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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Oman1 site
  • Sultan Qaboos University

    Muscat

Other trials in Oman

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.

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 groups in NCT03565549
Study groupRoleWhat they receive
MnemonicExperimentalIntervention group will receive a mnemonic aid to remember the CCHR
Receives: Behavioral: Mnemonic
CCHR ruleActive comparatorThe 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.

  1. 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.

  1. First posted21 Jun 2018
  2. Study start1 Dec 2018
  3. Primary completion1 Apr 2019
  4. Study completion1 Sep 2019

Resources

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)
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

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.

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