- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02093078
Cognitive Aids With Roles Defined (CARD) for Obstetrical Crises: A Multisite Cohort Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The CARD protocol offers an innovative yet simple solution to the barriers in crisis management that the literature has already identified. The study is part of a research program investigating strategies to improve crisis management. After completing several simulation studies on cognitive aids, crisis management debriefing, and a pilot CARD study, the investigators aim to explore and investigate the impact of an intervention on patient care.
The concept of a self-organizing team with explicitly defined roles may enhance patient safety. The CARD approach to crisis management is relevant to a broad number of situations, disciplines, and professions. The CARD protocol is easily exportable to any critical situation including intra-hospital arrest, trauma, or critical care patients. The concept of a self-organizing team with defined roles may ultimately enhance patient safety.
The investigators anticipate that their proposal will challenge the traditional way of thinking about cognitive aid, and may advance the theory in the two fields of cognitive aid and team work for crisis management.
The CARD cards with their associated roles and list of tasks will be specifically designed for code 333. In the 'baseline' phase, a research assistant will review Birthing Unit records daily to determine if a code 333 had been called in the preceding 24 hours. Outcome measures will be collected to establish baseline team performance. In order to account for the 'team training effect' and identify the 'CARD effect', both groups will receive didactic and simulation crisis management teaching, but training at the "case site" will include CARD teaching while the contemporaneous "control site" will receive team training without CARD. After the training period at both sites, CARD will be implemented at the "case sight" for code 333s while the "control site" will continue without CARD. Maternal and neonatal outcomes as well as team performance (times to delivery) will continue to be prospectively collected throughout.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada
- The Ottawa Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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. |
Control Arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Time to Delivery After a Code 333
Time Frame: from the time of calling in a code 333 to the time of birth (up to 1 day).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
standard clinical outcomes on patient charts
Time Frame: participants will be followed from when the code 333 was called until hospital discharge or mortality, whichever comes first (up to 3 years).
|
The clinical outcomes on patient charts include: Baby's status:
Mother clinical outcomes:
|
participants will be followed from when the code 333 was called until hospital discharge or mortality, whichever comes first (up to 3 years).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120926-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstetrical Emergency Situations
-
Johns Hopkins Bloomberg School of Public HealthNational Heart, Lung, and Blood Institute (NHLBI); Oakland UniversityRecruitingImproving Healthy Food Access in Food Insecurity Populations in Normal and Emergency SituationsUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
University of AarhusCompletedPhysiological Stress Responses to Standardises Stress Situations | Psychological Responses to Standardised Stress Situations | Behavioural Responses to Standardised Stress SituationsDenmark
-
TeamOBSAarhus University Hospital Skejby; Horsens HospitalCompletedEmergencies | Unspecified Obstetrical Trauma, With DeliveryDenmark
-
Centre Hospitalier Universitaire de NīmesWithdrawnIntravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations (PIVKIV)Renal Colic | Acute Renal ColicFrance
-
University Hospital, BrestCompletedPatients in Complex SituationsFrance
-
University Hospital, BrestCompletedPatients in Complex SituationsFrance
-
University Hospital, BrestCompleted
-
Nantes University HospitalUnknownElderly Patients in Complex SituationsFrance
-
University of VirginiaCompleted
Clinical Trials on CARD
-
University GhentFund for Scientific Research, Flanders, Belgium; International Centre for Reproductive...CompletedIntimate Partner ViolenceBelgium
-
Medical College of WisconsinCompleted
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Asociación Civil Impacta Salud...Completed
-
McMaster UniversityCompletedPolypharmacy | Medication Therapy Management | Comorbidity
-
University of AlbertaRoche Pharma AG; Institute of Health Economics, CanadaCompletedChronic Obstructive Pulmonary Disease | Pulmonary Fibrosis | Cystic Fibrosis | Pulmonary HypertensionCanada
-
Desert Orthopedic CenterNot yet recruitingJoint Diseases, Midlevel Providers, Nurse Practitioners, Physician Assistants, Patient Perceptions, Patient Preferences
-
Moorfields Eye Hospital NHS Foundation TrustCompleted
-
Wroclaw Medical UniversityWrocław University of Science and TechnologyRecruiting
-
Seattle Children's HospitalCompletedDisparities | Limited English Proficiency
-
Children's Mercy Hospital Kansas CityUniversity of South FloridaCompleted