Critical Illness Clinical Trial
— BRiDgEOfficial title:
Targeting Bias to Reduce Disparities in End of Life Care
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 participated 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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 23, 2024 |
Est. primary completion date | October 23, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Practicing physicians - Specializes 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Allen RS, Allen JY, Hilgeman MM, DeCoster J. End-of-life decision-making, decisional conflict, and enhanced information: race effects. J Am Geriatr Soc. 2008 Oct;56(10):1904-9. doi: 10.1111/j.1532-5415.2008.01929.x. Epub 2008 Sep 4. — View Citation
Barnato AE, Mohan D, Downs J, Bryce CL, Angus DC, Arnold RM. A randomized trial of the effect of patient race on physicians' intensive care unit and life-sustaining treatment decisions for an acutely unstable elder with end-stage cancer. Crit Care Med. 2011 Jul;39(7):1663-9. doi: 10.1097/CCM.0b013e3182186e98. — View Citation
Barnato AE. Challenges In Understanding And Respecting Patients' Preferences. Health Aff (Millwood). 2017 Jul 1;36(7):1252-1257. doi: 10.1377/hlthaff.2017.0177. — View Citation
Benton K, Stephens J, Vogel R, Ledlow G, Ackermann R, Babcock C, McCook G. The influence of race on end-of-life choices following a counselor-based palliative consultation. Am J Hosp Palliat Care. 2015 Feb;32(1):84-9. doi: 10.1177/1049909113506782. Epub 2013 Oct 1. — View Citation
Blair IV, Steiner JF, Fairclough DL, Hanratty R, Price DW, Hirsh HK, Wright LA, Bronsert M, Karimkhani E, Magid DJ, Havranek EP. Clinicians' implicit ethnic/racial bias and perceptions of care among Black and Latino patients. Ann Fam Med. 2013 Jan-Feb;11(1):43-52. doi: 10.1370/afm.1442. — View Citation
Byrd WM, Clayton LA. Race, medicine, and health care in the United States: a historical survey. J Natl Med Assoc. 2001 Mar;93(3 Suppl):11S-34S. — View Citation
Chuang E, Hope AA, Allyn K, Szalkiewicz E, Gary B, Gong MN. Gaps in Provision of Primary and Specialty Palliative Care in the Acute Care Setting by Race and Ethnicity. J Pain Symptom Manage. 2017 Nov;54(5):645-653.e1. doi: 10.1016/j.jpainsymman.2017.05.001. Epub 2017 Jul 29. — View Citation
Cicolello K, Anandarajah G. Multiple Stakeholders' Perspectives Regarding Barriers to Hospice Enrollment in Diverse Patient Populations: A Qualitative Study. J Pain Symptom Manage. 2019 May;57(5):869-879. doi: 10.1016/j.jpainsymman.2019.02.012. Epub 2019 Feb 18. — View Citation
Connor SR, Elwert F, Spence C, Christakis NA. Racial disparity in hospice use in the United States in 2002. Palliat Med. 2008 Apr;22(3):205-13. doi: 10.1177/0269216308089305. — View Citation
Cooper LA, Roter DL, Carson KA, Beach MC, Sabin JA, Greenwald AG, Inui TS. The associations of clinicians' implicit attitudes about race with medical visit communication and patient ratings of interpersonal care. Am J Public Health. 2012 May;102(5):979-87. doi: 10.2105/AJPH.2011.300558. Epub 2012 Mar 15. — View Citation
Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med. 2003 Dec 2;139(11):907-15. doi: 10.7326/0003-4819-139-11-200312020-00009. — View Citation
D'Agostino TA, Bylund CL. Nonverbal accommodation in health care communication. Health Commun. 2014;29(6):563-73. doi: 10.1080/10410236.2013.783773. Epub 2013 Oct 18. — View Citation
Elk R, Emanuel L, Hauser J, Bakitas M, Levkoff S. Developing and Testing the Feasibility of a Culturally Based Tele-Palliative Care Consult Based on the Cultural Values and Preferences of Southern, Rural African American and White Community Members: A Program by and for the Community. Health Equity. 2020 Mar 26;4(1):52-83. doi: 10.1089/heq.2019.0120. eCollection 2020. — View Citation
Elliott AM, Alexander SC, Mescher CA, Mohan D, Barnato AE. Differences in Physicians' Verbal and Nonverbal Communication With Black and White Patients at the End of Life. J Pain Symptom Manage. 2016 Jan;51(1):1-8. doi: 10.1016/j.jpainsymman.2015.07.008. Epub 2015 Aug 20. — View Citation
Feagin J, Bennefield Z. Systemic racism and U.S. health care. Soc Sci Med. 2014 Feb;103:7-14. doi: 10.1016/j.socscimed.2013.09.006. — View Citation
FitzGerald C, Hurst S. Implicit bias in healthcare professionals: a systematic review. BMC Med Ethics. 2017 Mar 1;18(1):19. doi: 10.1186/s12910-017-0179-8. — View Citation
Gonzalez CM, Kim MY, Marantz PR. Implicit bias and its relation to health disparities: a teaching program and survey of medical students. Teach Learn Med. 2014;26(1):64-71. doi: 10.1080/10401334.2013.857341. — View Citation
Gonzalez CM, Walker SA, Rodriguez N, Karp E, Marantz PR. It Can Be Done! A Skills-Based Elective in Implicit Bias Recognition and Management for Preclinical Medical Students. Acad Med. 2020 Dec;95(12S Addressing Harmful Bias and Eliminating Discrimination in Health Professions Learning Environments):S150-S155. doi: 10.1097/ACM.0000000000003697. — View Citation
Gramling R, Gajary-Coots E, Cimino J, Fiscella K, Epstein R, Ladwig S, Anderson W, Alexander SC, Han PK, Gramling D, Norton SA. Palliative Care Clinician Overestimation of Survival in Advanced Cancer: Disparities and Association With End-of-Life Care. J Pain Symptom Manage. 2019 Feb;57(2):233-240. doi: 10.1016/j.jpainsymman.2018.10.510. Epub 2018 Nov 1. Erratum In: J Pain Symptom Manage. 2019 Oct;58(4):e19-e20. — View Citation
Ingersoll LT, Alexander SC, Priest J, Ladwig S, Anderson W, Fiscella K, Epstein RM, Norton SA, Gramling R. Racial/ethnic differences in prognosis communication during initial inpatient palliative care consultations among people with advanced cancer. Patient Educ Couns. 2019 Jun;102(6):1098-1103. doi: 10.1016/j.pec.2019.01.002. Epub 2019 Jan 2. — View Citation
Johnson KS. Racial and ethnic disparities in palliative care. J Palliat Med. 2013 Nov;16(11):1329-34. doi: 10.1089/jpm.2013.9468. Epub 2013 Sep 27. — View Citation
Johnson RL, Roter D, Powe NR, Cooper LA. Patient race/ethnicity and quality of patient-physician communication during medical visits. Am J Public Health. 2004 Dec;94(12):2084-90. doi: 10.2105/ajph.94.12.2084. — View Citation
Kwak J, Haley WE. Current research findings on end-of-life decision making among racially or ethnically diverse groups. Gerontologist. 2005 Oct;45(5):634-41. doi: 10.1093/geront/45.5.634. — View Citation
Lee JJ, Long AC, Curtis JR, Engelberg RA. The Influence of Race/Ethnicity and Education on Family Ratings of the Quality of Dying in the ICU. J Pain Symptom Manage. 2016 Jan;51(1):9-16. doi: 10.1016/j.jpainsymman.2015.08.008. Epub 2015 Sep 16. — View Citation
Mack JW, Paulk ME, Viswanath K, Prigerson HG. Racial disparities in the outcomes of communication on medical care received near death. Arch Intern Med. 2010 Sep 27;170(17):1533-40. doi: 10.1001/archinternmed.2010.322. — View Citation
Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1. — View Citation
Maina IW, Belton TD, Ginzberg S, Singh A, Johnson TJ. A decade of studying implicit racial/ethnic bias in healthcare providers using the implicit association test. Soc Sci Med. 2018 Feb;199:219-229. doi: 10.1016/j.socscimed.2017.05.009. Epub 2017 May 4. — View Citation
Penner LA, Dovidio JF, Gonzalez R, Albrecht TL, Chapman R, Foster T, Harper FW, Hagiwara N, Hamel LM, Shields AF, Gadgeel S, Simon MS, Griggs JJ, Eggly S. The Effects of Oncologist Implicit Racial Bias in Racially Discordant Oncology Interactions. J Clin Oncol. 2016 Aug 20;34(24):2874-80. doi: 10.1200/JCO.2015.66.3658. Epub 2016 Jun 20. — View Citation
Rhodes RL, Batchelor K, Lee SC, Halm EA. Barriers to end-of-life care for African Americans from the providers' perspective: opportunity for intervention development. Am J Hosp Palliat Care. 2015 Mar;32(2):137-43. doi: 10.1177/1049909113507127. Epub 2013 Oct 4. — View Citation
Sabin J, Nosek BA, Greenwald A, Rivara FP. Physicians' implicit and explicit attitudes about race by MD race, ethnicity, and gender. J Health Care Poor Underserved. 2009 Aug;20(3):896-913. doi: 10.1353/hpu.0.0185. — View Citation
Sanders JJ, Johnson KS, Cannady K, Paladino J, Ford DW, Block SD, Sterba KR. From Barriers to Assets: Rethinking factors impacting advance care planning for African Americans. Palliat Support Care. 2019 Jun;17(3):306-313. doi: 10.1017/S147895151800038X. Epub 2018 Jun 5. — View Citation
Smith-Howell ER, Hickman SE, Meghani SH, Perkins SM, Rawl SM. End-of-Life Decision Making and Communication of Bereaved Family Members of African Americans with Serious Illness. J Palliat Med. 2016 Feb;19(2):174-82. doi: 10.1089/jpm.2015.0314. — View Citation
Teal CR, Gill AC, Green AR, Crandall S. Helping medical learners recognise and manage unconscious bias toward certain patient groups. Med Educ. 2012 Jan;46(1):80-8. doi: 10.1111/j.1365-2923.2011.04101.x. — View Citation
Wagner GJ, Riopelle D, Steckart J, Lorenz KA, Rosenfeld KE. Provider communication and patient understanding of life-limiting illness and their relationship to patient communication of treatment preferences. J Pain Symptom Manage. 2010 Mar;39(3):527-34. doi: 10.1016/j.jpainsymman.2009.07.012. Epub 2010 Feb 19. — View Citation
Welch LC, Teno JM, Mor V. End-of-life care in black and white: race matters for medical care of dying patients and their families. J Am Geriatr Soc. 2005 Jul;53(7):1145-53. doi: 10.1111/j.1532-5415.2005.53357.x. — View Citation
* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | verbal dominance | ratio of clinician to patient speaking time during the encounter, ranging from a minimum of 0 to a maximum of approximately 3 with a ratio of >1 meaning that the clinician dominated the discussion | during the intervention | |
Secondary | encounter duration | how long the physician speaks to the caregiver, ranging from 5 to 20 minutes with higher scores indicating more engagement | during the intervention | |
Secondary | Verbal communication | Quality of verbal communication as rated by standardized (actor) caregiver and researcher using the three-item CollaboRATE tool which has a minimum score of 0 and maximum of 30 with higher scores indicating better communication | during the intervention | |
Secondary | Nonverbal communication | Quality of nonverbal communication as rated by researcher using the Nonverbal Accommodation Analysis System which measures presence or absence of nonverbal communication behaviors (min 0= not present, max 1=present) for 10 communication behaviors during 2-minute time slices of videotaped encounters. | during the intervention |
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