Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Head Injury
Bottom Line
View on ClinicalTrials.gov: NCT02063087 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Head CT Decision Aid (Other)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury |
6.2; 5.26 | — |
| SECONDARY Patient Engagement in the Decision-making Process |
25; 13.3 | — |
| SECONDARY Decisional Conflict |
14.8; 19.2 | — |
| SECONDARY Trust in the Physician |
91.5; 89.3 | — |
| SECONDARY Parental Satisfaction |
254; 210 | — |
| SECONDARY Proportion of Children Who Undergo Head CT |
109; 116 | — |
| SECONDARY Healthcare Utilization - Number of Tests Ordered Within 7 Days |
1.84; 1.88; 0.65; 0.88; 0.41; 0.7 | — |
| SECONDARY Rate of Clinically Important Traumatic Brain Injury (ciTBI) |
0; 1 | — |
| SECONDARY Fidelity - Options for Care |
259; 0; 251; 0; 89; 0 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Parents and their child, seeking care for a child who:
- Is 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:
- GCS scores < 15
- Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination
- Brain tumors
- Ventricular shunts
- Bleeding disorder
- Pre-existing neurological disorders complicating assessment
- Neuroimaging at an outside hospital before transfer
- Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication)
- Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma
- Known to be pregnant
- Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.
- Strong suspicion of abuse for this head injury
Data sourced from ClinicalTrials.gov (NCT02063087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.