NCT04301648

Brief Summary

The hypothesis is that patients with structural heart disease who are treated by STructural heARt nurses obtain better results in indicators of quality of care, compared with the usual practice (or not assisted) by this type of new interventional cardiology's nursing role.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 3, 2020

Last Update Submit

March 21, 2020

Conditions

Valvular Heart DiseaseNurse's RoleCompetenceCardiac Disease

Keywords

Quality of Health Care/organization & administrationAdvanced Practice Nursing/trendsQuality Improvement/organization & administrationQuality of Health Care/standardsProfessional RoleStructural Heart DiseaseNurse's RoleValvular Heart DiseaseNurse's Competences

Outcome Measures

Primary Outcomes (3)

  • Structural Quality Indicators

    Structural quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's structural quality indicators could be some like: \- Percutaneous/transcatheter treatment waiting time (days). Data will be collected by medical history review.

    30 days

  • Process Quality Indicators

    Process quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's process quality indicators could be some like: \- Evaluation of procedural risk (points). The Society of Thoracic Surgery (STS) risk score will be used. The classification of the results is: * Less than or equal to 2 points means low surgical risk. * From 3 to 5 points means intermediate surgical risk. * Upper than or equal to 6 means high surgical risk.

    30 days

  • Outcome Quality Indicators

    Outcome quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's outcome quality indicators could be some like: \- Mortality after Percutaneous/transcatheter treatment for any medical cause (days). Data will be collected by medical history review.

    30 days

Study Arms (2)

Common Practice

ACTIVE COMPARATOR

Patients included in the phase before will receive common practice.

Other: Common Practice

STAR Nurse

EXPERIMENTAL

Patients included in the phase after will receive care by a STAR Nurse.

Other: STAR Nurse

Interventions

STAR NurseOTHER

This intervention will consist in that the nurse who is in the hemodynamic nurse's office will do the STAR Nurse's tasks and competences. Although the intervention will be detailed through phase 1 (integrative review) and 2 (Delphy methodology). It is expected that the main STAR nurse's competencies and tasks in the nurse's office will be: 1. To guarantee a comprehensive evaluation and appropriate triage to candidates for an interventional procedure of structural heart disease, coordinating the request for complementary tests and previous visits. 2. Make education to the patient and family. 3. Make communication bridge with cardiologists. 4. Establish specific patient-centered care processes. 5. Promote continuity of care after discharge, follow up after discharge, and reevaluate quality of life and fragility.

STAR Nurse
Common PracticeOTHER

Common practice will consist in that the nurse who is in the hemodynamic nurse's office will do her usual task that is exclusively health education.

Common Practice

Eligibility Criteria

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

You may qualify if:

  • Adult patients (\>18 years) who have been or will undergo any procedure of structural heart disease in the hemodynamic and interventional cardiology unit of the Hospital de la Santa Creu i Sant Pau.
  • Patients who accept to participate in the study.

You may not qualify if:

  • Patients with cognitive impairment, mental disability or other serious difficulty communicating.
  • Patients with insufficient fluency of the main languages.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FGS Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Heart Valve DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

ADRIAN MARQUEZ LOPEZ

CONTACT

+342919000amarquez@santpau.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Quasi-experimental design study, pre-post intervention type.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 10, 2020

Study Start

November 1, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

ES(1)