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

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

SUBMITTER: Hess EP

PROVIDER: S-EPMC4081461 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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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 EP Wyatt Kirk D KD Kharbanda Anupam B AB Louie Jeffrey P JP Dayan Peter S PS Tzimenatos Leah L Wootton-Gorges Sandra L SL Homme James L JL Pencille R N Laurie L LeBlanc Annie A Westphal Jessica J JJ Shepel Kathy K Shah Nilay D ND Branda Megan M Herrin Jeph J Montori Victor M VM Kuppermann Nathan N

Trials 20140625

<h4>Background</h4>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 ...[more]

PMID: 24965659

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Project description:ImportanceThe Pediatric Emergency Care Applied Research Network prediction rules for minor head trauma identify children at very low, intermediate, and high risk of clinically important traumatic brain injuries (ciTBIs) and recommend no computed tomography (CT) for those at very low risk. However, the prediction rules provide little guidance in the choice of home observation or CT in children at intermediate risk for ciTBI.ObjectiveTo compare a decision aid with usual care in parents of children at intermediate risk for ciTBI.Design, settings, and participantsThis cluster randomized trial was conducted in 7 geographically diverse US emergency departments (EDs) from April 1, 2014, to September 30, 2016. Eligible participants were emergency clinicians, children ages 2 to 18 years with minor head trauma at intermediate risk for ciTBI, and their parents.InterventionsClinicians were randomly assigned (1:1 ratio) to shared decision-making facilitated by the Head CT Choice decision aid or to usual care.Main outcomes and measuresThe primary outcome, selected by parent stakeholders, was knowledge of their child's risk for ciTBI and the available diagnostic options. Secondary outcomes included decisional conflict, parental involvement in decision-making, the ED CT rate, 7-day health care utilization, and missed ciTBI.ResultsA total of 172 clinicians caring for 971 children (493 decision aid; 478 usual care) with minor head trauma at intermediate risk for ciTBI were enrolled. The patient mean (SD) age was 6.7 (7.1) years, 575 (59%) were male, and 253 (26%) were of nonwhite race. Parents in the decision aid arm compared with the usual care arm had greater knowledge (mean [SD] questions correct: 6.2 [2.0] vs 5.3 [2.0]; mean difference, 0.9; 95% CI, 0.6-1.3), had less decisional conflict (mean [SD] decisional conflict score, 14.8 [15.5] vs 19.2 [16.6]; mean difference, -4.4; 95% CI, -7.3 to -2.4), and were more involved in CT decision-making (observing patient involvement [OPTION] scores: mean [SD], 25.0 [8.5] vs 13.3 [6.5]; mean difference, 11.7; 95% CI, 9.6-13.9). Although the ED CT rate did not significantly differ (decision aid, 22% vs usual care, 24%; odds ratio, 0.81; 95% CI, 0.51-1.27), the mean number of imaging tests was lower in the decision aid arm 7 days after injury. No child had a missed ciTBI.Conclusions and relevanceUse of a decision aid in parents of children at intermediate risk of ciTBI increased parent knowledge, decreased decisional conflict, and increased involvement in decision-making. The intervention did not significantly reduce the ED CT rate but safely decreased health care utilization 7 days after injury.Trial registrationClinicalTrials.gov Identifier: NCT02063087.

Project description:BackgroundTo date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated prospectively in an independent population. Our goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French pediatric population in multiple clinical settings.MethodsWe conducted a multicenter, prospective, non-interventional cohort study of patients with minor head trauma who presented to three emergency departments in France. We enrolled patients younger than 16 years of age seeking a consultation within 24 h of head trauma with Glasgow Coma Scale scores of 14-15.ResultsDuring the study period, we included 1499 children of which 421 (28 %) were under 2 years of age, and 955 (64 %) were male. A cranial computed tomography (CT) scan was performed on 76 patients (5.1 %). Of the 1499 included patients, 9 children (0.6 %) had a clinically-important traumatic brain injury, and none were classified as very low risk by the PECARN rule. In our study, the sensitivity of this clinical decision rule was 100 % (95 % CI 66.4 to 100 %), the specificity was 69.9 % (95 % CI 67.5 to 72.2 %) and the negative predictive value was 100 % (95 % CI 99.7 to 100 %).DiscussionOur study confirmed the good predictive performances of the PECARN clinical decision rule for minor head trauma in children. The PECARN rule performed similarly to our study and to its internal validation study.ConclusionsWe conducted an external validation study of the PECARN clinical decision rule for the detection of clinically-important traumatic brain injuries in children with minor head trauma, according to the methodological standards. The PECARN rule successfully identified all patients with clinically-important traumatic brain injuries, with a limited use of CT scans. Conducting a broad validation study with a large cohort is a prerequisite to provide sufficient statistical power before authorizing its implementation and generalization.Trial registrationThis study has been registered in ClinicalTrials.gov with identifier number: NCT02752711 on April 27, 2016.

Project description:Study objectiveTo improve the efficiency and appropriateness of computed tomography (CT) use in children with minor head trauma, clinical prediction rules were derived and validated by the Pediatric Emergency Care Applied Research Network (PECARN). The objective of this study was to conduct a cost-effectiveness analysis comparing the PECARN traumatic brain injury prediction rules to usual care for selective CT use.MethodsWe used decision analytic modeling to project the outcomes, costs, and cost-effectiveness of applying the PECARN rules compared with usual care in a hypothetical cohort of 1,000 children with minor blunt head trauma. Clinical management was directed by level of risk as specified by the presence or absence of variables in the PECARN traumatic brain injury prediction rules. Immediate costs of care (diagnostic testing, treatment [not including clinician time], and hospital stay) were derived on single-center data. Quality-adjusted life-year losses related to the sequelae of clinically important traumatic brain injuries and to radiation-induced cancers, number of CT scans, number of radiation-induced cancers, number of missed clinically important traumatic brain injury, and total costs were evaluated.ResultsCompared with the usual care strategy, the PECARN strategy was projected to miss slightly more children with clinically important traumatic brain injuries (0.26 versus 0.02 per 1,000 children) but used fewer cranial CT scans (274 versus 353), resulted in fewer radiation-induced cancers (0.34 versus 0.45), cost less ($904,940 versus $954,420), and had lower net quality-adjusted life-year loss (-4.64 versus -5.79). Because the PECARN strategy was more effective (less quality-adjusted life-year loss) and less costly, it dominated the usual care strategy. Results were robust under sensitivity analyses.ConclusionApplication of the PECARN traumatic brain injury prediction rules for children with minor head trauma would lead to beneficial outcomes and more cost-effective care.

Project description:BackgroundCurrent management of children with minor head trauma (MHT) and intracranial injuries is not evidence-based and may place some children at risk of harm. Evidence-based electronic clinical decision support (CDS) for management of these children may improve patient safety and decrease resource use. To guide these efforts, we evaluated the sociotechnical environment impacting the implementation of electronic CDS, including workflow and communication, institutional culture, and hardware and software infrastructure, among other factors.MethodsBetween March and May, 2020 semi-structured qualitative focus group interviews were conducted to identify sociotechnical influences on CDS implementation. Physicians from neurosurgery, emergency medicine, critical care, and pediatric general surgery were included, along with information technology specialists. Participants were recruited from nine health centers in the United States. Focus group transcripts were coded and analyzed using thematic analysis. The final themes were then cross-referenced with previously defined sociotechnical dimensions.ResultsWe included 28 physicians and four information technology specialists in seven focus groups (median five participants per group). Five physicians were trainees and 10 had administrative leadership positions. Through inductive thematic analysis, we identified five primary themes: (1) clinical impact; (2) stakeholders and users; (3) tool content; (4) clinical practice integration; and (5) post-implementation evaluation measures. Participants generally supported using CDS to determine an appropriate level-of-care for these children. However, some had mixed feelings regarding how the tool could best be used by different specialties (e.g. use by neurosurgeons versus non-neurosurgeons). Feedback from the interviews helped refine the tool content and also highlighted potential technical and workflow barriers to address prior to implementation.ConclusionsWe identified key factors impacting the implementation of electronic CDS for children with MHT and intracranial injuries. These results have informed our implementation strategy and may also serve as a template for future efforts to implement health information technology in a multidisciplinary, emergency setting.

Project description:BackgroundThe Canadian Computed Tomography (CT) Head Rule, a clinical decision rule designed to safely reduce imaging in minor head injury, has been rigorously validated and implemented, and yet expected decreases in CT were unsuccessful. Recent work has identified empathic care as a key component in decreasing CT overuse. Health information technology can hinder the clinician-patient relationship. Patient-centered decision tools to support the clinician-patient relationship are needed to promote evidence-based decisions.ObjectiveOur objective is to formatively evaluate an electronic tool that not only helps clinicians at the bedside to determine the need for CT use based on the Canadian CT Head Rule but also promotes evidence-based conversations between patients and clinicians regarding patient-specific risk and patients' specific concerns.MethodsUser-centered design with practice-based and participatory decision aid development was used to design, develop, and evaluate patient-centered decision support regarding CT use in minor head injury in the emergency department. User experience and user interface (UX/UI) development involved successive iterations with incremental refinement in 4 phases: (1) initial prototype development, (2) usability assessment, (3) field testing, and (4) beta testing. This qualitative approach involved input from patients, emergency care clinicians, health services researchers, designers, and clinical informaticists at every stage.ResultsThe Concussion or Brain Bleed app is the product of 16 successive iterative revisions in accordance with UX/UI industry design standards. This useful and usable final product integrates clinical decision support with a patient decision aid. It promotes shared use by emergency clinicians and patients at the point of care within the emergency department context. This tablet computer app facilitates evidence-based conversations regarding CT in minor head injury. It is adaptable to individual clinician practice styles. The resultant tool includes a patient injury evaluator based on the Canadian CT Head Rule and provides patient specific risks using pictographs with natural frequencies and cues for discussion about patient concerns.ConclusionsThis tool was designed to align evidence-based practices about CT in minor head injury patients. It establishes trust, empowers active participation, and addresses patient concerns and uncertainty about their condition. We hypothesize that, when implemented, the Concussion or Brain Bleed app will support-not hinder-the clinician-patient relationship, safely reduce CT use, and improve the patient experience of care.

Project description:IntroductionFor children who present to emergency departments (EDs) due to blunt head trauma, ED clinicians must decide who requires computed tomography (CT) scanning to evaluate for traumatic brain injury (TBI). The Pediatric Emergency Care Applied Research Network (PECARN) derived and validated two age-based prediction rules to identify children at very low risk of clinically-important traumatic brain injuries (ciTBIs) who do not typically require CT scans. In this case report, we describe the strategy used to implement the PECARN TBI prediction rules via electronic health record (EHR) clinical decision support (CDS) as the intervention in a multicenter clinical trial.MethodsThirteen EDs participated in this trial. The 10 sites receiving the CDS intervention used the Epic(®) EHR. All sites implementing EHR-based CDS built the rules by using the vendor's CDS engine. Based on a sociotechnical analysis, we designed the CDS so that recommendations could be displayed immediately after any provider entered prediction rule data. One central site developed and tested the intervention package to be exported to other sites. The intervention package included a clinical trial alert, an electronic data collection form, the CDS rules and the format for recommendations.ResultsThe original PECARN head trauma prediction rules were derived from physician documentation while this pragmatic trial led each site to customize their workflows and allow multiple different providers to complete the head trauma assessments. These differences in workflows led to varying completion rates across sites as well as differences in the types of providers completing the electronic data form. Site variation in internal change management processes made it challenging to maintain the same rigor across all sites. This led to downstream effects when data reports were developed.ConclusionsThe process of a centralized build and export of a CDS system in one commercial EHR system successfully supported a multicenter clinical trial.

Dataset Information

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

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

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