Mild Traumatic Brain InjuryNCT04140084
Wiki Head CT Choice Study: Adaptation of US Two Decision Aids to a Québec Local Context
A study testing Real-life clinical meetings in people with Mild Traumatic Brain Injury and Emergencies, run by Laval University at 1 site in Canada.
Trial summary
This study aims to adapt two decision aids (DAs) (pediatric and adult) developed in the United States to the Quebec context to develop context-adapted tools and training program that will facilitate the process of shared decision-making while taking a decision to use head computed tomography (CT scan) with patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Emergencies, Decision-making
- What is being tested?
- Real-life clinical meetings
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2018to 30 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the pediatric decision aid: Parents seeking care for a child or an adolescent that are less than 18 years old. The child must have experienced blunt head trauma (above the eyebrows and not isolated to face or eyes).The child must have at least one of the PECARN risk factors for clinically important TBI (except for the two higher risk variables of altered mental status or signs of skull fracture).
- For the adult decision aid: Adult participants that have had a diagnosis of mTBI before the interview or having a mTBI to be diagnosed by the physician at the moment and needs to make a decision about having a CTs.
- Eligible clinicians will be attending physicians, fellows, and residents caring for children or adult with minor head trauma.
- Children that have experienced blunt head trauma (above the eyebrows and not isolated to face or eyes).
- Children that have at least one of the PECARN risk factors for clinically important TBI (except for the two higher risk variables of altered mental status or signs of skull fracture).
- Adults who have experienced blunt head trauma (above the eyebrows and not isolated to face or eyes) within 24 hours without any of the high risk or medium risk CCHR criteria that mandate performing a head CT.
Who cannot join
- For the pediatric decision aid: Suspected case of child abuse.
- For the adult decision aid: No exclusion criteria.
- Retrospective analysis:
- Children with signs of skull fracture, GCS < 15 or other signs of altered mental status, brain tumour, penetrating head trauma, bleeding disorder or coagulopathy, ventricular shunt, preexisting neurological disease, syncope or seizure that preceded the head trauma, transferred to the ED with imaging already obtained, known pregnancy, suspected abuse, or > 2 PECARN risk factors.
- Adults that have a Glasgow coma scale less than 13, an obvious open skull fracture, take oral anticoagulants, or antiplatelet agents (excluding aspirin), or have a bleeding disorder, no causal factor of trauma (i.e. epilepsy, cardiac arrest), pregnancy, came back to emergency for the same head injury, no symptoms of head injury.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre integre de sante et de services sociaux de Chaudiere-Appalaches
Lévis, Quebec, G6V3Z1
Veronique Gelinas, MSc, 4188357121 ext. 6293, gelinasvg@gmail.com
Patrick Archambault, MD, MSc
About this study
Official title: Wiki Head CT Choice Study: Adaptation of Two Decision Aids to Support Shared Decision Making About Performing a Head CT for Adult and Pediatric Victims of Mild Traumatic Brain Injury
This study aims to adapt two decision aids (DAs) (pediatric and adult) developed in the United States to the Quebec context to develop context-adapted tools and training program that will facilitate the process of shared decision-making while taking a decision to use head computed tomography (CT scan) with patients suffering from a mild traumatic brain injury.
Read the detailed description
Background: Mild traumatic brain injury (mTBI) is among the most common neurological conditions with an estimated annual incidence rate of 450 to 650/100,000 in Canada. Head computed tomography (CT) scans are used as the reference standard test to rule out life-threatening complications, such as intracranial hemorrhage, but present potential exposition risks for the patient. Despite the use of clinical decision rules (Canadian Head CT Rule; Pediatric Head Injury/Trauma Algorithm (PECARN)), head CTs remain overused. Two decision aids (pediatric and adult) developed in the United States (U.S.) may help reduce the use of CTs for mTBI.
The goal of this study is to address the challenges of adapting two existing decision aids to local contexts. Stakeholders, including patients, or parents of patients, will be involved in adapting and validating the two existing decision aids to a local context and to create a training program about shared decision-making (SDM) in trauma care.
Objectives:
- Translate two decision aids for head CTs (pediatric and adult) developed in the United States and adapt them to the Quebec context;
- Create training for Emergency Medicine professionals on adopting decision aids with mTBI patients;
- Measure the appropriate use of CTs in two hospitals(CHU de Sainte-Justine, Hotel-Dieu de Levis) before implementing the tools.
Methods:
Phase 1 will be the translation and adaptation of two decision aids to support decision-making about performing a head CT for adult and pediatric mTBI using an iterative user-centered approach. (Translation of the decision aids on the use of CT scans for mTBI (pediatric and adult) produced in the United States; simple ethnographic observation of the interactions of emergency health professionals and mTBI patients to understand the needs of patients, family members and health professionals in deciding to conduct a head CT for mTBI patients for the redesign of the tools; rapid prototyping of our different decision aids using interviews and real-life clinical encounters.)
Phase 2 will be the development of a training session for healthcare professionals.
Phase 3 will be a retrospective analysis of medical records to evaluate the use of head CT for mTBI patients in two hospitals (pediatric and adult).
Expected results:
This study will adapt two decision aids to the context of trauma care in Quebec and create a training program about shared decision-making and decision aids in the context of the care of mTBI patients. The final content and user interface of the decision aid/training session will be influenced by the multiple comments received from the participants in this study. This novel online and in -person training program will be instrumental in implementing our novel decision aid in practice. The results generated from the implementation of the intervention will help other centers in Quebec, Canada and abroad use the educational program and decision aid. The results of this research project will contribute to the enhancement of many research fields such as the involvement of end- users in the development process of decision aids. This research project will offer new learning opportunities for graduate students to study how collaboration among multiple stakeholders can improve patient outcomes and how to develop patient- centered tools that respond to their needs and those of the clinicians that care for them. Finally, this project will advance our understanding of the use of shared decision-making and decision aids in the field of trauma care.
- Conditions
- Mild Traumatic Brain Injury, Emergencies, Decision-making
- Being tested
- Real-life clinical meetings
- Keywords
- Emergency Department, Mild Traumatic Brain Injury, Shared decision-making, Decision aids, Head computed tomography
- Medical subject headings
- Brain Concussion, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-life clinical meetingsDevice
Study coordinators will identify potentially eligible parent/patient dyads and adult patients based on a chief complaint related to head trauma recorded at the time of ED registration and communication with treating clinicians in realtime. After using the decision aid with their health professional, a cognitive interview session will then be organized with the dyads of participants (parents/patients and clinicians) to address any usability issues. These interviews will be audio recorded and transcribed verbatim for content analysis and future reference. This process will allow to identify any conceptual barriers and unanticipated user needs. Written consent form will be signed by participants.
| Study group | Role | What they receive |
|---|---|---|
| Translation, Redesign and Rapid prototyping with clinicians | No intervention | This step includes a translation of the tools (English to French) and a redesign work of the original tools. Then, the study will include clinicians (at least 20) from two healthcare settings (CHU Sainte-Justine, and the CISSS-CA (Hotel-Dieu de Levis). After a presentation of the two tools during the Emergency Physicians' departmental meetings, the written comments about the prototype version will be collected. A revision of the prototypes is scheduled at the end of this step. |
| Rapid prototyping with patients | No intervention | This step will include the assessment of the tools by patients (or parents of patients) that have had a previous mTBI at the CISSS-CA (Hotel-Dieu de Levis). The comments about the adult and pediatric prototypes (5 adult patients, 5 parents of pediatric patients) will be collected through interviews. A revision of the prototypes is scheduled at the end of this step. |
| Real-life clinical meetings | Experimental | This step will include a presentation of the tools to 5 emergency physicians so that they can use the tools with patients (5 adults, 5 parents of pediatric patients) in a realistic setting to identify any problems of use. The clinicians and patients that had used the tools during the clinical encounters will be then met during cognitive interviews to collect their comments on the tools and to address any usability issues. A final revision of the prototypes is scheduled at the end of this step. Receives: Device: Real-life clinical meetings |
| Training session developement | No intervention | This step includes the development of a training session on how to perform SDM with patients facing the decision to undergo head CTs for mTBI and about how to use our newly developed decision aids in this clinical setting. The content of the training session will be adapted to the needs, goals, strengths and limitations observed during the focus groups (departmental meetings) exploring health professionals' barriers to using a decision aid about head CTs in mTBI. The expertise of SAVIE (www.savie.ca) in producing online and interactive elearning programs will be mobilized in order to produce a training program that will integrate the content the investigators will have identified as the main skills, knowledge and competencies needing development among our health professionals to stimulate the use of SDM and our decision aids. SAVIE will produce a virtual elearning program adaptable to all media (PC, mobile device, tablet) and different health professionals. |
| Retrospective analysis | No intervention | This step will retrospectively analyze the medical records of traumatic brain injury adult patients (adult, 350, Hotel-Dieu de Levis) and pediatric patients (406, CHU de Sainte-Justine and Hotel-Dieu de Levis)) randomly selected throughout the year preceding this study in each of the two centers to determine the rate of head CT ordering, the head CT result and the appropriateness of having ordered the head CT based on the CCHR and PECARN criteria. One reviewer will judge the appropriateness of having done a CT scan according to the CCHR and PECARN criteria based on a structured extraction form that will previously be approved by the study's steering committee. To ensure validity, 10% of the analysis will be reviewed by an expert. The reviewer will look at prehospital data collection, triage information, physician's notes, nursing notes and head CT requisition form information to determine if any of the clinical decision rule criteria are present. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapting two decision aids to the context of trauma care in Quebec.
Adapting two decision aids to the context of trauma care in Quebec using interviews of 5 adult patients and 5 parents of pediatric patients and 2 focus group (during departmental meeting), as well as real-life medical encounters with 5 adult patients and 5 pediatric patients (and parents).
Measured: interviews or departmental meeting or clinical encounters with participants over a duration of one year
Create a training program about SDM in the context of the care of mTBI patients.
Create a training program about SDM in the context of the care of mTBI patients with specialists using the data and comments gathered during the rapid prototyping phase.
Measured: meetings over a 3 months periods
Understand CT scan overuse in two hospitals.
Understand CT scan overuse in two hospitals, one pediatric and one general hospital, by looking at health records (randomized samples).
Measured: retrospective analysis during a year (10 hours/week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start15 Nov 2018
- Primary completion15 Feb 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Archambault, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140084
- Sponsor's protocol ID
- 2017-393 - WikiDécisionTDM
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abras, Chadia, Diane Maloney-Krichmar, and Jenny Preece. 2004. "User-Centered Design." Bainbridge, W. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications 37 (4): 445-56.
Am., O'connor. 2006. "Ottawa Decision Support Framework to Address Decisional Conflict." 2006. https://decisionaid.ohri.ca/docs/develop/ODSF.pdf.
Archambault PM, van de Belt TH, Grajales FJ 3rd, Faber MJ, Kuziemsky CE, Gagnon S, Bilodeau A, Rioux S, Nelen WL, Gagnon MP, Turgeon AF, Aubin K, Gold I, Poitras J, Eysenbach G, Kremer JA, Legare F. Wikis and collaborative writing applications in health care: a scoping review. J Med Internet Res. 2013 Oct 8;15(10):e210. doi: 10.2196/jmir.2787.
PubMed 24103318Archambault PM. WikiBuild: a new application to support patient and health care professional involvement in the development of patient support tools. J Med Internet Res. 2011 Dec 8;13(4):e114. doi: 10.2196/jmir.1961.
PubMed 22155746Archambault PM, Bilodeau A, Gagnon MP, Aubin K, Lavoie A, Lapointe J, Poitras J, Croteau S, Pham-Dinh M, Legare F. Health care professionals' beliefs about using wiki-based reminders to promote best practices in trauma care. J Med Internet Res. 2012 Apr 19;14(2):e49. doi: 10.2196/jmir.1983.
PubMed 22515985Archambault PM, Gagnon S, Gagnon MP, Turcotte S, Lapointe J, Fleet R, Cote M, Beaupre P, Le Sage N, Emond M, Legare F. Development and validation of questionnaires exploring health care professionals' intention to use wiki-based reminders to promote best practices in trauma. JMIR Res Protoc. 2014 Oct 3;3(3):e50. doi: 10.2196/resprot.3762.
PubMed 25281856Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735"Choosing Wisely Canada." n.d. Choosing Wisely Canada. Five Things Physicians and Patients Should Question. Accessed June 2, 2015. http://www.choosingwiselycanada.org/recommendations/emergencymedicine/.
Curran JA, Brehaut J, Patey AM, Osmond M, Stiell I, Grimshaw JM. Understanding the Canadian adult CT head rule trial: use of the theoretical domains framework for process evaluation. Implement Sci. 2013 Feb 21;8:25. doi: 10.1186/1748-5908-8-25.
PubMed 23433082Dis, Iso. 2009. "9241-210: 2010. Ergonomics of Human System Interaction-Part 210: Human- Centred Design for Interactive Systems." International Standardization Organization (ISO). Switzerland.
Evans R, Edwards A, Brett J, Bradburn M, Watson E, Austoker J, Elwyn G. Reduction in uptake of PSA tests following decision aids: systematic review of current aids and their evaluations. Patient Educ Couns. 2005 Jul;58(1):13-26. doi: 10.1016/j.pec.2004.06.009.
PubMed 15950832Flynn D, Knoedler MA, Hess EP, Murad MH, Erwin PJ, Montori VM, Thomson RG. Engaging patients in health care decisions in the emergency department through shared decision-making: a systematic review. Acad Emerg Med. 2012 Aug;19(8):959-67. doi: 10.1111/j.1553-2712.2012.01414.x. Epub 2012 Jul 31.
PubMed 22853804Gagliardi AR, Alhabib S; members of Guidelines International Network Implementation Working Group. Trends in guideline implementation: a scoping systematic review. Implement Sci. 2015 Apr 21;10:54. doi: 10.1186/s13012-015-0247-8.
PubMed 25895908Gagliardi AR, Brouwers MC, Bhattacharyya OK. The development of guideline implementation tools: a qualitative study. CMAJ Open. 2015 Jan 13;3(1):E127-33. doi: 10.9778/cmajo.20140064. eCollection 2015 Jan-Mar.
PubMed 25844365Garrett, Jesse James. 2010. The Elements of User Experience: User-Centered Design for the Web and Beyond. Pearson Education.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wiki Head CT Choice Study: Adaptation of Two Decision Aids to Support Shared Decision Making About Performing a Head CT for Adult and Pediatric Victims of Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04140084
- Acronym / sponsor ID
- 2017-393 - WikiDécisionTDM
- Conditions
- Mild Traumatic Brain Injury, Emergencies, Decision-making
- Keywords
- Emergency Department, Mild Traumatic Brain Injury, Shared decision-making, Decision aids, Head computed tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 25 Oct 2019 (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.
This study aims to adapt two decision aids (DAs) (pediatric and adult) developed in the United States to the Quebec context to develop context-adapted tools and training program that will facilitate the process of shared decision-making while taking a decision to use head computed tomography (CT scan) with patients suffering from a mild traumatic brain injury.
Detailed description
Background: Mild traumatic brain injury (mTBI) is among the most common neurological conditions with an estimated annual incidence rate of 450 to 650/100,000 in Canada. Head computed tomography (CT) scans are used as the reference standard test to rule out life-threatening complications, such as intracranial hemorrhage, but present potential exposition risks for the patient. Despite the use of clinical decision rules (Canadian Head CT Rule; Pediatric Head Injury/Trauma Algorithm (PECARN)), head CTs remain overused. Two decision aids (pediatric and adult) developed in the United States (U.S.) may help reduce the use of CTs for mTBI.
The goal of this study is to address the challenges of adapting two existing decision aids to local contexts. Stakeholders, including patients, or parents of patients, will be involved in adapting and validating the two existing decision aids to a local context and to create a training program about shared decision-making (SDM) in trauma care.
Objectives:
- Translate two decision aids for head CTs (pediatric and adult) developed in the United States and adapt them to the Quebec context;
- Create training for Emergency Medicine professionals on adopting decision aids with mTBI patients;
- Measure the appropriate use of CTs in two hospitals(CHU de Sainte-Justine, Hotel-Dieu de Levis) before implementing the tools.
Methods:
Phase 1 will be the translation and adaptation of two decision aids to support decision-making about performing a head CT for adult and pediatric mTBI using an iterative user-centered approach. (Translation of the decision aids on the use of CT scans for mTBI (pediatric and adult) produced in the United States; simple ethnographic observation of the interactions of emergency health professionals and mTBI patients to understand the needs of patients, family members and health professionals in deciding to conduct a head CT for mTBI patients for the redesign of the tools; rapid prototyping of our different decision aids using interviews and real-life clinical encounters.)
Phase 2 will be the development of a training session for healthcare professionals.
Phase 3 will be a retrospective analysis of medical records to evaluate the use of head CT for mTBI patients in two hospitals (pediatric and adult).
Expected results:
This study will adapt two decision aids to the context of trauma care in Quebec and create a training program about shared decision-making and decision aids in the context of the care of mTBI patients. The final content and user interface of the decision aid/training session will be influenced by the multiple comments received from the participants in this study. This novel online and in -person training program will be instrumental in implementing our novel decision aid in practice. The results generated from the implementation of the intervention will help other centers in Quebec, Canada and abroad use the educational program and decision aid. The results of this research project will contribute to the enhancement of many research fields such as the involvement of end- users in the development process of decision aids. This research project will offer new learning opportunities for graduate students to study how collaboration among multiple stakeholders can improve patient outcomes and how to develop patient- centered tools that respond to their needs and those of the clinicians that care for them. Finally, this project will advance our understanding of the use of shared decision-making and decision aids in the field of trauma care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Translation, Redesign and Rapid prototyping with clinicians | No intervention | –This step includes a translation of the tools (English to French) and a redesign work of the original tools. Then, the study will include clinicians (at least 20) from two healthcare settings (CHU Sainte-Justine, and the CISSS-CA (Hotel-Dieu de Levis). After a presentation of the two tools during the Emergency Physicians' departmental meetings, the written comments about the prototype version will be collected. A revision of the prototypes is scheduled at the end of this step. |
| Rapid prototyping with patients | No intervention | –This step will include the assessment of the tools by patients (or parents of patients) that have had a previous mTBI at the CISSS-CA (Hotel-Dieu de Levis). The comments about the adult and pediatric prototypes (5 adult patients, 5 parents of pediatric patients) will be collected through interviews. A revision of the prototypes is scheduled at the end of this step. |
| Real-life clinical meetings | Experimental | Device: Real-life clinical meetingsThis step will include a presentation of the tools to 5 emergency physicians so that they can use the tools with patients (5 adults, 5 parents of pediatric patients) in a realistic setting to identify any problems of use. The clinicians and patients that had used the tools during the clinical encounters will be then met during cognitive interviews to collect their comments on the tools and to address any usability issues. A final revision of the prototypes is scheduled at the end of this step. |
| Training session developement | No intervention | –This step includes the development of a training session on how to perform SDM with patients facing the decision to undergo head CTs for mTBI and about how to use our newly developed decision aids in this clinical setting. The content of the training session will be adapted to the needs, goals, strengths and limitations observed during the focus groups (departmental meetings) exploring health professionals' barriers to using a decision aid about head CTs in mTBI. The expertise of SAVIE (www.savie.ca) in producing online and interactive elearning programs will be mobilized in order to produce a training program that will integrate the content the investigators will have identified as the main skills, knowledge and competencies needing development among our health professionals to stimulate the use of SDM and our decision aids. SAVIE will produce a virtual elearning program adaptable to all media (PC, mobile device, tablet) and different health professionals. |
| Retrospective analysis | No intervention | –This step will retrospectively analyze the medical records of traumatic brain injury adult patients (adult, 350, Hotel-Dieu de Levis) and pediatric patients (406, CHU de Sainte-Justine and Hotel-Dieu de Levis)) randomly selected throughout the year preceding this study in each of the two centers to determine the rate of head CT ordering, the head CT result and the appropriateness of having ordered the head CT based on the CCHR and PECARN criteria. One reviewer will judge the appropriateness of having done a CT scan according to the CCHR and PECARN criteria based on a structured extraction form that will previously be approved by the study's steering committee. To ensure validity, 10% of the analysis will be reviewed by an expert. The reviewer will look at prehospital data collection, triage information, physician's notes, nursing notes and head CT requisition form information to determine if any of the clinical decision rule criteria are present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For the pediatric decision aid: Parents seeking care for a child or an adolescent that are less than 18 years old. The child must have experienced blunt head trauma (above the eyebrows and not isolated to face or eyes).The child must have at least one of the PECARN risk factors for clinically important TBI (except for the two higher risk variables of altered mental status or signs of skull fracture).
- For the adult decision aid: Adult participants that have had a diagnosis of mTBI before the interview or having a mTBI to be diagnosed by the physician at the moment and needs to make a decision about having a CTs.
- Eligible clinicians will be attending physicians, fellows, and residents caring for children or adult with minor head trauma.
- Children that have experienced blunt head trauma (above the eyebrows and not isolated to face or eyes).
- Children that have at least one of the PECARN risk factors for clinically important TBI (except for the two higher risk variables of altered mental status or signs of skull fracture).
Key exclusion criteria (5 listed)
- For the pediatric decision aid: Suspected case of child abuse.
- For the adult decision aid: No exclusion criteria.
- Children with signs of skull fracture, GCS < 15 or other signs of altered mental status, brain tumour, penetrating head trauma, bleeding disorder or coagulopathy, ventricular shunt, preexisting neurological disease, syncope or seizure that preceded the head trauma, transferred to the ED with imaging already obtained, known pregnancy, suspected abuse, or > 2 PECARN risk factors.
- Adults that have a Glasgow coma scale less than 13, an obvious open skull fracture, take oral anticoagulants, or antiplatelet agents (excluding aspirin), or have a bleeding disorder, no causal factor of trauma (i.e. epilepsy, cardiac arrest), pregnancy, came back to emergency for the same head injury, no symptoms of head injury.
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 |
|---|---|---|
| Real-life clinical meetingsStudy coordinators will identify potentially eligible parent/patient dyads and adult patients based on a chief complaint related to head trauma recorded at the time of ED registration and communication with treating clinicians in realtime. After using the decision aid with their health professional, a cognitive interview session will then be organized with the dyads of participants (parents/patients and clinicians) to address any usability issues. These interviews will be audio recorded and transcribed verbatim for content analysis and future reference. This process will allow to identify any conceptual barriers and unanticipated user needs. Written consent form will be signed by participants. | Device | Real-life clinical meetings |
Primary outcome
Adapting two decision aids to the context of trauma care in Quebec.
Time frame: interviews or departmental meeting or clinical encounters with participants over a duration of one year
Adapting two decision aids to the context of trauma care in Quebec using interviews of 5 adult patients and 5 parents of pediatric patients and 2 focus group (during departmental meeting), as well as real-life medical encounters with 5 adult patients and 5 pediatric patients (and parents).
Create a training program about SDM in the context of the care of mTBI patients.
Time frame: meetings over a 3 months periods
Create a training program about SDM in the context of the care of mTBI patients with specialists using the data and comments gathered during the rapid prototyping phase.
Understand CT scan overuse in two hospitals.
Time frame: retrospective analysis during a year (10 hours/week)
Understand CT scan overuse in two hospitals, one pediatric and one general hospital, by looking at health records (randomized samples).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- BackgroundAbras, Chadia, Diane Maloney-Krichmar, and Jenny Preece. 2004. "User-Centered Design." Bainbridge, W. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications 37 (4): 445-56.
- BackgroundAm., O'connor. 2006. "Ottawa Decision Support Framework to Address Decisional Conflict." 2006. https://decisionaid.ohri.ca/docs/develop/ODSF.pdf.
- Background: PubMed 24103318Archambault PM, van de Belt TH, Grajales FJ 3rd, Faber MJ, Kuziemsky CE, Gagnon S, Bilodeau A, Rioux S, Nelen WL, Gagnon MP, Turgeon AF, Aubin K, Gold I, Poitras J, Eysenbach G, Kremer JA, Legare F. Wikis and collaborative writing applications in health care: a scoping review. J Med Internet Res. 2013 Oct 8;15(10):e210. doi: 10.2196/jmir.2787.
- Background: PubMed 22155746Archambault PM. WikiBuild: a new application to support patient and health care professional involvement in the development of patient support tools. J Med Internet Res. 2011 Dec 8;13(4):e114. doi: 10.2196/jmir.1961.
- Background: PubMed 22515985Archambault PM, Bilodeau A, Gagnon MP, Aubin K, Lavoie A, Lapointe J, Poitras J, Croteau S, Pham-Dinh M, Legare F. Health care professionals' beliefs about using wiki-based reminders to promote best practices in trauma care. J Med Internet Res. 2012 Apr 19;14(2):e49. doi: 10.2196/jmir.1983.
- Background: PubMed 25281856Archambault PM, Gagnon S, Gagnon MP, Turcotte S, Lapointe J, Fleet R, Cote M, Beaupre P, Le Sage N, Emond M, Legare F. Development and validation of questionnaires exploring health care professionals' intention to use wiki-based reminders to promote best practices in trauma. JMIR Res Protoc. 2014 Oct 3;3(3):e50. doi: 10.2196/resprot.3762.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Background"Choosing Wisely Canada." n.d. Choosing Wisely Canada. Five Things Physicians and Patients Should Question. Accessed June 2, 2015. http://www.choosingwiselycanada.org/recommendations/emergencymedicine/.
- Background: PubMed 23433082Curran JA, Brehaut J, Patey AM, Osmond M, Stiell I, Grimshaw JM. Understanding the Canadian adult CT head rule trial: use of the theoretical domains framework for process evaluation. Implement Sci. 2013 Feb 21;8:25. doi: 10.1186/1748-5908-8-25.
- BackgroundDis, Iso. 2009. "9241-210: 2010. Ergonomics of Human System Interaction-Part 210: Human- Centred Design for Interactive Systems." International Standardization Organization (ISO). Switzerland.
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- Background: PubMed 22853804Flynn D, Knoedler MA, Hess EP, Murad MH, Erwin PJ, Montori VM, Thomson RG. Engaging patients in health care decisions in the emergency department through shared decision-making: a systematic review. Acad Emerg Med. 2012 Aug;19(8):959-67. doi: 10.1111/j.1553-2712.2012.01414.x. Epub 2012 Jul 31.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-life clinical meetings in people with Mild Traumatic Brain Injury and Emergencies, run by Laval University 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Archambault, MD, MSc (4188357121 ext. 3905, patrick.m.archambault@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adapting two decision aids to the context of trauma care in Quebec. (time frame: interviews or departmental meeting or clinical encounters with participants over a duration of one year). The study lists 3 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 NCT04140084, which also lists 54 linked publications.
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 25 Oct 2019.