Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult
NCT ID: NCT04508543
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
110 participants
OBSERVATIONAL
2021-12-07
2025-02-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Masking:
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Impact of Provider Demographics on Patients' Continuity of Care
NCT04315402
Gender Bias in the Overuse Studies Conducting in Primary Care
NCT05233852
Testing Preliminary Effectiveness of a Training to Support CHWs Outreach on Dental to African American Caregivers
NCT05511935
Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates
NCT05426200
Feasibility and Efficacy Study for a Pre-visit Lab Protocol for Adult Medicine Physicals
NCT05707364
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Non-verbal communication score
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).
Caucasian (Control)
Self-identified as Caucasian and Non-Hispanic
Non-verbal communication score
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non-verbal communication score
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Having surgery in the South Operating Rooms of Oregon Health \& Science University
* Possessing the capacity for consent
Exclusion Criteria
* Vulnerable populations including prisoners and decisionally impaired adults
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oregon Health and Science University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Brandon M Togioka
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brandon M Togioka, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health and Science University
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Study00022536
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.