NCT03470194

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 5, 2021

Completed
Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

December 22, 2017

Results QC Date

June 14, 2019

Last Update Submit

March 9, 2021

Conditions

Keywords

Quality CareAccess to health careInterpretation services

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Other: Interpretation Modality: Telephonic

Interventions

Use of In-Person interpretation support for LEP participant during clinical appointment

Interpretation Modality: In person

Use of telephonic interpretation support for LEP participant during clinical appointment

Interpretation Modality: Telephonic

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U Mass Memorial Hospital

Worcester, Massachusetts, 01605, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Results Point of Contact

Title
Dr Danielle Taylor
Organization
U Mass Memorial

Study Officials

  • Michael Flynn, MD

    UMass Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2017

First Posted

March 19, 2018

Study Start

December 15, 2017

Primary Completion

June 10, 2019

Study Completion

June 15, 2019

Last Updated

April 5, 2021

Results First Posted

April 5, 2021

Record last verified: 2021-03

Locations