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Completed

NCT Number: NCT05179278

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

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.

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Key information

Conditions

Valvular Heart Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post-surgical nurse follow-up

Other

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

Primary outcomes

  1. Waiting time

    Time frame: Pre-intervention

    Time since Heart-team accepted until the intervention

  2. 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)

  3. 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)

  4. Admission time

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

    Time since intervention until hospital discharge

  5. Rate of Hospital readmission

    Time frame: One mounth after intervention

    Hospital readminission after the intervention for cardiac reasons

  6. Rate of Hospital readmission

    Time frame: One year after intervention

    Hospital readminission after the intervention for cardiac reasons

  7. Rate of Mortality

    Time frame: Into admission time

    Mortality for all reasons (cardiac or other reason)

  8. Rate of Mortality

    Time frame: One mounth after intervention

    Mortality for all reasons (cardiac or other reason)

  9. Rate of Mortality

    Time frame: One year after intervention

    Mortality for all reasons (cardiac or other reason)

  10. Rate of Intrahospital complications

    Time frame: Into admission time

    Procedure complications (vascular, stroke and cardiac complication)

  11. Rate of Intrahospital complications

    Time frame: One mounth after intervention

    Procedure complications (vascular, stroke and cardiac complication)

  12. Rate of Intrahospital complications

    Time frame: One year after intervention

    Procedure complications (vascular, stroke and cardiac complication)

  13. Rate of Nosocomial infection

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

    Infection adquired during hospital admission

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2022
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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