Clinical trial NCT04508543: Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult
Official title: Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Racism
Healthcare Disparities
Minority Health
Keywords: Implicit Bias
Unconscious Bias
Racial disparities
Non-verbal communication
Anesthesia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nonverbal Communication Score (NCS score, range 0-4)
timeFrame: 1 hour
Secondary outcomes:
measure: Non-Verbal Communication and Patient Medical Risk
timeFrame: 8 hours
measure: NCS and Surgical Risk
timeFrame: 8 hours
measure: Anesthesia Provider Observes Outcome Assessor
timeFrame: 8 hours
Other outcomes:
measure: Evaluate following based on Non-Verbal Communication and Anesthesia Decision Making
timeFrame: 8 hours
measure: Total Parenteral Morphine Equiv. Administered
timeFrame: 8 hours
measure: Duration of Preanesthesia Anesthesia Consult
timeFrame: 1 hour
measure: Anxiety Measure
timeFrame: 8 hours
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Brandon M Togioka, MD
role: PRINCIPAL_INVESTIGATOR
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