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

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179278
• Other study ID #: IIBSP-CEH-2020-140
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Other:
• Post-surgical nurse follow-up
Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waiting time	Time since Heart-team accepted until the intervention	Pre-intervention
Primary	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
Primary	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
Primary	Admission time	Time since intervention until hospital discharge	During hospital admission ( until the last day of admission)
Primary	Rate of Hospital readmission	Hospital readminission after the intervention for cardiac reasons	One mounth after intervention
Primary	Rate of Hospital readmission	Hospital readminission after the intervention for cardiac reasons	One year after intervention
Primary	Rate of Mortality	Mortality for all reasons (cardiac or other reason)	Into admission time
Primary	Rate of Mortality	Mortality for all reasons (cardiac or other reason)	One mounth after intervention
Primary	Rate of Mortality	Mortality for all reasons (cardiac or other reason)	One year after intervention
Primary	Rate of Intrahospital complications	Procedure complications (vascular, stroke and cardiac complication)	Into admission time
Primary	Rate of Intrahospital complications	Procedure complications (vascular, stroke and cardiac complication)	One mounth after intervention
Primary	Rate of Intrahospital complications	Procedure complications (vascular, stroke and cardiac complication)	One year after intervention
Primary	Rate of Nosocomial infection	Infection adquired during hospital admission	During hospital admission (until the last day of admission)