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. Hess, Kirk D. Wyatt, Anupam B. Kharbanda, Jeffrey P. Louie, Peter S. Dayan, Leah Tzimenatos, Sandra L. Wootton-Gorges, James L. Homme, Laurie P. RN, Annie LeBlanc, Jessica J. Westphal, Kathy Shepel, Nilay D Shah, Megan Branda, Jeph Herrin, Victor Manuel Montori, Nathan Kuppermann

Research output: Contribution to journalArticle

27 Citations (Scopus)

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.

Original languageEnglish (US)
Article number253
JournalTrials
Volume15
Issue number1
DOIs
StatePublished - Jun 25 2014

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Decision Support Techniques
Craniocerebral Trauma
Multicenter Studies
Parents
Head
Tomography
Hospital Emergency Service
Delivery of Health Care
Decision Making
Video Recording
Hospital Records
Electronic Health Records
Emergency Medical Services
Ionizing Radiation
Patient Satisfaction
Telephone
Brain Neoplasms
Cause of Death
Emotions
Leukemia

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)
  • Medicine(all)

Cite this

Hess, E. P., Wyatt, K. D., Kharbanda, A. B., Louie, J. P., Dayan, P. S., Tzimenatos, L., ... Kuppermann, N. (2014). Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: Study protocol for a multicenter randomized trial. Trials, 15(1), [253]. https://doi.org/10.1186/1745-6215-15-253

Effectiveness of the head CT choice decision aid in parents of children with minor head trauma : Study protocol for a multicenter randomized trial. / Hess, Erik P.; Wyatt, Kirk D.; Kharbanda, Anupam B.; Louie, Jeffrey P.; Dayan, Peter S.; Tzimenatos, Leah; Wootton-Gorges, Sandra L.; Homme, James L.; RN, Laurie P.; LeBlanc, Annie; Westphal, Jessica J.; Shepel, Kathy; Shah, Nilay D; Branda, Megan; Herrin, Jeph; Montori, Victor Manuel; Kuppermann, Nathan.

In: Trials, Vol. 15, No. 1, 253, 25.06.2014.

Research output: Contribution to journalArticle

Hess, EP, Wyatt, KD, Kharbanda, AB, Louie, JP, Dayan, PS, Tzimenatos, L, Wootton-Gorges, SL, Homme, JL, RN, LP, LeBlanc, A, Westphal, JJ, Shepel, K, Shah, ND, Branda, M, Herrin, J, Montori, VM & Kuppermann, N 2014, 'Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: Study protocol for a multicenter randomized trial', Trials, vol. 15, no. 1, 253. https://doi.org/10.1186/1745-6215-15-253
Hess, Erik P. ; Wyatt, Kirk D. ; Kharbanda, Anupam B. ; Louie, Jeffrey P. ; Dayan, Peter S. ; Tzimenatos, Leah ; Wootton-Gorges, Sandra L. ; Homme, James L. ; RN, Laurie P. ; LeBlanc, Annie ; Westphal, Jessica J. ; Shepel, Kathy ; Shah, Nilay D ; Branda, Megan ; Herrin, Jeph ; Montori, Victor Manuel ; Kuppermann, Nathan. / Effectiveness of the head CT choice decision aid in parents of children with minor head trauma : Study protocol for a multicenter randomized trial. In: Trials. 2014 ; Vol. 15, No. 1.
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AU - Hess, Erik P.

AU - Wyatt, Kirk D.

AU - Kharbanda, Anupam B.

AU - Louie, Jeffrey P.

AU - Dayan, Peter S.

AU - Tzimenatos, Leah

AU - Wootton-Gorges, Sandra L.

AU - Homme, James L.

AU - RN, Laurie P.

AU - LeBlanc, Annie

AU - Westphal, Jessica J.

AU - Shepel, Kathy

AU - Shah, Nilay D

AU - Branda, Megan

AU - Herrin, Jeph

AU - Montori, Victor Manuel

AU - Kuppermann, Nathan

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N2 - 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.

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