Equity Report Cards for Acute Pain in Injured Children

Overseen By Caleb E Ward, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Equity Report Cards for acute pain in injured children?

The study on the effects of a pain-reporting education program showed that training children to report pain more accurately can improve their pain assessment, suggesting that educational interventions can enhance pain management. Additionally, the multidimensional knowledge translation strategy improved pain assessment and management practices in hospitalized children, indicating that structured approaches can lead to better pain outcomes. ^{1 2 3 4 5}

Is the treatment generally safe for children?

The research articles focus on adverse event reporting and safety in pediatric settings, but they do not provide specific safety data for the treatment 'Equity Report Cards for Acute Pain in Injured Children.' They highlight the importance of monitoring and reporting adverse events to improve safety in pediatric care. ^{6 7 8 9 10}

How does the treatment 'Equity Report Cards' for acute pain in injured children differ from other treatments?

The 'Equity Report Cards' treatment is unique because it focuses on assessing and improving the equity of pain management in children, rather than directly treating pain. This approach is different from standard treatments that typically involve medication or physical interventions to alleviate pain. ^{3 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Caleb E Ward, MD, MPH

Principal Investigator

Children's National Research Institute

Eligibility Criteria

This trial is for Emergency Medical Services (EMS) providers who treat injured children. It aims to see if using 'Equity Report Cards' can reduce treatment differences based on race and ethnicity.

Inclusion Criteria

I am under 18 years old.

Assessed by District of Columbia Fire and Emergency Medical Services (DC FEMS)

My main health issue is due to an injury.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Collection of two years of retrospective data to establish a baseline

2 months

Intervention Phase 1

Distribution of EMS Agency-level 'Equity Report Cards' to agency leadership and frontline EMS providers

5 months

Intervention Phase 2

Distribution of Battalion-level 'Equity Report Cards' to agency leadership and frontline EMS providers

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Equity Report Cards

Trial Overview The intervention being tested is the use of 'Equity Report Cards' in EMS settings, which are designed to monitor and improve how pain in injured children is recognized and treated, focusing on reducing racial and ethnic disparities.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Distribution of Equity Report Cards

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

American Academy of Pediatrics

Collaborator

Trials

46

Recruited

4,071,000+

Findings from Research

The Brazilian Portuguese version of the Pediatric Trigger Toolkit was successfully translated and adapted for use in Brazilian hospitals, involving a thorough validation process that included expert consensus and cultural adaptation.

The toolkit demonstrated a positive predictive value of 13.51% for identifying adverse drug events in pediatric patients, with antihistamine triggers being the most effective, indicating its potential utility in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients. Silva, LT., Modesto, ACF., Martins, RR., et al.[2020]

In a study of 6,376 children treated in pediatric emergency departments, 3.0% experienced at least one adverse event related to their care, highlighting a significant safety risk in this setting.

Most of these adverse events (76.5%) were deemed preventable, primarily due to management and diagnostic issues, indicating that there are clear opportunities for improving patient safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe are paediatric emergency departments? A national prospective cohort study. Plint, AC., Newton, AS., Stang, A., et al.[2022]

The study introduced a new voluntary and anonymous reporting system for near-miss and patient harm events in a pediatric intensive care unit, highlighting its importance for enhancing patient safety.

The effectiveness of the Patient Safety Report was demonstrated, showing it successfully captures incidents that could lead to patient harm, allowing for better assessment and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an anonymous reporting system on near-miss and harmful medical error reporting in a pediatric intensive care unit. Grant, MJ., Larsen, GY.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors affecting emergency department assessment and management of pain in children. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Association of race and socioeconomic status with time to pain control among pediatric trauma patients managed nonoperatively. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Pain-Reporting Education Program on Children's Pain Reports-Results From a Randomized Controlled Post-operative Pediatric Pain Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The social ecology of changing pain management: do I have to cry? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pain in hospitalized children: Effect of a multidimensional knowledge translation strategy on pain process and clinical outcomes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Disparities in Adverse Event Reporting for Hospitalized Children. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients. [2020]

8. England pubmed.ncbi.nlm.nih.gov

How safe are paediatric emergency departments? A national prospective cohort study. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Pediatric drug safety signal detection: a new drug-event reference set for performance testing of data-mining methods and systems. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of an anonymous reporting system on near-miss and harmful medical error reporting in a pediatric intensive care unit. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Pain assessment in the paediatric Emergency Department: whose view counts? [2019]

12. Norway pubmed.ncbi.nlm.nih.gov

Validity and reliability of a Swedish version of the Non-Communicating Children's Pain Checklist--Postoperative Version. [2019]

13. France pubmed.ncbi.nlm.nih.gov

Prevalence of moderate-severe pain in hospitalized children. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Clinical validation of the paediatric pain profile. [2022]