Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.hogan@va.gov', 'phone': '781-687-3181', 'title': 'Dr. Timothy P. Hogan', 'organization': 'VA-CHOIR'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Participants were recruited at only three VA facilities, which limits generalizability.'}}, 'adverseEventsModule': {'description': 'All-Cause Mortality was not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Supported Adoption Intervention', 'description': 'Supported adoption intervention\n\nSupported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)', 'otherNumAtRisk': 595, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 595, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Usual Care', 'description': 'Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.', 'otherNumAtRisk': 601, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 601, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Rate of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Supported Adoption Intervention', 'description': 'Supported adoption intervention\n\nSupported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)'}, {'id': 'OG001', 'title': 'Arm 2: Usual Care', 'description': 'Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Six months', 'description': 'Measure the change in rate of use of secure messaging in intervention versus control Veterans, reported as participants in each arm that sent a secure message during study period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants who received the Supported Adoption Intervention as analyzed was 2 less (these materials were returned/wrong address) than initially randomized and baseline characteristics are presented for.'}, {'type': 'SECONDARY', 'title': 'Patient Self-reported Access to Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Supported Adoption Intervention', 'description': 'Supported adoption intervention\n\nSupported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)'}, {'id': 'OG001', 'title': 'Arm 2: Usual Care', 'description': 'Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six month follow-up', 'description': 'To explore the impact of secure messaging use on healthcare encounters, the investigators will compare the responses of each arm at 6-month follow-up assessment for Patient Self-reported Access to communication using 2 Questions adapted from the Survey of Healthcare Experience of Patients Scale which inquires, "How easy is it for you to communicate with your doctor when you need to?" and, "How easy is it for you to get to see your nurse when you need to?" Responses to scale were 1= "Never", 2= "Sometimes", 3= "Usually", 4= "Always"; where "Always" was the best score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 6-month follow-up survey'}, {'type': 'SECONDARY', 'title': 'Care Coordination: Patient Assessment of Chronic Illness Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Supported Adoption Intervention', 'description': 'Supported adoption intervention\n\nSupported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)'}, {'id': 'OG001', 'title': 'Arm 2: Usual Care', 'description': 'Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.12', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '2.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six month follow-up', 'description': "To explore the impact of secure messaging use on healthcare encounters, the investigators will use the Patient Assessment of Chronic Illness Care (PACIC) designed to assess patients' perceptions of the degree to which their care experiences are consistent with the chronic care model and includes subscale scores for patient activation, goal setting/tailoring, and follow-up/coordination. Investigators compared arms at 6-month follow-up using scale 0 (not a problem) - 4 (very big problem), where 0 indicates the desired response.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed 6-month follow-up assessment'}, {'type': 'SECONDARY', 'title': 'Physician Accessibility and Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Supported Adoption Intervention', 'description': 'Supported adoption intervention\n\nSupported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)'}, {'id': 'OG001', 'title': 'Arm 2: Usual Care', 'description': 'Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.24', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '5.97', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'To explore the impact of secure messaging use on healthcare encounters, the investigators will compare each arm at 6-month follow-up assessment with responses from Health Care Climate Questionnaire (HCCQ), a 15-item scale adapted to assess the degree to which patient healthcare provider is accessible and supportive (taking the participant\'s perspective, encouraging and answering questions, supporting their plans) This is a Likert scale ranging from 1 = "Strongly Disagree" to 7 = "Strongly Agree"; where in all but one question - 1 = "Strongly Agree" is the desired response. Responses were totaled, inverting the one question and mean was determined.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed 6-month follow-up survey'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Supported Adoption Intervention', 'description': 'Supported adoption intervention\n\nSupported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)'}, {'id': 'FG001', 'title': 'Arm 2: Usual Care', 'description': 'Usual care control: As a usual control, Veterans did not receive additional information outside of usual care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '595'}, {'groupId': 'FG001', 'numSubjects': '601'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '595'}, {'groupId': 'FG001', 'numSubjects': '601'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '595', 'groupId': 'BG000'}, {'value': '601', 'groupId': 'BG001'}, {'value': '1196', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Supported Adoption Intervention', 'description': 'Supported adoption intervention\n\nSupported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)'}, {'id': 'BG001', 'title': 'Arm 2: General Wellness Information', 'description': 'General wellness information\n\nActive comparator control: The investigators will use an attention control (a control intended to balance the attention Veterans receive from the facility mailings and to enhance masking of intervention versus control). As an attention control must not have information about the intended intervention, the investigators will mail out general wellness information available on the VHA National Center for Prevention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '53.8', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '535', 'groupId': 'BG000'}, {'value': '539', 'groupId': 'BG001'}, {'value': '1074', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '420', 'groupId': 'BG000'}, {'value': '415', 'groupId': 'BG001'}, {'value': '835', 'groupId': 'BG002'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Other Race', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'MIssing', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2016-01-05', 'resultsFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-09', 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Rate of Use', 'timeFrame': 'Baseline and Six months', 'description': 'Measure the change in rate of use of secure messaging in intervention versus control Veterans, reported as participants in each arm that sent a secure message during study period.'}], 'secondaryOutcomes': [{'measure': 'Patient Self-reported Access to Communication', 'timeFrame': 'Six month follow-up', 'description': 'To explore the impact of secure messaging use on healthcare encounters, the investigators will compare the responses of each arm at 6-month follow-up assessment for Patient Self-reported Access to communication using 2 Questions adapted from the Survey of Healthcare Experience of Patients Scale which inquires, "How easy is it for you to communicate with your doctor when you need to?" and, "How easy is it for you to get to see your nurse when you need to?" Responses to scale were 1= "Never", 2= "Sometimes", 3= "Usually", 4= "Always"; where "Always" was the best score.'}, {'measure': 'Care Coordination: Patient Assessment of Chronic Illness Care', 'timeFrame': 'Six month follow-up', 'description': "To explore the impact of secure messaging use on healthcare encounters, the investigators will use the Patient Assessment of Chronic Illness Care (PACIC) designed to assess patients' perceptions of the degree to which their care experiences are consistent with the chronic care model and includes subscale scores for patient activation, goal setting/tailoring, and follow-up/coordination. Investigators compared arms at 6-month follow-up using scale 0 (not a problem) - 4 (very big problem), where 0 indicates the desired response."}, {'measure': 'Physician Accessibility and Engagement', 'timeFrame': 'Six months', 'description': 'To explore the impact of secure messaging use on healthcare encounters, the investigators will compare each arm at 6-month follow-up assessment with responses from Health Care Climate Questionnaire (HCCQ), a 15-item scale adapted to assess the degree to which patient healthcare provider is accessible and supportive (taking the participant\'s perspective, encouraging and answering questions, supporting their plans) This is a Likert scale ranging from 1 = "Strongly Disagree" to 7 = "Strongly Agree"; where in all but one question - 1 = "Strongly Agree" is the desired response. Responses were totaled, inverting the one question and mean was determined.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supported adoption', 'Secure messaging', 'Patient aligned care team (PACT)', 'My HealtheVet Coordinator'], 'conditions': ['Non-secure Message Senders']}, 'referencesModule': {'references': [{'pmid': '33206052', 'type': 'DERIVED', 'citation': 'Shimada SL, Zocchi MS, Hogan TP, Kertesz SG, Rotondi AJ, Butler JM, Knight SJ, DeLaughter K, Kleinberg F, Nicklas J, Nazi KM, Houston TK. Impact of Patient-Clinical Team Secure Messaging on Communication Patterns and Patient Experience: Randomized Encouragement Design Trial. J Med Internet Res. 2020 Nov 18;22(11):e22307. doi: 10.2196/22307.'}], 'seeAlsoLinks': [{'url': 'http://www.queri.research.va.gov/partnered_evaluation/ehealth.cfm', 'label': 'Click here for more information about this study: eHealth Partnered Evaluation Initiative (PEC 15-470)'}]}, 'descriptionModule': {'briefSummary': 'On October 1, 2016, the VHA Office of Telehealth and the Connected Health Office will merge to create a single entity that will be responsible for the implementation and evaluation of eHealth technologies across the healthcare system. In an effort to successfully fulfill its mission, the new combined Connected Health/Telehealth Office is pledging $1,100,000 for an eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of eHealth technologies across VHA, and to measure their impacts on dimensions of access and other outcomes. Developed in close consultation with leadership of the new office, the proposed objectives of the eHealth PEI are to (1) implement a patient-level "supported adoption intervention" for secure messaging and evaluate the impact of secure messaging use through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA\'s automated telehealth text messaging system to Veterans and clinical team members.', 'detailedDescription': 'eHealth is a model for the delivery and receipt of healthcare services with an expanding evidence base that suggests great potential to increase access and support the transition from episodic to continuous care. In this model, patients, their families, and clinical team members use eHealth technologies that support functions (e.g., communication, behavior support, transactions) that are critical to disease prevention and health management which in turn influences behaviors, processes and outcomes.\n\nIn October 2016, the existing Office of Telehealth and the Connected Health Office will merge to create a single Office to oversee the implementation and evaluation of eHealth technologies across VHA. The new combined Connected Health/Telehealth Office will manage the full spectrum of technologies included in the current Offices of Telehealth (e.g., clinical video telehealth, home telehealth, tele-ICU) and Connected Health (e.g., patient portal, secure messaging, mobile apps), as well as new technologies that span these offices (such as the new Automated Telehealth Texting System). Recognizing the importance of rigorous evaluation to its mission, the Connected Health/Telehealth Office is pledging funds for an eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of eHealth technologies across VHA, and to measure their impacts on dimensions of access, as well as Veteran and clinical team experiences, healthcare processes, and Veteran health outcomes.\n\nDeveloped in close consultation with Connected Health/Telehealth Office leadership, the proposed objectives of the eHealth PEI are to (1) implement a patient-level "supported adoption intervention" for secure messaging and evaluate the impact of secure messaging use through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA\'s automated telehealth text messaging system to Veterans and clinical team members. The evaluation work associated with each of these two objectives will be guided by the Practical, Robust Implementation and Sustainability Model (PRISM).\n\nThe implementation and evaluation of eHealth technologies is not just the mission of the new Connected Health/Telehealth Office, it is also the vision of VHA. In addition to addressing the needs of the investigators\' operational partner, the aforementioned objectives map to key strategies and transformational actions detailed in the Blueprint for Excellence, and align with a recently developed Virtual Access Strategy Document intended to guide the efforts of the Connected Health/Telehealth Office. The proposed eHealth PEI team includes leadership and investigators from the eHealth Quality Enhancement Research Initiative (QUERI) who are recognized authorities in informatics, implementation science, and mixed methods evaluation, and have longstanding, collaborative relationships with constituents in the Connected Health/Telehealth Office.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Authenticated My HealtheVet users who have not sent a secure message\n* Active patients who have an appointment scheduled in the following year\n\nExclusion Criteria:\n\n* Authenticated My HealtheVet users who have sent a secure message\n* Inactive patients (who do not have an appointment scheduled in the following year)'}, 'identificationModule': {'nctId': 'NCT02665468', 'acronym': 'eHealth PEI', 'briefTitle': 'eHealth Partnered Evaluation Initiative', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'eHealth Partnered Evaluation Initiative (PEC 15-470)', 'orgStudyIdInfo': {'id': 'PEX 16-001'}, 'secondaryIdInfos': [{'id': 'PEC 15-470', 'type': 'OTHER_GRANT', 'domain': 'QUERI Partnered Evaluation Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1: Supported Adoption Intervention (SAI)', 'description': 'Supported adoption intervention', 'interventionNames': ['Behavioral: Supported adoption intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: General wellness information', 'description': 'General wellness information', 'interventionNames': ['Behavioral: Active comparator control']}], 'interventions': [{'name': 'Supported adoption intervention', 'type': 'BEHAVIORAL', 'otherNames': ['SAI'], 'description': 'An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)', 'armGroupLabels': ['Arm 1: Supported Adoption Intervention (SAI)']}, {'name': 'Active comparator control', 'type': 'BEHAVIORAL', 'otherNames': ['General wellness information'], 'description': 'The investigators will use an attention control (a control intended to balance the attention Veterans receive from the facility mailings and to enhance masking of intervention versus control). As an attention control must not have information about the intended intervention, the investigators will mail out general wellness information available on the VHA National Center for Prevention', 'armGroupLabels': ['Arm 2: General wellness information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham VA Medical Center, Birmingham, AL', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '01730', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System, Salt Lake City, UT', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Timothy Patrick Hogan, PhD MS BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}