Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01955005
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2013-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of the My HealtheVet for Health Information Sharing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Carolyn.Turvey@VA.Gov', 'phone': '319 338 0581', 'title': 'Carolyn L Turvey', 'phoneExt': '7714', 'organization': 'Iowa City VA Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'One Year', 'description': 'This is a low risk study. The only potential adverse event was inadvertent confidentiality breech.', 'eventGroups': [{'id': 'EG000', 'title': 'My HealtheVet Training', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.\n\nMy HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Internet Skills Training', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.\n\nInternet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'My HealtheVet Training', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.\n\nMy HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.'}, {'id': 'OG001', 'title': 'Internet Skills Training', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.\n\nInternet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': "This was a 2x2 comparison using Fisher's exact due to low expected cell count. Fisher's exact p\\<0.001", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1-2 week of non-VA provider visit', 'description': 'The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was collected from the provider completed questionnaire. The reduced sample size is due to the response rate for the My Healthe Vet training group providers (74%) and the Internet Skills Training group (52%).'}, {'type': 'SECONDARY', 'title': 'Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'My HealtheVet Training', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.\n\nMy HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.'}, {'id': 'OG001', 'title': 'Internet Skills Training', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.\n\nInternet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Z score', 'ciNumSides': 'TWO_SIDED', 'paramValue': '568.5', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Typically within 1 month of non-VA provider visit', 'description': 'A medication discrepancy metric was be calculated by comparing the current VA medication list with the non-VA provider medication list to determine the total number of distinct medications. The number of discrepant medications between these lists is the numerator and is divided by the total number of distinct medications on both lists combined. This will yield a range of scores between score between 0 and 1, with 1 indicating perfect agreement between the two lists.', 'unitOfMeasure': 'proportion of medications discrepant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Medication reconciliation was based on Medical Record Review, therefore there was better representation of the entire sample. 2 Veterans were not included in the Internet Skills Training group because the medical records sent from the Non-VA provider were not adequate to determine an accurate medication list.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'My HealtheVet Training', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.\n\nMy HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.'}, {'id': 'OG001', 'title': 'Internet Skills Training', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.\n\nInternet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Table Probability', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0142', 'statisticalMethod': "Fisher's Exact", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Typically within 1 month of non-VA provider visit', 'description': 'Therapeutic duplication will be defined as concurrent use of more than one medication from the same therapeutic class. For laboratory duplication, we will review non-VA and VA medical records 6 months prior to the non-VA provider visit. Each patient will be assigned a dichotomous indicator for whether they received therapeutic duplication and/or laboratory duplication during their non-VA provider visit', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some veterans had their laboratories drawn prior to the medical visit and were therefore excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'My HealtheVet Training', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.\n\nMy HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.'}, {'id': 'FG001', 'title': 'Internet Skills Training', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.\n\nInternet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'My HealtheVet Training', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.\n\nMy HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.'}, {'id': 'BG001', 'title': 'Internet Skills Training', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.\n\nInternet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Veterans with a diagnosis of at least one chronic health condition taking 5 or more medications who have both a VA and a non-VA provider.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-08', 'studyFirstSubmitDate': '2013-08-20', 'resultsFirstSubmitDate': '2015-10-14', 'studyFirstSubmitQcDate': '2013-09-26', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-02', 'studyFirstPostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider', 'timeFrame': 'Within 1-2 week of non-VA provider visit', 'description': 'The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists', 'timeFrame': 'Typically within 1 month of non-VA provider visit', 'description': 'A medication discrepancy metric was be calculated by comparing the current VA medication list with the non-VA provider medication list to determine the total number of distinct medications. The number of discrepant medications between these lists is the numerator and is divided by the total number of distinct medications on both lists combined. This will yield a range of scores between score between 0 and 1, with 1 indicating perfect agreement between the two lists.'}, {'measure': 'Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.', 'timeFrame': 'Typically within 1 month of non-VA provider visit', 'description': 'Therapeutic duplication will be defined as concurrent use of more than one medication from the same therapeutic class. For laboratory duplication, we will review non-VA and VA medical records 6 months prior to the non-VA provider visit. Each patient will be assigned a dichotomous indicator for whether they received therapeutic duplication and/or laboratory duplication during their non-VA provider visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health Records, Personal', 'Delivery of healthcare', 'Consumer Participation', 'Internet'], 'conditions': ['Chronic Illness']}, 'descriptionModule': {'briefSummary': "This study aims to conduct a pilot of an intervention to improve care coordination between VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record, My HealtheVet (MHV). Participants will be randomized to receive either training on 1) how to use My HealtheVet to share VA health information or 2) training on how to how to search the Internet for health information and decide which Internet sites have good quality information. The investigators predict that Veterans who receive the My HealtheVet training will have fewer medication errors and duplication of services between the VA and outside providers.", 'detailedDescription': "This study aims to conduct a pilot of an intervention to improve care coordination between VA and non-VA providers using the Department of Veteran's Affairs' (VA) personal health record, My HealtheVet (MHV). Background: The Blue Button feature of My HealtheVet allows Veterans to print out a comprehensive summary of their health that can be shared with non-VA providers. Dual use is common and has been associated with negative health outcomes including higher mortality. Preliminary data collected by the principal investigator in collaboration with the My HealtheVet Performance Evaluation workgroup shows that few Veterans enrolled in My HealtheVet use it to inform either VA or non-VA providers of their care. To remedy this, the principal investigator has developed an online video and companion paper-based training. This training will teach Veterans how to use the Blue Button feature and why it is important to share the print out with their non-VA provider. Methods: To participate, Veterans must have an upcoming non-VA provider appointment, be prescribed 5 or more medications, and be registered on My HealtheVet with a premium account. Participants will be randomized to receive either training on how to use the Blue Button or training on how to search for health information on the Internet and if that information is good quality. Veterans in both arms will receive training materials and phone support. After the non-VA provider visit, both the Veteran and the provider will be asked to indicate what occurred during the visit, including whether or not the Veteran gave the provider the Blue Button print out. Both Veterans and providers will also be asked to complete a 15-minute qualitative interview about their experience during the visit. Medical records of the non-VA provider visit will be obtained. Outcomes: The main outcome for the study is whether the patient provided the non-VA provider a copy of his or her health information printed from My HealtheVet. In addition, comparison between the VA and non-VA provider records will be conducted to test whether Veterans who completed the training had 1) better medication reconciliation between the VA and the non-VA provider and 2) fewer instances of therapeutic or laboratory duplication. The results of this pilot will be used to inform a larger randomized controlled trial of the training intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Upcoming Non-VA provider appointment\n* Take 5 or more prescribed medications\n* Have or obtain a My HealtheVet premium account\n* Access to computer, printer, \\& Internet to complete study protocol\n\nExclusion Criteria:\n\n* No non-VA provider or upcoming appointment\n* Less than 5 medications\n* No premium MHV account'}, 'identificationModule': {'nctId': 'NCT01955005', 'briefTitle': 'Use of the My HealtheVet for Health Information Sharing', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Pilot of My HealtheVet Training to Improve Co-Managed Care for Veterans', 'orgStudyIdInfo': {'id': 'PPO 13-178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'My HealtheVet Training', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.', 'interventionNames': ['Behavioral: My HealtheVet Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internet Skills Training', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.', 'interventionNames': ['Other: Internet Skills Training']}], 'interventions': [{'name': 'My HealtheVet Training', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.', 'armGroupLabels': ['My HealtheVet Training']}, {'name': 'Internet Skills Training', 'type': 'OTHER', 'description': 'Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.', 'armGroupLabels': ['Internet Skills Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52246-2208', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa City VA Health Care System, Iowa City, IA', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Carolyn L Turvey, PhD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iowa City VA Health Care System, Iowa City, IA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}