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

Abstract

BackgroundBlunt 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/DesignThis 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.DiscussionThis 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 registrationClinicalTrials.gov registration number: NCT02063087. Registration date February 13, 2014.

Shared Decision-making in the Emergency Department: Respecting Patient Autonomy When Seconds Count

“…After assessing and stabilizing the trauma patient, the clinician reinitiates a conversation with the child's parents. Using a recently developed decision aid designed to facilitate risk communication and decision-making with parents of children with minor head trauma, Head CT Choice (Data Supplement S1, available as supporting information in the online version of this paper), 25 the clinician explains to the parents that their child does indeed have a concussion (which the clinician diagnosed from the history and physical examination alone) 26 and that his symptoms may take several days to a few months to resolve. The clinician then reframes the conversation to focus on the child's risk for bleeding in or around the brain, which may require a stay in the hospital or a surgical procedure and can be excluded with a head CT.…”

The Physician‐as‐Stakeholder: An Exploratory Qualitative Analysis of Physicians’ Motivations for Using Shared Decision Making in the Emergency Department

“…[1][2][3][4][5][6][7] Defined as "a collaborative process that allows patients and their providers to make health care decisions together, taking into account the best scientific evidence available, as well as the patient's values and preferences," 8 SDM has been called the "pinnacle of patientcentered care" and promoted as an ethical imperative based on principles of patient autonomy. 9,10 Despite increasing interest in the impact of SDM in the emergency department (ED), [11][12][13][14][15][16] little research has focused on the emergency physician (EP) as a stakeholder in SDM research. "Stakeholders" are defined as "Individuals, organizations or communities that have a direct interest in the process and outcomes of a project, research or policy endeavor."…”

The Role of Education in the Implementation of Shared Decision Making in Emergency Medicine: A Research Agenda

“…13 Currently there are only a few EM studies of clinical instruments and other interventions to facilitate adoption of SDM into clinical practice. 14,15 Priorities.…”

“…Decision aids for common clinical presentations have been developed and could be used as valuable teaching tools for residents learning to implement SDM in their patient encounters. 13,15,29 Furthermore, programs should engage residents to learn these skills, as well as recognize the potential barriers and facilitators to implementing SDM in the clinical setting. 30,31 Priorities.…”