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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

Primary Purpose

Valvular Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Post-surgical nurse follow-up
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Valvular Heart Disease focused on measuring valvular heart disease, nurse consultation, health indicators, post-surgical follow-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de la Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group: post-surgical face-to-face follow up consultation

Control Group: post-surgical telephone follow up consultation

Arm Description

Outcomes

Primary Outcome Measures

Waiting time
Time since Heart-team accepted until the 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)
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)
Admission time
Time since intervention until hospital discharge
Rate of Hospital readmission
Hospital readminission after the intervention for cardiac reasons
Rate of Hospital readmission
Hospital readminission after the intervention for cardiac reasons
Rate of Mortality
Mortality for all reasons (cardiac or other reason)
Rate of Mortality
Mortality for all reasons (cardiac or other reason)
Rate of Mortality
Mortality for all reasons (cardiac or other reason)
Rate of Intrahospital complications
Procedure complications (vascular, stroke and cardiac complication)
Rate of Intrahospital complications
Procedure complications (vascular, stroke and cardiac complication)
Rate of Intrahospital complications
Procedure complications (vascular, stroke and cardiac complication)
Rate of Nosocomial infection
Infection adquired during hospital admission

Secondary Outcome Measures

Full Information

First Posted
August 5, 2021
Last Updated
May 22, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT05179278
Brief Title
Impact of a PROgram of Cardiovascular Nurse interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: a Quasi-experimental Ambispective Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
valvular heart disease, nurse consultation, health indicators, post-surgical follow-up

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group: post-surgical face-to-face follow up consultation
Arm Type
Experimental
Arm Title
Control Group: post-surgical telephone follow up consultation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Post-surgical nurse follow-up
Intervention Description
Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year
Primary Outcome Measure Information:
Title
Waiting time
Description
Time since Heart-team accepted until the intervention
Time Frame
Pre-intervention
Title
Satisfaction assessed by SUCMA 14 Questionnaire
Description
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)
Time Frame
One mounth after intervention
Title
Satisfaction assessed by SUCMA 14 Questionnaire
Description
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)
Time Frame
One year after intervention
Title
Admission time
Description
Time since intervention until hospital discharge
Time Frame
During hospital admission ( until the last day of admission)
Title
Rate of Hospital readmission
Description
Hospital readminission after the intervention for cardiac reasons
Time Frame
One mounth after intervention
Title
Rate of Hospital readmission
Description
Hospital readminission after the intervention for cardiac reasons
Time Frame
One year after intervention
Title
Rate of Mortality
Description
Mortality for all reasons (cardiac or other reason)
Time Frame
Into admission time
Title
Rate of Mortality
Description
Mortality for all reasons (cardiac or other reason)
Time Frame
One mounth after intervention
Title
Rate of Mortality
Description
Mortality for all reasons (cardiac or other reason)
Time Frame
One year after intervention
Title
Rate of Intrahospital complications
Description
Procedure complications (vascular, stroke and cardiac complication)
Time Frame
Into admission time
Title
Rate of Intrahospital complications
Description
Procedure complications (vascular, stroke and cardiac complication)
Time Frame
One mounth after intervention
Title
Rate of Intrahospital complications
Description
Procedure complications (vascular, stroke and cardiac complication)
Time Frame
One year after intervention
Title
Rate of Nosocomial infection
Description
Infection adquired during hospital admission
Time Frame
During hospital admission (until the last day of admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonatan Valverde Bernal
Phone
+34680843586
Email
jvalverdeb@santpau.cat

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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