Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT05265312
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2022-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'etseng3@jhmi.edu', 'phone': '410-583-2774', 'title': 'Dr. Eva Tseng', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse event data not collected', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Clinic', 'description': 'START diabetes prevention clinical pathway', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Clinic', 'description': 'Routine usual care', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '873', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}, {'units': 'pcp visits', 'counts': [{'value': '1754', 'groupId': 'OG000'}, {'value': '2328', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Clinic', 'description': 'START diabetes prevention clinical pathway'}, {'id': 'OG001', 'title': 'Control Clinic', 'description': 'Routine usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period', 'unitOfMeasure': 'pcp visits', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pcp visits', 'denomUnitsSelected': 'pcp visits'}, {'type': 'PRIMARY', 'title': 'Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '873', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}, {'units': 'pcp visits', 'counts': [{'value': '1754', 'groupId': 'OG000'}, {'value': '2328', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Clinic', 'description': 'START diabetes prevention clinical pathway'}, {'id': 'OG001', 'title': 'Control Clinic', 'description': 'Routine usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'pcp visits', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pcp visits', 'denomUnitsSelected': 'pcp visits'}, {'type': 'PRIMARY', 'title': 'Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '873', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}, {'units': 'pcp visits', 'counts': [{'value': '1754', 'groupId': 'OG000'}, {'value': '2328', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Clinic', 'description': 'START diabetes prevention clinical pathway'}, {'id': 'OG001', 'title': 'Control Clinic', 'description': 'Routine usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'pcp visits', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'pcp visits', 'denomUnitsSelected': 'pcp visits'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '873', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Clinic', 'description': 'START diabetes prevention clinical pathway'}, {'id': 'OG001', 'title': 'Control Clinic', 'description': 'Routine usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '800', 'groupId': 'OG000'}, {'value': '906', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Fasting glucose or Hemoglobin A1c', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Achieve 5% or Greater Reduction in Weight Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '873', 'groupId': 'OG000'}, {'value': '1037', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Clinic', 'description': 'START diabetes prevention clinical pathway'}, {'id': 'OG001', 'title': 'Control Clinic', 'description': 'Routine usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 12 months', 'description': 'Proportion achieving 5% or greater weight reduction', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Clinic', 'description': 'Patients with prediabetes seen for routine care at intervention clinic\n\nSTART diabetes prevention clinical pathway: The diabetes prevention clinical pathway will focus on the following steps:\n\n1. Screen/test - testing of eligible patients for prediabetes/diabetes\n2. Education - Primary Care Physicians (PCPs) will be encouraged to take an online learning module and in-person group training on prediabetes management and patients with prediabetes will receive a handout about prediabetes prior to their upcoming PCP visit\n3. Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit\n4. Referral - patients may be referred to Diabetes Prevention Program (DPP) and/or medical nutrition therapy (MNT)\n5. Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes.'}, {'id': 'FG001', 'title': 'Control Clinic', 'description': 'Patients with prediabetes seen for routine care at control clinic'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '873'}, {'groupId': 'FG001', 'numSubjects': '1037'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '873'}, {'groupId': 'FG001', 'numSubjects': '1037'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '873', 'groupId': 'BG000'}, {'value': '1037', 'groupId': 'BG001'}, {'value': '1910', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Clinic', 'description': 'START diabetes prevention clinical pathway'}, {'id': 'BG001', 'title': 'Control Clinic', 'description': 'Routine usual care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '545', 'groupId': 'BG000'}, {'value': '617', 'groupId': 'BG001'}, {'value': '1162', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '327', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '747', 'groupId': 'BG002'}]}]}, {'title': 'Non-binary', 'categories': [{'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': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '825', 'groupId': 'BG000'}, {'value': '977', 'groupId': 'BG001'}, {'value': '1802', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Declined to Answer', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '544', 'groupId': 'BG000'}, {'value': '604', 'groupId': 'BG001'}, {'value': '1148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-11', 'size': 167815, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-29T10:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1910}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2022-02-22', 'resultsFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-29', 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit', 'timeFrame': '12 months', 'description': 'Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period'}, {'measure': 'Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days', 'timeFrame': '12 months'}, {'measure': 'Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period', 'timeFrame': '12 months', 'description': 'Fasting glucose or Hemoglobin A1c'}, {'measure': 'Achieve 5% or Greater Reduction in Weight Compared to Baseline', 'timeFrame': 'Baseline and 12 months', 'description': 'Proportion achieving 5% or greater weight reduction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes prevention', 'Primary care', 'Clinical pathway', 'Pragmatic intervention'], 'conditions': ['PreDiabetes', 'Prediabetic State']}, 'descriptionModule': {'briefSummary': "Prediabetes is a significant public health problem affecting 88 million U.S. adults. Evidence suggest that the vast majority of people with prediabetes are unaware of having this condition and many are not receiving appropriate care for prediabetes, including referral to evidence-based programs like the Diabetes Prevention Programs (DPP). In the investigator's retrospective cohort study of patients with prediabetes from Johns Hopkins Health Systems, the investigators found that the rates of prediabetes clinical care activities are low. In the investigators' qualitative studies, the investigators found that primary care physician (PCP) barriers include low knowledge about Diabetes Prevention Programs and misperceptions of insurance coverage of these programs and inadequate clinical staff to address prediabetes. Common patient barriers to taking action to prevent diabetes include lack of motivation, time and resources.\n\nBased on prior research, comprehensive strategies are urgently needed to improve prediabetes care. Using these findings, the investigators have designed and plan to implement a diabetes prevention clinical pathway which seeks to address some of these common clinician and patient barriers. The investigators hypothesize that the clinical pathway will result in increased clinician screening and intervention and improve patient engagement in diabetes prevention. The investigators will compare results from the intervention clinic compared to a control clinic. If successful, the investigators plan to implement and test the effectiveness of this clinical pathway across the entire health system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prediabetes based on prediabetes registry\n* Age ≥ 18 years\n* PCP visit during intervention period\n* Patient of Johns Hopkins Green Spring Station (GSS) General Internal Medicine or Johns Hopkins Community Physicians (JHCP) Internal Medicine clinic.\n\nExclusion Criteria:\n\n* Visit with clinician who's not their Primary Care Physician (PCP)"}, 'identificationModule': {'nctId': 'NCT05265312', 'briefTitle': 'Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care', 'orgStudyIdInfo': {'id': 'IRB00313490'}, 'secondaryIdInfos': [{'id': 'K23DK118205', 'link': 'https://reporter.nih.gov/quickSearch/K23DK118205', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention clinic', 'description': 'Patients with prediabetes seen for routine care at intervention clinic', 'interventionNames': ['Other: START diabetes prevention clinical pathway']}, {'type': 'NO_INTERVENTION', 'label': 'Control clinic', 'description': 'Patients with prediabetes seen for routine care at control clinic'}], 'interventions': [{'name': 'START diabetes prevention clinical pathway', 'type': 'OTHER', 'description': 'The diabetes prevention clinical pathway will focus on the following steps:\n\n1. Screen/test - testing of eligible patients for prediabetes/diabetes\n2. Education - PCPs will be encouraged to take an online learning module and in-person group training on prediabetes management and patients with prediabetes will receive a handout about prediabetes prior to their upcoming PCP visit\n3. Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit\n4. Referral - patients may be referred to DPPs and/or medical nutrition therapy (MNT)\n5. Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes.', 'armGroupLabels': ['Intervention clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21204', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins General Internal Medicine clinic at Green Spring Station', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}], 'overallOfficials': [{'name': 'Eva Tseng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}