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

Study Overview
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Brief Summary
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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.

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

Conditions
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Valvular Heart Disease

Intervention / Treatment
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* Other: Post-surgical nurse follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients accepted for Heart-Team for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation Patients visited in the pre-surgical nursing consultation Exclusion Criteria: Patients with language barrier Patients undergoing emergency surgery for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group: post-surgical face-to-face follow up consultation<br> | Other: Post-surgical nurse follow-up<br>* Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year<br>|
| Experimental: Control Group: post-surgical telephone follow up consultation<br> | Other: Post-surgical nurse follow-up<br>* Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waiting time | Time since Heart-team accepted until the intervention | Pre-intervention | 
| Satisfaction assessed by SUCMA 14 Questionnaire | 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) | One mounth after intervention | 
| Satisfaction assessed by SUCMA 14 Questionnaire | 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) | One year after intervention | 
| Admission time | Time since intervention until hospital discharge | During hospital admission ( until the last day of admission) | 
| Rate of Hospital readmission | Hospital readminission after the intervention for cardiac reasons | One mounth after intervention | 
| Rate of Hospital readmission | Hospital readminission after the intervention for cardiac reasons | One year after intervention | 
| Rate of Mortality | Mortality for all reasons (cardiac or other reason) | Into admission time | 
| Rate of Mortality | Mortality for all reasons (cardiac or other reason) | One mounth after intervention | 
| Rate of Mortality | Mortality for all reasons (cardiac or other reason) | One year after intervention | 
| Rate of Intrahospital complications | Procedure complications (vascular, stroke and cardiac complication) | Into admission time | 
| Rate of Intrahospital complications | Procedure complications (vascular, stroke and cardiac complication) | One mounth after intervention | 
| Rate of Intrahospital complications | Procedure complications (vascular, stroke and cardiac complication) | One year after intervention | 
| Rate of Nosocomial infection | Infection adquired during hospital admission | During hospital admission (until the last day of admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valvular heart disease, nurse consultation, health indicators, post-surgical follow-up