NCT00788632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,128

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

November 7, 2008

Last Update Submit

March 20, 2013

Conditions

Osteoporosis

Keywords

OsteoporosisBMDBisphosphonatesEducational materialsPatient Stories

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density (BMD) testing

    12 months

Secondary Outcomes (2)

  • Osteoporosis prescription medications

    12 months

  • Patient-Physician communication regarding osteoporosis treatment and testing

    12 months

Study Arms (3)

educational materials

EXPERIMENTAL

Patient educational DVD and brochure

Behavioral: Patient educational DVD and brochure

physician education

OTHER

Physician web modules

Behavioral: Physician web modules

System intervention

EXPERIMENTAL

Self-referral letter with toll-free number provided

Behavioral: System

Interventions

Patient educational DVD and brochureBEHAVIORAL

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".

educational materials
Physician web modulesBEHAVIORAL

Web based osteoporosis continuing medical education (CME) materials

physician education
SystemBEHAVIORAL

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

System intervention

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • female
  • age 65 or older

You may not qualify if:

  • prior osteoporosis testing (BMD)
  • prior osteoporosis treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente Southeast

Atlanta, Georgia, 30305, United States

Location

Kasier Permanente Northwest

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Kenneth G Saag, MD, MSc

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 11, 2008

Study Start

May 1, 2010

Primary Completion

December 1, 2011

Study Completion

October 1, 2012

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(2)