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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788632
First Posted: November 11, 2008
Last Update Posted: March 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham
  Purpose
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.

Condition Intervention
Osteoporosis Behavioral: Patient educational DVD and brochure Behavioral: Physician web modules Behavioral: System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)

Resource links provided by NLM:


Further study details as provided by Kenneth Saag, MD, MSc, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Bone Mineral Density (BMD) testing [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Osteoporosis prescription medications [ Time Frame: 12 months ]
  • Patient-Physician communication regarding osteoporosis treatment and testing [ Time Frame: 12 months ]

Enrollment: 12128
Study Start Date: May 2010
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: educational materials
Patient educational DVD and brochure
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 education
Physician web modules
Behavioral: Physician web modules
Web based osteoporosis continuing medical education (CME) materials
Experimental: System intervention
Self-referral letter with toll-free number provided
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • age 65 or older

Exclusion Criteria:

  • prior osteoporosis testing (BMD)
  • prior osteoporosis treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788632


Locations
United States, Georgia
Kaiser Permanente Southeast
Atlanta, Georgia, United States, 30305
United States, Oregon
Kasier Permanente Northwest
Portland, Oregon, United States, 97227
Sponsors and Collaborators
University of Alabama at Birmingham
Kaiser Permanente
Investigators
Principal Investigator: Kenneth G Saag, MD, MSc University of Alabama at Birmingham
  More Information

Responsible Party: Kenneth Saag, MD, MSc, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00788632     History of Changes
Other Study ID Numbers: X080219004
First Submitted: November 7, 2008
First Posted: November 11, 2008
Last Update Posted: March 22, 2013
Last Verified: March 2013

Keywords provided by Kenneth Saag, MD, MSc, University of Alabama at Birmingham:
Osteoporosis
BMD
Bisphosphonates
Educational materials
Patient Stories

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases