Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice
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|ClinicalTrials.gov Identifier: NCT02063087|
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : May 9, 2019
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head Injury||Other: Head CT Decision Aid||Not Applicable|
The investigators' long term goal is to promote evidence-based, patient-centered evaluation in the acute setting, to more closely tailor testing to disease risk. The investigators will compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration through the following aim:
Test if the decision aid, Head CT Choice, improves validated patient-centered outcome measures and safely decreases healthcare utilization. The investigators will randomize at the clinician level. Through the use of the intervention, Head CT Choice, the investigators aim to significantly increase parents' knowledge, engagement, and satisfaction, decrease the rate of head CT use, and decrease 7-day total healthcare utilization, with no significant increase in adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||971 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Shared Decision Making in Parents of Children With Head Trauma: Head CT Choice|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||January 2017|
Active Comparator: Decision Aid
Head CT Decision Aid
Other: Head CT Decision Aid
The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED.
No Intervention: Usual Care
Clinicians and patients do not have access to the Head CT Decision Aid
- Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury [ Time Frame: Day 1 (immediately after the clinical encounter) ]Knowledge will be measured by means of a post visit survey delivered immediately after the clinical encounter in the emergency department. The investigators will assess parents' knowledge regarding their child's quantitative risk for a significant brain injury, the pros and cons of head CT compared to active observation, and what signs and symptoms parents should watch for in the next 24-48 hours that should prompt a return visit to the ED. Each knowledge question will provide the parent(s) with three options to respond (True, False, or Unsure), and the parent(s) will receive a score of 1 for a correct response and 0 for an incorrect response and any response of 'Unsure' will be considered incorrect. An overall score will be calculated by summing the correct responses and dividing by the number of questions asked.
- Patient Engagement in the Decision-making Process [ Time Frame: Day 1 (during the ED visit) ]Using the OPTION validated scale, the investigators will measure the degree to which clinicians engage parents' in the decision making process. The OPTION scale will be assessed by having 2 observers independently review and score the video recordings of the encounter between the parent and the child's emergency department clinician. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48 and multiplied by 100. This creates a score that ranges from 0-100, where higher scores are reflective of a higher level of parental engagement.
- Decisional Conflict [ Time Frame: Day 1 (immediately after the clinical encounter) ]The investigators will measure the degree of conflict patients experience related to feeling uninformed using the validated Decisional Conflict Scale (DCS). The 16 items of DCS are scored on a 0-4 scale; the items are summed, divided by 16 and then multiplied by 25. The scale is from 0-100 where higher scores are reflective of parental uncertainty about the choice.
- Trust in the Physician [ Time Frame: Day 1 (immediately after the clinical encounter) ]The investigators will measure parents' trust in their clinician using the validated Trust in Physician Scale (TPS). There are 9 items with a scale of 1-5, the items are subtracted by 1, summed, divided by 9 and then multiplied by 25. The scale ranges from 0-100 where higher values are reflective of higher levels of trust in their physician.
- Parental Satisfaction [ Time Frame: Day 1 (immediately after the clinical encounter) ]The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.
- Proportion of Children Who Undergo Head CT [ Time Frame: Day 1 (anytime during the index emergency department visit) ]The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.
- Healthcare Utilization - Number of Tests Ordered Within 7 Days [ Time Frame: 7-days ]The investigators will assess healthcare utilization for the subsequent 7-days after the ED visit. Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty visits, and diagnostics including CT use which will be obtained via a health record review, review of itemized hospital charges on the UB-92 and UB-04 forms (summary billing statements), and parental report via the 7 day follow-up by the study coordinator. Outcomes are reported as number of tests or procedures per patient, categorized based on the Berenson-Eggers Types of Service (BETOS) codes.
- Rate of Clinically Important Traumatic Brain Injury (ciTBI) [ Time Frame: 7-days ]The investigators will assess safety by comparing the rate of ciTBI in each arm of the study. The investigators will define ciTBI as we did in the original PECARN study: death from TBI, intubation for more than 24 hours for TBI, neurosurgical procedure, or hospital admission of 2 nights or more associated with TBI on CT.
- Fidelity - Options for Care [ Time Frame: Day 1 ]We will measure the degree to which the intervention is implemented as intended in both intervention and control groups when reviewing the recordings. The recordings in the intervention group will serve as a measure of the fidelity with which the intervention was delivered as intended. We will use a checklist of elements present and absent for quantification of implementation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063087
|United States, California|
|University of California, Davis Medical Center|
|Sacramento, California, United States, 95817|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Children's Hospitals and Clinics of MN, Minneapolis|
|Minneapolis, Minnesota, United States, 55404|
|University of Minnesota Masonic Children's Hospital|
|Minneapolis, Minnesota, United States, 55454|
|Rochester, Minnesota, United States, 55905|
|Children's Hospitals and Clincis of MN, St Paul ED|
|Saint Paul, Minnesota, United States, 55102|
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||M.Fernanda Bellolio, MD||Mayo Clinic|