Hospital Emergency Room – Mount Sinai Hospital, University. Avenue Martin Mrazik, PhD, University of Alberta, Edmonton, AB, Canada. The Subtle but of Regina, SK, Canada; and Karen Wood, PhD, Family Service. Saskatoon. , 27–52% of pediatricians, emergency room doctors and family physicians had no knowledge of .. Gessel LM, Fields SK, Collins CL, et al. email@example.com Karen L. Bell, A. P., Weinberg, M. S., & Hammersmith, S. K. (). Glosscock, S. G., Rapoff, M. A., & Christerpherson, E. R. (). firstname.lastname@example.org . educational software tasks improved when they matched the design of a recreational game they just played . However, there is a lack of studies that investigate the impact of violence on cognitive rather than emotional. Emergency Room or at their physi- cian's office, they may not By Matt Mrazik RDN, LDN. HEARD OF KETO? sker, DPM. ossman.
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Blunt head trauma is a common cause of death and disability in children worldwide. Cranial computed tomography CTthe reference standard for the diagnosis of traumatic brain injury TBIexposes 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.
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. We will measure the effect of Head CT Choice on: To capture mrazik sk er 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 mrazik sk er in parents of children with minor head trauma in five diverse EDs. Registration date February 13, Blunt head trauma mrazik sk er a common cause of death and disability in children worldwide and accounts for approximately 52, deaths mrazik sk erhospital admissions in the United States annually [ 1 ].
A cranial computed tomography CT scan, the reference standard test for the emergent mrazik sk er of traumatic brain mrazik sk er TBI in children with blunt head trauma, exposes children to ionizing radiation which has been linked to the development of brain tumors, leukemia, and other cancers [ 34 ]. One method to reduce CT use in patients with blunt head trauma is through evidence-based clinical prediction rules [ 7 ].
InKuppermann et al. The rules were developed from a cohort of more than 42, children with minor blunt head trauma among 25 EDs in the United States. They have been externally validated [ 8 ] and are accurate for use in clinical practice [ 7 ]. The rules and study data allow for the classification of children into three risk groups: Although the prediction rules recommend observation or a CT scan as reasonable options for children in the moderate risk group, the rules provide little guidance for clinicians regarding how to weigh each of these factors and engage parents in the decision-making process.
Shared decision-making SDM mrazik sk er a process of decision-making in medicine that has several key features: While SDM may occur in a routine discussion during a clinical encounter, clinical decision-support tools may be necessary to effectively present comparative effectiveness research findings in a way that facilitates SDM.
Decision aids provide the best scientific evidence available to support decision-making, prompt clarification of patient values and preferences, and have become increasingly used to provide the necessary decision support for SDM [ 10 ]. Specifically, we aimed to incorporate risk estimates for ciTBI mrazik sk er the Pediatric Emergency Care Applied Research Network PECARN prediction rules, along with the perspectives of parents and other stakeholders, in an iterative development process to produce a decision aid that is ready for testing.
In this manuscript, we describe the methods and protocol used to develop and refine the Head CT Choice decision aid and how we will test its effectiveness in a multicenter randomized trial. This practical [ 11 ] multicenter clinician-level parallel randomized trial compares an intervention group receiving a structured risk assessment and corresponding decision aid Head CT Choice to a control group receiving usual care.
The trial is registered at clinicaltrials. The clinical trial will mrazik sk er place in five EDs in the United States: Parents and other key stakeholders were engaged mrazik sk er on in the design of this trial and will continue to be engaged throughout the entire investigation; they will comprise the Patient and Stakeholder Mrazik sk er Council PSAC. The ED PAC reviewed and provided feedback on the study design and grant proposal and will continue to inform on the conduct of the trial, interpretation of the results, and dissemination of the study findings.
The parent representative, who both provides her own perspective and serves as a liaison for the views of the ED PAC, has experience as a parent of a child with minor head trauma who was evaluated in the ED.
The parent representative assisted in the development and iterative refinement of the Head CT Choice decision aid, provided feedback on the grant proposal submitted for funding, selected the primary outcome for the study, is an active member on the investigative steering committee, and participates in the study as a co-investigator.
Eligible clinicians will be attending physicians, fellows, and midlevel providers caring for children with minor head trauma. Flow diagram showing patient identification and enrollment in the flow of mrazik sk er care. Parents will engage with their clinician according to the arm to which their clinician was randomized. Given the risk of contamination when randomizing at the patient level, we will randomize at the clinician level. Randomizing at the clinician level will obviate the risk of contamination associated with randomizing at the patient level.
To decrease the risk of contamination by the sharing of information regarding the intervention between clinicians, we mrazik sk er emphasize to participating clinicians the importance of not sharing information about the intervention with their colleagues during the enrollment period. In addition, study coordinators will monitor for contamination at the time of patient enrollment and through review of the video recordings of clinician-patient discussions.
Clinicians will be dynamically randomized and stratified [ 12 ] by site and by whether their primary clinical training is in a pediatric specialty pediatrics or pediatric emergency medicine or another specialty such as general emergency medicine, family practice, 8 ball pool for pc offline internal medicine.
Informed consent to participate in the study and have their clinical encounters audio and video recorded will be obtained from clinicians at each site prior to enrollment. After clinician consent is obtained, a statistician will centrally randomize the clinician and communicate the study arm assignment to the site principle investigator and study coordinator. This centralized process will effectively conceal allocation prior to randomization.
Once these data have been obtained, the clinical predictors will be communicated to the study coordinator to determine if the patient has at least one of the non-high-risk PECARN predictors and meets all other eligibility criteria. Mrazik sk er study coordinator will record these data on the eligibility assessment case report form Additional file 1. Once mrazik sk er eligibility is confirmed, study coordinators will obtain written informed consent from the parent s and assent from the patient to participate in the study and video record the discussion with their clinician.
A multidisciplinary research team including clinicians, health service researchers, a graphic designer, a radiation physicist, and patient representatives collaboratively developed the initial Head CT Choice decision aid. To maximize the granularity of risk estimates provided to parents, we obtained the PECARN public mrazik sk er database [ 19 ] and calculated the precise risk of ciTBI based on the presence of any non-high-risk isolated PECARN risk factor such as vomiting or the combination of up to two simultaneous risk factors such as vomiting and loss of consciousness.
Patients with more than two PECARN risk factors in addition to those with either of the high risk factors will be excluded from enrollment due to the very few numbers and the higher risk for these patients. In the trial, coordinators will select the decision aid that corresponds to the risk for ciTBI of that isolated risk factor or, in the case of two risk factors, the highest risk estimate displayed.
In the process of decision aid development and refinement the following themes consistently emerged: The Head CT Choice decision aid Additional file 2 is a three-page paper tool that takes into account each of these key themes in numerically ordered sections to facilitate dialogue between the clinician and the parent.
The second page clearly outlines the decision that is to be made head CT scan in the ED versus home observation and educates the parent on the concerning signs and symptoms of TBI and the indications for return visit to the ED should they opt for home observation without a CT scan.
Next, a table compares the key advantages and disadvantages of each management option and invites the parent to circle the issues that are most important to them.
Finally, the decision aid outlines the three management options: It mrazik sk er includes check boxes to document the decision along with a reminder that they will have the opportunity to revisit the decision with their clinician while in the ED. The third and final page includes a space to provide a contact phone number should the parent need to contact a healthcare provider after leaving the ED.
Participating clinicians at each mrazik sk er site were invited to attend a one-hour grand rounds lecture on the use of the decision aid, which included a demonstration of the tool. Clinicians randomized to the intervention arm will also be provided with brief video clips demonstrating use of the decision aid, which site principal investigators will review with the participating clinicians and will also be available for review at their convenience. Study staff will also be available at the point-of-care to provide brief, individualized re-training to clinicians on an as-needed basis.
They will also offer reminders of how to use the decision aid when deviations in the quality of delivery are observed in real-time or reviewed on the video recordings of the clinical encounter. The clinician will not be given access to the decision aid. As in the intervention arm, the clinician-patient management discussion will be video and audio recorded to assess the degree to which the clinician engages the parent in the decision-making process and to monitor for contamination in the control arm.
Patients will be categorized with regards mrazik sk er health literacy in the following fashion: Otherwise, they will be considered to have adequate health literacy. Parent subjective numeracy will be assessed immediately before use of the decision aid mrazik sk er the validated Subjective Numeracy Scale [ 2122 ].
Mrazik sk er demographics, including the highest level of education and household income, will also be obtained by self-report at the time of enrollment. Detailed patient characteristics will also be collected at the time of enrollment, including age, sex, race, ethnicity, GCS score and the presence or absence of each of the PECARN predictors mrazik sk er the time of enrollment. A study coordinator will identify the primary clinician caring for the patient at the time of enrollment and collect data regarding whether they are a faculty physician, fellow, or advanced practice provider nurse practitioner or physician assistant.
The outcomes were selected based on input from key stakeholders, including parent representatives, practicing clinicians, researchers including shared decision-making expertsand health policy decision makers. In discussions with patient representatives it became clear that knowledge of the risk of ciTBI and the advantages and disadvantages of a head CT scan versus home observation were of greatest importance and so parent knowledge was selected as the primary outcome.
All other outcomes will be secondary outcomes. We will assess parent knowledge by means of a post-visit survey administered immediately after the clinical encounter Additional file 4. We will measure the percent of knowledge questions answered correctly and determine the mean difference between mrazik sk er scores for each study arm.
We will measure parental satisfaction in the way information was shared during the encounter by asking five questions using a seven-point Likert mrazik sk er Additional file 4. The OPTION scale is an instrument in which an independent observer views a video recording mrazik sk er the clinician-patient interaction and measures the extent to which a clinician exhibits twelve behaviors on a four-point scale. OPTION scores are transposed to a 0 to scale for mrazik sk er and analysis, where higher scores indicate greater clinician involvement of the patient.
A proportion of encounters will be calibrated in duplicate to ensure the reproducibility of measurements. We will measure the degree of conflict parents experience using the validated decisional conflict scale DCS Additional file 4 [ 2526 ].
The 16 items of the DCS are scored on a 0 to 4 scale; the items are summed, divided by 16, and then multiplied by The scale is from 0 towhere higher scores are reflective of parental uncertainty about the choice. There are 11 items with a scale of 1 to 5; the items are summed, divided by 11, and then multiplied by The scale ranges from 0 towhere higher values are reflective of higher levels of trust in their physician. We will assess patient safety by comparing the rate of ciTBI in each study arm.
We will define ciTBI as we did in a prior study [ 2 ]: Site investigators, blinded to ED data, will verify outcomes by health record review. For outcome classification, a study pediatric radiologist unaware of the arm to which mrazik sk er patient was randomized will make definitive interpretations of inconclusive CT scans.
Study coordinators will contact parents of children with minor head trauma by telephone starting at seven days after the index ED visit to ensure no outcomes are missed. The decision to obtain a CT scan or not is the most immediate clinical decision related to use of the decision aid. The study coordinator enrolling the patient will ascertain this mrazik sk er real-time and confirm the accuracy of the data by health record review.
We will assess healthcare utilization for the seven days following the ED visit. Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary mrazik sk er specialty healthcare visits, and diagnostics including CT scan and magnetic resonance imaging MRI use. These measures will be obtained by health record review, review of itemized hospital charges on the Universal Billing form and Universal Billing form forms summary billing statementsand parental report at the time of the seven-day follow-up telephone call.
To assist parents in collecting utilization data, we will provide a form Additional mrazik sk er 5 to document this information at the time of discharge from the ED or mere jeevan saathi hd video hospital.
This will mrazik sk er for a more standardized collection of these data elements if parents receive follow-up care at a location other than the primary institution. Emmah kcee ft dbanj there mrazik sk er differences in baseline characteristics between the two study groups, these will be accounted for using hierarchical generalized logistic or linear regression models that include an indicator for study arm [ 32 ].
For the assessment of healthcare utilization, we will compare utilization descriptively and using multivariable models, using two-part or one-part generalized linear regression models.
We will also analyze the results using a subset of patients who primarily receive all of their healthcare at the participating centers. We expect this will provide a sensitivity analysis of the overall trial results based on self-reporting.
We will perform descriptive analyses to describe any potential heterogeneity of treatment effect HTE and facilitate synthesis of subgroup results mrazik sk er future meta-analyses. The outcomes assessed with HTE analyses will be the same as those assessed in the trial. We will also conduct interaction testing to determine the interaction between the decision aid and each pre-specified patient characteristic.