Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-29 @ 5:43 AM
Study NCT ID:
NCT00793260
Status:
COMPLETED
Last Update Posted:
2008-11-19
First Post:
2008-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Dive Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-18', 'studyFirstSubmitDate': '2008-11-17', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.'}], 'secondaryOutcomes': [{'measure': 'Secondary measures included utilization of selected services.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Disease', 'Arthritis', 'Uterine Diseases', 'Spinal Diseases', 'Preventive Health Services']}, 'referencesModule': {'references': [{'pmid': '20860506', 'type': 'DERIVED', 'citation': "Wennberg DE, Marr A, Lang L, O'Malley S, Bennett G. A randomized trial of a telephone care-management strategy. N Engl J Med. 2010 Sep 23;363(13):1245-55. doi: 10.1056/NEJMsa0902321."}]}, 'descriptionModule': {'briefSummary': 'Compare two care management support program models on medical costs and utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All employees, dependents and retirees in one of seven large employer groups, including a state university system, a state employee group, two manufacturing companies, a natural resource extraction company, a public educational service agency, and a nonprofit multiple employer association for independent colleges were eligible for inclusion.\n\nExclusion Criteria:\n\n* no financial information was available from their facility and professional claims;\n* they were in an employer sub-group ineligible for care support services;\n* they asked not be to contacted or were deceased;\n* gender information was missing from their eligibility files;\n* their claims data from the year prior to the start of the study indicated diagnoses of HIV, AIDS, end-stage renal disease (ESRD), organ transplants, or necrotizing fasciitis (intended to improve the likelihood of a balanced distribution of costs and conditions); OR\n* they were in an employer sub-group with less than four months of enrollment prior to the study start date (resulting in too little information for stratification).'}, 'identificationModule': {'nctId': 'NCT00793260', 'briefTitle': 'Deep Dive Randomized Control Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Health Dialog'}, 'officialTitle': 'Deep Dive Randomized Control Trial', 'orgStudyIdInfo': {'id': 'DeepDive'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Support Group', 'description': 'Predictive models in the Usual-Support Group were aimed at identifying individuals through medical claims and administrative data (such as hospitalization notification). The output of the predictive models is a rank-ordered, or stratified, list of individuals who have support needs. These lists were then used to generate outbound mail, interactive voice response (IVR) calls or calls by health coaches.', 'interventionNames': ['Behavioral: Usual-Support']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Support Group', 'description': 'The Enhanced-Support Group intervention used more sophisticated predictive models, more extensive outreach to engage individuals, and provided tighter feedback loops to inform the care support process.', 'interventionNames': ['Behavioral: Enhanced Support']}], 'interventions': [{'name': 'Enhanced Support', 'type': 'BEHAVIORAL', 'description': "The Enhanced-Support Group program used lower risk thresholds for targeted outreach of individuals with chronic illness and for those likely to face discrete surgical interventions. Individuals at high financial risk but without one of the five chronic conditions were included in the Enhanced-Support Group.\n\nThe Enhanced-Support Group received up to five initial reach attempts while the Usual-Support Group received up to three attempts.\n\nThe Enhanced-Support Group used a 'tight loop' management structure including detailed, timely coach level feedback reports on efficiency and effectiveness.", 'armGroupLabels': ['Enhanced Support Group']}, {'name': 'Usual-Support', 'type': 'BEHAVIORAL', 'description': 'Predictive models in the Usual-Support Group were aimed at identifying individuals through medical claims and administrative data (such as hospitalization notification). The output of the predictive models is a rank-ordered, or stratified, list of individuals who have support needs. These lists were then used to generate outbound mail, interactive voice response (IVR) calls or calls by health coaches.', 'armGroupLabels': ['Usual Support Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04101', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Health Dialog Analytic Solutions, Inc', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}], 'overallOfficials': [{'name': 'David E Wennberg, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Dialog'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Health Dialog', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Health Net California', 'class': 'UNKNOWN'}, {'name': 'Highmark Blue Cross Blue Shield', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'David E. Wennberg, MD, MPH / Chief Science & Products Officer', 'oldOrganization': 'Health Dialog Analytic Solutions, Inc'}}}}