Improving Quality of Osteoporosis Care Through Patient Storytelling
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Pamphlet
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Female
- Age 65 or older
- At least one visit with a primary care physician in the previous 12 months
Exclusion Criteria:
- DXA scan in the previous 5 years
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Educational Pamphlet and letter
Arm Description
Letter invites patient to self-schedule a DXA; educational pamphlet includes information about DXA scans
Outcomes
Primary Outcome Measures
DXA scheduled
Patient scheduled a DXA within 6 months of receiving intervention materials
Secondary Outcome Measures
Full Information
NCT ID
NCT01112098
First Posted
April 26, 2010
Last Updated
May 6, 2011
Sponsor
University of Alabama at Birmingham
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT01112098
Brief Title
Improving Quality of Osteoporosis Care Through Patient Storytelling
Official Title
Randomized Trial of a Mailed Intervention and Self-Scheduling to Improve Osteoporosis Screening in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Procter and Gamble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient intervention materials (i.e., a personalized letter and osteoporosis information pamphlet) designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve osteoporosis quality of care.
Detailed Description
While the occurrence of a fragility fracture (e.g. hip fracture) is indicative of low BMD and a clinical diagnosis of osteoporosis made, osteoporosis can be identified in asymptomatic patients using dual energy x-ray absorptiometry (DXA). United States (U.S.) guidelines recommend screening bone density tests using central DXA in all women 65 years or older. However, fewer than one-third of eligible U.S. women age 65 and older undergo DXA testing. The main barrier to achieving greater rates of osteoporosis screening is identifying a systematic, effective, and generalizable way for healthcare providers and patients to schedule DXA results.
Given that national guidelines recommend DXA screening for all older women, the reasons a majority of women do not receive DXA testing are likely multifactorial. Patients and their health care providers may be unaware of preventative screening recommendations and the reasons for these recommendations. Screening tests that are required relatively infrequently (i.e. less than once a year) may be difficult for patients and physicians to remember if there are few triggers (e.g. seasonality as a trigger to motivate influenza vaccination). Additionally, primary care providers (PCPs) are responsible for managing a large number of comorbidities and acute care needs and may be unable to stay current with all preventative care needs during increasingly short clinic visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2997 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Pamphlet and letter
Arm Type
Experimental
Arm Description
Letter invites patient to self-schedule a DXA; educational pamphlet includes information about DXA scans
Intervention Type
Behavioral
Intervention Name(s)
Patient Pamphlet
Other Intervention Name(s)
Educational Materials, Written Materials, Mailed Letter
Intervention Description
letter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan
Primary Outcome Measure Information:
Title
DXA scheduled
Description
Patient scheduled a DXA within 6 months of receiving intervention materials
Time Frame
6 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
At least one visit with a primary care physician in the previous 12 months
Exclusion Criteria:
DXA scan in the previous 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey R Curtis, MD, MPH, MS
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22836812
Citation
Warriner AH, Outman RC, Kitchin E, Chen L, Morgan S, Saag KG, Curtis JR. A randomized trial of a mailed intervention and self-scheduling to improve osteoporosis screening in postmenopausal women. J Bone Miner Res. 2012 Dec;27(12):2603-10. doi: 10.1002/jbmr.1720.
Results Reference
derived
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Improving Quality of Osteoporosis Care Through Patient Storytelling
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