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

Mayo Clinic

Status: Completed

Conditions: Head Injury

Treatments: Other: Head CT Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT02063087

FP00071515 (Other Identifier)

13-004659

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 971 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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971 participants in 2 patient groups

Decision Aid

Active Comparator group

Description:

Head CT Decision Aid

Treatment:

Other: Head CT Decision Aid

Usual Care

No Intervention group

Description:

Clinicians and patients do not have access to the Head CT Decision Aid