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

Osteoporosis Clinical Trial

— ICOMMIITT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788632
• Other study ID #: X080219004
• Status: Completed
• Phase: N/A
• First received: November 7, 2008
• Last updated: March 20, 2013
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12128
• Est. completion date: October 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• female

• age 65 or older

Exclusion Criteria:

• prior osteoporosis testing (BMD)

• prior osteoporosis treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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".
• Physician web modules
Web based osteoporosis continuing medical education (CME) materials
• 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

Locations

Country	Name	City	State
United States	Kaiser Permanente Southeast	Atlanta	Georgia
United States	Kasier Permanente Northwest	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density (BMD) testing		12 months	No
Secondary	Osteoporosis prescription medications		12 months	No
Secondary	Patient-Physician communication regarding osteoporosis treatment and testing		12 months	No