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

NCT04205825 | Unknown

• 1 other identifier: IIBSP-LVS-2017-49
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complication of Surgical Procedure

Keywords

Nursing; Patient Safety; Checklist; Cardiology

Outcome Measures

Primary Outcomes (1)

• INCIDENCE of PERIOPERATIVE COMPLICATIONS

  The perioperative complications will be collected after randomization, from discharge or up to24 hours post-procedure. The clinical history will be reviewed to evaluate the incidence of complications. Expected complications will be: severe systemic complications (major cardiovascular events \[MACE\], coronary artery complications, and structural complications), peripheral vascular complications, and reactions to contrast media.

  from the discharge or up to 24 hours post-procedure

Secondary Outcomes (3)

• Socio-demographic data

  from the discharge or up to 24 hours post-procedure

• Clinical data

  from the discharge or up to 24 hours post-procedure

• Procedure data

  from the discharge or up to 24 hours post-procedure

Study Arms (2)

New Safety Checklist

EXPERIMENTAL

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.

Other: The New Safety Checklist

Habitual Practice

NO INTERVENTION

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

Interventions

The New Safety Checklist 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.

New Safety Checklist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

FGS Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Central Study Contacts

Adrian Marquez Lopez, RN. MsC. PhD student.

CONTACT

+342919000; amarquez@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 20, 2019
• Study Start: December 2, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

ES (1)