Clinical trial NCT02063087: Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Official title: Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury
Keywords: Head CT
Head Injury
Pediatric
Emergency Department
Decision Aids
Shared Decision Making
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of California, Davis
name: University of Minnesota Masonic Children's Hospital
name: Columbia University
name: Flying Buttress Associates
name: Children's Hospitals and Clinics of Minnesota
name: Nationwide Children's Hospital
name: Boston Children's Hospital
First posted: 2014-02-14
Enrollment: 971
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury
timeFrame: Day 1 (immediately after the clinical encounter)
Secondary outcomes:
measure: Patient Engagement in the Decision-making Process
timeFrame: Day 1 (during the ED visit)
measure: Decisional Conflict
timeFrame: Day 1 (immediately after the clinical encounter)
measure: Trust in the Physician
timeFrame: Day 1 (immediately after the clinical encounter)
measure: Parental Satisfaction
timeFrame: Day 1 (immediately after the clinical encounter)
measure: Proportion of Children Who Undergo Head CT
timeFrame: Day 1 (anytime during the index emergency department visit)
measure: Healthcare Utilization - Number of Tests Ordered Within 7 Days
timeFrame: 7-days
measure: Rate of Clinically Important Traumatic Brain Injury (ciTBI)
timeFrame: 7-days
measure: Fidelity - Options for Care
timeFrame: Day 1
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of MN, Minneapolis
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospitals and Clincis of MN, St Paul ED
state: Minnesota
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Mayo Clinic
name: M.Fernanda Bellolio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14.
citation: Hess EP, Homme JL, Kharbanda AB, Tzimenatos L, Louie JP, Cohen DM, Nigrovic LE, Westphal JJ, Shah ND, Inselman J, Ferrara MJ, Herrin J, Montori VM, Kuppermann N. Effect of the Head Computed Tomography Choice Decision Aid in Parents of Children With Minor Head Trauma: A Cluster Randomized Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182430. doi: 10.1001/jamanetworkopen.2018.2430.
citation: Hess EP, Wyatt KD, Kharbanda AB, Louie JP, Dayan PS, Tzimenatos L, Wootton-Gorges SL, Homme JL, Pencille R N L, LeBlanc A, Westphal JJ, Shepel K, Shah ND, Branda M, Herrin J, Montori VM, Kuppermann N. Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial. Trials. 2014 Jun 25;15:253. doi: 10.1186/1745-6215-15-253.