Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain. STAR Nurse Project.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Structural Quality Indicators
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with cognitive impairment, mental disability or other serious difficulty communicating.
- •Patients with insufficient fluency of the main languages.
研究组 & 干预措施
Common Practice
Patients included in the phase before will receive common practice.
干预措施: Common Practice (Other)
STAR Nurse
Patients included in the phase after will receive care by a STAR Nurse.
干预措施: STAR Nurse (Other)
结局指标
主要结局
Structural Quality Indicators
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点