PainPAINEDNCT05488080
PAINED: Project Addressing INequities in the Emergency Department
A study testing Department-level audit and feedback and electronic health record-embedded clinical decision support in people with Pain and Appendicitis, run by Children's National Research Institute at 1 site in United States.
Trial summary
Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Pain, Appendicitis, Bias, Racial
- What is being tested?
- Department-level audit and feedback and electronic health record-embedded clinical decision support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,032 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 31 Aug 2027
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All Children's National Hospital Emergency Department clinicians
- Patients 0-21 years with symptoms suggestive of appendicitis or long bone fracture
Who cannot join
- Emergency Severity Index (ESI 1)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20016-1838
About this study
Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.
- Conditions
- Pain, Appendicitis, Bias, Racial, Fractures, Bone
- Being tested
- Department-level audit and feedback and electronic health record-embedded clinical decision support
- Medical subject headings
- Pain, Appendicitis, Racism, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Department-level audit and feedback and electronic health record-embedded clinical decision supportBehavioural
This intervention will provide clinicians with Equity Report Cards and clinician decision support on mitigating disparities in quality of care.
| Study group | Role | What they receive |
|---|---|---|
| Department-level audit and feedback and electronic health record-embedded clinical decision support | Experimental | Clinicians will receive monthly pooled, department-level 'Equity Report Cards' that will provide aggregate information on clinical data stratified by patient race/ethnicity. Subsequently, for all visits that may be related to appendicitis or long bone fracture, clinicians will then receive real-time, electronic health record-embedded clinical decision support regarding pain management. Receives: Behavioral: Department-level audit and feedback and electronic health record-embedded clinical decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Percentage of patients with pain reduction, pain is measured on a 0 to 10 scale, 0 is the minimum and 10 is the maximum, a lower score is a better outcome.
Measured: Equity Report Cards provided monthly to clinicians over a 24-month period
Analgesia use
Rate of analgesia use
Measured: Equity Report Cards provided monthly to clinicians over a 24-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start27 Feb 2023
- Primary completion31 Aug 2026
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- The study design is a pragmatic clinical trial.
- Masking
- None (open label)
- Enrolment
- 22,032 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Goyal, Children's National Research Institute
- Investigators
- Monika Goyal, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488080
- Sponsor's protocol ID
- FP00005944 / 1R61DK135406 - 01
- Acronym
- PAINED
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAINED: Project Addressing INequities in the Emergency Department
- ClinicalTrials.gov ID
- NCT05488080
- Acronym / sponsor ID
- PAINED / FP00005944 / 1R61DK135406 - 01
- Conditions
- Pain, Appendicitis, Bias, Racial, Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22,032 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 4 Aug 2022 (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.
Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design is a pragmatic clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Department-level audit and feedback and electronic health record-embedded clinical decision support | Experimental | Behavioral: Department-level audit and feedback and electronic health record-embedded clinical decision supportClinicians will receive monthly pooled, department-level 'Equity Report Cards' that will provide aggregate information on clinical data stratified by patient race/ethnicity. Subsequently, for all visits that may be related to appendicitis or long bone fracture, clinicians will then receive real-time, electronic health record-embedded clinical decision support regarding pain management. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All Children's National Hospital Emergency Department clinicians
- Patients 0-21 years with symptoms suggestive of appendicitis or long bone fracture
Key exclusion criteria (1 listed)
- Emergency Severity Index (ESI 1)
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 |
|---|---|---|
| Department-level audit and feedback and electronic health record-embedded clinical decision supportThis intervention will provide clinicians with Equity Report Cards and clinician decision support on mitigating disparities in quality of care. | Behavioural | Department-level audit and feedback and electronic health record-embedded clinical decision support |
Primary outcome
Pain reduction
Time frame: Equity Report Cards provided monthly to clinicians over a 24-month period
Percentage of patients with pain reduction, pain is measured on a 0 to 10 scale, 0 is the minimum and 10 is the maximum, a lower score is a better outcome.
Analgesia use
Time frame: Equity Report Cards provided monthly to clinicians over a 24-month period
Rate of analgesia use
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 22 Oct 2026.
- 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. This study is not recruiting at the moment.
Monika Goyal 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 Department-level audit and feedback and electronic health record-embedded clinical decision support in people with Pain and Appendicitis, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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?
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?
Pain reduction (time frame: Equity Report Cards provided monthly to clinicians over a 24-month period). 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?
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 22 Oct 2026.