Head Injury
Conditions
Keywords
Head CT, Head Injury, Pediatric, Emergency Department, Decision Aids, Shared Decision Making
Brief summary
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.
Detailed description
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.
Interventions
OTHERHead 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.
Sponsors
Patient-Centered Outcomes Research Institute
University of California, Davis
University of Minnesota Masonic Children's Hospital
Columbia University
Flying Buttress Associates
Children's Hospitals and Clinics of Minnesota
Nationwide Children's Hospital
Boston Children's Hospital
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Parents and their child, seeking care for a child who: 1. Is \< 18 years of age; 2. Had blunt trauma above the eyebrows (not isolated to face or eyes); 3. Is positive for at least 1 of the PECARN clinical prediction rule predictors described below: 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: 1. GCS scores \< 15 2. Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination 3. Brain tumors 4. Ventricular shunts 5. Bleeding disorder 6. Pre-existing neurological disorders complicating assessment 7. Neuroimaging at an outside hospital before transfer 8. Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication) 9. Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma 10. Known to be pregnant 11. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid. 12. Strong suspicion of abuse for this head injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict | 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 | 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 | 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. |
| Patient Engagement in the Decision-making Process | 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. |
| Healthcare Utilization - Number of Tests Ordered Within 7 Days | 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) | 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 | 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. |
| Proportion of Children Who Undergo Head CT | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid Head CT Decision Aid
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. | 493 |
| Usual Care Clinicians and patients do not have access to the Head CT Decision Aid | 478 |
| Total | 971 |
Baseline characteristics
| Characteristic | Decision Aid | Usual Care | Total |
|---|---|---|---|
| Age, Customized Age Group 2 to18 years old | 370 Participants | 369 Participants | 739 Participants |
| Age, Customized Age Group <2 years old | 123 Participants | 109 Participants | 232 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 62 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 439 Participants | 416 Participants | 855 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian / Pacific Islander / American Indian | 24 Participants | 19 Participants | 43 Participants |
| Race/Ethnicity, Customized Race Black | 61 Participants | 54 Participants | 115 Participants |
| Race/Ethnicity, Customized Race Other | 37 Participants | 58 Participants | 95 Participants |
| Race/Ethnicity, Customized Race White | 371 Participants | 347 Participants | 718 Participants |
| Region of Enrollment United States | 493 participants | 478 participants | 971 participants |
| Sex: Female, Male Female | 203 Participants | 193 Participants | 396 Participants |
| Sex: Female, Male Male | 290 Participants | 285 Participants | 575 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 493 | 0 / 478 |
| other Total, other adverse events | 0 / 493 | 0 / 478 |
| serious Total, serious adverse events | 0 / 493 | 0 / 478 |
Outcome results
Primary
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)
Population: Analysis limited to participants with complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury | 6.2 Number of questions correct out of 10 | Standard Deviation 2 |
| Usual Care | Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury | 5.26 Number of questions correct out of 10 | Standard Deviation 2 |
Secondary
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)
Population: Analysis limited to participants with complete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Decisional Conflict | 14.8 Units on a scale | Standard Deviation 15.5 |
| Usual Care | Decisional Conflict | 19.2 Units on a scale | Standard Deviation 16.6 |
Secondary
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
Population: participants who consented to recording, and with a recording of sufficient quality to be scored
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid | Fidelity - Options for Care | Decision aid used during the decision-making | 251 Participants |
| Decision Aid | Fidelity - Options for Care | Clinician discuss any options for care | 266 Participants |
| Decision Aid | Fidelity - Options for Care | Decision aid was shared with the parent/caregiver | 157 Participants |
| Decision Aid | Fidelity - Options for Care | Discussed option to get a CT scan now | 257 Participants |
| Decision Aid | Fidelity - Options for Care | Decision aid was used by clinician alone | 89 Participants |
| Decision Aid | Fidelity - Options for Care | Discussed active observation at home | 260 Participants |
| Decision Aid | Fidelity - Options for Care | Undetermined decision aid use (audio recording) | 5 Participants |
| Decision Aid | Fidelity - Options for Care | Discussed option to let the ED clinician decide | 14 Participants |
| Decision Aid | Fidelity - Options for Care | Decision aid brought into the room | 259 Participants |
| Usual Care | Fidelity - Options for Care | Discussed option to let the ED clinician decide | 1 Participants |
| Usual Care | Fidelity - Options for Care | Decision aid brought into the room | 0 Participants |
| Usual Care | Fidelity - Options for Care | Decision aid used during the decision-making | 0 Participants |
| Usual Care | Fidelity - Options for Care | Decision aid was used by clinician alone | 0 Participants |
| Usual Care | Fidelity - Options for Care | Decision aid was shared with the parent/caregiver | 0 Participants |
| Usual Care | Fidelity - Options for Care | Undetermined decision aid use (audio recording) | 0 Participants |
| Usual Care | Fidelity - Options for Care | Clinician discuss any options for care | 233 Participants |
| Usual Care | Fidelity - Options for Care | Discussed option to get a CT scan now | 196 Participants |
| Usual Care | Fidelity - Options for Care | Discussed active observation at home | 215 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Evaluation and Management Codes for ED Visit | 1.84 number of tests or procedures performed | Standard Deviation 0.23 |
| Decision Aid | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Imaging | 0.65 number of tests or procedures performed | Standard Deviation 0.41 |
| Decision Aid | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Tests | 0.41 number of tests or procedures performed | Standard Deviation 0.32 |
| Decision Aid | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Procedures | 0.17 number of tests or procedures performed | Standard Deviation 0.13 |
| Decision Aid | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Other | 0.23 number of tests or procedures performed | Standard Deviation 0.28 |
| Decision Aid | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Unclassified | 0.02 number of tests or procedures performed | Standard Deviation 0.02 |
| Usual Care | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Other | 0.38 number of tests or procedures performed | Standard Deviation 0.46 |
| Usual Care | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Evaluation and Management Codes for ED Visit | 1.88 number of tests or procedures performed | Standard Deviation 0.2 |
| Usual Care | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Procedures | 0.26 number of tests or procedures performed | Standard Deviation 0.19 |
| Usual Care | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Imaging | 0.88 number of tests or procedures performed | Standard Deviation 0.56 |
| Usual Care | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Unclassified | 0.02 number of tests or procedures performed | Standard Deviation 0.03 |
| Usual Care | Healthcare Utilization - Number of Tests Ordered Within 7 Days | Tests | 0.7 number of tests or procedures performed | Standard Deviation 0.55 |
Secondary
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)
Population: Analysis limited to participants who completed a post-encounter survey
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision Aid | Parental Satisfaction | 254 participants Strongly Satisfied |
| Usual Care | Parental Satisfaction | 210 participants Strongly Satisfied |
Secondary
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)
Population: Analysis limited to patients who consented to recording and had a recording of sufficient quality to analyze
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Patient Engagement in the Decision-making Process | 25 Units on a scale | Standard Deviation 8.5 |
| Usual Care | Patient Engagement in the Decision-making Process | 13.3 Units on a scale | Standard Deviation 6.5 |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Aid | Proportion of Children Who Undergo Head CT | 109 Participants |
| Usual Care | Proportion of Children Who Undergo Head CT | 116 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Aid | Rate of Clinically Important Traumatic Brain Injury (ciTBI) | 0 Participants |
| Usual Care | Rate of Clinically Important Traumatic Brain Injury (ciTBI) | 1 Participants |
Secondary
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)
Population: Analysis limited to patients with complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Trust in the Physician | 91.5 units on a scale | Standard Deviation 11.9 |
| Usual Care | Trust in the Physician | 89.3 units on a scale | Standard Deviation 13.7 |