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

NCT04140084 | Unknown

• 1 other identifier: 2017-393 - WikiDécisionTDM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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)

Study Arms (5)

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.

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.

Interventions

Real-life clinical meetings DEVICE

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.

Real-life clinical meetings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• For the pediatric decision aid: Suspected case of child abuse.
• Retrospective analysis:
• 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.
• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Lévis, Quebec, G6V3Z1, Canada

RECRUITING

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MeSH Terms

Conditions

Brain Concussion; Emergencies

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patrick Archambault, MD, MSc

CONTACT

4188357121; patrick.m.archambault@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 25, 2019
• Study Start: November 15, 2018
• Primary Completion: February 15, 2020
• Study Completion: April 30, 2020
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)