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

Study Overview
=================
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.

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

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Behavioral: Patient educational DVD and brochure
* Behavioral: Physician web modules
* Behavioral: System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female age 65 or older Exclusion Criteria: prior osteoporosis testing (BMD) prior osteoporosis treatment

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: educational materials<br>Patient educational DVD and brochure | Behavioral: Patient educational DVD and brochure<br>* 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.<br>|
| Other: physician education<br>Physician web modules | Behavioral: Physician web modules<br>* Web based osteoporosis continuing medical education (CME) materials<br>|
| Experimental: System intervention<br>Self-referral letter with toll-free number provided | Behavioral: System<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) testing |  | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, BMD, Bisphosphonates, Educational materials, Patient Stories