Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-004659
NCT ID: NCT02063087
Sponsor Protocol Number: 13-004659
About this study
The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Parents and their child, seeking care for a child who:
- Is < 18 years of age;
- Had blunt trauma above the eyebrows (not isolated to face or eyes);
- Is positive for at least 1 of the PECARN clinical prediction rule predictors described below:
- PECARN Predictors for children < 2 years of age:
- Severe mechanism (PECARN definition)*
- Loss of consciousness > 5 seconds
- Acting abnormally per parent
- Initial ED GCS < 15 by attending (or CT decision-maker)
- Other signs of altered mental status (PECARN definition)
- Presence of occipital, temporal or parietal scalp hematoma
- Palpable skull fracture or unclear if skull fracture
- PECARN predictors for children 2-18 years of age:
- Severe mechanism (PECARN definition)*
- Any loss of consciousness
- Any vomiting since the injury
- Severe headache in ED
- Initial ED GCS < 15 by attending (or CT decision-maker)
- Other signs of altered mental status (PECARN definition)**
- Any sign of basilar skull fracture
Clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma
Exclusion Criteria:
Parents of children with:
- Palpable/unclear skull fracture or signs of basilar skull fracture on physical examination
- Penetrating trauma (e.g., gunshot, stab)
- GCS score < 14 or other signs of altered mental status (PECARN definition)
- > 24 hours since the injury
- Brain tumors
- Ventricular shunts
- Bleeding disorder
- Pre-existing neurological disorders complicating assessment
- Syncope or seizure that preceded (led to) head trauma
- Patient known to be pregnant
- Neuroimaging at an outside hospital before transfer
- Patient has 3 or more PECARN risk factors
- Parent(s) have, in their clinician's best judgment, communication barriers such as visual or hearing impairment that preclude use of the decision aid
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Nilay Shah, Ph.D. |
Closed for enrollment |
|
More information
Publications
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CT imaging of head-injured children has risks of radiation-induced malignancy. Our aim was to identify children at very low risk of clinically-important traumatic brain injuries (ciTBI) for whom CT might be unnecessary.
Read More on PubMed