Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)

NCT ID: NCT00788632

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-10-31

Brief Summary

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

educational materials

Patient educational DVD and brochure

Group Type: EXPERIMENTAL

Patient educational DVD and brochure

Intervention Type: BEHAVIORAL

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".

physician education

Physician web modules

Group Type: OTHER

Physician web modules

Intervention Type: BEHAVIORAL

Web based osteoporosis continuing medical education (CME) materials

System intervention

Self-referral letter with toll-free number provided

Group Type: EXPERIMENTAL

System

Intervention Type: BEHAVIORAL

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

Interventions

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".

Intervention Type: BEHAVIORAL

Physician web modules

Web based osteoporosis continuing medical education (CME) materials

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• female
• age 65 or older

Exclusion Criteria

• prior osteoporosis testing (BMD)
• prior osteoporosis treatment

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Saag, MD, MSc

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth G Saag, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Kaiser Permanente Southeast

Atlanta, Georgia, United States

Kasier Permanente Northwest

Portland, Oregon, United States

Countries

United States

Other Identifiers

X080219004

Identifier Type: -

Identifier Source: org_study_id