Clinical trial NCT01112098: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2010-04-28
Enrollment: 2997
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: DXA scheduled
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jeffrey R Curtis, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.