Reducing Clinician Bias for Better Pain Treatment

(PAINED Trial)

Recruiting at 1 trial location

Overseen By Meleah Boyle

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Emergency severity index 1

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

Compensation: Varies

Number of Visits: Unknown

22032 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to improve pain treatment for children in emergency rooms, emphasizing fairness in care regardless of race or ethnicity. The researchers aim to reduce bias among doctors by using monthly reports and instant decision tools, such as department-level audit and feedback and electronic health record-embedded clinical decision support, to guide pain management. The focus is on children visiting the emergency department with suspected appendicitis (an inflamed appendix) or broken bones. Children with these symptoms who visit the emergency room might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that seeks to ensure equitable pain management for all children.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications.

What prior data suggests that these interventions are safe for use in clinical settings?

Research has shown that department-level checks and feedback, combined with electronic health record tools for decision-making, are generally safe. Many healthcare settings have used these tools to enhance patient care without causing harm.

Studies have found that audit and feedback systems can positively influence healthcare practices. They provide information that helps doctors and nurses make better decisions, leading to improved patient outcomes without safety risks.

Additionally, clinical decision support systems (CDSS) help healthcare providers make informed decisions quickly. These systems offer advice based on the latest medical knowledge and patient information. They have been used safely to manage chronic pain and other conditions.

In summary, both audit and feedback systems and CDSS are well-accepted in healthcare settings. No evidence suggests significant safety concerns for patients or healthcare providers when using these tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial focusing on reducing clinician bias for better pain treatment because it introduces department-level audit and feedback paired with electronic health record-embedded clinical decision support. This approach is unique because it provides clinicians with "Equity Report Cards," which offer insights into how pain management varies by patient race and ethnicity, helping to address disparities in treatment. Additionally, the real-time decision support system aids clinicians during patient visits, ensuring more equitable and evidence-based pain management decisions. This innovative combination aims to improve the standard of care by integrating data-driven insights directly into the clinical workflow, potentially reducing bias and enhancing treatment outcomes across diverse patient populations.

What evidence suggests that this protocol is effective for reducing clinician bias in pain treatment?

This trial will evaluate the effectiveness of department-level audit and feedback combined with electronic health record-embedded clinical decision support in reducing clinician bias for better pain treatment. Research has shown that certain tools can improve health outcomes for various patient groups. For example, clinical decision support systems (CDSS) built into electronic health records promote fairness in healthcare, particularly for patients who often face unequal treatment. One study found that clinical dashboards, which display visual data, help doctors make fairer treatment choices. These tools provide real-time feedback based on data, reducing bias in decision-making. Although these tools have been used in many healthcare settings, their effectiveness in managing pain for conditions like appendicitis or fractures is still under investigation in this trial. ^{1 4 5 6 7}

Who Is on the Research Team?

Monika Goyal, MD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for clinicians at Children's National Hospital Emergency Department. It aims to address racial and ethnic inequities in pain management among children with appendicitis or broken bones by targeting clinician implicit bias.

Inclusion Criteria

All Children's National Hospital Emergency Department clinicians

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians receive monthly 'Equity Report Cards' and real-time clinical decision support for pain management

24 months

Monthly visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Department-level audit and feedback and electronic health record-embedded clinical decision support

Trial Overview The study tests two interventions: department-level audit and feedback, plus electronic health record-embedded clinical decision support, to see if they can reduce healthcare inequalities in emergency pain treatment.

How Is the Trial Designed?

Group I: Department-level audit and feedback and electronic health record-embedded clinical decision support Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Published Research Related to This Trial

A study involving 129 medical residents and fellows used computer-simulated patients to explore how patient race and clinical ambiguity affect pain management decisions, revealing that providers' treatment choices varied based on these factors, particularly for white patients.

The findings suggest that racial disparities in pain care are influenced by the ambiguity of clinical scenarios, indicating that interventions to reduce these disparities should address patient, provider, and contextual factors rather than solely focusing on provider biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interaction of patient race, provider bias, and clinical ambiguity on pain management decisions. Hirsh, AT., Hollingshead, NA., Ashburn-Nardo, L., et al.[2022]

A study involving 382 primary care physicians revealed that patient race and behavior significantly influence opioid prescribing decisions for chronic low back pain, with black patients receiving more aggressive treatment when exhibiting 'challenging' behaviors.

In contrast, white patients were more likely to receive escalated treatment when displaying 'non-challenging' behaviors, highlighting potential biases in pain management that need to be addressed to improve care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient race and physicians' decisions to prescribe opioids for chronic low back pain. Burgess, DJ., Crowley-Matoka, M., Phelan, S., et al.[2022]

A targeted educational intervention on opioid overprescribing led to a significant reduction in opioid prescriptions, with mean morphine milligram equivalents (MME) decreasing from 780 to 613 for opioid naive patients and from 1,015 to 861 for non-naive patients.

The study, which analyzed data from 5,882 patients over a two-year period, highlights the importance of ongoing provider education in effectively reducing opioid prescribing practices in an academic orthopaedic setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Intervention to Increase Awareness of Opioid Overprescribing Significantly Reduces Narcotic Prescribing Within an Academic Orthopaedic Practice. King, C., Curran, J., Devanagondi, S., et al.[2021]

In a study with 107 participants, feedback about their use of demographic cues (like sex, race, or age) in pain management decisions revealed that 26.9% to 55.5% believed this awareness would change their future clinical decisions.

A significant majority (66.6% to 79.1%) of participants who recognized their use of these cues expressed a willingness to engage in an online tutorial aimed at reducing biases in pain management, indicating potential for technology to help improve clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual human technology to provide immediate feedback about participants' use of demographic cues and knowledge of their cue use. Wandner, LD., Letzen, JE., Torres, CA., et al.[2021]

A targeted educational intervention was effective in improving the adoption of clinical decision support (CDS) systems among 478 healthcare providers who were previously overriding these systems, with 34% of them starting to review prescription drug monitoring programs (PDMP) after receiving educational messages.

This study highlights that low-resource strategies, like sending educational messages via email or EHR chat, can significantly enhance the effectiveness of CDS in preventing medical errors and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted messaging to improve the adoption of clinical decision support for prescription drug monitoring program use. Sommers, S., Tolle, H., Napier, C., et al.[2023]

Computerized physician order entry (CPOE) systems significantly reduce medication errors, with 23 out of 25 studies showing a relative risk reduction ranging from 13% to 99%.

CPOE systems also lower the risk of adverse drug events (ADEs), with 6 out of 9 studies reporting a significant reduction of 35% to 98%, indicating their potential effectiveness in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of electronic prescribing on medication errors and adverse drug events: a systematic review. Ammenwerth, E., Schnell-Inderst, P., Machan, C., et al.[2022]

Opioid alerts in clinical decision support systems were overridden 96.3% of the time, indicating a high override rate compared to non-opioid alerts, which raises concerns about alert fatigue among healthcare providers.

Despite the high override rates, only 0.31% of patients experienced adverse drug events related to opioids, and none of these events were preventable by the alerts, suggesting that while alerts can avert some adverse events, the system generates many unnecessary alerts that could hinder patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. Genco, EK., Forster, JE., Flaten, H., et al.[2018]

Clinical decision support (CDS) systems, especially those used for opioid prescribing, need rigorous validation to ensure they do not mislead clinicians and potentially harm patients, as highlighted by the risks associated with flawed predictions.

The paper emphasizes the importance of higher standards for clinical and technical validation of CDS systems, using the Stratification Tool for Opioid Risk Mitigation (STORM) and NarxCare as case studies to illustrate the need for improved oversight in predicting opioid-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A call for better validation of opioid overdose risk algorithms. McElfresh, DC., Chen, L., Oliva, E., et al.[2023]

A randomized controlled trial involving 436 physician residents and fellows showed that a tailored virtual intervention significantly reduced treatment bias against black patients by 85% and against low SES patients by 76% one week after the intervention.

The intervention not only decreased bias but also increased compassion among providers towards patients, suggesting that personalized feedback and virtual interactions can lead to more equitable pain treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial testing a virtual perspective-taking intervention to reduce race and socioeconomic status disparities in pain care. Hirsh, AT., Miller, MM., Hollingshead, NA., et al.[2022]

In a study of 147 patients on high-dose opioid therapy, 34% reduced their opioid dosage after implementing the Opioid Safety Initiative, with the median daily dose decreasing from 315 mg to 278 mg.

There was a notable improvement in adherence to safety policies, including an increase in informed consent completion from 31% to 48% and biannual urine drug screenings from 44% to 61%, indicating enhanced monitoring practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of multidisciplinary chart reviews on opioid dose reduction and monitoring practices. Rivich, J., McCauliff, J., Schroeder, A.[2019]

The Opioid Safety Initiative (OSI) implemented by the Veterans Health Administration led to a significant reduction in high-dosage opioid prescriptions, with a 16% decrease in patients receiving daily dosages over 100 morphine equivalents from October 2012 to September 2014.

The OSI was associated with a monthly decrease of 331 patients on high-dosage opioids (>100 MEQ) and 781 patients on concurrent benzodiazepines, demonstrating the effectiveness of large-scale interventions in promoting safer opioid prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Opioid Safety Initiative on opioid-related prescribing in veterans. Lin, LA., Bohnert, ASB., Kerns, RD., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9471705/

Effectiveness of clinical dashboards as audit and feedback or ... This systematic review aims to investigate the effectiveness of clinical dashboards used as CDSS or A&F tools (as a standalone intervention or part of a ...

2. researchgate.net researchgate.net/publication/366009032_Electronic_Health_Record-Integrated_Clinical_Decision_Support_for_Clinicians_Serving_Populations_Facing_Health_Care_Disparities_Literature_Review

Electronic Health Record-Integrated Clinical Decision ... Conclusions: CDS tools may improve health equity and outcomes for patients who face disparities. The present review underscores the need for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9476612/

Assessing the use of a clinical decision support tool for ... This article describes the design and functionality of a CDS tool for chronic noncancer pain in primary care.

4. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/clinical-decision-support-chronic-pain-management-medstar

Clinical Decision Support for Chronic Pain Management Developing, implementing, disseminating, and evaluating CDS for both patients and clinicians in the area of chronic pain management.

5. academic.oup.com academic.oup.com/jamia/article/30/9/1561/7207843

Potential bias and lack of generalizability in electronic health ... Abstract. Embedded pragmatic clinical trials (ePCTs) play a vital role in addressing current population health problems, and their use of electronic health.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11338587/

Audit and feedback: effects on professional practice and ... To assess the effects of audit and feedback on the practice of healthcare professionals and patient outcomes and to examine factors that may explain variation ...

7. researchgate.net researchgate.net/publication/332873378_Electronic_Health_Records_and_Use_of_Clinical_Decision_Support

Electronic Health Records and Use of Clinical Decision ... A CDSS is a computer-generated tool which consolidates clinical knowledge and information to provide prompts supporting and facilitating decision-making.