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RacismIMPLICITNCT04508543

Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult

An observational study of Racism and Healthcare Disparities, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a prospective, observational, single-center study to evaluate the effect of race and ethnicity on anesthesia provider-patient interactions. The investigators will also attempt to validate a new tool for assessing non-verbal communication during the preanesthesia consult. Masking: 1. Patient 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Racism, Healthcare Disparities, Minority Health
What is being tested?
Non-verbal communication score
How many people
110 participants
Where
1 siteUnited States
Study dates
7 Dec 2021to 10 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients greater than or equal to 18 years old or greater, undergoing surgery and/or a surgical procedure in the South Operating Rooms at Oregon Health \& Science University and possessing the capacity for consent, including minorities and Women of all racial/ethnic groups.

Who may be able to join

  • 18 years of age or greater
  • Having surgery in the South Operating Rooms of Oregon Health \& Science University
  • Possessing the capacity for consent

Who cannot join

  • Children
  • Vulnerable populations including prisoners and decisionally impaired adults

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Health and Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

This will be a prospective, observational, single-center study to evaluate the effect of race and ethnicity on anesthesia provider-patient interactions. The investigators will also attempt to validate a new tool for assessing non-verbal communication during the preanesthesia consult.

Masking:

Read more
  1. Patient
  2. Anesthesia providers (attending anesthesiologist and resident or Certified Registered Nurse Anesthetist)

The patient and anesthesia provider(s) will not be told that the purpose of the study is to compare provider-patient interactions with minority patients to provider-patient interactions with Caucasian patients. The patient and anesthesia provider will be told that the investigators are conducting a study to evaluate provider-patient communication in the preanesthesia setting. The outcome assessor will be part of the research team. Accordingly, they will not be masked.

This is a pilot study void of sample size calculations. The investigators hope to enroll 100-200 patients in the study. While not a randomized study, the investigators hope to achieve a balanced number of minority and Caucasian patients.

Read the detailed description

Primary Objective:

  1. To compare nonverbal communication score (NCS, range 0 - 4) between minority and Caucasian non-Hispanic patients. The score is a sum of four components, each contribute to a score range 0 - 1. The four components are: percent time spent with open body language, percent time spent interacting with the patient or surrogate, distance from the patient along the long axis of the patient's body (distance from the head), and distance from the patient along the axis perpendicular to the patient's body (distance from the handrail).

Secondary Objectives:

  1. To evaluate the association between NCS and patient medical risk, defined by the Charlson Co-Morbidity Index, range 0 - 37).
  2. To evaluate the association between NCS and surgical risk. High risk surgeries will include intraperitoneal, intrathoracic, and suprainguinal vascular surgery, as classified by the Revised Cardiac Risk Index (RCRI). Lower risk surgery will include surgery in all other locations.
  3. To evaluate the association between NCS and anesthesia decision making. In particular the investigators will evaluate the association between NCS and the incidence of arterial line insertion, the incidence of 2nd peripheral intravenous line insertion, the incidence of foley catheterization, the incidence of regional anesthesia blocks placed for postoperative analgesia, and parenteral morphine equivalent administration during surgery.
  4. To evaluate the association between NCS and change in patient anxiety, as assessed by change in patient anxiety measured by the difference in anxiety on a Visual Analog Scale (VAS) score before preanesthesia anesthesia consult and after preanesthesia anesthesia consult.
  5. To evaluate the association between NCS and the duration of the preanesthesia anesthesia consult, defined between the time the anesthesia provider enters the Post-Anesthesia Care Unit (PACU) bay and the time the anesthesia provider leaves the PACU bay.
  6. To evaluate the impact of the observer to the study result, which will be assessed by recording the number of times the anesthesia provider looks at the outcome assessor.

Feasibility assessment: Feasibility for future investigation will be assessed by analyzing the following outcomes. Success will need to be found in all of the following areas to conclude a larger prospective study is feasible.

  1. Is data collection by an observer technically feasible? Ability to obtain complete data to compute the primary outcome in > 95% of patients will be threshold for success.
  2. Is the patient consent rate reasonable? Ability to consent > 50% of eligible patients will be the threshold for success.
  3. Is there good agreement between raters? Mean NCS < 10% between raters will be the threshold for success.
  4. Is the sample size, based upon the found difference in NCS between minority and Caucasian non-Hispanic patients, reasonable?

A sample size calculation yielding less than 500 patients will be the threshold for success.

Population: Patients will be 18 years old or greater, undergoing surgery in the South Operating Rooms at Oregon Health \& Science University and possessing the capacity for consent.

Number of Sites: Single center trial

Study Arms: Minority (case): Self-identified as being a member of group traditionally underrepresented in the medical profession relative to the proportion in the general population: African-American/Black, Mexican-American, Native American (American Indians, Alaska Natives, and Native Hawaiians), and mainland Puerto Rican.

Control: Self-identified as Caucasian and non-Hispanic

Study Duration: Institutional Review Board submission and approval is expected to take 3 months. Study initiation, enrollment, and data collection is expected to take 12 months. Data analysis, manuscript writing, editing, submission and revision to a peer-reviewed journal is expected to take 12 months.

In summary, the study should be completed in under 3 years.

Subject Participation Duration: Individual subjects will be included the study for a portion of their time in the PACU for preanesthesia assessment. Total time of subject participation including time for recruitment, enrollment, data collection during the preanesthesia consult, and post-consult data collection will be less than 1 hour.

Estimated Time to Complete Enrollment: Estimated time from enrollment into study of the first subject to enrollment into study of the last subject is 12 months.

Being tested
Non-verbal communication score
Keywords
Implicit Bias, Unconscious Bias, Racial disparities, Non-verbal communication, Anesthesia
Medical subject headings
Racism, Bias, Implicit, Nonverbal Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-verbal communication scoreOther

    1. To compare nonverbal communication score (NCS, range 0 - 4) between minority and Caucasian non-Hispanic patients. The score is a sum of four components, each contribute to a score range 0 - 1. The four components are: percent time spent with open body language, percent time spent interacting with the patient or surrogate, distance from the patient along the long axis of the patient's body (distance from the head), and distance from the patient along the axis perpendicular to the patient's body (distance from the handrail).
Study groups in NCT04508543
Study groupRoleWhat they receive
Minority (Case)Self-identified as being a member of group traditionally underrepresented in the medical profession relative to the proportion in the general population: African-American/Black, Mexican-American, Native American (American Indians, Alaska Natives, and Native Hawaiians), and mainland Puerto Rican.
Receives: Other: Non-verbal communication score
Caucasian (Control)Self-identified as Caucasian and Non-Hispanic
Receives: Other: Non-verbal communication score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nonverbal Communication Score (NCS score, range 0-4)

    The score is a sum of four components, each contribute to a score range 0 - 1.

    1. Percent time spent with open body language: defined as the anesthesia provider facing the patient and not placing anything between the anesthesia provider and the patient. 2) Percent time spent interacting with the patient or surrogate: Time spent interacting with the patient is defined as time the physician made eye contact with the patient or surrogate. Time spent talking to the patient, but not making eye contact will not be counted. Eye contact made during the physical examination will be counted. 3) Distance from the patient along the long axis of the patient's body (distance from the head) which will be assessed 15 seconds after the physician enters the preanesthesia bay. 4) Distance from the patient along the axis perpendicular to the patient's body (distance from the handrail).

    Measured: 1 hour

Secondary outcomes (3)
  1. Non-Verbal Communication and Patient Medical Risk

    To evaluate the association between NCS and patient medical risk, defined by the Charlson Co-Morbidity Index, range 0 - 37).

    Measured: 8 hours

  2. NCS and Surgical Risk

    To evaluate the association between NCS and surgical risk. High risk surgeries will include intraperitoneal, intrathoracic, and suprainguinal vascular surgery, as classified by the Revised Cardiac Risk Index. Lower risk surgery will include surgery in all other locations.

    Measured: 8 hours

  3. Anesthesia Provider Observes Outcome Assessor

    To evaluate the impact of the observer to the study result, which will be assessed by recording the number of times the anesthesia provider looks at the outcome assessor.

    Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start7 Dec 2021
  3. Primary completion11 Feb 2022
  4. Study completion10 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04508543
Sponsor's protocol ID
Study00022536
Acronym
IMPLICIT
Status last verified
Feb 2025
First submitted
7 Aug 2020
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28249596
  • 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.

    PubMed 26297851
  • Hall WJ, Chapman MV, Lee KM, Merino YM, Thomas TW, Payne BK, Eng E, Day SH, Coyne-Beasley T. Implicit Racial/Ethnic Bias Among Health Care Professionals and Its Influence on Health Care Outcomes: A Systematic Review. Am J Public Health. 2015 Dec;105(12):e60-76. doi: 10.2105/AJPH.2015.302903. Epub 2015 Oct 15.

    PubMed 26469668
  • 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.

    PubMed 19648715
  • AAMC. Percentage of all active physicians by race/ethnicity, 2018. Association of American Medical Colleges. https://www.aamc.org/data-reports/workforce/interactive-data/figure-18-percentage-all-active-physicians-race/ethnicity-2018. Published 2019. Accessed April 6, 2020, 2020.

  • AAMC. Underrepresented in Medicine Definition. Association of American Medical Colleges. https://www.aamc.org/what-we-do/mission-areas/diversity-inclusion/underrepresented-in-medicine. Published 2004. Accessed March 10, 2020, 2020.

  • Hagiwara N, Slatcher RB, Eggly S, Penner LA. Physician Racial Bias and Word Use during Racially Discordant Medical Interactions. Health Commun. 2017 Apr;32(4):401-408. doi: 10.1080/10410236.2016.1138389. Epub 2016 Jun 16.

    PubMed 27309596
  • Hagiwara N, Mezuk B, Elston Lafata J, Vrana SR, Fetters MD. Study protocol for investigating physician communication behaviours that link physician implicit racial bias and patient outcomes in Black patients with type 2 diabetes using an exploratory sequential mixed methods design. BMJ Open. 2018 Oct 18;8(10):e022623. doi: 10.1136/bmjopen-2018-022623.

    PubMed 30341127
  • 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.

    PubMed 23319505
  • 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.

    PubMed 27325865
  • 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.

    PubMed 28532892
  • Schulman KA, Berlin JA, Harless W, Kerner JF, Sistrunk S, Gersh BJ, Dube R, Taleghani CK, Burke JE, Williams S, Eisenberg JM, Escarce JJ. The effect of race and sex on physicians' recommendations for cardiac catheterization. N Engl J Med. 1999 Feb 25;340(8):618-26. doi: 10.1056/NEJM199902253400806.

    PubMed 10029647
  • Haider AH, Schneider EB, Sriram N, Dossick DS, Scott VK, Swoboda SM, Losonczy L, Haut ER, Efron DT, Pronovost PJ, Lipsett PA, Cornwell EE 3rd, MacKenzie EJ, Cooper LA, Freischlag JA. Unconscious race and social class bias among acute care surgical clinicians and clinical treatment decisions. JAMA Surg. 2015 May;150(5):457-64. doi: 10.1001/jamasurg.2014.4038.

    PubMed 25786199
  • Goyal MK, Johnson TJ, Chamberlain JM, Casper TC, Simmons T, Alessandrini EA, Bajaj L, Grundmeier RW, Gerber JS, Lorch SA, Alpern ER; Pediatric Care Applied Research Network (PECARN). Racial and Ethnic Differences in Antibiotic Use for Viral Illness in Emergency Departments. Pediatrics. 2017 Oct;140(4):e20170203. doi: 10.1542/peds.2017-0203. Epub 2017 Sep 5.

    PubMed 28872046
  • Obeidat SS, Rakshe S, Fareh R, Norris K, Ye S, Zuo LW, Togioka BM. Impact of Unconscious Race Bias Among Anesthesia Providers on Nonverbal Communication During the Preoperative Anesthesia Consult: A Prospective, Observational Study. J Racial Ethn Health Disparities. 2025 Aug 22. doi: 10.1007/s40615-025-02604-5. Online ahead of print.

    PubMed 40844570

Questions about this trial

What is this clinical trial studying?

An observational study of Racism and Healthcare Disparities, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nonverbal Communication Score (NCS score, range 0-4) (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04508543, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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