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Improving Quality of Osteoporosis Care Through Patient Storytelling

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT01112098
Collaborator
Procter and Gamble (Industry)
2,997
Enrollment
1
Location
1
Arm
33
Duration (Months)
90.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient Pamphlet
 N/A

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 Design

Study Type:
Interventional
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 :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. DXA scheduled [6 months]

      Patient scheduled a DXA within 6 months of receiving intervention materials

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • Procter and Gamble

    Investigators

    • Principal Investigator: Jeffrey R Curtis, MD, MPH, MS, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01112098
    Other Study ID Numbers:
    • X070502003
    First Posted:
    Apr 28, 2010
    Last Update Posted:
    May 10, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Osteoporosis

    Study Results

    No Results Posted as of May 10, 2011