Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 5:56 AM
Study NCT ID:
NCT03470194
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2017-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'danielle.taylor@umassmemorial.org', 'phone': '508-334-9840', 'title': 'Dr Danielle Taylor', 'organization': 'U Mass Memorial'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'This did not involve any medical intervention which could result in a serious adverse event, mortality or other adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Interpretation Modality: In Person', 'description': 'Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Interpretation Modality: Telephonic', 'description': 'Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interpretation Modality: In Person', 'description': 'Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment'}, {'id': 'OG001', 'title': 'Interpretation Modality: Telephonic', 'description': 'Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '100'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '98.8'}]}]}], 'analyses': [{'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately assessed after office visit', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interpretation Modality: In Person', 'description': 'Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment'}, {'id': 'FG001', 'title': 'Interpretation Modality: Telephonic', 'description': 'Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Interpretation Modality: In Person', 'description': 'Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: In Person: Use of In-Person interpretation support for LEP participant during clinical appointment'}, {'id': 'BG001', 'title': 'Interpretation Modality: Telephonic', 'description': 'Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit\n\nInterpretation Modality: Telephonic: Use of telephonic interpretation support for LEP participant during clinical appointment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '52.4', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '54.1', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Language of Translation', 'classes': [{'categories': [{'title': 'Spanish', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Portugese', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-10', 'size': 204238, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-09T09:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2017-12-22', 'resultsFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-09', 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Immediately assessed after office visit', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality Care', 'Access to health care', 'Interpretation services'], 'conditions': ['Pelvic Floor Disorders']}, 'referencesModule': {'references': [{'pmid': '32649326', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nAfter 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.\n\nThose assigned to the control group will receive phone translation services and the experimental group will have in person interpreters.\n\nAt the subsequent visit, demographic information will be collected and patients will then receive interpretation services from the phone or an in-person interpreter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LEP speaking Spanish and Portuguese female patients presenting to the U Mass UROGYN clinic with or without Ad-hoc interpreters\n* Spanish and Portuguese speaking female patients with LEP presenting to the U Mass UROGYN clinic for an office visit of any type\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Under 18 years of age\n* Pregnant women\n* Prisoners\n* LEP subjects who decline interpreter services\n* Non -Spanish or Non - Portuguese speaking subjects\n* Patients with cognitive impairment\n* Visually or hearing impaired patients\n* Patients not requiring a follow up appointment'}, 'identificationModule': {'nctId': 'NCT03470194', 'acronym': 'SIPI', 'briefTitle': 'Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Urogynecological Office Visits and Patient Satisfaction of Limited English-Proficient Patients With Phone Interpreter Services Compared to In-Person Interpreters: Randomized Controlled Trial (SIPI)', 'orgStudyIdInfo': {'id': 'H00013745'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interpretation Modality: In person', 'description': 'Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit', 'interventionNames': ['Other: Interpretation Modality: In Person']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interpretation Modality: Telephonic', 'description': 'Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit', 'interventionNames': ['Other: Interpretation Modality: Telephonic']}], 'interventions': [{'name': 'Interpretation Modality: In Person', 'type': 'OTHER', 'description': 'Use of In-Person interpretation support for LEP participant during clinical appointment', 'armGroupLabels': ['Interpretation Modality: In person']}, {'name': 'Interpretation Modality: Telephonic', 'type': 'OTHER', 'description': 'Use of telephonic interpretation support for LEP participant during clinical appointment', 'armGroupLabels': ['Interpretation Modality: Telephonic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'U Mass Memorial Hospital', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Michael Flynn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Worcester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}