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Clinical Trials/NCT05179278
NCT05179278
Completed
Not Applicable

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 Pau1 site in 1 country194 target enrollmentFebruary 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Valvular Heart Disease
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
194
Locations
1
Primary Endpoint
Admission time
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2021
End Date
June 1, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Admission time

Time Frame: During hospital admission ( until the last day of admission)

Time since intervention until hospital discharge

Rate of Intrahospital complications

Time Frame: One year after intervention

Procedure complications (vascular, stroke and cardiac complication)

Waiting time

Time Frame: Pre-intervention

Time since Heart-team accepted until the intervention

Rate of Mortality

Time Frame: One year after intervention

Mortality for all reasons (cardiac or other reason)

Rate of Hospital readmission

Time Frame: One year after intervention

Hospital readminission after the intervention for cardiac reasons

Rate of Nosocomial infection

Time Frame: During hospital admission (until the last day of admission)

Infection adquired during hospital admission

Satisfaction assessed by SUCMA 14 Questionnaire

Time Frame: 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)

Study Sites (1)

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