Obstetrical Emergency SituationsNCT02093078
Cognitive Aids With Roles Defined (CARD) for Obstetrical Crises: A Multisite Cohort Study
An observational study of Obstetrical Emergency Situations, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstetrical Emergency Situations
- What is being tested?
- CARD
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 346 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Obstetrical Emergency Situations
- Being tested
- CARD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CARD | |
| Control Arm | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The clinical outcomes on patient charts include:
Baby's status:
- Apgar score, at 1 and 5 minutes
- Arterial potential hydrogen (pH) of the cord at birth
- Unplanned admission to intensive care for the baby
- Infant status at 1 hour of age
- Length of stay of the baby in hospital
- Mortality
Mother clinical outcomes:
- Unplanned admission to ICU for the mother
- Length of stay of the mother in hospital
- Mortality
Measured: participants will be followed from when the code 333 was called until hospital discharge or mortality, whichever comes first (up to 3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetrical Emergency SituationsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Sylvain Boet, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093078
- Sponsor's protocol ID
- 20120926-01H
- Status last verified
- Sep 2018
- First submitted
- 7 Feb 2014
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Aids With Roles Defined (CARD) for Obstetrical Crises: A Multisite Cohort Study
- ClinicalTrials.gov ID
- NCT02093078
- Acronym / sponsor ID
- 20120926-01H
- Conditions
- Obstetrical Emergency Situations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, The Ottawa Hospital Academic Medical Association
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARD | – | Behavioral: CARDIntervention: 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- must hold a staff position at The Ottawa Hospital (Civic or General campus) in one of the following positions:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARDIntervention: 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. | Behavioural | CARD |
Primary outcome
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Boet, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetrical Emergency Situations, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.