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Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult

Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04508543
Acronym
IMPLICIT
Enrollment
110
Registered
2020-08-11
Start date
2021-12-07
Completion date
2025-02-10
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthcare Disparities, Minority Health, Racism

Keywords

Implicit Bias, Unconscious Bias, Racial disparities, Non-verbal communication, Anesthesia

Brief 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. 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.

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.

Interventions

OTHERNon-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).

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Children * Vulnerable populations including prisoners and decisionally impaired adults

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Non-Verbal Communication and Patient Medical Risk8 hoursTo evaluate the association between NCS and patient medical risk, defined by the Charlson Co-Morbidity Index, range 0 - 37).
NCS and Surgical Risk8 hoursTo 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.
Anesthesia Provider Observes Outcome Assessor8 hoursTo 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.

Other

MeasureTime frameDescription
Evaluate following based on Non-Verbal Communication and Anesthesia Decision Making8 hoursTo evaluate the association between NCS and anesthesia decision making. In particular the investigators will evaluate the association between NCS and the incidence of the following procedures: 1. Insertion of arterial line insertion, 2. Insertion of second peripheral intravenous line 3. Insertion of foley catheterization 4. Nerve block placed for postoperative analgesia
Total Parenteral Morphine Equiv. Administered8 hoursTo evaluate the association between NCS and parenteral morphine equivalent administration during surgery.
Duration of Preanesthesia Anesthesia Consult1 hourTo 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.
Anxiety Measure8 hoursTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026