Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00788632
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2008-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-20', 'studyFirstSubmitDate': '2008-11-07', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density (BMD) testing', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Osteoporosis prescription medications', 'timeFrame': '12 months'}, {'measure': 'Patient-Physician communication regarding osteoporosis treatment and testing', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'BMD', 'Bisphosphonates', 'Educational materials', 'Patient Stories'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to rigorously test the incremental impact of simple, generalizable interventions to improve healthcare among older women at high risk for osteoporosis. Building on the experience of our University of Alabama at Birmingham (UAB) interdisciplinary team we have designed an innovative, scientifically rigorous, and highly feasible implementation research project in partnership with two Kaiser Permanente (KP) research centers. Kaiser Permanente, one of the Nation's largest Healthcare Organizations, uses an integrated electronic medical record (EMR), with full capture of pharmacy, clinical (including BMD results), and claims data, and cares for a racially/ethnically, socio-economically, and geographically diverse population. To address innovative questions in implementation research, we will perform a multi-modal group randomized trial involving over 18,000 patients seen by over 330 primary care providers (PCPs) at 25 KP facilities in the Northwest and Southeast. If proven effective, our system-centered and patient-centered approach will advance the state of implementation science and be applicable to evidence implementation in other musculoskeletal disorders and to other health care settings."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* age 65 or older\n\nExclusion Criteria:\n\n* prior osteoporosis testing (BMD)\n* prior osteoporosis treatment'}, 'identificationModule': {'nctId': 'NCT00788632', 'acronym': 'ICOMMIITT', 'briefTitle': 'Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)', 'orgStudyIdInfo': {'id': 'X080219004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'educational materials', 'description': 'Patient educational DVD and brochure', 'interventionNames': ['Behavioral: Patient educational DVD and brochure']}, {'type': 'OTHER', 'label': 'physician education', 'description': 'Physician web modules', 'interventionNames': ['Behavioral: Physician web modules']}, {'type': 'EXPERIMENTAL', 'label': 'System intervention', 'description': 'Self-referral letter with toll-free number provided', 'interventionNames': ['Behavioral: System']}], 'interventions': [{'name': 'Patient educational DVD and brochure', 'type': 'BEHAVIORAL', 'description': 'Construct a tailored direct-to-patient intervention to educate and activate older women about osteoporosis testing and treatment and aimed at improving patient-provider communication and "closing the loop" between knowledge communication and action. The intervention will include risk assessment, will be delivered through culturally/ethnically tailored "story-telling", and will be mailed-out as both a paper copy (Booklet) and an interactive DVD (allowing the patient to use the delivery mediums they are most comfortable with). A follow-up brochure will be sent as a "booster".', 'armGroupLabels': ['educational materials']}, {'name': 'Physician web modules', 'type': 'BEHAVIORAL', 'description': 'Web based osteoporosis continuing medical education (CME) materials', 'armGroupLabels': ['physician education']}, {'name': 'System', 'type': 'BEHAVIORAL', 'description': 'Create a practice redesign strategy to alert patients that they should receive a BMD test and provide them with direct patient access to schedule their own test', 'armGroupLabels': ['System intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30305', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kaiser Permanente Southeast', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kasier Permanente Northwest', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Kenneth G Saag, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kenneth Saag, MD, MSc', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}