Improving Quality of Osteoporosis Care Through Patient Storytelling

NCT ID: NCT01112098

Last Updated: 2011-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2997 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-04-30

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Educational Pamphlet and letter

Letter invites patient to self-schedule a DXA; educational pamphlet includes information about DXA scans

Group Type: EXPERIMENTAL

Patient Pamphlet

Intervention Type: BEHAVIORAL

letter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan

Interventions

Patient Pamphlet

letter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan

Intervention Type: BEHAVIORAL

Other Intervention Names

Educational Materials; Written Materials; Mailed Letter

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

UAB

Principal Investigators

Jeffrey R Curtis, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22836812 (View on PubMed)

Other Identifiers

X070502003

Identifier Type: -

Identifier Source: org_study_id