NCT05179278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 18, 2025

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

August 5, 2021

Last Update Submit

November 14, 2025

Conditions

Valvular Heart Disease

Keywords

valvular heart diseasenurse consultationhealth indicatorspost-surgical follow-up

Outcome Measures

Primary Outcomes (13)

  • 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)

Study Arms (2)

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

EXPERIMENTAL
Other: Post-surgical nurse follow-up

Control Group: post-surgical telephone follow up consultation

EXPERIMENTAL
Other: Post-surgical nurse follow-up

Interventions

Post-surgical nurse follow-upOTHER

Follow-up face-to-face consultation or follow-up telephone consultation a month after the intervention and telephone consultation at one year

Control Group: post-surgical telephone follow up consultationIntervention Group: post-surgical face-to-face follow up consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients accepted for Heart-Team for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation
  • Patients visited in the pre-surgical nursing consultation

You may not qualify if:

  • Patients with language barrier
  • Patients undergoing emergency surgery for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (1)

  • Valverde Bernal J, Martinez-Soler F, Berga Congost G, Martinez Perez J, Asmarats L, Moreno Arroyo C. Impact of a PROgram of Cardiovascular nursE interventionS in a VALVular haEmodynamic Unit (PROCESS-VALVE) on Quality Indicators: A Quasi-Experimental Ambispective Study. Int J Gen Med. 2023 Sep 20;16:4257-4265. doi: 10.2147/IJGM.S412369. eCollection 2023.

    PMID: 37750105DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2021

First Posted

January 5, 2022

Study Start

February 25, 2021

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

November 18, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)