- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470194
Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial (SIPI)
Urogynecological Office Visits and Patient Satisfaction of Limited English-Proficient Patients With Phone Interpreter Services Compared to In-Person Interpreters: Randomized Controlled Trial (SIPI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial. Patients presenting to the UMass Memorial UROGYN clinic will be screened for eligibility using the inclusion and exclusion criteria. LEP patients will be identified as patients that initiate conversation in a non-English language and are only able to communicate adequately regarding their medical problem in a non-English language.
After patients have been seen for their scheduled office visit, they will be invited to participate in the study. Once the patient has agreed to participate in the study the participant will be randomized. Study assignment will be revealed using sequentially numbered sealed opaque envelopes. Randomization will be performed using software and a block randomization scheme to yield a 50% chance of having an in-person interpreter.
Those assigned to the control group will receive phone translation services and the experimental group will have in person interpreters.
At the subsequent visit, demographic information will be collected and patients will then receive interpretation services from the phone or an in-person interpreter.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01605
- U Mass Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- LEP speaking Spanish and Portuguese female patients presenting to the U Mass UROGYN clinic with or without Ad-hoc interpreters
- Spanish and Portuguese speaking female patients with LEP presenting to the U Mass UROGYN clinic for an office visit of any type
Exclusion Criteria:
- Unable to provide consent
- Under 18 years of age
- Pregnant women
- Prisoners
- LEP subjects who decline interpreter services
- Non -Spanish or Non - Portuguese speaking subjects
- Patients with cognitive impairment
- Visually or hearing impaired patients
- Patients not requiring a follow up appointment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Interpretation Modality: In person
Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit
|
Use of In-Person interpretation support for LEP participant during clinical appointment
|
Active Comparator: Interpretation Modality: Telephonic
Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit
|
Use of telephonic interpretation support for LEP participant during clinical appointment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: Immediately assessed after office visit
|
Patient satisfaction will be measured by a 14 - item questionnaire.
The questionnaire was created, validated, and used in a previous study from the field of Emergency medicine.
There are 3 subscales assessing patient satisfaction with interpreter, nursing, and physician.
Satisfaction with interpreters was calculated using the summation index of 4 items.
Satisfaction with physician and nursing communication was measure by a summated index of 5 items that measure increasing level of satisfaction with a likert scale.
Answers ranged from 1 to 4 where 4 equaled "strongly agree" and 1 equaled "strongly disagree".
All items were weighted on a 100 point scale to facilitate interpretation of the means.
A lower score means less satisfaction/greater dissatisfaction and a higher score indicates more satisfaction/less dissatisfaction.
|
Immediately assessed after office visit
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Flynn, MD, UMass Worcester
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00013745
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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