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Open Access Study protocol

Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial

Erik P Hess1234*, Kirk D Wyatt5, Anupam B Kharbanda6, Jeffrey P Louie7, Peter S Dayan8, Leah Tzimenatos9, Sandra L Wootton-Gorges10, James L Homme11, Laurie Pencille RN1, Annie LeBlanc134, Jessica J Westphal12, Kathy Shepel13, Nilay D Shah134, Megan Branda134, Jeph Herrin1415, Victor M Montori116 and Nathan Kuppermann9

Author Affiliations

1 Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, 55905 Rochester, MN, USA

2 Department of Emergency Medicine, Division of Emergency Medicine Research, Mayo Clinic, 200 First Street SW, 55905 Rochester, MN, USA

3 Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, 200 First Street SW, 55905 Rochester, MN, USA

4 Robert D and Patricia E Kern Center for the Science of Healthcare Delivery, Mayo Clinic, 200 First Street SW, 55902 Rochester, MN, USA

5 Mayo Medical School, Mayo Clinic College of Medicine, 200 First Street SW, 55902 Rochester, MN, USA

6 Children’s Hospitals and Clinics of Minnesota, 345 North Smith Avenue, 55102 St. Paul, MN, USA

7 University of Minnesota Amplatz Children’s Hospital, 2450 Riverside Ave, 55455 Minneapolis, MN, USA

8 Departments of Emergency Medicine and Pediatrics, Columbia University College of Physicians and Surgeons, 3959 Broadway CHN, 1-116 10032 New York, NY, USA

9 Departments of Emergency Medicine and Pediatrics, University of California Davis School of Medicine, 2315 Stockton Boulevard, 95817 Davis, CA, USA

10 Department of Radiology, University of California Davis School of Medicine, 4860 Y Street, Suite 3100, 95817 Davis, CA, USA

11 Division of Pediatric Emergency Medicine, Departments of Emergency Medicine and Pediatrics, Mayo Clinic, 200 First Street SW, 55902 Rochester, MN, USA

12 Parent Representative, Rochester, MN, USA

13 Section of Creative Media, Mayo Clinic, 200 First Street SW, 55902 Rochester, MN, USA

14 Department of Cardiology, Yale University School of Medicine, 330 Cedar St, Boardman 110, P.O. Box 208056, 06520-8056 New Haven, CT, USA

15 Health Research and Educational Trust, 1 N Franklin St, 60606 Chicago, IL, USA

16 Division of Endocrinology and Metabolism, Department of Internal Medicine, Mayo Clinic, 200 First Street SW, 55902 Rochester, MN, USA

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Trials 2014, 15:253  doi:10.1186/1745-6215-15-253

Published: 25 June 2014

Abstract

Background

Blunt head trauma is a common cause of death and disability in children worldwide. Cranial computed tomography (CT), the reference standard for the diagnosis of traumatic brain injury (TBI), exposes children to ionizing radiation which has been linked to the development of brain tumors, leukemia, and other cancers. We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home.

Methods/Design

This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid, ‘Head CT Choice’, to a control group receiving usual care. The trial will be conducted at five diverse emergency departments (EDs) in Minnesota and California. Clinicians will be randomized to decision aid or usual care. Parents visiting the ED with children who are less than 18-years-old, have experienced blunt head trauma within 24 hours, and have one or two risk factors for clinically-important TBI (ciTBI) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment. We will measure the effect of Head CT Choice on: (1) parent knowledge regarding their child’s risk of ciTBI, the available diagnostic options, and the risks of radiation exposure associated with a cranial CT scan (primary outcome); (2) parent engagement in the decision-making process; (3) the degree of conflict parents experience related to feeling uninformed; (4) patient and clinician satisfaction with the decision made; (5) the rate of ciTBI at seven days; (6) the proportion of patients in whom a cranial CT scan is obtained; and (7) seven-day healthcare utilization. To capture these outcomes, we will administer parent and clinician surveys immediately after each clinical encounter, obtain video recordings of parent-clinician discussions, administer parent healthcare utilization diaries, analyze hospital billing records, review the electronic medical record, and conduct telephone follow-up.

Discussion

This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in parents of children with minor head trauma in five diverse EDs.

Trial registration

ClinicalTrials.gov registration number: NCT02063087. Registration date February 13, 2014.