Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
Primary Purpose
Trauma, Injuries
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Pediatric Trauma Center
Sponsored by
About this trial
This is an interventional health services research trial for Trauma
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients (<18 years old) with an acute injury at the time of a transfer consultation call to UC Davis Trauma Surgery, Orthopedic Surgery, or Neurosurgery from eleven outside emergency departments
Sites / Locations
- University of California-Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Telephone consultation
Virtual Pediatric Trauma Center
Arm Description
Telephone consultation to a pediatric trauma specialist
The Virtual Pediatric Trauma Center (VPTC), uses live video, or telehealth, to bring the expertise of a Level I pediatric trauma center virtually to patients at a hospital emergency department.
Outcomes
Primary Outcome Measures
CAHPS Communication Subscale
19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey; specifically, we will report the following measures: Communication between you and your child's nurses (composite measure); Communication between you and your child's doctors (composite measure); Communication about your child's medicines (composite measure); Keeping you informed about your child's care (composite measure) Privacy when talking with doctors, nurses, and other providers (single-item measure); Preparing you and your child to leave the hospital (composite measure); Keeping you informed about your child's care in the Emergency Room (single-item measure). Higher scores are better; 0 (minimum) - 100 (maximum)
State-Trait Anxiety Inventory Form Y
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Secondary Outcome Measures
Transfer Rates
Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups
30-day healthcare utilization
Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty healthcare visits, and diagnostics; these rates will be compared between the control and intervention groups
3-day Out of Pocket Costs
The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
30-day Out of Pocket Costs
The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
State-Trait Anxiety Inventory Form Y
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Full Information
NCT ID
NCT04469036
First Posted
July 8, 2020
Last Updated
October 26, 2022
Sponsor
University of California, Davis
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04469036
Brief Title
Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
Official Title
Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
More than 41 million children, or 55 percent of all children in the United States, live more than 30 minutes away from a pediatric trauma center. The management of pediatric trauma requires medical expertise that is only available at Level I pediatric trauma centers, which are specialized pediatric referral hospitals located in large urban cities. Smaller hospitals lack pediatric trauma expertise and resources to properly care for these children. When a small hospital receives a child with trauma, the standard of care is to conduct a telephone consultation to a pediatric trauma specialist, err on the side of safety, and transfer the child to the regional Level I pediatric trauma center.
A newer model of care, the Virtual Pediatric Trauma Center (VPTC), uses live video, or telemedicine, to bring the expertise of a Level I pediatric trauma center virtually to patients at any hospital emergency department. While the VPTC model is being used more frequently, the advantages and disadvantages of these two systems of care remain unknown, particularly with regard to parent/family-centered outcomes.
The goal of this study is to optimize the patient and family experience and to minimize distress, healthcare utilization, and out-of-pocket costs following the injury of a child. The results of this project will help to optimize communication, confidence, and shared decision making between parents/families and clinical staff from both the transferring and receiving hospitals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Injuries
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped-wedge
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telephone consultation
Arm Type
No Intervention
Arm Description
Telephone consultation to a pediatric trauma specialist
Arm Title
Virtual Pediatric Trauma Center
Arm Type
Experimental
Arm Description
The Virtual Pediatric Trauma Center (VPTC), uses live video, or telehealth, to bring the expertise of a Level I pediatric trauma center virtually to patients at a hospital emergency department.
Intervention Type
Other
Intervention Name(s)
Virtual Pediatric Trauma Center
Intervention Description
Telehealth
Primary Outcome Measure Information:
Title
CAHPS Communication Subscale
Description
19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey; specifically, we will report the following measures: Communication between you and your child's nurses (composite measure); Communication between you and your child's doctors (composite measure); Communication about your child's medicines (composite measure); Keeping you informed about your child's care (composite measure) Privacy when talking with doctors, nurses, and other providers (single-item measure); Preparing you and your child to leave the hospital (composite measure); Keeping you informed about your child's care in the Emergency Room (single-item measure). Higher scores are better; 0 (minimum) - 100 (maximum)
Time Frame
3 days after emergency department visit
Title
State-Trait Anxiety Inventory Form Y
Description
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Time Frame
3 days after emergency department visit
Secondary Outcome Measure Information:
Title
Transfer Rates
Description
Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups
Time Frame
48 hours after emergency department visit
Title
30-day healthcare utilization
Description
Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty healthcare visits, and diagnostics; these rates will be compared between the control and intervention groups
Time Frame
30 days after emergency department visit
Title
3-day Out of Pocket Costs
Description
The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
Time Frame
3 days after emergency department visit
Title
30-day Out of Pocket Costs
Description
The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
Time Frame
30 days after emergency department visit
Title
State-Trait Anxiety Inventory Form Y
Description
State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
Time Frame
30 days after emergency department visit
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients (<18 years old) with an acute injury at the time of a transfer consultation call to UC Davis Trauma Surgery, Orthopedic Surgery, or Neurosurgery from eleven outside emergency departments
Facility Information:
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The study team is determining whether or not to share IPD.
Links:
URL
https://studypages.com/s/improving-family-centered-pediatric-trauma-care-standard-of-care-versus-the-virtual-pediatric-trauma-center-774878/
Description
Learn more or sign up for the study here!
Learn more about this trial
Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
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