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

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

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.

Study Overview

• Status: Unknown
• Conditions: Valvular Heart Disease; Cardiac Disease; Nurse's Role; Competence
• Intervention / Treatment: Other: Common Practice; Other: STAR Nurse

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 Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • FGS Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Common Practice; Patients included in the phase before will receive common practice.	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.
Experimental: STAR Nurse; Patients included in the phase after will receive care by a STAR Nurse.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 21, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Valvular Heart Disease; Structural Heart Disease; Nurse's Role; Professional Role; Quality of Health Care/organization & administration; Advanced Practice Nursing/trends; Quality Improvement/organization & administration; Quality of Health Care/standards; Nurse's Competences
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: IIBSP-STA-2019-123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No