Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult (IMPLICIT)

October 31, 2023 updated by: Brandon M Togioka, Oregon Health and Science University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nonverbal Communication Score (NCS score, range 0-4)
Time Frame: 1 hour

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).
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Verbal Communication and Patient Medical Risk
Time Frame: 8 hours
To evaluate the association between NCS and patient medical risk, defined by the Charlson Co-Morbidity Index, range 0 - 37).
8 hours
NCS and Surgical Risk
Time Frame: 8 hours
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.
8 hours
Anesthesia Provider Observes Outcome Assessor
Time Frame: 8 hours
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.
8 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate following based on Non-Verbal Communication and Anesthesia Decision Making
Time Frame: 8 hours

To 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
8 hours
Total Parenteral Morphine Equiv. Administered
Time Frame: 8 hours
To evaluate the association between NCS and parenteral morphine equivalent administration during surgery.
8 hours
Duration of Preanesthesia Anesthesia Consult
Time Frame: 1 hour
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.
1 hour
Anxiety Measure
Time Frame: 8 hours
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.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Brandon M Togioka, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Study00022536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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