Wiki Head CT Choice Study: Adaptation of US Two Decision Aids to a Québec Local Context

Emergencies Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04140084
• Other study ID #: 2017-393 - WikiDécisionTDM
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2019
• Source: Laval University
• Contact: Patrick Archambault, MD, MSc
• Phone: 4188357121
• Email: patrick.m.archambault[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 suffering from a mild traumatic brain injury.

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:

1. Translate two decision aids for head CTs (pediatric and adult) developed in the United States and adapt them to the Quebec context;

2. Create training for Emergency Medicine professionals on adopting decision aids with mTBI patients;

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Decision-making
• Emergencies
• Mild Traumatic Brain Injury

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Centre integre de sante et de services sociaux de Chaudiere-Appalaches	Levis	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	interviews or departmental meeting or clinical encounters with participants over a duration of one year
Primary	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.	meetings over a 3 months periods
Primary	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).	retrospective analysis during a year (10 hours/week)