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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05502029
Other study ID # 22-36587
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2023
Est. completion date June 12, 2023

Study information

Verified date July 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with limited English proficiency (LEP) are at significant risk of receiving care different from those who are English proficient. Through Translating Anesthetic Care Throughout (TACT), the investigators aim to reduce the disparities experienced by participants with LEP undergoing anesthesia by continuing language translation from the preoperative area into the operating room, where participants will be better able to understand what is happening in an otherwise foreign environment. At this time, some participants receive translation in the preoperative area using an interpreter. No further translation is provided beyond the preoperative area unless there is a provider with language concordance or interpretation skills within the perioperative team. The investigators plan to study how extended translation changes a participant's understanding of and feelings about the perioperative period. Supporting language translation for LEP participants from the preoperative area into their operating room (OR) experience will enable providers to better understand how to care for participants from different cultural and language backgrounds and will help us understand how to better serve our community at large. The investigators hypothesize that participants who receive continual translation will have improved informed consent, have improved trust of their anesthesia providers, and be more satisfied with patient care. In addition, they anticipate that the care team also will benefit by the enhanced communication with the participant.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 12, 2023
Est. primary completion date June 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants who identify another language other than English as their preferred language - Participants with planned general anesthesia Exclusion Criteria: - Participants whose preferred language is documented as English - Participants with planned sedation or monitored anesthesia care

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Extended translation
Translation extended beyond the preoperative area
Standard translation
Translation in the preoperative area

Locations

Country Name City State
United States UCSF Medical Center at Mount Zion San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Mount Zion Health Fund

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Informed consent success as assessed by Likert scale The participant will be asked how well their anesthesia provider prepared them for their general anesthesia experience. A 5-point Likert scale response will be used for the assessment ranging from 1 (not at all) to 5 (extremely well). One week after general anesthesia
Primary Participant trust as assessed by survey Participants will be asked whether they trusted their provider(s) using a yes/no response. One week after general anesthesia
Primary Participant satisfaction as assessed by Likert scale Participants will be asked whether they were satisfied with their anesthesia experience using a yes/no response. One week after general anesthesia
Secondary Participant anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a 6-question validated tool used to generate a score to assess a patient's level of preoperative anxiety. Questions 1, 2, 4, and 5 represent anxiety. Each of these questions is assessed with a Likert scale in which 1 rpresents agreement of not at all and 5 represents extremely. Scores from the four anxiety-representing questions are totaled with a possible range from 4 to 20 with a lower score indicating less anxiety and a higher score more anxiety. A score of greater than or equal to 11 signifies participant anxiety. The day before surgery
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