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

Primary Purpose

Valvular Heart Disease, Nurse's Role, Competence

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
STAR Nurse
Common Practice
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Valvular Heart Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FGS Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Common Practice

STAR Nurse

Arm Description

Patients included in the phase before will receive common practice.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
March 21, 2020
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT04301648
Brief Title
Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experimental design study, pre-post intervention type.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Common Practice
Arm Type
Active Comparator
Arm Description
Patients included in the phase before will receive common practice.
Arm Title
STAR Nurse
Arm Type
Experimental
Arm Description
Patients included in the phase after will receive care by a STAR Nurse.
Intervention Type
Other
Intervention Name(s)
STAR Nurse
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Common Practice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Structural Quality Indicators
Description
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.
Time Frame
30 days
Title
Process Quality Indicators
Description
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.
Time Frame
30 days
Title
Outcome Quality Indicators
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ADRIAN MARQUEZ LOPEZ
Phone
+342919000
Ext
7926
Email
amarquez@santpau.cat
Facility Information:
Facility Name
FGS Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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