Pelvic Floor DisordersSIPINCT03470194
Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial
A study testing Interpretation Modality: In Person and Interpretation Modality: Telephonic in people with Pelvic Floor Disorders, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Interpretation Modality: In Person and Interpretation Modality: Telephonic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with cognitive impairment
- Visually or hearing impaired patients
- Patients not requiring a follow up appointment
Trial locations and contacts
1 site in 1 country.
United States1 site
U Mass Memorial Hospital
Worcester, Massachusetts, 01605
About this study
Official title: Urogynecological Office Visits and Patient Satisfaction of Limited English-Proficient Patients With Phone Interpreter Services Compared to In-Person Interpreters: Randomized Controlled Trial (SIPI)
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
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Interpretation Modality: In Person, Interpretation Modality: Telephonic
- Keywords
- Quality Care, Access to health care, Interpretation services
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation Modality: In PersonOther
Use of In-Person interpretation support for LEP participant during clinical appointment
Interpretation Modality: TelephonicOther
Use of telephonic interpretation support for LEP participant during clinical appointment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Interpretation Modality: In Person |
| Interpretation Modality: Telephonic | Active comparator | Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit Receives: Other: Interpretation Modality: Telephonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately assessed after office visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start15 Dec 2017
- Primary completion10 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Flynn, MD, Principal investigator, UMass Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470194
- Sponsor's protocol ID
- H00013745
- Acronym
- SIPI
- Status last verified
- Mar 2021
- First submitted
- 22 Dec 2017
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32649326
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urogynecological Office Visits and Patient Satisfaction of Limited English-Proficient Patients With Phone Interpreter Services Compared to In-Person Interpreters: Randomized Controlled Trial (SIPI)
- ClinicalTrials.gov ID
- NCT03470194
- Acronym / sponsor ID
- SIPI / H00013745
- Conditions
- Pelvic Floor Disorders
- Keywords
- Quality Care, Access to health care, Interpretation services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpretation Modality: In person | Active comparator | Other: Interpretation Modality: In PersonParticipants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit |
| Interpretation Modality: Telephonic | Active comparator | Other: Interpretation Modality: TelephonicParticipants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Unable to provide consent
- Under 18 years of age
- Pregnant women
- Prisoners
- LEP subjects who decline interpreter services
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 |
|---|---|---|
| Interpretation Modality: In PersonUse of In-Person interpretation support for LEP participant during clinical appointment | Other | Interpretation Modality: In person |
| Interpretation Modality: TelephonicUse of telephonic interpretation support for LEP participant during clinical appointment | Other | Interpretation Modality: Telephonic |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32649326Taylor 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.
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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.
Michael Flynn, MD principal investigator
UMass Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation Modality: In Person and Interpretation Modality: Telephonic in people with Pelvic Floor Disorders, run by University of Massachusetts, Worcester 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 9 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 5 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Satisfaction (time frame: Immediately assessed after office visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470194, which also lists 1 linked publication.
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 5 Apr 2021.