Bias Mitigation Training for End-of-Life Care

(BRiDgE-Sim Trial)

No longer recruiting at 1 trial location

Overseen By Elizabeth Chuang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Hospice, Palliative Medicine, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how doctors communicate with families of seriously ill patients, with a focus on reducing racial bias. Researchers are testing two types of training: one combines communication skills with bias reduction (Communication and Bias Mitigation Training), and the other focuses solely on communication skills. The goal is to determine if adding bias reduction helps doctors communicate better with Black family members. This trial suits physicians who work with seriously ill patients in hospitals and specialize in areas like oncology or critical care. As an unphased study, it offers a unique opportunity to improve communication and reduce bias in healthcare settings.

Will I have to stop taking my current medications?

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

What prior data suggests that this training intervention is safe for improving communication in end-of-life care?

Research has shown that training can help doctors communicate better with patients and their families at the end of life. This training teaches doctors to listen carefully and share important information clearly. It also helps them understand and respect the wishes of patients and families.

Studies have found that this training makes discussions about end-of-life care easier and more effective, reducing stress for both patients and doctors. Regarding safety, these training sessions have not shown any negative effects. They primarily involve role-playing and discussions, which are generally safe.

Bias mitigation training helps doctors recognize and reduce hidden biases. This training has been successfully adapted from programs used with medical students. Although specific safety data for this training is lacking, the methods used—such as discussions and exercises—are similar to other safe training programs.

Overall, both types of training aim to improve communication and understanding, and they appear safe based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance end-of-life care by addressing biases that may affect patient interactions. Unlike standard communication training, which focuses on general palliative care techniques, the experimental training incorporates bias mitigation strategies adapted for clinicians. This includes transformational learning methods like critical reflection and perspective-taking exercises, which are designed to tackle racial bias and improve communication with diverse patient groups. By potentially improving clinician-patient interactions, this approach could lead to more personalized and equitable care in end-of-life situations.

What evidence suggests that this trial's training interventions could be effective for improving communication in end-of-life care?

Research has shown that training programs for end-of-life care, including activities like role-playing and reflection, can enhance healthcare professionals' communication skills. For example, one study found that oncologists who received communication training were more effective at discussing end-of-life issues with patients. Another study demonstrated that such training improved doctors' ability to deliver bad news to patients and their families. In this trial, participants will join one of two groups: one group will receive Communication and Bias Mitigation Training, which includes strategies to reduce bias and improve communication with Black patients and their families, while the other group will receive Communication Training Only, focusing on standard palliative care techniques. Although direct evidence of the combined training's effectiveness is limited, the individual components have shown positive results in similar situations. ^{1 6 7 8 9}

Who Is on the Research Team?

Elizabeth Chuang, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for physicians specializing in oncology, critical care, hospitalist medicine, emergency medicine or geriatrics who frequently care for seriously ill patients. It's not open to those trained in Hospice and Palliative Medicine or doctors who spend less than 10% of their time with critically ill hospitalized patients.

Inclusion Criteria

Practicing physicians specializing in oncology, critical care, hospitalist medicine, emergency medicine, or geriatrics

Exclusion Criteria

Physicians who do not care for seriously ill patients in the hospital at least 10% of their working time

Physicians trained in Hospice and Palliative Medicine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Simulated Clinical Encounter

Physicians participate in a simulated clinical encounter with a standardized caregiver to assess communication behaviors and implicit bias.

1 day

1 visit (in-person)

Phase 2: Communication Training

Randomized training session to mitigate implicit bias and improve communication skills, including a VR experience and role-play exercises.

1 half-day workshop

1 visit (in-person)

Follow-up

Participants are monitored for changes in communication behavior and bias mitigation effectiveness post-training.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Communication and Bias Mitigation Training
• Communication skills training

Trial Overview

The study tests a training program designed to improve how doctors communicate with families of critically ill patients by reducing racial biases. Doctors will be randomly assigned to either bias mitigation plus communication training or just communication training and then evaluated on their interactions.

How Is the Trial Designed?

Group I: Communication and Bias Mitigation Training Experimental Treatment 1 Intervention

This is a communication training session based on a culturally-based program developed with rural, southern Black patients and families and modified for an urban, northern population. A strategy of bias mitigation successfully used with medical students will be adapted for practicing clinicians using results of phase 1. This strategy is based on transformational learning theory and incorporates critical reflection, guided dialogue, perspective taking exercises, role plays and strategy development. If specific communication behaviors are found related to bias and stereotyping in phase 1, these will be discussed and targeted using these techniques. Otherwise, these techniques will be used to address racial bias generally. The intervention will be incorporated within the communication training session.

Group II: Communication Training Only Active Control 1 Intervention

This is a communication training session based on standard palliative care techniques to listen empathically, share prognostic information and treatment options, elicit patient and family goals and values related to their treatment, and facilitate shared decision-making regarding end-of-life treatment.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

University of Nebraska Lincoln

Collaborator

Trials

40

Recruited

13,200+

Tulane University School of Medicine

Collaborator

Trials

35

Recruited

117,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A systematic review of 10 studies found that communication-skills training for noncancer acute-based healthcare staff positively impacts their behavior when discussing end-of-life care with patients and families, enhancing confidence and self-efficacy.

Despite the positive outcomes, the studies varied in quality and design, indicating a need for more rigorous research, such as randomized controlled trials, to better assess the effectiveness of these training interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of communication-skills training interventions in end-of-life noncancer care in acute hospital-based services: A systematic review. Lord, L., Clark-Carter, D., Grove, A.[2018]

There is a significant gap between patients' and physicians' attitudes regarding the handling of medical errors, as well as between existing disclosure policies and their actual implementation in practice, highlighting the need for improved communication and transparency in healthcare.

Barriers to full disclosure of adverse events include fear of consequences, lack of skills, and insufficient institutional support, which not only affect patient safety but also traumatize healthcare workers, known as the 'second victim' phenomenon. A comprehensive approach involving multiple levels of the healthcare system is necessary to address these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disclosure of adverse events in the United States and Canada: an update, and a proposed framework for improvement. Wu, AW., Boyle, DJ., Wallace, G., et al.[2021]

Online communication skills training (CST) significantly improved health professionals' self-assessed communication skills, confidence, and objective knowledge, based on a review of 19 studies involving 1116 health professionals and patients.

While the training showed promise in enhancing communication skills in oncology settings, the direct impact on patient outcomes remains unclear and requires further research to establish effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of online communication skills training for cancer and palliative care health professionals: A systematic review. Berg, MN., Ngune, I., Schofield, P., et al.[2021]

A review of 23 studies highlighted that healthcare professionals face challenges in effectively disclosing adverse events, indicating a need for better communication strategies and training.

Implementing specific interpersonal communication skills and fostering an open organizational culture can help healthcare professionals provide more effective and tailored disclosures to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disclosing Adverse Events in Clinical Practice: The Delicate Act of Being Open. Myren, BJ., de Hullu, JA., Bastiaans, S., et al.[2022]

Patients want to be informed about adverse events in healthcare, and this transparency is supported by safety experts and policymakers.

Enhancing the disclosure process through better policies and training can lead to increased patient satisfaction, improved relationships between patients and physicians, and ultimately a higher quality of healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 380: Disclosure and discussion of adverse events. [2009]

A randomized controlled trial involving 141 oncologists demonstrated that the PALLI-COM communication skills training significantly improved their ability to address palliative care and end-of-life issues, particularly in showing empathy and explaining concepts related to care.

Participants in the training group reported enhanced self-efficacy and confidence in dealing with terminally ill patients, indicating that such training could be beneficial for improving communication in advanced cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a communication training for oncologists on early addressing palliative and end-of-life care in advanced cancer care (PALLI-COM): a randomized, controlled trial. Harnischfeger, N., Rath, HM., Alt-Epping, B., et al.[2023]

A systematic review of 24 publications identified 22 interventions aimed at improving communication about palliative care and end-of-life issues among oncologists, with most interventions showing significant positive effects on communication skills.

The majority of these interventions focused on specific issues like breaking bad news and utilized role-playing as a teaching strategy, highlighting the need for future studies to address a broader range of communication topics and improve the quality of research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing palliative care and end-of-life issues in patients with advanced cancer: a systematic review of communication interventions for physicians not specialised in palliative care. Harnischfeger, N., Rath, HM., Oechsle, K., et al.[2022]

A study involving 143 internal medicine trainees found no significant correlation between trainees' self-assessments of their end-of-life communication skills and the assessments from patients, families, and clinician-evaluators, suggesting that self-perception may not accurately reflect actual communication quality.

The only significant association found was that higher self-ratings by trainees on 'treatment discussions' were linked to lower ratings from families, indicating a potential disconnect between how trainees view their skills and how they are perceived by others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal medicine trainee self-assessments of end-of-life communication skills do not predict assessments of patients, families, or clinician-evaluators. Dickson, RP., Engelberg, RA., Back, AL., et al.[2021]

A simulation-based communication skills training for internal medicine and nurse practitioner trainees did not significantly improve patient-reported quality of communication or quality of end-of-life care, based on a study involving 472 trainees and 1866 patient ratings.

Interestingly, the training was associated with a small increase in depressive symptoms among patients of trainees who underwent the intervention, suggesting potential negative effects on patient well-being despite the training's intent to enhance communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. Curtis, JR., Back, AL., Ford, DW., et al.[2022]

A study involving 14 obstetrics and gynecology residents showed that their ability to disclose adverse outcomes to patients significantly improved after participating in a formal teaching workshop, with scores increasing from an average of 59.1% to 80.1%.

The use of an objective structured clinical examination (OSCE) effectively assessed the residents' communication skills, highlighting its value in medical education for teaching and evaluating sensitive communication practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing residents' communication skills: disclosure of an adverse event to a standardized patient. Posner, G., Nakajima, A.[2022]

A study involving 14 clinicians revealed that motivations for reporting serious oncology-associated adverse drug reactions included scientific curiosity and public health concerns, but feedback from pharmaceutical manufacturers was predominantly negative.

The research highlights the need for improved pharmacovigilance mechanisms, such as big data and registries, to enhance the reporting and documentation of adverse drug events, addressing barriers like complacency and indifference among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. Bennett, CL., Schooley, B., Taylor, MA., et al.[2020]

Educational interventions aimed at training healthcare professionals in end-of-life communication skills significantly improve their self-efficacy, knowledge, and communication scores compared to standard teaching methods, based on a systematic review of 20 studies involving 5727 articles.

Despite these improvements, the evidence quality is low to very low, and there is insufficient data to determine if these training programs positively impact patient-level outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational interventions to train healthcare professionals in end-of-life communication: a systematic review and meta-analysis. Chung, HO., Oczkowski, SJ., Hanvey, L., et al.[2018]

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