Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04503993
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2020-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Planet Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006514', 'term': 'Hepatitis B Surface Antigens'}], 'ancestors': [{'id': 'D006511', 'term': 'Hepatitis B Antigens'}, {'id': 'D018963', 'term': 'Hepatitis Antigens'}, {'id': 'D000956', 'term': 'Antigens, Viral'}, {'id': 'D014764', 'term': 'Viral Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5004}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2020-08-04', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of hepatitis B order panel', 'timeFrame': 'Within 1 year after placement of the order'}], 'secondaryOutcomes': [{'measure': 'Linkage to care of those found to be infected with hepatitis B', 'timeFrame': 'Within 3 months after a positive HBsAg test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This quality improvement project utilizes Epic Health Planet to increase screening for chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory panels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record\n\nExclusion Criteria:\n\n\\- previously completed hepatitis B screening tests'}, 'identificationModule': {'nctId': 'NCT04503993', 'briefTitle': 'Healthy Planet Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Utilizing Electronic Health Systems to Enhance Screening and Linkage to Care for Chronic Hepatitis B', 'orgStudyIdInfo': {'id': '1423112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hepatitis B Healthy Planet Arm', 'description': 'This is a single arm study where all patients eligible patients will receive a hepatitis B order set', 'interventionNames': ['Other: Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody']}], 'interventions': [{'name': 'Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody', 'type': 'OTHER', 'description': 'The hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools.', 'armGroupLabels': ['Hepatitis B Healthy Planet Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}