Cognitive AidsNCT02440607
Effect of an Electronic Cognitive Aid Versus Static Cognitive Aid on the Management of a Simulated Crisis
A study testing Electronic Cognitive Aid and Static Cognitive Aid in people with Cognitive Aids, run by Endeavor Health at 1 site in United States.
Trial summary
Clinical decision support tools with in the electronic medical record can improve clinical care processes. To date, there is little evidence evaluating crisis management with such decision support tools. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cognitive Aids
- What is being tested?
- Electronic Cognitive Aid and Static Cognitive Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- resident physicians training in Anesthesia
Who cannot join
- Non resident anesthesia providers
Trial locations and contacts
1 site in 1 country.
United States1 site
Grainger Center for Simulation
Evanston, Illinois, 60201
About this study
Official title: The Effect of an Electronic Dynamic Cognitive Aid Versus a Static Cognitive Aid on the Management of a Simulated Crisis
Clinical decision support tools with in the electronic medical record can improve clinical care processes. To date, there is little evidence evaluating crisis management with such decision support tools. The investigators aim to create an electronic cognitive aid with embedded decision support to aid clinicians during the management of a crisis. In order to test the effectiveness of this tool, investigators seek to compare the simulated medical management of a crisis (malignant hyperthermia) using a traditional cognitive aid (laminated card) versus a dynamic electronic visual aid with decision support.
- Conditions
- Cognitive Aids
- Being tested
- Electronic Cognitive Aid, Static Cognitive Aid
- Keywords
- Randomization, cognitive aids types, aids
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Cognitive AidOther
Static Cognitive AidOther
| Study group | Role | What they receive |
|---|---|---|
| Electronic aid | Experimental | The dynamic aid will consist of a centralized electronic aid embedded within a simulated EMR. Receives: Other: Electronic Cognitive Aid |
| Static Cognitive aid | Active comparator | The static aid represents the standard algorithm put forth by a leading clinical care organization. Receives: Other: Static Cognitive Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on Task Checklist
Number of tasks successfully performed as rated on video review
Measured: Time 0-30min
Anesthesia Nontechnical skills score
Overall performance score; Video of management of crisis will be reviewed after completion of the scenario.
Measured: Time0-30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive AidsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440607
- Sponsor's protocol ID
- EH15-111
- Status last verified
- Sep 2019
- First submitted
- 22 Apr 2015
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Shear TD, Deshur M, Benson J, Houg S, Wang C, Katz J, Aitchison P, Ochoa P, Wang E, Szokol J. The Effect of an Electronic Dynamic Cognitive Aid Versus a Static Cognitive Aid on the Management of a Simulated Crisis: A Randomized Controlled Trial. J Med Syst. 2018 Nov 22;43(1):6. doi: 10.1007/s10916-018-1118-z.
PubMed 30467609
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Electronic Dynamic Cognitive Aid Versus a Static Cognitive Aid on the Management of a Simulated Crisis
- ClinicalTrials.gov ID
- NCT02440607
- Acronym / sponsor ID
- EH15-111
- Conditions
- Cognitive Aids
- Keywords
- Randomization, cognitive aids types, aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 May 2015 (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.
Clinical decision support tools with in the electronic medical record can improve clinical care processes. To date, there is little evidence evaluating crisis management with such decision support tools. The investigators aim to create an electronic cognitive aid with embedded decision support to aid clinicians during the management of a crisis. In order to test the effectiveness of this tool, investigators seek to compare the simulated medical management of a crisis (malignant hyperthermia) using a traditional cognitive aid (laminated card) versus a dynamic electronic visual aid with decision support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic aid | Experimental | Other: Electronic Cognitive AidThe dynamic aid will consist of a centralized electronic aid embedded within a simulated EMR. |
| Static Cognitive aid | Active comparator | Other: Static Cognitive AidThe static aid represents the standard algorithm put forth by a leading clinical care organization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- resident physicians training in Anesthesia
Key exclusion criteria (1 listed)
- Non resident anesthesia providers
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 |
|---|---|---|
| Electronic Cognitive Aid | Other | Electronic aid |
| Static Cognitive Aid | Other | Static Cognitive aid |
Primary outcome
Performance on Task Checklist
Time frame: Time 0-30min
Number of tasks successfully performed as rated on video review
Anesthesia Nontechnical skills score
Time frame: Time0-30min
Overall performance score; Video of management of crisis will be reviewed after completion of the scenario.
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 11 Sep 2019.
- Derived from this study: PubMed 30467609Shear TD, Deshur M, Benson J, Houg S, Wang C, Katz J, Aitchison P, Ochoa P, Wang E, Szokol J. The Effect of an Electronic Dynamic Cognitive Aid Versus a Static Cognitive Aid on the Management of a Simulated Crisis: A Randomized Controlled Trial. J Med Syst. 2018 Nov 22;43(1):6. doi: 10.1007/s10916-018-1118-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Cognitive Aid and Static Cognitive Aid in people with Cognitive Aids, run by Endeavor Health at 1 site in United States.
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 1 inclusion and 1 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 11 Sep 2019. 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 United States. 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?
Performance on Task Checklist (time frame: Time 0-30min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440607, which also lists 1 linked publication.
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 11 Sep 2019.