Trial Outcomes & Findings for Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center (NCT NCT04469036)
NCT ID: NCT04469036
Last Updated: 2025-03-04
Results Overview
19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey. We created an "Overall" score representing the sum of the subscales. Analyses compared normalized scores (from 0 to 1) for the overall score and each of the subscale scores, which higher scores implying improved experiences of care. Adjusted mean differences were calculated using mixed-effects regression models, accounting for a small number of potential confounders, with splines to adjust for calendar time. We collected data on the following measures: "When your child was admitted to this emergency department" (Yes, definitely; Yes, somewhat; No), "Your experience with nurses" (Never, Sometimes, Usually, Always), "Your experience with doctors" (Never, Sometimes, Usually, Always), "Your experience with providers" (Never, Sometimes, Usually, Always), "When your child left this hospital" (Yes, definitely; Yes, somewhat; No)
COMPLETED
NA
595 participants
3 days after emergency department visit
2025-03-04
Participant Flow
Recruitment for this project began on 11/30/2020. Electronic medical record data was collected from a Transfer Center report that included children who presented to one of the participating sites with a transfer consultation to UC Davis Trauma, Orthopedics, or Neurosurgery services.
We used a prospective stepped-wedge trial design. After 6-month pre-implementation, study began with all 10 hospitals beginning in standard of care and patients enrolled for 13, 8-week periods. 706 patients were assessed for eligibility, 73 patients did not meet inclusion criteria and 38 were excluded from the study. 595 enrolled patients were then randomized to the study. Parents (not enrolled in the study) of the patients were then contacted to complete surveys.
Unit of analysis: Hospitals
Participant milestones
| Measure |
Virtual Pediatric Trauma Center (Intervention)
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
Start of Standard of Care: 8-week Period
STARTED
|
0 0
|
32 10
|
|
Start of Standard of Care: 8-week Period
COMPLETED
|
0 0
|
32 10
|
|
Start of Standard of Care: 8-week Period
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 1
STARTED
|
5 1
|
32 9
|
|
Hospital Randomization Phase 1
COMPLETED
|
5 1
|
32 9
|
|
Hospital Randomization Phase 1
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 2
STARTED
|
7 2
|
46 8
|
|
Hospital Randomization Phase 2
COMPLETED
|
7 2
|
46 8
|
|
Hospital Randomization Phase 2
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 3
STARTED
|
21 3
|
29 7
|
|
Hospital Randomization Phase 3
COMPLETED
|
21 3
|
29 7
|
|
Hospital Randomization Phase 3
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 4
STARTED
|
23 4
|
28 6
|
|
Hospital Randomization Phase 4
COMPLETED
|
23 4
|
28 6
|
|
Hospital Randomization Phase 4
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 5
STARTED
|
35 5
|
24 5
|
|
Hospital Randomization Phase 5
COMPLETED
|
35 5
|
24 5
|
|
Hospital Randomization Phase 5
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 6
STARTED
|
34 6
|
15 4
|
|
Hospital Randomization Phase 6
COMPLETED
|
34 6
|
15 4
|
|
Hospital Randomization Phase 6
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 7
STARTED
|
23 7
|
8 3
|
|
Hospital Randomization Phase 7
COMPLETED
|
23 7
|
8 3
|
|
Hospital Randomization Phase 7
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 8
STARTED
|
36 8
|
5 2
|
|
Hospital Randomization Phase 8
COMPLETED
|
36 8
|
5 2
|
|
Hospital Randomization Phase 8
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 9
STARTED
|
40 9
|
7 1
|
|
Hospital Randomization Phase 9
COMPLETED
|
40 9
|
7 1
|
|
Hospital Randomization Phase 9
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 10
STARTED
|
47 10
|
0 0
|
|
Hospital Randomization Phase 10
COMPLETED
|
47 10
|
0 0
|
|
Hospital Randomization Phase 10
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 11
STARTED
|
54 10
|
0 0
|
|
Hospital Randomization Phase 11
COMPLETED
|
54 10
|
0 0
|
|
Hospital Randomization Phase 11
NOT COMPLETED
|
0 0
|
0 0
|
|
Hospital Randomization Phase 12
STARTED
|
44 10
|
0 0
|
|
Hospital Randomization Phase 12
COMPLETED
|
44 10
|
0 0
|
|
Hospital Randomization Phase 12
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
Baseline characteristics by cohort
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=369 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=226 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
Total
n=595 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
369 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
595 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.1 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
8 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
8 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
227 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
125 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Black
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, White
|
170 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Other
|
47 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Insurance Type
Commercial
|
129 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Insurance Type
Medicaid
|
240 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
|
Language
English
|
331 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
539 Participants
n=5 Participants
|
|
Language
Spanish
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Language
Other/Missing
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Injury Severity Score
0 - 8 (minor injuries)
|
290 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
|
Injury Severity Score
9 - 15 (moderate injuries)
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Injury Severity Score
24 (severe injuries)
|
24 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Glasgow Coma Scale Score
3 - 14
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Glasgow Coma Scale Score
15
|
345 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
553 Participants
n=5 Participants
|
|
Distance in miles from outlying hospital
|
38.2 Miles
STANDARD_DEVIATION 36.3 • n=5 Participants
|
48.8 Miles
STANDARD_DEVIATION 52.4 • n=7 Participants
|
42.3 Miles
STANDARD_DEVIATION 43.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 days after emergency department visitPopulation: All participants who received either Virtual Pediatric Model of Care or a Telephone Consultation that reported Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey scores, data analyzed as Intention-to-Treat.
19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey. We created an "Overall" score representing the sum of the subscales. Analyses compared normalized scores (from 0 to 1) for the overall score and each of the subscale scores, which higher scores implying improved experiences of care. Adjusted mean differences were calculated using mixed-effects regression models, accounting for a small number of potential confounders, with splines to adjust for calendar time. We collected data on the following measures: "When your child was admitted to this emergency department" (Yes, definitely; Yes, somewhat; No), "Your experience with nurses" (Never, Sometimes, Usually, Always), "Your experience with doctors" (Never, Sometimes, Usually, Always), "Your experience with providers" (Never, Sometimes, Usually, Always), "When your child left this hospital" (Yes, definitely; Yes, somewhat; No)
Outcome measures
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=199 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=146 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
Overall patient experience of care
|
0.769 score on a scale
Standard Deviation 0.209
|
0.775 score on a scale
Standard Deviation 0.223
|
|
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
When Your Child Was Admitted to this Hospital
|
0.735 score on a scale
Standard Deviation 0.335
|
0.747 score on a scale
Standard Deviation 0.357
|
|
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
Your Experience with Nurses at [hospital name]
|
0.878 score on a scale
Standard Deviation 0.205
|
0.890 score on a scale
Standard Deviation 0.214
|
|
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
Your Experience with Doctors at [hospital name]
|
0.872 score on a scale
Standard Deviation 0.230
|
0.865 score on a scale
Standard Deviation 0.254
|
|
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
Your Experience with Providers at [hospital name]
|
0.859 score on a scale
Standard Deviation 0.208
|
0.875 score on a scale
Standard Deviation 0.203
|
|
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
When Your Child Left the ED at [hospital name]
|
0.645 score on a scale
Standard Deviation 0.331
|
0.632 score on a scale
Standard Deviation 0.359
|
PRIMARY outcome
Timeframe: 3 days after emergency department visitPopulation: All participants who received either Virtual Pediatric Model of Care or a Telephone Consultation that reported State-trait anxiety scores at 3-days, data analyzed as Intention-to-Treat.
State-Trait Anxiety Inventory measures state anxiety levels in adults. Responses for the State Anxiety scale assess intensity of current feelings "at this moment". Participant response choices include: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Data below represent total mean and standard deviation scores between the two groups.
Outcome measures
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=194 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=142 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
3-Day State-Trait Anxiety Inventory Form Y
|
1.775 score on a scale
Standard Deviation 0.594
|
1.812 score on a scale
Standard Deviation 0.620
|
SECONDARY outcome
Timeframe: Transfer from initial ED visit to UCDHPopulation: 338 patients transferred to UC Davis Health, numbers reported in the table indicate patient disposition from UC Davis Health Emergency Department, data was analyzed using Intention-to-Treat analysis.
Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups.
Outcome measures
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=369 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=226 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
Transfer Rates
Transferred to UCDH
|
338 Participants
|
212 Participants
|
|
Transfer Rates
Discharged Home from UCDH ED
|
127 Participants
|
73 Participants
|
|
Transfer Rates
Admitted to the Ward
|
107 Participants
|
71 Participants
|
|
Transfer Rates
Admitted to the ICU
|
32 Participants
|
32 Participants
|
|
Transfer Rates
Taken to Operating Room
|
72 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 30 days after emergency department visitPopulation: Healthcare Utilization of patients evaluated at 30-days after discharge following an ER visit, Intention-to-Treat analysis used.
Healthcare utilization included hospitalization and re-hospitalization as measures. Two analyses were done to study 30-day healthcare utilization comparing the intervention and control group. First, the VPTC model of care was compared to the standard of care with respect to ED and hospital use, including transfer and subsequent care needed following initial injury. Second, the VPTC model of care was compared to the standard of care with respect to healthcare (hospital) charges.
Outcome measures
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=369 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=226 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
30-Day Healthcare Utilization
Total Post-Transfer Initial Care Charges in Dollars
|
77,805 Dollars
Standard Deviation 93,219
|
79,468 Dollars
Standard Deviation 103,570
|
|
30-Day Healthcare Utilization
Total Subsequent Care Charges in Dollars
|
3,228 Dollars
Standard Deviation 37,330
|
976 Dollars
Standard Deviation 8,495
|
|
30-Day Healthcare Utilization
Total 30-Day Charges in Dollars
|
81,032 Dollars
Standard Deviation 105,762
|
90,443 Dollars
Standard Deviation 104,401
|
SECONDARY outcome
Timeframe: 3 days after emergency department visitPopulation: Modified Intention-to-Treat analysis of patients that reported 3-day Out-of-Pocket cost data.
At 3-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.
Outcome measures
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=173 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=127 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
3-Day Out-of-Pocket Costs
3-Day Medical Out-of-Pocket Costs in Dollars
|
151 Dollars
Standard Deviation 1,521
|
507 Dollars
Standard Deviation 4,478
|
|
3-Day Out-of-Pocket Costs
3-Day Non-Medical Out-of-Pocket Costs in Dollars
|
228 Dollars
Standard Deviation 405
|
335 Dollars
Standard Deviation 735
|
|
3-Day Out-of-Pocket Costs
3-Day Total Out-of-Pocket Costs in Dollars
|
379 Dollars
Standard Deviation 1,572
|
842 Dollars
Standard Deviation 4,596
|
SECONDARY outcome
Timeframe: 30 days after emergency department visitPopulation: Modified Intention-to-Treat analysis of patients that reported 30-day out of pocket cost data.
At 30-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.
Outcome measures
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=166 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=120 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
30-Day Out-of-Pocket Costs
30-Day Medical Out-of-Pocket Costs in Dollars
|
247 Dollars
Standard Deviation 926
|
3,293 Dollars
Standard Deviation 31,945
|
|
30-Day Out-of-Pocket Costs
30-Day Non-Medical Out-of-Pocket Costs in Dollars
|
625 Dollars
Standard Deviation 4,670
|
216 Dollars
Standard Deviation 411
|
|
30-Day Out-of-Pocket Costs
30-Day Total Out-of-Pocket Costs in Dollars
|
872 Dollars
Standard Deviation 4,747
|
3,509 Dollars
Standard Deviation 32,022
|
SECONDARY outcome
Timeframe: 30 days after emergency department visit using Intention-to-Treat analysis.Population: All participants who received either Virtual Pediatric Model of Care or a Telephone Consultation that reported State-trait anxiety scores at 30-days, data analyzed as Intention-to-Treat.
State-Trait Anxiety Inventory was used to measure state anxiety levels. Responses for the State Anxiety scale assess intensity of current feelings "at this moment". Participant choices included: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Data below represent total mean and standard deviation scores between the two groups.
Outcome measures
| Measure |
Virtual Pediatric Trauma Center (Intervention)
n=190 Participants
The Virtual Pediatric Trauma Center uses telehealth for consultation with a pediatric trauma specialist.
|
Telephone Consultation (Control)
n=134 Participants
Telephone consultations uses audio-only to connect with a pediatric trauma specialist.
|
|---|---|---|
|
30-Day State-Trait Anxiety Inventory Form Y
|
1.776 score on a scale
Standard Deviation 0.647
|
1.798 score on a scale
Standard Deviation 0.621
|
Adverse Events
Virtual Pediatric Trauma Center
Telephone Consultation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place