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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

November 7, 2008
March 20, 2013
May 2010
December 2011   (final data collection date for primary outcome measure)
Bone Mineral Density (BMD) testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
BMD testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00788632 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Osteoporosis
  • 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".
  • Behavioral: Physician web modules
    Web based osteoporosis continuing medical education (CME) materials
  • 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
  • Experimental: educational materials
    Patient educational DVD and brochure
    Intervention: Behavioral: Patient educational DVD and brochure
  • physician education
    Physician web modules
    Intervention: Behavioral: Physician web modules
  • Experimental: System intervention
    Self-referral letter with toll-free number provided
    Intervention: Behavioral: System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12128
October 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female
  • age 65 or older

Exclusion Criteria:

  • prior osteoporosis testing (BMD)
  • prior osteoporosis treatment
Female
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00788632
X080219004
No
Kenneth Saag, MD, MSc, University of Alabama at Birmingham
University of Alabama at Birmingham
Kaiser Permanente
Principal Investigator: Kenneth G Saag, MD, MSc University of Alabama at Birmingham
University of Alabama at Birmingham
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP