An interventional study of Head CT Decision Aid in Head Injury, sponsored by Mayo Clinic. Completed at 7 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research
The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.
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.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
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Parents and their child, seeking care for a child who:
PECARN Predictors for children \< 2 years of age:
Severe mechanism (PECARN definition)* Loss of consciousness > 5 seconds Acting abnormally per parent Initial ED GCS \< 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture
PECARN predictors for children 2-18 years of age:
Severe mechanism (PECARN definition)* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS \< 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)** Any sign of basilar skull fracture Clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma
Exclusion Criteria:
Parents of children with:
Head CT Decision Aid
Other: Head CT Decision Aid
Clinicians and patients do not have access to the 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.
Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury
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.
Time frame: Day 1 (immediately after the clinical encounter)
Patient Engagement in the Decision-making Process
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.
Time frame: Day 1 (during the ED visit)
Decisional Conflict
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.
Time frame: Day 1 (immediately after the clinical encounter)
Trust in the Physician
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.
Time frame: Day 1 (immediately after the clinical encounter)
Parental Satisfaction
The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.
Time frame: Day 1 (immediately after the clinical encounter)
Proportion of Children Who Undergo Head CT
The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.
Time frame: Day 1 (anytime during the index emergency department visit)
Healthcare Utilization - Number of Tests Ordered Within 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.
Time frame: 7-days
Rate of Clinically Important Traumatic Brain Injury (ciTBI)
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.
Time frame: 7-days
Fidelity - Options for Care
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.
Time frame: Day 1
| Milestone | Decision Aid | Usual Care |
|---|---|---|
| Started | 493 | 478 |
| Completed | 493 | 478 |
| Not completed | 0 | 0 |
| Milestone | Decision Aid | Usual Care |
|---|---|---|
| Started | 493 | 478 |
| Completed | 493 | 478 |
| Not completed | 0 | 0 |
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.
| Number of questions correct out of 10 | Decision Aid | Usual Care |
|---|---|---|
| Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury | 6.2 ± 2.0 | 5.26 ± 2.0 |
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.
| Units on a scale | Decision Aid | Usual Care |
|---|---|---|
| Patient Engagement in the Decision-making Process | 25 ± 8.5 | 13.3 ± 6.5 |
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.
| Units on a scale | Decision Aid | Usual Care |
|---|---|---|
| Decisional Conflict | 14.8 ± 15.5 | 19.2 ± 16.6 |
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.
| units on a scale | Decision Aid | Usual Care |
|---|---|---|
| Trust in the Physician | 91.5 ± 11.9 | 89.3 ± 13.7 |
The investigators will assess parents' satisfaction by comparing the number of patients who reported being "strongly satisfied" with their choice.
| participants "Strongly Satisfied" | Decision Aid | Usual Care |
|---|---|---|
| Parental Satisfaction | 254 | 210 |
The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.
| Participants | Decision Aid | Usual Care |
|---|---|---|
| Proportion of Children Who Undergo Head CT | 109 | 116 |
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.
| number of tests or procedures performed | Decision Aid | Usual Care |
|---|---|---|
| Evaluation and Management Codes for ED Visit | 1.84 ± 0.23 | 1.88 ± 0.2 |
| Imaging | 0.65 ± 0.41 | 0.88 ± 0.56 |
| Tests | 0.41 ± 0.32 | 0.7 ± 0.55 |
| Procedures | 0.17 ± 0.13 | 0.26 ± 0.19 |
| Other | 0.23 ± 0.28 | 0.38 ± 0.46 |
| Unclassified | 0.02 ± 0.02 | 0.02 ± 0.03 |
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.
| Participants | Decision Aid | Usual Care |
|---|---|---|
| Rate of Clinically Important Traumatic Brain Injury (ciTBI) | 0 | 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.
| Participants | Decision Aid | Usual Care |
|---|---|---|
| Decision aid brought into the room | 259 | 0 |
| Decision aid used during the decision-making | 251 | 0 |
| Decision aid was used by clinician alone | 89 | 0 |
| Decision aid was shared with the parent/caregiver | 157 | 0 |
| Undetermined decision aid use (audio recording) | 5 | 0 |
| Clinician discuss any options for care | 266 | 233 |
| Discussed option to get a CT scan now | 257 | 196 |
| Discussed active observation at home | 260 | 215 |
| Discussed option to let the ED clinician decide | 14 | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decision Aid | 0/493 (0%) | 0/493 (0%) | 0/493 (0%) |
| Usual Care | 0/478 (0%) | 0/478 (0%) | 0/478 (0%) |
| Age, Customized(Participants) | Decision Aid | Usual Care | Total |
|---|---|---|---|
| Age Group — <2 years old | 123 | 109 | 232 |
| Age Group — 2 to18 years old | 370 | 369 | 739 |
| Sex: Female, Male(Participants) | Decision Aid | Usual Care | Total |
|---|---|---|---|
| Female | 203 | 193 | 396 |
| Male | 290 | 285 | 575 |
| Ethnicity (NIH/OMB)(Participants) | Decision Aid | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 54 | 62 | 116 |
| Not Hispanic or Latino | 439 | 416 | 855 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Decision Aid | Usual Care | Total |
|---|---|---|---|
| Race — White | 371 | 347 | 718 |
| Race — Black | 61 | 54 | 115 |
| Race — Asian / Pacific Islander / American Indian | 24 | 19 | 43 |
| Race — Other | 37 | 58 | 95 |
| Region of Enrollment(participants) | Decision Aid | Usual Care | Total |
|---|---|---|---|
| United States | 493 | 478 | 971 |
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