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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient educational DVD and brochure
Physician web modules
System
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, BMD, Bisphosphonates, Educational materials, Patient Stories

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female
  • age 65 or older

Exclusion Criteria:

  • prior osteoporosis testing (BMD)
  • prior osteoporosis treatment

Sites / Locations

  • Kaiser Permanente Southeast
  • Kasier Permanente Northwest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

educational materials

physician education

System intervention

Arm Description

Patient educational DVD and brochure

Physician web modules

Self-referral letter with toll-free number provided

Outcomes

Primary Outcome Measures

Bone Mineral Density (BMD) testing

Secondary Outcome Measures

Osteoporosis prescription medications
Patient-Physician communication regarding osteoporosis treatment and testing

Full Information

First Posted
November 7, 2008
Last Updated
March 20, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT00788632
Brief Title
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Acronym
ICOMMIITT
Official Title
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, BMD, Bisphosphonates, Educational materials, Patient Stories

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
educational materials
Arm Type
Experimental
Arm Description
Patient educational DVD and brochure
Arm Title
physician education
Arm Type
Other
Arm Description
Physician web modules
Arm Title
System intervention
Arm Type
Experimental
Arm Description
Self-referral letter with toll-free number provided
Intervention Type
Behavioral
Intervention Name(s)
Patient educational DVD and brochure
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Physician web modules
Intervention Description
Web based osteoporosis continuing medical education (CME) materials
Intervention Type
Behavioral
Intervention Name(s)
System
Intervention Description
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
Primary Outcome Measure Information:
Title
Bone Mineral Density (BMD) testing
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Osteoporosis prescription medications
Time Frame
12 months
Title
Patient-Physician communication regarding osteoporosis treatment and testing
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female age 65 or older Exclusion Criteria: prior osteoporosis testing (BMD) prior osteoporosis treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth G Saag, MD, MSc
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Southeast
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30305
Country
United States
Facility Name
Kasier Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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