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临床试验/NCT05179278
NCT05179278已完成不适用

Impact of a PROgram of Cardiovascular Nurse interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: a Quasi-experimental Ambispective Study

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2021年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
194
试验地点
2
主要终点
Admission time

研究概览

简要总结

The objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (PROCESS-VALVE) on quality indicators of the health of patients undergoing percutaneous valve procedures. (waiting times, patient satisfaction, admission times, hospital readmission, mortality, intrahospital complications and nosocomial infections). Design of the study is an ambispective quasi-experimental study. For the control group, data will be collected retrospectively from patients undergoing percutaneous valve procedures who did not receive pre- or postsurgical consultations. The intervention group will comprise those patients who agree to participate in the study and the haemodynamic nurse valve consultation program (PROCESS-VALVE). In addition, the investigators will assess whether a face-to-face postsurgical consultation improved quality indicators compared to postsurgical telephone consultation; for this, a sub-study will be carried out comparing face-to-face or telephone postsurgical follow-up by means of a randomised controlled clinical trial with simple blinding in the intervention group. Study area will be at the Hemodynamic Unit of the Hospital de la Santa Creu i Sant Pau and the study population are chosen patients for percutaneous valvular intervention who attend the pre-surgical consultation at our center. Dependent variable will be the indicators cited in the study aim and the independent variable will be the pre-surgical and post-surgical consultation. In pre-surgical consultation will be done a patient recruitment and will collect sociodemographic and clinical data. At patient will be done an individualized interview with an Ad-Hoc questionnaire and to collect fragility level of study and level of planned connections. In the subsequent follow-up, all pacients will receive a follow-up visit and collect satisfaction and quality indicators. But this pacients will be randomized to telephone follow-up or face-to-face follow up. Sample size has been calculated in 194 to be distributed equally in both groups and the clinical trials groups will be formed by 94 patients in each group The protocol has been modified to an ambispective quasi-experimental study with a subsequent randomization for the type of follow-up (telephone vs face-to-face) due to organizational changes in the participant center.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Patients accepted for Heart-Team for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation
  • Patients visited in the pre-surgical nursing consultation

排除标准

  • Patients with language barrier
  • Patients undergoing emergency surgery for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation

结局指标

主要结局

Admission time

时间窗: During hospital admission ( until the last day of admission)

Time since intervention until hospital discharge

Rate of Intrahospital complications

时间窗: One year after intervention

Procedure complications (vascular, stroke and cardiac complication)

Waiting time

时间窗: Pre-intervention

Time since Heart-team accepted until the intervention

Rate of Mortality

时间窗: One year after intervention

Mortality for all reasons (cardiac or other reason)

Rate of Hospital readmission

时间窗: One year after intervention

Hospital readminission after the intervention for cardiac reasons

Rate of Nosocomial infection

时间窗: During hospital admission (until the last day of admission)

Infection adquired during hospital admission

Satisfaction assessed by SUCMA 14 Questionnaire

时间窗: One year after intervention

Use of an adaptation Sucma 14 Questionnaire (in english Questionnaire Satisfaction of Users of Major Ambulatory Surgery). This scale is former for 14 independent questions with 5 options response (likert scale)

次要结局

未报告次要终点

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (2)

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