NCT05502029

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

August 12, 2022

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Participant anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale

    The day before surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

Translator in preoperative area

Behavioral: Standard translation

Intervention

EXPERIMENTAL

Translator in preoperative area, continued through transport to the operating room, and in the operating room until the patient is under general anesthesia

Behavioral: Extended translation

Interventions

Translation extended beyond the preoperative area

Intervention

Translation in the preoperative area

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who identify another language other than English as their preferred language
  • Participants with planned general anesthesia

You may not qualify if:

  • Participants whose preferred language is documented as English
  • Participants with planned sedation or monitored anesthesia care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Medical Center at Mount Zion

San Francisco, California, 94115, United States

Location

Study Officials

  • Odmara Barreto Chang, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 16, 2022

Study Start

February 14, 2023

Primary Completion

June 12, 2023

Study Completion

June 12, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

This is a pilot study whose results are intended to inform the investigators of whether additional study is warranted.

Locations