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临床试验/NCT04508543
NCT04508543已完成不适用

Assessing Patient-provider Interactions During the Preoperative Anesthesia Consult

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Nonverbal Communication Score (NCS score, range 0-4)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Vulnerable populations including prisoners and decisionally impaired adults

结局指标

主要结局

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

时间窗: 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).

次要结局

  • Non-Verbal Communication and Patient Medical Risk(8 hours)
  • NCS and Surgical Risk(8 hours)
  • Anesthesia Provider Observes Outcome Assessor(8 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brandon M Togioka

Principal Investigator

Oregon Health and Science University

研究点 (1)

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