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Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology

NCT ID: NCT04205825

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-12-01

Brief Summary

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The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used.

Detailed Description

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The aim of this study is to develop a New Safety Checklist in perioperative patients undergoing cardiac catheterization in interventional cardiology units and assess it impact on the incidence of perioperative complications compared to habitual practice.

The study will consist in two phases; the first phase: development of the New Safety Checklist, and the second phase will be a multicenter randomized clinical trial, a parallel two-arm corresponding to the use of the New Safety Checklist compared to the habitual practice in all patients undergoing cardiac catheterization in interventional cardiology units, according to the inclusion criteria..

The expected number of patients in this trial will be 6000. The principal outcome of this study will be: the incidence of perioperative complications. The secondary outcomes will be: socio-demographic data, clinical patient data and procedure type data. Data collection will be done through reviewing clinical history.

Conditions

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Complication of Surgical Procedure

Keywords

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Nursing Patient Safety Checklist Cardiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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New Safety Checklist

Patients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist.

Group Type EXPERIMENTAL

The New Safety Checklist

Intervention Type OTHER

Patients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist.

Habitual Practice

Patients randomized in this arm they will receive the habitual practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The New Safety Checklist

Patients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (\>18 years) undergoing cardiological intervention in hemodynamic units and interventionist cardiology.
* Patients who accept to participate in the study.

Exclusion Criteria

* Patients undergoing urgent procedure.
* Patients requiring ventilatory support or in a situation of hemodynamic instability.
* Patients with cognitive impairment, mental disability or other serious difficulty in communication.
* Patients with insufficient fluidity of the main languages.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FGS Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Adrian Marquez Lopez, RN. MsC. PhD student.

Role: CONTACT

Phone: +342919000

Email: [email protected]

Facility Contacts

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Adrian Marquez Lopez, RN. MsC. PhD student.

Role: primary

Other Identifiers

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IIBSP-LVS-2017-49

Identifier Type: -

Identifier Source: org_study_id