Bias Mitigation Training for End-of-Life Care

(BRiDgE-Sim Trial)

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

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to determine the ways in which clinician implicit racial biases affect clinician communication with family members of patients near the end of life and to test a novel physician training intervention to reduce the effects of implicit racial bias on quality of communication. Phase 1: A sample of 50 physicians who care for seriously ill patients, including oncologists, critical care physicians and hospital-based internists will participate in a simulated clinical encounter with a Black standardized family member (actor) of a hypothetical case patient. Measures of implicit and explicit bias will be correlated with verbal and nonverbal communication behavior. Phase 2: This is a 2-arm randomized feasibility pilot of an intervention to mitigate the effects of clinician implicit bias on communication behavior. Physicians who treat patients with serious illness including oncologists, critical care physicians and hospital-based internists will be recruited to participate in a communication training session to reduce the effects of implicit bias or a control training session focusing only on communication skills. Their communication behavior will be videotaped during a simulated encounter with a Black standardized family member (actor) of a hypothetical patient with serious illness before and after the training sessions. The communication behavior before and after the training session will be compared between physicians that received the communication skills only intervention versus the physicians that received the communication skills and bias mitigation training. The primary hypothesis is that physicians who receive both the communication skills and the bias mitigation training will have greater improvements in communication skills with the Black standardized caregiver (actor) compared with those who receive only the communication skills training. This registration is inclusive of phase 2 only as phase 2 is the clinical trial portion of this research. Phase 1 is not a clinical trial as it was an observational study that did not include an intervention. Phase 1 data was used to inform the structure and analysis of phase 2.

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 data supports the effectiveness of the treatment Communication and Bias Mitigation Training, Communication skills training for end-of-life care?

Research shows that training healthcare professionals in communication skills can improve their ability to discuss end-of-life care with patients and families, which is often a challenging area for many. Studies have found that such training can enhance the quality of communication, although the direct impact on patient-reported outcomes is still being explored. ^{1 2 3 4 5}

Is Bias Mitigation Training for End-of-Life Care safe for humans?

The research articles reviewed focus on communication skills and disclosure of adverse events in healthcare, but they do not provide specific safety data for Bias Mitigation Training for End-of-Life Care. However, communication skills training generally involves non-invasive methods and is considered safe for participants. ^{6 7 8 9 10}

How is the treatment 'Communication and Bias Mitigation Training' unique for end-of-life care?

This treatment is unique because it focuses on improving healthcare professionals' communication skills specifically for end-of-life care, which is often not adequately covered in standard training. It aims to address both communication and bias, helping professionals facilitate more effective and compassionate discussions with patients and their families during a critical time. ^{1 2 3 11 12}

Research Team

Elizabeth Chuang, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Educational interventions to train healthcare professionals in end-of-life communication: a systematic review and meta-analysis. [2018]

2. United States 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. [2022]

3. United States 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. [2021]

4. England 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. [2023]

5. England 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing residents' communication skills: disclosure of an adverse event to a standardized patient. [2022]

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

Disclosing Adverse Events in Clinical Practice: The Delicate Act of Being Open. [2022]

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

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

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

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]

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

Disclosure of adverse events in the United States and Canada: an update, and a proposed framework for improvement. [2021]

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

Effectiveness of online communication skills training for cancer and palliative care health professionals: A systematic review. [2021]

12. England 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. [2018]