Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice



Status:Recruiting
Conditions:Hospital, Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any - 18
Updated:11/15/2017
Start Date:April 2014
End Date:September 2016
Contact:Erik Hess, MD, MSc
Email:hess.erik@mayo.edu
Phone:(507)284-7221

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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.

The investigators' long term goal is to promote evidence-based, patient-centered evaluation
in the acute setting, to more closely tailor testing to disease risk. The investigators will
compare the use of risk stratification tools with usual clinical approaches to treatment
selection or administration through the following aim:

Test if the decision aid, Head CT Choice, improves validated patient-centered outcome
measures and safely decreases healthcare utilization. The investigators will randomize at the
clinician level. Through the use of the intervention, Head CT Choice, the investigators aim
to significantly increase parents' knowledge, engagement, and satisfaction, decrease the rate
of head CT use, and decrease 7-day total healthcare utilization, with no significant increase
in adverse events.

Inclusion Criteria:

Parents and their child, seeking care for a child who:

1. Is < 18 years of age;

2. Had blunt trauma above the eyebrows (not isolated to face or eyes);

3. 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:

1. GCS scores < 15

2. Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull
fracture on physical examination

3. Brain tumors

4. Ventricular shunts

5. Bleeding disorder

6. Pre-existing neurological disorders complicating assessment

7. Neuroimaging at an outside hospital before transfer

8. Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow
response to verbal communication)

9. Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma

10. Known to be pregnant

11. Communication barriers such as visual or hearing impairment that may preclude use of
the decision aid.

12. Strong suspicion of abuse for this head injury
We found this trial at
5
sites
2450 Riverside Avenue
Minneapolis, Minnesota 55454
Principal Investigator: Jeffrey Louie, MD
Phone: 612-273-4800
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Minneapolis, Minnesota 55404
Principal Investigator: Anupam Karbanda, MD
Phone: 651-220-6000
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Minneapolis, MN
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Rochester, Minnesota 55905
Principal Investigator: Erik Hess, MD, MSc
Phone: 507-284-7221
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Rochester, MN
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Leah Tzimenatos, MD
Phone: 916-816-4542
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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St. Paul, Minnesota 55102
Principal Investigator: Anupam Karbanda, MD
Phone: 651-220-6000
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St. Paul, MN
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