Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to determine if In-person interpreters increases patient satisfaction of URGYN office visits compared to the use of phone interpreter services for Limited English Proficient (LEP) patients
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interpretation Modality: In person | Active Comparator | Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit |
|
| Interpretation Modality: Telephonic | Active Comparator | Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpretation Modality: In Person | Other | Use of In-Person interpretation support for LEP participant during clinical appointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
female
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Flynn, MD | UMass Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U Mass Memorial Hospital | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32649326 | Derived | Taylor DL, Sierra T, Maheshwari D, Hall C, Leung K, Flynn M. Satisfaction With Telephone Versus In-Person Interpretation Services in Limited English-Proficient Urogynecology Patients: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):388-392. doi: 10.1097/SPV.0000000000000880. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Interpretation Modality: In Person | Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit Interpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment |
| FG001 | Interpretation Modality: Telephonic |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Interpretation Modality: Telephonic | Other | Use of telephonic interpretation support for LEP participant during clinical appointment |
|
Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit Interpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Interpretation Modality: In Person | Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit Interpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment |
| BG001 | Interpretation Modality: Telephonic | Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit Interpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Language of Translation | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Satisfaction | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately assessed after office visit |
|
|
|
|
1 week
This did not involve any medical intervention which could result in a serious adverse event, mortality or other adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interpretation Modality: In Person | Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit Interpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment | 0 | 38 | 0 | 38 | 0 | 38 |
| EG001 | Interpretation Modality: Telephonic | Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit Interpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Danielle Taylor | U Mass Memorial | 508-334-9840 | danielle.taylor@umassmemorial.org |
| Mar 9, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Portugese |
|