TraumaNCT04469036
Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
A study testing Virtual Pediatric Trauma Center in people with Trauma and Injuries, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- What is being tested?
- Virtual Pediatric Trauma Center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 27 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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*
- Parents/guardians of the above patients will be contacted to complete surveys
Who cannot join
- Pediatric patients who are wards of the state
- Pediatric patients who die before the 3-day survey is administered
- Pediatric patients receiving cardiopulmonary resuscitation prior to presentation to either the outside or UC Davis emergency department
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
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.
Read the detailed description
The American College of Surgeons Committee on Trauma (ACS-COT) has been committed to improving the care provided to injured patients since 1922. An essential component of their efforts has been the creation of minimum standards for trauma facilities and a tiered trauma care system. As detailed in the ACS-COT published guidelines, Resources for Optimal Care of the Injured Patient, these standards outline the five levels of trauma facilities that define varying levels of commitment, readiness, resources, policies, patient care, and performance improvement. A Level I trauma center is the highest designation and is only granted to hospitals that are able to provide the highest level of care to all injured patients. The ACS-COT Trauma Center Verification process has been instrumental in improving outcomes among injured children and adults, and has become the national model of trauma care coordination as well as the prototype for trauma care on an international level.
While the regionalization of trauma care has resulted in improved outcomes, the current standard of care has created disparities in access for patients injured in geographically isolated locations. When children living in remote communities are injured and present to a non-pediatric trauma center emergency department (ED), they are transferred to the regionalized Level I pediatric trauma center. In more than half of the states in the US, a majority of children live more than 30 miles from a designated Level I pediatric trauma center. Currently, there are more than 41 million children in the US that have poor access to care, living more than 30 miles from a pediatric trauma center, and it is these children who would benefit the most from a re-engineered system of care that addresses the disparities in access for injured children.
Because the current regionalization of trauma centers has created disparities in access, many pediatric trauma experts, including health policy makers, health services researchers, and front line clinicians, have advocated for the use of telemedicine so that the Level I pediatric trauma center expertise can be transmitted to the receiving EDs where a majority of pediatric trauma patients initially present. This newer system of care has been commonly referred to as the "Virtual Pediatric Trauma Center" (VPTC) and is increasingly used by many hospitals and EDs throughout the country. The VPTC creates a model of care that connects EDs in non-Level I trauma centers using telemedicine to bring expert pediatric trauma care to the bedside of injured children, no matter which hospital the patient presents to first. While this newer model of care enables participation of parents/families in the initial trauma care, there is conflicting and limited literature comparing this model to the current standard of care as it relates to parent/family-experience and distress, healthcare utilization, and financial impact on parents/families.
As evidence, in preparation for the original proposal for this study, we conducted three meetings with community advisory boards, which laid the foundation for the study design and evaluation (see: Community and Stakeholder Involvement During Study Development below). For the resubmission of that proposal, we reconvened with members from each of these boards to focus more on parent/family-centered measures. Our team of clinical investigators, consortium hospital partners, as well as our two broadly representative community advisory boards, are confident that these two models of care can be effectively compared, and that the results will provide important solutions to problems facing families wanting to improve specialized trauma care for children. As highlighted in the PCORI Research Prioritization Topic Brief entitled, "Rural Trauma Care," improving rural trauma care is a "high-impact target."20 Recent data derived on adult patients have documented the impact that telemedicine can have on clinical outcomes in a variety of trauma settings. Having the core members of a regionalized Level I pediatric trauma center available virtually at the bedside of injured children has the potential to have a positive impact on the parent and family involvement in shared decision making, which may reduce unnecessary and financially burdensome transfers. Alternatively, parents and families may prefer to err on the side of safety and have an injured child immediately transferred to the regional Level I pediatric trauma center, so delaying or avoiding the transfer of an injured child to a better equipped and staffed facility could result in increased parent/family distress, healthcare utilization, and out-of-pocket costs. Hence, a rigorous comparison of the two prevailing models of care is needed to inform the choice between them.
- Being tested
- Virtual Pediatric Trauma Center
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Pediatric Trauma CenterOther
Telehealth
| Study group | Role | What they receive |
|---|---|---|
| Telephone Consultation (Control) | No intervention | Telephone consultation to a pediatric trauma specialist. |
| Virtual Pediatric Trauma Center (Intervention) | Experimental | The Virtual Pediatric Trauma Center uses telehealth to consult a pediatric trauma specialist. Receives: Other: Virtual Pediatric Trauma Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
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)
Measured: 3 days after emergency department visit
3-Day State-Trait Anxiety Inventory Form Y
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.
Measured: 3 days after emergency department visit
Secondary outcomes (5)
Transfer Rates
Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups.
Measured: Transfer from initial ED visit to UCDH
30-Day Healthcare Utilization
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.
Measured: 30 days after emergency department visit
3-Day Out-of-Pocket Costs
At 3-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.
Measured: 3 days after emergency department visit
30-Day Out-of-Pocket Costs
At 30-days, surveys requested parents of patients to self-report medical and non-medical Out-of-Pocket costs following their ED visit.
Measured: 30 days after emergency department visit
30-Day State-Trait Anxiety Inventory Form Y
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.
Measured: 30 days after emergency department visit using Intention-to-Treat analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start30 Nov 2020
- Primary completion27 Nov 2022
- Study completion27 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge
- Masking
- None (open label)
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469036
- Sponsor's protocol ID
- 1623230
- Status last verified
- Nov 2024
- First submitted
- 8 Jul 2020
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The "Virtual Pediatric Trauma Center" (VPTC) is a model of care that utilizes telemedicine for acutely injured children presenting to non-pediatric trauma center hospitals to obtain consultations from pediatric trauma specialists. This randomized controlled trial compared the standard of care (telephone consultation from a referring non-pediatric trauma center connected to a pediatric trauma specialist at a level I pediatric trauma center) to the VPTC model of care (telemedicine consultation between the referring facility and pediatric specialist) for pediatric trauma injuries. Data comparing the two models was collected to assess parent/family experience of care and distress, transfer rates, healthcare utilization, and financial impact on parents/families. 595 children were enrolled during the two-year active study period and data was collected from parent/family surveys and the electronic health record (EHR).
Publications
Marcin JP, Rosenthal JL, Tancredi DJ, Rinderknecht T, Hamline MY, Leshikar H, Zwienenberg M, Galante JM, Hoch JS, Mouzoon J, Haynes SC, Rominger K, Sanders A, Sauers-Ford H, Dizon R, Lavine JL, Kuppermann N. Telemedicine Consultation for Pediatric Trauma in Community ED Visits and Parent Experience of Care: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2636546. doi: 10.1001/jamanetworkopen.2026.36546.
PubMed 42905708Marcin JP, Tancredi DJ, Galante JM, Rinderknecht TN, Haus BM, Leshikar HB, Zwienenberg M, Rosenthal JL, Grether-Jones KL, Hamline MY, Hoch JS, Kuppermann N. Measuring the impact of a "Virtual Pediatric Trauma Center" (VPTC) model of care using telemedicine for acutely injured children versus the standard of care: study protocol for a prospective stepped-wedge trial. Trials. 2022 Dec 27;23(1):1051. doi: 10.1186/s13063-022-06996-1.
PubMed 36575536
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center
- ClinicalTrials.gov ID
- NCT04469036
- Acronym / sponsor ID
- 1623230
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Nov 2022 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The American College of Surgeons Committee on Trauma (ACS-COT) has been committed to improving the care provided to injured patients since 1922. An essential component of their efforts has been the creation of minimum standards for trauma facilities and a tiered trauma care system. As detailed in the ACS-COT published guidelines, Resources for Optimal Care of the Injured Patient, these standards outline the five levels of trauma facilities that define varying levels of commitment, readiness, resources, policies, patient care, and performance improvement. A Level I trauma center is the highest designation and is only granted to hospitals that are able to provide the highest level of care to all injured patients. The ACS-COT Trauma Center Verification process has been instrumental in improving outcomes among injured children and adults, and has become the national model of trauma care coordination as well as the prototype for trauma care on an international level.
While the regionalization of trauma care has resulted in improved outcomes, the current standard of care has created disparities in access for patients injured in geographically isolated locations. When children living in remote communities are injured and present to a non-pediatric trauma center emergency department (ED), they are transferred to the regionalized Level I pediatric trauma center. In more than half of the states in the US, a majority of children live more than 30 miles from a designated Level I pediatric trauma center. Currently, there are more than 41 million children in the US that have poor access to care, living more than 30 miles from a pediatric trauma center, and it is these children who would benefit the most from a re-engineered system of care that addresses the disparities in access for injured children.
Because the current regionalization of trauma centers has created disparities in access, many pediatric trauma experts, including health policy makers, health services researchers, and front line clinicians, have advocated for the use of telemedicine so that the Level I pediatric trauma center expertise can be transmitted to the receiving EDs where a majority of pediatric trauma patients initially present. This newer system of care has been commonly referred to as the "Virtual Pediatric Trauma Center" (VPTC) and is increasingly used by many hospitals and EDs throughout the country. The VPTC creates a model of care that connects EDs in non-Level I trauma centers using telemedicine to bring expert pediatric trauma care to the bedside of injured children, no matter which hospital the patient presents to first. While this newer model of care enables participation of parents/families in the initial trauma care, there is conflicting and limited literature comparing this model to the current standard of care as it relates to parent/family-experience and distress, healthcare utilization, and financial impact on parents/families.
As evidence, in preparation for the original proposal for this study, we conducted three meetings with community advisory boards, which laid the foundation for the study design and evaluation (see: Community and Stakeholder Involvement During Study Development below). For the resubmission of that proposal, we reconvened with members from each of these boards to focus more on parent/family-centered measures. Our team of clinical investigators, consortium hospital partners, as well as our two broadly representative community advisory boards, are confident that these two models of care can be effectively compared, and that the results will provide important solutions to problems facing families wanting to improve specialized trauma care for children. As highlighted in the PCORI Research Prioritization Topic Brief entitled, "Rural Trauma Care," improving rural trauma care is a "high-impact target."20 Recent data derived on adult patients have documented the impact that telemedicine can have on clinical outcomes in a variety of trauma settings. Having the core members of a regionalized Level I pediatric trauma center available virtually at the bedside of injured children has the potential to have a positive impact on the parent and family involvement in shared decision making, which may reduce unnecessary and financially burdensome transfers. Alternatively, parents and families may prefer to err on the side of safety and have an injured child immediately transferred to the regional Level I pediatric trauma center, so delaying or avoiding the transfer of an injured child to a better equipped and staffed facility could result in increased parent/family distress, healthcare utilization, and out-of-pocket costs. Hence, a rigorous comparison of the two prevailing models of care is needed to inform the choice between them.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Telephone Consultation (Control) | No intervention | –Telephone consultation to a pediatric trauma specialist. |
| Virtual Pediatric Trauma Center (Intervention) | Experimental | Other: Virtual Pediatric Trauma CenterThe Virtual Pediatric Trauma Center uses telehealth to consult a pediatric trauma specialist. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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*
- Parents/guardians of the above patients will be contacted to complete surveys
Key exclusion criteria (3 listed)
- Pediatric patients who are wards of the state
- Pediatric patients who die before the 3-day survey is administered
- Pediatric patients receiving cardiopulmonary resuscitation prior to presentation to either the outside or UC Davis emergency department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Pediatric Trauma CenterTelehealth | Other | Virtual Pediatric Trauma Center (Intervention) |
Primary outcome
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale
Time frame: 3 days after emergency department visit
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)
3-Day State-Trait Anxiety Inventory Form Y
Time frame: 3 days after emergency department visit
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.
5 secondary outcomes
Transfer Rates
Time frame: Transfer from initial ED visit to UCDH
30-Day Healthcare Utilization
Time frame: 30 days after emergency department visit
3-Day Out-of-Pocket Costs
Time frame: 3 days after emergency department visit
30-Day Out-of-Pocket Costs
Time frame: 30 days after emergency department visit
30-Day State-Trait Anxiety Inventory Form Y
Time frame: 30 days after emergency department visit using Intention-to-Treat analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42905708Marcin JP, Rosenthal JL, Tancredi DJ, Rinderknecht T, Hamline MY, Leshikar H, Zwienenberg M, Galante JM, Hoch JS, Mouzoon J, Haynes SC, Rominger K, Sanders A, Sauers-Ford H, Dizon R, Lavine JL, Kuppermann N. Telemedicine Consultation for Pediatric Trauma in Community ED Visits and Parent Experience of Care: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2636546. doi: 10.1001/jamanetworkopen.2026.36546.
- Derived from this study: PubMed 36575536Marcin JP, Tancredi DJ, Galante JM, Rinderknecht TN, Haus BM, Leshikar HB, Zwienenberg M, Rosenthal JL, Grether-Jones KL, Hamline MY, Hoch JS, Kuppermann N. Measuring the impact of a "Virtual Pediatric Trauma Center" (VPTC) model of care using telemedicine for acutely injured children versus the standard of care: study protocol for a prospective stepped-wedge trial. Trials. 2022 Dec 27;23(1):1051. doi: 10.1186/s13063-022-06996-1.
- Individual participant dataSharing planned: Yes. The "Virtual Pediatric Trauma Center" (VPTC) is a model of care that utilizes telemedicine for acutely injured children presenting to non-pediatric trauma center hospitals to obtain consultations from pediatric trauma specialists. This randomized controlled trial compared the standard of care (telephone consultation from a referring non-pediatric trauma center connected to a pediatric trauma specialist at a level I pediatric trauma center) to the VPTC model of care (telemedicine consultation between the referring facility and pediatric specialist) for pediatric trauma injuries. Data comparing the two models was collected to assess parent/family experience of care and distress, transfer rates, healthcare utilization, and financial impact on parents/families. 595 children were enrolled during the two-year active study period and data was collected from parent/family surveys and the electronic health record (EHR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Pediatric Trauma Center in people with Trauma and Injuries, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey Communication Subscale (time frame: 3 days after emergency department visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469036, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.