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

March 20, 2013 updated by: Kenneth Saag, MD, MSc, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30305
        • Kaiser Permanente Southeast
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kasier Permanente Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • age 65 or older

Exclusion Criteria:

  • prior osteoporosis testing (BMD)
  • prior osteoporosis treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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".
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density (BMD) testing
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Osteoporosis prescription medications
Time Frame: 12 months
12 months
Patient-Physician communication regarding osteoporosis treatment and testing
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Kaiser Permanente

Investigators

  • Principal Investigator: Kenneth G Saag, MD, MSc, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X080219004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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