Improving Quality of Osteoporosis Care Through Patient Storytelling

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01112098
First received: April 26, 2010
Last updated: May 6, 2011
Last verified: May 2011
  Purpose

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 Intervention
Osteoporosis
Behavioral: Patient Pamphlet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Randomized Trial of a Mailed Intervention and Self-Scheduling to Improve Osteoporosis Screening in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • DXA scheduled [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient scheduled a DXA within 6 months of receiving intervention materials


Enrollment: 2997
Study Start Date: July 2008
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112098

Locations
United States, Alabama
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
  More Information

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey R. Curtis, MD MPH, UAB
ClinicalTrials.gov Identifier: NCT01112098     History of Changes
Other Study ID Numbers: X070502003
Study First Received: April 26, 2010
Last Updated: May 6, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014