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Sponsors and Collaborators: |
University of Alabama at Birmingham Kaiser Permanente |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00788632 |
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 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.
Condition | Intervention |
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Osteoporosis |
Behavioral: Patient educational DVD and brochure Behavioral: Physician web modules Behavioral: System |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT) |
Estimated Enrollment: | 18000 |
Study Start Date: | March 2010 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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educational materials: Experimental |
Behavioral: Patient educational DVD and brochure
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".
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physician education |
Behavioral: Physician web modules
Web based osteoporosis CME materials
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System intervention: Experimental |
Behavioral: System
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
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Kaiser Permanente Southeast | |
Atlanta, Georgia, United States | |
United States, Oregon | |
Kasier Permanente Northwest | |
Portland, Oregon, United States |
Responsible Party: | University of Alabama at Birmingham ( Kenneth G. Saag, MD, MSc ) |
Study ID Numbers: | X080219004 |
Study First Received: | November 7, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00788632 |
Health Authority: | United States: Institutional Review Board |
Osteoporosis BMD Bisphosphonates Educational materials Patient Stories |
Diphosphonates Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |