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

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00788632
First received: November 7, 2008
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Bone Mineral Density (BMD) testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Osteoporosis prescription medications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient-Physician communication regarding osteoporosis treatment and testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 7, 2008
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Osteoporosis
BMD
Bisphosphonates
Educational materials
Patient Stories

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

ClinicalTrials.gov processed this record on May 23, 2013