Traumatic Brain InjuryNCT03565549
VAGABOND: a Mnemonic to Aid in the Memory Retention of the Canadian CT Head Rule
A study testing Mnemonic and CCHR rule in people with Traumatic Brain Injury and Education, run by Sultan Qaboos University at 1 site in Oman.
Trial summary
The aim of this study is to assess the effectiveness and usefulness of a simple one word mnemonic in the memory retention of the different components of the Canadian CT Head Rule (CCHR) in senior medical students and interns. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Traumatic Brain Injury, Education
- What is being tested?
- Mnemonic and CCHR rule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteOman
- Study dates
- 1 Dec 2018to 1 Sep 2019
- 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all final year medical students and interns
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VAGABOND: a Mnemonic to Aid in the Memory Retention of the Canadian CT Head Rule for Patients With Minor Head Injury: A Randomized Controlled Trial on Interns and Senior Medical Students
The aim of this study is to assess the effectiveness and usefulness of a simple one word mnemonic in the memory retention of the different components of the Canadian CT Head Rule (CCHR) in senior medical students and interns. The CCHR, a clinical decision rule used by emergency physicians to determine the need of head CT in the context of minor traumatic brain injury (mTBI). A rapid recall of the rule in the clinical setting would be expected to improve its utilization and overcome one of the barriers in its implementation. This would ultimately result in better utilization of resources and reduction in unnecessary exposure to radiation.
Read the detailed description
Introduction
Minor head injury is a serious public health problem. It is defined as a history of loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale (GCS) score of 13-15 [1]. Patients with minor head injury are frequently encountered in the emergency department and the outpatient settings [2]. In the United States, it is estimated that each year there are about 1.2 million Emergency Department (ED) visits and 800,000 visits to the outpatient setting related to minor head injury [2]. Although most patients with minor head injury can be discharged without sequelae after observation, a small proportion deteriorates and requires neurosurgical intervention for intracranial pathology [3]. Therefore, early diagnosis of such injuries by computed tomography (CT) followed by early surgery is very important in the treatment of those patients. Therefore, when faced with such situation, clinicians have to make the decision whether further investigation in the form of CT imaging of the head is necessary to rule out an intracranial lesion. Not imaging a minor head injury could potentially lead to significant consequences if an intracranial pathology is missed. On the other hand, imaging all patients will lead to unacceptable exposure to ionizing radiation and waste valuable health resources.
Clinical decision rules (CDRs) are tools that attempt to formally test, simplify, and increase the accuracy of clinicians' diagnostic and prognostic assessments. They guide clinicians, establish pretest probability, provide screening tests for common problems, and estimate risk [4]. A number of CDRs have been developed to guide clinicians dealing with minor head injuries on deciding whether CT scan of the head is indicated or not [1,5,6,7,8,9,10,11,12]. Among the multitude of CDRs, the Canadian CT Head Rule (CCHR) has been repeatedly shown to be useful with good sensitivity and specificity [13,14]. It was first developed and tested among 3212 patients with head injuries in 10 Canadian institutions between 1996 and 1999 and published in 2001[1].
The CCHR consists of five high-risk factors (failure to reach GCS of 15 within 2 h, suspected open skull fracture, any sign of basal skull fracture, vomiting ≥2 episodes, or age ≥65 years) and two additional medium-risk factors (amnesia before impact >30 min and dangerous mechanism of injury). The high-risk factors are 100% sensitive for predicting need for neurological intervention, and would require only 32% of patients to undergo CT. The medium-risk factors are 98·4% sensitive and 49·6% specific for predicting clinically important brain injury, and would require only 54% of patients to undergo CT [1].
Despite its demonstrated validity, awareness and use of the rule remains low in many parts of the developed world, including Canada [15]. In fact there is evidence that implementation of the rule did not lead to a reduction in emergency department use of CT imaging and in some occasions there was actually an increase over time in use of CT scans [16]. Several barriers of implementation have been suggested. One of these is physicians' forgetting the details of the rule at the bedside [17]. Having a simple mnemonic that acts as a memory aid to the different components of the rule may help overcome this barrier. Mnemonics have been shown to enhance retention of clinical decision rules such as the Ottawa Ankle and Foot Rules [18]. Therefore, this study proposes the hypothesis that a mnemonic to remember the CCHR will enhance retention of the components of this clinical decision rule by physicians and medical students.
Method:
This is a single-blinded randomized controlled trial to evaluate whether the use of a mnemonic would improve mid-term and long-term knowledge and retention of the CCHR. The participants will be interns and medical students from the Sultan Qaboos University and Oman Medical College. The study tool will be an online survey that will be emailed to all enrolled medical students in both institutions. The initial email will gather demographic and level of education of participants and their initial knowledge about the CCHR. Then participants will be randomized to receive either a table of the rule produced by the developers of the rule listing the CCHR and a second group will receive the mnemonic. The second email will measure the immediate retention of the rule. A follow up email six months after the randomization will assess the retention of the CCHR between the two arms of the study.
The study will aim to recruit all interns and final year medical students. The study will require at least 150 participants in each arm in order to attain 95% power in detecting a 5% difference between variable of the two arms. Randomization will be done using a software program.
The mnemonic VAGABOND will be used to enhance students' retention of the CCHR in this study. The mnemonic stands for:
V for Vomiting more than 2 times A for Amnesia G for GCS less than 15 for more than 2 hours A for Age more than 65 years B for Basal skull fracture ON for OpeN skull fracture D for Dangerous mechanism
The questionnaires are accessible on the following weblinks:
https://docs.google.com/forms/d/1Q3EltuGLuedWJ6w7mzbXi8j4VXCW7vMnq6ThI-rAtVo/edit?ts=5b08ccb1
https://docs.google.com/forms/d/17QbSQEWdqb97Qhlz2hA5gnAIMDcJkHB5bsK8EL4mG5s/edit
Data will be directly entered into a pre-populated Statistical Package for Social Sciences (SPSS) datasheet. The study will present a descriptive analysis of all the variables collected. In order to assess the significance of differences in the variables between the two arms of participants, a series of Chi-Square tests and the Fisher exact tests will be used where appropriate. The Statistical Package for Social Sciences (SPSS) software will be utilized in the data analysis
Implications:
The study will assess whether the use of a mnemonic enhances the awareness of a clinical decision rule among interns and medical students. It will highlight the value of using simple mnemonics in teaching clinical decision-making. Such data is valuable for medical educators in other settings where critical clinical decisions can be made based on available rules.
- Conditions
- Traumatic Brain Injury, Education
- Being tested
- Mnemonic, CCHR rule
- Keywords
- Brain, Trauma, Medical education, Emergency department
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MnemonicBehavioural
A mnemonic used as a memory aid
CCHR ruleBehavioural
A list of the CCHR items
| Study group | Role | What they receive |
|---|---|---|
| Mnemonic | Experimental | Intervention group will receive a mnemonic aid to remember the CCHR Receives: Behavioral: Mnemonic |
| CCHR rule | Active comparator | The control group will receive the CCHR only Receives: Behavioral: CCHR rule |
What is being measured
The primary outcome is the main question the study is designed to answer.
memory retention of the Canadian CT Head Rule
the effectiveness and usefulness of a simple one word mnemonic in the memory retention of the different components of the Canadian CT Head Rule
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Dec 2018
- Primary completion1 Apr 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Al Kashmiri, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565549
- Sponsor's protocol ID
- SultanQU
- Status last verified
- Mar 2020
- First submitted
- 11 Jun 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAGABOND: a Mnemonic to Aid in the Memory Retention of the Canadian CT Head Rule for Patients With Minor Head Injury: A Randomized Controlled Trial on Interns and Senior Medical Students
- ClinicalTrials.gov ID
- NCT03565549
- Acronym / sponsor ID
- SultanQU
- Conditions
- Traumatic Brain Injury, Education
- Keywords
- Brain, Trauma, Medical education, Emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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.
The aim of this study is to assess the effectiveness and usefulness of a simple one word mnemonic in the memory retention of the different components of the Canadian CT Head Rule (CCHR) in senior medical students and interns. The CCHR, a clinical decision rule used by emergency physicians to determine the need of head CT in the context of minor traumatic brain injury (mTBI). A rapid recall of the rule in the clinical setting would be expected to improve its utilization and overcome one of the barriers in its implementation. This would ultimately result in better utilization of resources and reduction in unnecessary exposure to radiation.
Detailed description
Introduction
Minor head injury is a serious public health problem. It is defined as a history of loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale (GCS) score of 13-15 [1]. Patients with minor head injury are frequently encountered in the emergency department and the outpatient settings [2]. In the United States, it is estimated that each year there are about 1.2 million Emergency Department (ED) visits and 800,000 visits to the outpatient setting related to minor head injury [2]. Although most patients with minor head injury can be discharged without sequelae after observation, a small proportion deteriorates and requires neurosurgical intervention for intracranial pathology [3]. Therefore, early diagnosis of such injuries by computed tomography (CT) followed by early surgery is very important in the treatment of those patients. Therefore, when faced with such situation, clinicians have to make the decision whether further investigation in the form of CT imaging of the head is necessary to rule out an intracranial lesion. Not imaging a minor head injury could potentially lead to significant consequences if an intracranial pathology is missed. On the other hand, imaging all patients will lead to unacceptable exposure to ionizing radiation and waste valuable health resources.
Clinical decision rules (CDRs) are tools that attempt to formally test, simplify, and increase the accuracy of clinicians' diagnostic and prognostic assessments. They guide clinicians, establish pretest probability, provide screening tests for common problems, and estimate risk [4]. A number of CDRs have been developed to guide clinicians dealing with minor head injuries on deciding whether CT scan of the head is indicated or not [1,5,6,7,8,9,10,11,12]. Among the multitude of CDRs, the Canadian CT Head Rule (CCHR) has been repeatedly shown to be useful with good sensitivity and specificity [13,14]. It was first developed and tested among 3212 patients with head injuries in 10 Canadian institutions between 1996 and 1999 and published in 2001[1].
The CCHR consists of five high-risk factors (failure to reach GCS of 15 within 2 h, suspected open skull fracture, any sign of basal skull fracture, vomiting ≥2 episodes, or age ≥65 years) and two additional medium-risk factors (amnesia before impact >30 min and dangerous mechanism of injury). The high-risk factors are 100% sensitive for predicting need for neurological intervention, and would require only 32% of patients to undergo CT. The medium-risk factors are 98·4% sensitive and 49·6% specific for predicting clinically important brain injury, and would require only 54% of patients to undergo CT [1].
Despite its demonstrated validity, awareness and use of the rule remains low in many parts of the developed world, including Canada [15]. In fact there is evidence that implementation of the rule did not lead to a reduction in emergency department use of CT imaging and in some occasions there was actually an increase over time in use of CT scans [16]. Several barriers of implementation have been suggested. One of these is physicians' forgetting the details of the rule at the bedside [17]. Having a simple mnemonic that acts as a memory aid to the different components of the rule may help overcome this barrier. Mnemonics have been shown to enhance retention of clinical decision rules such as the Ottawa Ankle and Foot Rules [18]. Therefore, this study proposes the hypothesis that a mnemonic to remember the CCHR will enhance retention of the components of this clinical decision rule by physicians and medical students.
Method:
This is a single-blinded randomized controlled trial to evaluate whether the use of a mnemonic would improve mid-term and long-term knowledge and retention of the CCHR. The participants will be interns and medical students from the Sultan Qaboos University and Oman Medical College. The study tool will be an online survey that will be emailed to all enrolled medical students in both institutions. The initial email will gather demographic and level of education of participants and their initial knowledge about the CCHR. Then participants will be randomized to receive either a table of the rule produced by the developers of the rule listing the CCHR and a second group will receive the mnemonic. The second email will measure the immediate retention of the rule. A follow up email six months after the randomization will assess the retention of the CCHR between the two arms of the study.
The study will aim to recruit all interns and final year medical students. The study will require at least 150 participants in each arm in order to attain 95% power in detecting a 5% difference between variable of the two arms. Randomization will be done using a software program.
The mnemonic VAGABOND will be used to enhance students' retention of the CCHR in this study. The mnemonic stands for:
V for Vomiting more than 2 times A for Amnesia G for GCS less than 15 for more than 2 hours A for Age more than 65 years B for Basal skull fracture ON for OpeN skull fracture D for Dangerous mechanism
The questionnaires are accessible on the following weblinks:
https://docs.google.com/forms/d/1Q3EltuGLuedWJ6w7mzbXi8j4VXCW7vMnq6ThI-rAtVo/edit?ts=5b08ccb1
https://docs.google.com/forms/d/17QbSQEWdqb97Qhlz2hA5gnAIMDcJkHB5bsK8EL4mG5s/edit
Data will be directly entered into a pre-populated Statistical Package for Social Sciences (SPSS) datasheet. The study will present a descriptive analysis of all the variables collected. In order to assess the significance of differences in the variables between the two arms of participants, a series of Chi-Square tests and the Fisher exact tests will be used where appropriate. The Statistical Package for Social Sciences (SPSS) software will be utilized in the data analysis
Implications:
The study will assess whether the use of a mnemonic enhances the awareness of a clinical decision rule among interns and medical students. It will highlight the value of using simple mnemonics in teaching clinical decision-making. Such data is valuable for medical educators in other settings where critical clinical decisions can be made based on available rules.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mnemonic | Experimental | Behavioral: MnemonicIntervention group will receive a mnemonic aid to remember the CCHR |
| CCHR rule | Active comparator | Behavioral: CCHR ruleThe control group will receive the CCHR only |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all final year medical students and interns
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| MnemonicA mnemonic used as a memory aid | Behavioural | Mnemonic |
| CCHR ruleA list of the CCHR items | Behavioural | CCHR rule |
Primary outcome
memory retention of the Canadian CT Head Rule
Time frame: 6 months
the effectiveness and usefulness of a simple one word mnemonic in the memory retention of the different components of the Canadian CT Head Rule
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 31 Mar 2020.
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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 Mnemonic and CCHR rule in people with Traumatic Brain Injury and Education, run by Sultan Qaboos University at 1 site in Oman.
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 31 Mar 2020. 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 Oman. 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?
memory retention of the Canadian CT Head Rule (time frame: 6 months). 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 31 Mar 2020.