Limited English ProficiencyTACTNCT05502029
Translating Anesthesia Care Throughout
A study testing Extended translation and Standard translation in people with Limited English Proficiency and Perioperative Care, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Limited English Proficiency, Perioperative Care
- What is being tested?
- Extended translation and Standard translation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2023to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who identify another language other than English as their preferred language
- Participants with planned general anesthesia
Who cannot join
- Participants whose preferred language is documented as English
- Participants with planned sedation or monitored anesthesia care
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center at Mount Zion
San Francisco, California, 94115
About this study
Official title: 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.
- Conditions
- Limited English Proficiency, Perioperative Care
- Being tested
- Extended translation, Standard translation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended translationBehavioural
Translation extended beyond the preoperative area
Standard translationBehavioural
Translation in the preoperative area
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Translator in preoperative area Receives: 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 Receives: Behavioral: Extended translation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: One week after general anesthesia
Secondary outcomes (1)
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.
Measured: The day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start14 Feb 2023
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited English ProficiencyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Zion Health Fund
- Responsible party
- Sponsor
- Investigators
- Odmara Barreto Chang, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502029
- Sponsor's protocol ID
- 22-36587
- Acronym
- TACT
- Status last verified
- Jul 2023
- First submitted
- 12 Aug 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study whose results are intended to inform the investigators of whether additional study is warranted.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Anesthetic Care Throughout: A Feasibility Randomized Trial
- ClinicalTrials.gov ID
- NCT05502029
- Acronym / sponsor ID
- TACT / 22-36587
- Conditions
- Limited English Proficiency, Perioperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Mount Zion Health Fund
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Standard translationTranslator in preoperative area |
| Intervention | Experimental | Behavioral: Extended translationTranslator in preoperative area, continued through transport to the operating room, and in the operating room until the patient is under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who identify another language other than English as their preferred language
- Participants with planned general anesthesia
Key exclusion criteria (2 listed)
- Participants whose preferred language is documented as English
- Participants with planned sedation or monitored anesthesia care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended translationTranslation extended beyond the preoperative area | Behavioural | Intervention |
| Standard translationTranslation in the preoperative area | Behavioural | Control |
Primary outcome
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).
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.
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.
1 secondary outcome
Participant anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale
Time frame: The day before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No. This is a pilot study whose results are intended to inform the investigators of whether additional study is warranted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odmara Barreto Chang, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended translation and Standard translation in people with Limited English Proficiency and Perioperative Care, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed consent success as assessed by Likert scale (time frame: One week after general anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.