Pain, AcuteNCT06531421
Use of Equity Report Cards to Mitigate Disparities in Emergency Medical Services (EMS) Care for Injured Children
A study testing Equity Report Cards in people with Pain, Acute, run by Children's National Research Institute at 1 site in United States.
Trial summary
This trial will assess whether development and sharing of 'Equity Report Cards' focussed on the recognition and treatment of pain for injured children by Emergency Medical Services (EMS) can help decrease disparities by race and ethnicity. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Equity Report Cards
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Children less than 18 years old
- Assessed by District of Columbia Fire and Emergency Medical Services (DC FEMS)
- Injury related chief complaint, primary or secondary impression
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20002
Caleb E Ward, MD, MPH, 202-476-5000, caward@childrensnational.org
Caleb E Ward, MD, MPH
About this study
This trial will assess whether development and sharing of 'Equity Report Cards' focussed on the recognition and treatment of pain for injured children by Emergency Medical Services (EMS) can help decrease disparities by race and ethnicity.
Read the detailed description
This is a pragmatic trial using an interrupted time-series design. The investigators will collect two years of retrospective data to establish a baseline. At month 2 the investigators will distribute EMS Agency-level 'Equity Report Cards' to both agency leadership and all frontline EMS providers. This 'Equity Report Card' will contain monthly pooled, agency-level information summarizing clinical data for injured children stratified by race/ethnicity. At month 7 the investigators will also distribute Battalion-level 'Equity Report Cards' to agency leadership and all frontline EMS providers. The 'Equity Report Card' will include baseline historical data and a 3-month rolling average for each of the study outcomes. The 'Equity Report Card' will also include an action plan with evidenced based recommendations specifically targeted to improve care.
The outcomes for this study include both process measures (including documentation of pain scores, administration of any analgesia and administration of opiate analgesia) and also patient-centered clinical outcomes (reduction of pain as reported by the patient). These key study outcomes align with performance measures developed by the National EMS Quality Alliance (NEMSQA).
Patient race and ethnicity will be abstracted from the EMS medical record. The investigators will also collect data regarding potential confounding variables including patient age, sex, geographic location of encounter and other dispatch details.
The investigators will conduct an interrupted time series analysis (ITSA) to evaluate the magnitude and statistical significance of the average difference (intercept) and difference between trajectories (slopes) for our 24 month control (T0) and each of the two intervention 5 month time periods (T1 and T2). This will allow the investigators to measure the impact of each additional intervention (EMS agency-level followed by the addition of Battalion-level 'Equity Report Cards').
- Conditions
- Pain, Acute
- Being tested
- Equity Report Cards
- Keywords
- Racial Groups
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equity Report CardsOther
At month 2 the investigators will distribute EMS Agency-level 'Equity Report Cards' to both agency leadership and all frontline EMS providers. This 'Equity Report Card' will contain monthly pooled, agency-level information summarizing clinical data for injured children stratified by race/ethnicity. At month 7 the investigators will also distribute Battalion-level 'Equity Report Cards' to agency leadership and all frontline EMS providers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Distribution of Equity Report Cards Receives: Other: Equity Report Cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain
Proportion of children who have a reduction in pain score
Measured: 1 year
Secondary outcomes (3)
Pain score documented
Proportion of children who have a pain score documented by EMS
Measured: 1 year
Any analgesia administered
Proportion of children who have any analgesia administered by EMS
Measured: 1 year
Opiate analgesia administered
Proportion of children who have opiate analgesia administered by EMS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pragmatic single-arm trial using an interrupted time-series design.
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Caleb E Ward, MD, MPH, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531421
- Sponsor's protocol ID
- 00001103
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Equity Report Cards to Mitigate Disparities in Emergency Medical Services (EMS) Care for Injured Children
- ClinicalTrials.gov ID
- NCT06531421
- Acronym / sponsor ID
- 00001103
- Conditions
- Pain, Acute
- Keywords
- Racial Groups
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Doris Duke Charitable Foundation
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will assess whether development and sharing of 'Equity Report Cards' focussed on the recognition and treatment of pain for injured children by Emergency Medical Services (EMS) can help decrease disparities by race and ethnicity.
Detailed description
This is a pragmatic trial using an interrupted time-series design. The investigators will collect two years of retrospective data to establish a baseline. At month 2 the investigators will distribute EMS Agency-level 'Equity Report Cards' to both agency leadership and all frontline EMS providers. This 'Equity Report Card' will contain monthly pooled, agency-level information summarizing clinical data for injured children stratified by race/ethnicity. At month 7 the investigators will also distribute Battalion-level 'Equity Report Cards' to agency leadership and all frontline EMS providers. The 'Equity Report Card' will include baseline historical data and a 3-month rolling average for each of the study outcomes. The 'Equity Report Card' will also include an action plan with evidenced based recommendations specifically targeted to improve care.
The outcomes for this study include both process measures (including documentation of pain scores, administration of any analgesia and administration of opiate analgesia) and also patient-centered clinical outcomes (reduction of pain as reported by the patient). These key study outcomes align with performance measures developed by the National EMS Quality Alliance (NEMSQA).
Patient race and ethnicity will be abstracted from the EMS medical record. The investigators will also collect data regarding potential confounding variables including patient age, sex, geographic location of encounter and other dispatch details.
The investigators will conduct an interrupted time series analysis (ITSA) to evaluate the magnitude and statistical significance of the average difference (intercept) and difference between trajectories (slopes) for our 24 month control (T0) and each of the two intervention 5 month time periods (T1 and T2). This will allow the investigators to measure the impact of each additional intervention (EMS agency-level followed by the addition of Battalion-level 'Equity Report Cards').
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pragmatic single-arm trial using an interrupted time-series design.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Equity Report CardsDistribution of Equity Report Cards |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children less than 18 years old
- Assessed by District of Columbia Fire and Emergency Medical Services (DC FEMS)
- Injury related chief complaint, primary or secondary impression
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Equity Report CardsAt month 2 the investigators will distribute EMS Agency-level 'Equity Report Cards' to both agency leadership and all frontline EMS providers. This 'Equity Report Card' will contain monthly pooled, agency-level information summarizing clinical data for injured children stratified by race/ethnicity. At month 7 the investigators will also distribute Battalion-level 'Equity Report Cards' to agency leadership and all frontline EMS providers. | Other | Intervention |
Primary outcome
Reduction in pain
Time frame: 1 year
Proportion of children who have a reduction in pain score
3 secondary outcomes
Pain score documented
Time frame: 1 year
Any analgesia administered
Time frame: 1 year
Opiate analgesia administered
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Caleb E Ward, MD, MPH principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equity Report Cards in people with Pain, Acute, run by Children's National Research Institute 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caleb E Ward, MD, MPH (202-476-5000, caward@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.