Recruiting

Observational Study

Sponsor:

Laval University

Code:

NCT04140084

Conditions

Mild Traumatic Brain Injury

Emergencies

Decision-making

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Real-life clinical meetings

Study Details

Brief 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 suffering from a mild traumatic brain injury.

Conditions

Mild Traumatic Brain Injury

Emergencies

Decision-making

Study ID

NCT04140084

Start date

Nov 15, 2018

Status verified date

Oct, 2019

Completion date

Apr 30, 2020

Anticipated

Primary completion date

Feb 15, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Rapid-prototyping steps:

Inclusion criteria:

  • 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.

Exclusion criteria:

  • For the pediatric decision aid: Suspected case of child abuse.
  • For the adult decision aid: No exclusion criteria.

Retrospective analysis:

Inclusion criteria:

  • 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.

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Translation, Redesign and Rapid prototyping with clinicians

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.

no intervention: Rapid prototyping with patients

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.

experimental: Real-life clinical meetings

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.

no intervention: Training session developement

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.

no intervention: Retrospective analysis

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.

Interventions

Real-life clinical meetings

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.

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 ]
  • Create a training program about SDM in the context of the care of mTBI patients. [ Time Frame: meetings over a 3 months periods ]
  • Understand CT scan overuse in two hospitals. [ Time Frame: retrospective analysis during a year (10 hours/week) ]

Central Contacts and Locations

Central contacts

Patrick Archambault, MD, MSc

4188357121patrick.m.archambault@gmail.com

Locations

Centre integre de sante et de services sociaux de Chaudiere-Appalaches

Recruiting

Levis, Quebec, Canada, G6V3Z1

Contacts

Veronique Gelinas, MSc

4188357121gelinasvg@gmail.com

Principal Investigator:

Patrick Archambault, MD, MSc

More Information

Sponsor

Laval University

Last update posted

Oct 25, 2019

Last verified

Oct, 2019

Keywords

  • Emergency Department
  • Mild Traumatic Brain Injury
  • Shared decision-making
  • Decision aids
  • Head computed tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2019-10-25.