Impact of a PROgram of Cardiovascular Nurse interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: a Quasi-experimental Ambispective Study
November 14, 2025 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
194
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08041
- Hospital de la Santa Creu i Sant Pau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional 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
|
Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year
|
|
Experimental: Control Group: post-surgical telephone follow up consultation
|
Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction assessed by SUCMA 14 Questionnaire
Time Frame: One mounth 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)
|
One mounth after intervention
|
|
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)
|
One year after intervention
|
|
Rate of Hospital readmission
Time Frame: One mounth after intervention
|
Hospital readminission after the intervention for cardiac reasons
|
One mounth after intervention
|
|
Rate of Hospital readmission
Time Frame: One year after intervention
|
Hospital readminission after the intervention for cardiac reasons
|
One year after intervention
|
|
Rate of Mortality
Time Frame: Into admission time
|
Mortality for all reasons (cardiac or other reason)
|
Into admission time
|
|
Rate of Mortality
Time Frame: One mounth after intervention
|
Mortality for all reasons (cardiac or other reason)
|
One mounth after intervention
|
|
Rate of Mortality
Time Frame: One year after intervention
|
Mortality for all reasons (cardiac or other reason)
|
One year after intervention
|
|
Rate of Intrahospital complications
Time Frame: Into admission time
|
Procedure complications (vascular, stroke and cardiac complication)
|
Into admission time
|
|
Rate of Intrahospital complications
Time Frame: One mounth after intervention
|
Procedure complications (vascular, stroke and cardiac complication)
|
One mounth after intervention
|
|
Rate of Intrahospital complications
Time Frame: One year after intervention
|
Procedure complications (vascular, stroke and cardiac complication)
|
One year after intervention
|
|
Waiting time
Time Frame: Pre-intervention
|
Time since Heart-team accepted until the intervention
|
Pre-intervention
|
|
Admission time
Time Frame: During hospital admission ( until the last day of admission)
|
Time since intervention until hospital discharge
|
During hospital admission ( until the last day of admission)
|
|
Rate of Nosocomial infection
Time Frame: During hospital admission (until the last day of admission)
|
Infection adquired during hospital admission
|
During hospital admission (until the last day of admission)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2021
Primary Completion (Actual)
June 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
August 5, 2021
First Submitted That Met QC Criteria
January 4, 2022
First Posted (Actual)
January 5, 2022
Study Record Updates
Last Update Posted (Estimated)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-CEH-2020-140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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