Targeting Bias to Reduce Disparities in End of Life Care

NCT05165888 | Completed Results DMC

• 2 other identifiers: 2021-128985K23MD015277-03
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Terminal Illness; Critical Illness

Keywords

Palliative; Communication

Outcome Measures

Primary Outcomes (1)

• Verbal Dominance

  Verbal dominance was determined by the ratio of clinician to caregiver speaking time during the encounter, ranging from a minimum of 0 to a maximum of approximately 3. A ratio of \>1 indicates that the clinician dominated the discussion. Ratio of clinician to caregiver speaking times are expressed as decimals and summarized both prior to and following the intervention by study arm.

  During the intervention, up to 5 hours

Secondary Outcomes (12)

• Encounter Duration

  During the intervention, up to 5 hours

• Verbal Communication

  During the intervention, up to 5 hours

• Modified NAAS Score

  Duration of intervention, up to 5 hours

• Physician Talk Time

  During the intervention, up to 5 hours

• Pauses

  During the intervention, up to 5 hours

Study Arms (2)

Communication and Bias Mitigation Training

EXPERIMENTAL

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.

Behavioral: Communication and Bias Mitigation Training

Communication Training Only

ACTIVE COMPARATOR

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.

Behavioral: Communication skills training

Interventions

Communication and Bias Mitigation Training BEHAVIORAL

Training to improve communication skills and reduce the effect of racial bias on clinician communication behavior

Communication and Bias Mitigation Training

Communication skills training BEHAVIORAL

Training to improve communication skills between physicians and caregivers.

Communication Training Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Nebraska Lincoln: collaborator
• Tulane University School of Medicine: collaborator
• Dartmouth College: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (35)

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Related Links

• Diversity in the Physician Workforce: Facts \& FIgures 2014. American Association of Medical Colleges

MeSH Terms

Conditions

Critical Illness; Communication

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

This is a small pilot intervention that was underpowered to detect a meaningful difference in primary or secondary outcomes. The total duration of the encounter has limited informational value since many of the encounters were ended by the study team after a set amount of time due to time constraints.

Results Point of Contact

• Title: Dr. Elizabeth Chuang
• Organization: Montefiore Medical Center

echuang@montefiore.org

718-920-6378

Study Officials

• Elizabeth Chuang, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 21, 2021
• Study Start: February 3, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available at the completion of data analysis and dissemination for the studies, within two years of study completion and will remain available indefinitely.
• Access Criteria: Investigators must submit their analysis proposal to the PCRC which will review the request for scientific integrity, feasibility, and analytic rigor and IRB approval or exempt status.

Locations

US (1)