NCT04140084

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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: 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.

Conditions

• Mild Traumatic Brain Injury
• Emergencies
• Decision-making

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-15
• Primary completion: 2020-02-15
• Completion: 2020-04-30
• First posted: 2019-10-25
• Last updated: 2019-10-25

Locations

1 site across 1 country: Canada