- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05502029
Translating Anesthesia Care Throughout (TACT)
July 31, 2023 updated by: University of California, San Francisco
Translating Anesthetic Care Throughout: A Feasibility Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
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
-
-
California
-
San Francisco, California, United States, 94115
- UCSF Medical Center at Mount Zion
-
-
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
Yes
Description
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 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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Translator in preoperative area
|
Translation in the preoperative area
|
Experimental: Intervention
Translator in preoperative area, continued through transport to the operating room, and in the operating room until the patient is under general anesthesia
|
Translation extended beyond the preoperative area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Informed consent success as assessed by Likert scale
Time Frame: One week after general anesthesia
|
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
Time Frame: One week after general anesthesia
|
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
Time Frame: One week after general anesthesia
|
Participants will be asked whether they were satisfied with their anesthesia experience using a yes/no response.
|
One week after general anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale
Time Frame: The day before surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Odmara Barreto Chang, MD, PhD, University of California, San Francisco
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)
February 14, 2023
Primary Completion (Actual)
June 12, 2023
Study Completion (Actual)
June 12, 2023
Study Registration Dates
First Submitted
August 12, 2022
First Submitted That Met QC Criteria
August 12, 2022
First Posted (Actual)
August 16, 2022
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 22-36587
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a pilot study whose results are intended to inform the investigators of whether additional study is warranted.
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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