NCT02093078

Brief Summary

Crisis resource management represents the set of non technical skills, such as communication, leadership, delegation, and prioritization, that allow effective teamwork for optimal patient care during an urgent and critical situation. The Cognitive Aids with Roles Defined (CARD) is a new concept of cognitive aid addressing the well-documented issue of teamwork in crisis management. It relies on large identification cards specially designed for each team members profession and role. During a life threatening clinical situation, the CARD protocol focuses on clarification of individual roles and distribution of tasks for crisis management rather than creating an additional algorithm identifying either a list of actions to be taken or the dose of a medication. This study aims to evaluate the clinical impact of introducing the CARD protocol in obstetrical emergency situations ("code 333") in clinical practice at The Ottawa Hospital. Hypothesis: CARD protocol will: (i) decrease the total time taken to deliver the baby, and (ii) improve clinical outcome for the mother and baby compared to traditional management without the CARD protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

February 7, 2014

Last Update Submit

September 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Time to Delivery After a Code 333

    The primary outcome measure is the exact time from when the code 333 is called, to the time of delivery (up to 1 day).

    from the time of calling in a code 333 to the time of birth (up to 1 day).

Secondary Outcomes (1)

  • standard clinical outcomes on patient charts

    participants will be followed from when the code 333 was called until hospital discharge or mortality, whichever comes first (up to 3 years).

Study Arms (2)

CARD

Intervention: CARD This group will be introduced to the CARD protocol which focuses on clarification of individual roles and distribution of tasks. It relies on large identification cards specially designed for each team member's profession and role. Each card worn by a team member identifies the specific tasks associated with that individual's role. CARD enables the team leader and other team members to quickly recognize everyone's role at the code, and each team member can commence their assigned tasks without delay.

Behavioral: CARD

Control Arm

Interventions

CARDBEHAVIORAL

Intervention: CARD This group will be introduced to the CARD protocol which focuses on clarification of individual roles and distribution of tasks. It relies on large identification cards specially designed for each team member's profession and role. Each card worn by a team member identifies the specific tasks associated with that individual's role. CARD enables the team leader and other team members to quickly recognize everyone's role at the code, and each team member can commence their assigned tasks without delay.

CARD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twelve obstetrical unit teams (4 registered nurses (RN), 1 operating room attendant, 1 respiratory therapist (RT) assisting anesthesia, 1 RT assisting neonatal, 2 neonatal RNs) will be recruited for the study

You may qualify if:

  • must hold a staff position at The Ottawa Hospital (Civic or General campus) in one of the following positions:
  • registered nurses (RN)
  • operating room attendant
  • respiratory therapist (RT)
  • assisting anesthesia
  • RT assisting neonatal
  • neonatal RNs

You may not qualify if:

  • not a staff member at The Ottawa Hospital (Civic or General campus)
  • holding a position that is different from any of the following: registered nurse, operating room attendant, respiratory therapist, assisting anesthesia, RT assisting neonatal, neonatal RN
  • investigators involved in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Study Officials

  • Sylvain Boet, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

March 20, 2014

Study Start

January 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations