Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-04 @ 2:55 AM
Study NCT ID:
NCT03431259
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2018-01-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inpatient Enrollment of Patient Portal App
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mheng@mgh.harvard.edu', 'phone': '6176430149', 'title': 'Marilyn Heng, Principal Investigator', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Enrollment Group', 'description': 'Patient Gateway: Patients will be enrolled in the Patient Gateway app with the assistance of a research coordinator as an inpatient.', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Information Group', 'description': 'Patients will be provided with information sheet only on how to enroll for Patient Gateway app.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 0, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Return to Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrollment Group', 'description': 'Patient Gateway: Patients will be enrolled in the Patient Gateway app with the assistance of a research coordinator as an inpatient.'}, {'id': 'OG001', 'title': 'Information Group', 'description': 'Patients will be provided with information sheet only on how to enroll for Patient Gateway app.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0574', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.570', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months postoperative', 'description': 'The number of patients enrolled who return to clinic for a followup visit at 3 months postop. It will be a count and proportion of the occurrence of a patient returning to clinic for followup', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Use of Any the Patient Gateway Portal at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrollment Group', 'description': 'Patient Gateway: Patients will be enrolled in the Patient Gateway app with the assistance of a research coordinator as an inpatient.'}, {'id': 'OG001', 'title': 'Information Group', 'description': 'Patients will be provided with information sheet only on how to enroll for Patient Gateway app.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months postoperative', 'description': 'The number of patients who used the patient gateway portal for any purpose at 3 months. This will be a count of participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrollment Group', 'description': 'Patient Gateway: Patients will be enrolled in the Patient Gateway app with the assistance of a research coordinator as an inpatient.'}, {'id': 'FG001', 'title': 'Information Group', 'description': 'Patients will be provided with information sheet only on how to enroll for Patient Gateway app.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrollment Group', 'description': 'Patient Gateway: Patients will be enrolled in the Patient Gateway app with the assistance of a research coordinator as an inpatient.'}, {'id': 'BG001', 'title': 'Information Group', 'description': 'Patients will be provided with information sheet only on how to enroll for Patient Gateway app.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '16', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '53.5', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Non-White race', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White/Caucasian race', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Median income by Zipcode', 'classes': [{'categories': [{'measurements': [{'value': '83221', 'spread': '26358', 'groupId': 'BG000'}, {'value': '80888', 'spread': '27853', 'groupId': 'BG001'}, {'value': '82039', 'spread': '27091', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'dollars', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Injury vs Acute Infection', 'classes': [{'categories': [{'title': 'Injury or Acute Infection', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Elective', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Admission Subspecialty', 'classes': [{'categories': [{'title': 'Joints', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Oncology', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Sports/Shoulder', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Spine', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Trauma', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-07', 'size': 284254, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-08T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2018-01-20', 'resultsFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2018-02-06', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-08', 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to Clinic', 'timeFrame': '3 months postoperative', 'description': 'The number of patients enrolled who return to clinic for a followup visit at 3 months postop. It will be a count and proportion of the occurrence of a patient returning to clinic for followup'}, {'measure': 'Use of Any the Patient Gateway Portal at 3 Months', 'timeFrame': '3 months postoperative', 'description': 'The number of patients who used the patient gateway portal for any purpose at 3 months. This will be a count of participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder']}, 'referencesModule': {'references': [{'pmid': '35969452', 'type': 'DERIVED', 'citation': 'Bhashyam AR, Bansal M, McGovern MM, van der Vliet QMJ, Heng M. In-hospital Enrollment Into an Electronic Patient Portal Results in Improved Follow-up After Orthopedic Surgery: Cluster Randomized Controlled Trial. JMIR Perioper Med. 2022 Aug 11;5(1):e37148. doi: 10.2196/37148.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine if inpatient enrollment into a patient communication app improves clinic follow-up of orthopedic trauma patients and improves survey completion rates after orthopedic trauma.', 'detailedDescription': 'Follow-up in trauma is historically poor. As a result, outcomes from trauma are difficult to collect via surveys and are often significantly influenced by selection bias. Patient interaction apps like Patient Gateway are thought to facilitate greater participant involvement and adherence to treatment regimens. The investigators will explore if inpatient enrollment into Patient Gateway would improve clinic follow-up rates. Increasing follow-up rates could improve the quality of care delivered.\n\nIn addition, self-administered survey questionnaires are an important data collection tool in clinical practice, public health research and epidemiology. However, survey completion rates are typically poor in orthopaedic trauma.\n\nWith the evaluation of modern technology, electronic applications are being increasingly used in both hospital and personal settings. In outpatient clinics, questionnaires to measure outcomes and monitor quality of care are administered by staff members using hospital owned tablet devices. Recently, applications to complete these surveys on personal devices have been developed.\n\nIn a recent Cochrane review on the comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods it was concluded that there are no data available on response rates. The investigators will attempt to address this question.\n\nAll Patient Gateway naïve patients aged 18 years or older able to consent for themselves and admitted to the hospital for an orthopedic condition with the need for outpatient follow-up will be invited to participate in this study. Exclusion criteria will be patients unable to consent for themselves, inability to communicate in English, and no possession of a smartphone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to the hospital for an orthopedic condition with the need for outpatient follow-up\n* able to consent for themselves\n\nExclusion Criteria:\n\n* unable to consent for themselves\n* inability to communicate in English\n* no possession of a smartphone'}, 'identificationModule': {'nctId': 'NCT03431259', 'briefTitle': 'Inpatient Enrollment of Patient Portal App', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Does Inpatient Enrollment Into a Patient Communication App (Patient Gateway) Result in Improved Follow-up and Survey Completion Rates After Orthopaedic Trauma?', 'orgStudyIdInfo': {'id': '2017P001594'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enrollment group', 'interventionNames': ['Other: Patient Gateway']}, {'type': 'NO_INTERVENTION', 'label': 'Information group'}], 'interventions': [{'name': 'Patient Gateway', 'type': 'OTHER', 'description': 'Patients will be enrolled in the Patient Gateway app.', 'armGroupLabels': ['Enrollment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in Orthopaedic Surgery', 'investigatorFullName': 'Marilyn Heng', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}