promote continuity of care after discharge, follow up after discharge, and reevaluate quality of life and fragility.

Interventions

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:

1. 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.

2. Make education to the patient and family.

3. Make communication bridge with cardiologists.

4. Establish specific patient-centered care processes.

5. Promote continuity of care after discharge, follow up after discharge, and reevaluate quality of life and fragility.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

FGS Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Central Contacts

ADRIAN MARQUEZ LOPEZ

Role: CONTACT

amarquez@santpau.cat

+342919000 ext. 7926

Other Identifiers

IIBSP-STA-2019-123

Identifier Type: -

Identifier Source: org_study_id