Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-01-01 @ 1:27 PM
Study NCT ID:
NCT04894903
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2021-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of a Patient Portal Intervention to Address Diabetes Care Gaps
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.martinez@vumc.org', 'phone': '615-936-1010', 'title': 'William Martinez, MD, MS', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 0, 'seriousNumAtRisk': 217, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 0, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'motor vehicle accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'No Care Gaps', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': 'One Care Gap', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'title': 'Two Care Gaps', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Three Care Gaps', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Four Care Gaps', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '3-months follow-up', 'categories': [{'title': 'No Care Gaps', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'title': 'One Care Gap', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'title': 'Two Care Gaps', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Three Care Gaps', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Four Care Gaps', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '6-months follow-up', 'categories': [{'title': 'No Care Gaps', 'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}, {'title': 'One Care Gap', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'title': 'Two Care Gaps', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Three Care Gaps', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Four Care Gaps', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '12-months follow-up', 'categories': [{'title': 'No Care Gaps', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}, {'title': 'One Care Gap', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'title': 'Two Care Gaps', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Three Care Gaps', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Four Care Gaps', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.68', 'pValueComment': 'This is the calculated p-value. We used an alpha level of 0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for baseline number of gaps'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up', 'description': 'Number of diabetes care gaps per patient out of four possible:\n\n1. no diabetes eye exam in the last 12 months,\n2. no hemoglobin A1C blood test in the last 6 months,\n3. no urine microalbumin in the last 12 months, and\n4. no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two participants in the control group were excluded from analysis because they dropped out from the study prior to 3-month data collection. The mixed effects regression analysis requires at least one measurement in the follow-up period. Two individuals dropped out prior the any follow-up data collection and therefore are not included in the mixed effects regression analysis.'}, {'type': 'SECONDARY', 'title': 'Patient Initiated Orders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Hemoglobin a1c', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Urine microalbumin', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Pneumococcal vaccine', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes eye exam', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12-month follow-up', 'description': 'The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c).', 'unitOfMeasure': 'orders initiated', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is limited to the intervention arm only because only patients in the intervention arm were able to initiate orders via the study intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Understanding of Diabetes Monitoring and Preventative Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Baseline to 3-months: Recommended frequency of hemoglobin A1C testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6-months: Recommended frequency of hemoglobin A1C testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12-months: Recommended frequency of hemoglobin A1C testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 3-months: Recommended frequency of urine microalbumin testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6-months: Recommended frequency of urine microalbumin testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12-months: Recommended frequency of urine microalbumin testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 3-months: Recommended frequency of pneumococcal vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6-months: Recommended frequency of pneumococcal vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12-months: Recommended frequency of pneumococcal vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 3-months: Recommended frequency of diabetes eye exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 6-months: Recommended frequency of diabetes eye exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 12-months: Recommended frequency of diabetes eye exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Correct to Wrong', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'No Change', 'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}, {'title': 'Wrong to Correct', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.62', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': "Unique study specific items (four items) to assess participant's understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. Each multiple-choice item has only one correct answer and the overall measure is scored as the percent of the items answered correctly.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed varies because not all participants answered all items at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Confidence Toward Managing Diabetes in General', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.17', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': 'The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of the confidence a person has in managing their own health and health care and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). Responses result in total raw scores ranging from 1 to 10. The score for the scale is the mean of the items. Higher scores indicate greater confidence in managing diabetes in general.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed varies because not all participants answered all items at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': '3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': '12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.51', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': "The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 contains 5 items which have a five-point response option (0-4 representing 'Not a problem' through to 'Serious problem'). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress care (e.g., Diabetes Eye Exams) will be administered to all study participants.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed varies because not all participants answered all items at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Satisfaction/Usability of My Health at Vanderbilt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.3', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '80.2', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': '3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.1', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '14.8', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.0', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '79.0', 'spread': '14.8', 'groupId': 'OG001'}]}]}, {'title': '12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '15.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-3.19', 'ciUpperLimit': '0.71', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up', 'description': "The System Usability Scale (SUS) is a valid measure of usability and assesses user's perceptions of ease of use, likability of the interface, and overall satisfaction. Each question on the 10-item questionnaire is scored on a 5-point Likert scale \\[0 (Strongly disagree) to 4 (strongly agree)\\] and the sum is totaled (0-40). The total sum is then multiplied by 2.5 to convert the original scores to a range of 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed varies because not all participants answered all items at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Glucose Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Change in Hemoglobin A1C: Baseline to 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-month follow-up', 'description': "Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.", 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed differs because not all patients had a qualifying A1c value in the EHR for the timepoint.'}, {'type': 'SECONDARY', 'title': 'Treatment Intensification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Antihyperglycemic medications: baseline to 3-month follow-up', 'categories': [{'title': 'No change in the number of medications', 'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}, {'title': 'Decrease in the number of medications', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Increase in the number of medications', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antihyperglycemic medications: baseline to 6-month follow-up', 'categories': [{'title': 'No change in the number of medications', 'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}, {'title': 'Decrease in the number of medications', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Increase in the number of medications', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antihyperglycemic medications: baseline to 12-month follow-up', 'categories': [{'title': 'No change in the number of medications', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}, {'title': 'Decrease in the number of medications', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Increase in the number of medications', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antihypertensive medications: baseline to 3-month follow-up', 'categories': [{'title': 'No change in the number of medications', 'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}, {'title': 'Decrease in the number of medications', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Increase in the number of medications', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antihypertensive medications: baseline to 6-month follow-up', 'categories': [{'title': 'No change in the number of medications', 'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}, {'title': 'Decrease in the number of medications', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Increase in the number of medications', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Antihypertensive medications: baseline to 12-month follow-up', 'categories': [{'title': 'No change in the number of medications', 'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}, {'title': 'Decrease in the number of medications', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Increase in the number of medications', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': 'The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '29.8', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': '3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '30.2', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '30.7', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': '12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.5', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Change baseline to 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '1.22', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': "The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed varies because not all participants answered all items at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Reported Services Completed Outside Vanderbilt System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12-month follow-up', 'description': 'The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention.', 'unitOfMeasure': 'reports', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is limited to the intervention arm only because only patients in the intervention arm were able to report diabetes eye exams received outside the Vanderbilt University Medical Center health system using the study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '212'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'moved or exited health system', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '440 patients were enrolled and sent the baseline survey. 433 patients completed the baseline survey. Completion of the baseline survey was required prior randomization and assignment to a study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\nDiabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex/Gender', 'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'White or Caucasian', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'eHealth Literacy', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '33.1', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The eHealth Literacy Scale (eHEALS) was used to assess eHealth literacy. The eHEALS is an 8-item survey that uses a 5-point Likert scale, where 1 is "strongly disagree" and 5 is "strongly agree". The eHEALS is scored on a scale of 8-40, with higher scores indicating greater eHealth literacy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Two participants in the control group were excluded from analysis because they dropped out from the study prior to 3-month data collection. The mixed effects regression analysis requires at least one measurement in the follow-up period. Two individuals dropped out prior the any follow-up data collection and therefore are not included in the study analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-19', 'size': 229676, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-03T23:38', 'hasProtocol': True}, {'date': '2022-03-10', 'size': 1644426, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-22T23:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2021-05-11', 'resultsFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-23', 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Diabetes Care Gaps at Baseline, 3 Months, 6 Months, and 12 Months', 'timeFrame': 'Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up', 'description': 'Number of diabetes care gaps per patient out of four possible:\n\n1. no diabetes eye exam in the last 12 months,\n2. no hemoglobin A1C blood test in the last 6 months,\n3. no urine microalbumin in the last 12 months, and\n4. no pneumococcal vaccination of any kind ( i.e., never received PPSV-23, PCV-13, PCV-15, or PCV-20) The presence of a diabetes care gap will be assessed by electronic health record (EHR) abstraction.'}], 'secondaryOutcomes': [{'measure': 'Patient Initiated Orders', 'timeFrame': '12-month follow-up', 'description': 'The number of patient-initiated orders via the study intervention for evidence-based diabetes monitoring and preventative services (e.g., A1c).'}, {'measure': 'Change in Understanding of Diabetes Monitoring and Preventative Care', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': "Unique study specific items (four items) to assess participant's understanding of measures of diabetes monitoring and preventative care (e.g., Diabetes Eye Exams) will be administered to all study participants. Each multiple-choice item has only one correct answer and the overall measure is scored as the percent of the items answered correctly."}, {'measure': 'Change in Confidence Toward Managing Diabetes in General', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': 'The 5-item Manage Disease in General Scale of the Chronic Disease Self-Efficacy Scales is a validated measure of the confidence a person has in managing their own health and health care and is closely related to patient activation. The items were adapted to be specific to diabetes rather than a generic condition or illness. Each item uses a 10-point Likert-type scale of response options ranging from 1 (not at all confident) to 10 (totally confident). Responses result in total raw scores ranging from 1 to 10. The score for the scale is the mean of the items. Higher scores indicate greater confidence in managing diabetes in general.'}, {'measure': 'Change in Diabetes Distress', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': "The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The PAID-5 contains 5 items which have a five-point response option (0-4 representing 'Not a problem' through to 'Serious problem'). Total scores on the PAID-5 can range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress care (e.g., Diabetes Eye Exams) will be administered to all study participants."}, {'measure': 'Satisfaction/Usability of My Health at Vanderbilt', 'timeFrame': 'Baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up', 'description': "The System Usability Scale (SUS) is a valid measure of usability and assesses user's perceptions of ease of use, likability of the interface, and overall satisfaction. Each question on the 10-item questionnaire is scored on a 5-point Likert scale \\[0 (Strongly disagree) to 4 (strongly agree)\\] and the sum is totaled (0-40). The total sum is then multiplied by 2.5 to convert the original scores to a range of 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability. The SUS has been used in several studies of patient facing health information technology (the article describing its psychometric properties has been cited over 500 times) and has excellent internal consistency reliability (Cronbach's alpha of 0.91)."}, {'measure': 'Change in Blood Glucose Control', 'timeFrame': 'Baseline to 12-month follow-up', 'description': "Participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record."}, {'measure': 'Treatment Intensification', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': 'The addition of: (a) antihyperglycemic medications and (b) antihypertensive medications will be assessed by EHR abstraction.'}, {'measure': 'Change in Diabetes Self-efficacy', 'timeFrame': 'Baseline to 3-month follow-up, baseline to 6-month follow-up, and baseline to 12-month follow-up', 'description': "The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes."}, {'measure': 'Reported Services Completed Outside Vanderbilt System', 'timeFrame': '12-month follow-up', 'description': 'The number of patient reports of diabetes eye exams received outside the Vanderbilt University Medical Center health system submitted via the study intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Self-efficacy', 'Patient Web Portals', 'Health Information Technology'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '38941148', 'type': 'DERIVED', 'citation': 'Hackstadt AJ, Elasy TA, Gangaputra S, Harper KJ, Mayberry LS, Nelson LA, Peterson NB, Rosenbloom ST, Yu Z, Martinez W. Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e56123. doi: 10.2196/56123.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of a novel patient portal intervention on the number of patients with diabetes care gaps (e.g., no diabetes eye exam i the last 12 months). The intervention is designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring \\& preventative care (e.g., annual urine microalbumin) are due and (b) allow patients to initiate orders for the care.', 'detailedDescription': "Participants will be recruited from 14 VUMC-affiliate adult primary care clinics located throughout Middle Tennessee. Patients will be randomized 1:1 to the intervention or usual care. 500 adult patients with type 1 or 2 diabetes mellitus will be assigned to one of two arms. 250 will be assigned to receive access to the intervention embedded within an existing patient web portal (My Health at Vanderbilt) at Vanderbilt University Medical Center. 250 will be assigned to a usual care comparison arm with access to the currently available version of My Health at Vanderbilt without the study intervention. At enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (EHR) before being assigned to the intervention or control arm. Participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the EHR at 3-month, 6-month, and 12-month follow-ups to assess outcomes. In addition, system usage data (user analytics) will be collected throughout the study period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established patient with a participating primary care physician from a participating clinic\n* Type 1 or 2 diabetes mellitus\n* Able to read in English\n* Age 18 to 75 years old\n* Mobile device (smartphone or tablet) with internet access\n* Active My Health at Vanderbilt (MHAV) account\n\nExclusion Criteria:\n\n* A medical condition that prevents use of a mobile device\n* Pregnant or planning to become pregnant during the study period\n* Severe difficulty seeing\n* On dialysis'}, 'identificationModule': {'nctId': 'NCT04894903', 'briefTitle': 'Effects of a Patient Portal Intervention to Address Diabetes Care Gaps', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: A Pragmatic Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '212257'}, 'secondaryIdInfos': [{'id': 'R18DK123373', 'link': 'https://reporter.nih.gov/quickSearch/R18DK123373', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention.\n\n.', 'interventionNames': ['Other: Diabetes Care Gaps Patient Portal Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care).'}], 'interventions': [{'name': 'Diabetes Care Gaps Patient Portal Intervention', 'type': 'OTHER', 'description': 'The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes monitoring \\& preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'William Martinez, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Deidentified individual participant data that underlie the results reported will be available after publication in a peer reviewed journal and posted on clinical trials and ending after 36 months after publication.', 'ipdSharing': 'YES', 'description': 'After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.', 'accessCriteria': 'Researchers should provide a methodologically sound proposal to achieve their proposed aims. Proposals may be submitted to the principal investigator up to 36 months following publication. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'William Martinez, MD, MS', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}