Reducing Clinician Bias for Better Pain Treatment

(PAINED Trial)

Overseen By Meleah Boyle

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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for reducing clinician bias in pain treatment?

Research shows that providing personalized feedback and virtual interactions with patients can significantly reduce treatment bias in clinicians, leading to more equitable pain care. Additionally, electronic health record-based clinical decision support has been effective in improving prescription practices, suggesting its potential to enhance pain treatment decisions. ^{1 2 3 4 5}

Is the treatment for reducing clinician bias in pain treatment safe for humans?

The treatment, which includes electronic health record-embedded clinical decision support, has been associated with safer prescribing practices, such as reducing risky opioid regimens. However, there are concerns about the validation of these systems, as flawed predictions could potentially harm patients. ^{6 7 8 9 10}

How does this treatment differ from other treatments for pain management?

This treatment is unique because it focuses on reducing clinician bias through a virtual perspective-taking intervention, which provides personalized feedback and interactions with virtual patients to address racial and socioeconomic disparities in pain care, rather than directly altering the medication or dosage given to patients. ^{1 2 5 6 11}

Research Team

Monika Goyal, MD

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

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

The interaction of patient race, provider bias, and clinical ambiguity on pain management decisions. [2022]

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

Targeted Intervention to Increase Awareness of Opioid Overprescribing Significantly Reduces Narcotic Prescribing Within an Academic Orthopaedic Practice. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Targeted messaging to improve the adoption of clinical decision support for prescription drug monitoring program use. [2023]

5. United States 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. [2021]

6. United States 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Impact of multidisciplinary chart reviews on opioid dose reduction and monitoring practices. [2019]

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

Impact of the Opioid Safety Initiative on opioid-related prescribing in veterans. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A call for better validation of opioid overdose risk algorithms. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The effect of electronic prescribing on medication errors and adverse drug events: a systematic review. [2022]

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

Patient race and physicians' decisions to prescribe opioids for chronic low back pain. [2022]