Improving Quality of Osteoporosis Care Through Patient Storytelling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112098
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : May 10, 2011
Procter and Gamble
Information provided by:
University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Behavioral: Patient Pamphlet Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2997 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Randomized Trial of a Mailed Intervention and Self-Scheduling to Improve Osteoporosis Screening in Postmenopausal Women
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Educational Pamphlet and letter
Letter invites patient to self-schedule a DXA; educational pamphlet includes information about DXA scans
Behavioral: Patient Pamphlet
letter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan
Other Names:
  • Educational Materials
  • Written Materials
  • Mailed Letter

Primary Outcome Measures :
  1. DXA scheduled [ Time Frame: 6 months ]
    Patient scheduled a DXA within 6 months of receiving intervention materials

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112098

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Procter and Gamble
Principal Investigator: Jeffrey R Curtis, MD, MPH, MS University of Alabama at Birmingham

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeffrey R. Curtis, MD MPH, UAB Identifier: NCT01112098     History of Changes
Other Study ID Numbers: X070502003
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases