Clinical trial NCT02093078: Cognitive Aids With Roles Defined (CARD) for Obstetrical Crises: A Multisite Cohort Study
Official title: Cognitive Aids With Roles Defined (CARD) for Obstetrical Crises: A Multisite Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetrical Emergency Situations
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Anesthesiologists' Society
name: The Ottawa Hospital Academic Medical Association
First posted: 2014-03-20
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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.

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.

Eligibility criteria: Inclusion Criteria:

* must hold a staff position at The Ottawa Hospital (Civic or General campus) in one of the following positions:

  1. registered nurses (RN)
  2. operating room attendant
  3. respiratory therapist (RT)
  4. assisting anesthesia
  5. RT assisting neonatal
  6. 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

Primary outcomes:
measure: Total Time to Delivery After a Code 333
timeFrame: from the time of calling in a code 333 to the time of birth (up to 1 day).
Secondary outcomes:
measure: standard clinical outcomes on patient charts
timeFrame: participants will be followed from when the code 333 was called until hospital discharge or mortality, whichever comes first (up to 3 years).
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Sylvain Boet, MD
role: PRINCIPAL_INVESTIGATOR
References: