Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT02578628
Status:
TERMINATED
Last Update Posted:
2018-05-08
First Post:
2015-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discontinuation of Automated Engagement Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 488}}, 'statusModule': {'whyStopped': 'Data source became unavailable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2015-10-10', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Claims paid in past 12 months for covered services', 'timeFrame': '3 years', 'description': 'Total and breakdown by categories'}], 'secondaryOutcomes': [{'measure': 'Lipid test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Estimated glomerular filtration', 'timeFrame': '3 years'}, {'measure': 'Hemoglobin test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Serum calcium test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Serum phosphorus test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Urine albumin-to-creatinine ratio test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Serum parathyroid hormone test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Serum albumin test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Serum electrolytes test completed within time allotted per disease stage', 'timeFrame': '3 years'}, {'measure': 'Latest LDL <100 mg/dl AND completed within time allotted per disease stage', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving care from Empire Physicians Medical Group (EPMG), an Independent Practice Association located in Palm Desert, California. The system monitors routine clinical laboratory test results and send messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. This study will assess what happens to laboratory results, utilization of laboratory tests, and costs of care when ther system is discontinued.', 'detailedDescription': 'The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving care from Empire Physicians Medical Group (EPMG), an Independent Practice Association located in Palm Desert, California. The system monitors routine clinical laboratory test results and send messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. Patients receive first class letters directing them to call their provider. Providers receive fax or electronic messages directing them to reach out to the patient to arrange follow-up care. It has been used for over three years and appears to have improved adherence to Chronic Kidney Disease (CKD) treatment guidelines by influencing both patient and provider actions. EPMG wishes to restrict the service to those patients with advanced CKD and discontinue it for CKD stages 1-3. The investigators propose implementing this new policy in a randomized fashion with one half of the current early stage patients continuing to receive the service while the other half will no longer receive messages. The investigators will monitor laboratory results and health care utilization for both groups to determine what effect, if any, discontinuation has on quality of care.\n\nHuman subjects will either continue to receive letters from the service when their tests are overdue or require additional clinical attention, or will no longer receive the service. All subjects will continue to receive care from their providers. The main outcomes include the frequency of recommended tests for CKD, the level of those tests, and utilization of health care services as indicated by claims data provided by EPMG. No additional data collection will occur beyond that which has been routinely done for clinical care. The study will continue for 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nReceiving services from Patient Engagement Services at randomization. CKD Stages 1, 2 or 3. Under the care of Empire Physicians Medical Group of Palm Desert, California.\n\nExclusion Criteria:\n\nPatient refusal.'}, 'identificationModule': {'nctId': 'NCT02578628', 'briefTitle': 'Discontinuation of Automated Engagement Support', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Discontinuation of Automated Engagement Support', 'orgStudyIdInfo': {'id': '15-453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'These subjects will continue to receive Patient Engagement services.', 'interventionNames': ['Other: Patient Engagement']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'These patients will have all Patient Engagement services discontinued.'}], 'interventions': [{'name': 'Patient Engagement', 'type': 'OTHER', 'description': 'The patient engagement system monitors routine clinical laboratory test results and sends messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. Patients receive first class letters directing them to call their provider. Providers receive fax or electronic messages directing them to reach out to the patient to arrange follow-up care.', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92211', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Empire Physicians Medical Group', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}], 'overallOfficials': [{'name': 'Benjamin Littenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient Engagement Systems', 'class': 'INDUSTRY'}, {'name': 'Empire Physicians Medical Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Benjamin Littenberg', 'investigatorAffiliation': 'University of Vermont'}}}}