Patient Activation After DXA Result Notification

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7749 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-11-30

Brief Summary

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There is growing evidence that patients undergoing bone mineral density testing (BMD) often do not take important steps to improve their bone health. The investigators will conduct a randomized-controlled trial to evaluate the impact of a novel and practical patient activation intervention (mailing patients their bone density test results) on the quality of bone-related healthcare and the cost-effectiveness of BMD testing. Equally important, the investigators intervention could easily be modified to include other patient populations and chronic diseases.

Detailed Description

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Bone mineral density (BMD) peaks in early adulthood and declines progressively with aging. As BMD declines from normal, to low (formerly called osteopenia), to osteoporosis, risk of fractures progressively increases. In an effort to prevent bone loss and reduce fracture risk, most widely accepted guidelines including the U.S. Preventive Services Task Force and Surgeon General's Office now recommend BMD screening of older adults using dual energy x-ray absorptiometry (DXA). The rationale for screening is that patients and their providers will use DXA results as a "cue to action" and take necessary steps to enhance bone health through lifestyle modification (e.g., weight bearing exercise), Calcium/Vitamin D supplementation, and pharmacotherapy when indicated. However, multiple studies have demonstrated that patients and providers often fail take recommended actions following DXA testing, thus defeating much of the purpose of screening. Over the past five years we have systematically developed and pilot tested a low-cost and practical patient activation intervention based upon the Health Belief Model. The intervention consists of the DXA scanning center mailing each patient a customized letter containing the results of their DXA scan plus educational information about osteoporosis, supplemented by a follow-up phone call from a nurse educator. Preliminary studies have demonstrated that the intervention is well received by both patients and providers and enhances bone-related quality of care. The overarching objective of the current proposal is to rigorously examine the impact of our patient activation intervention on bone-related quality of care in adults undergoing screening DXA scans through a randomized-controlled trial conducted at three study sites. In addition, we will examine the real-world costs associated with our intervention and the impact of our intervention on the overall cost-effectiveness of BMD screening. We hypothesize that the activation intervention will increase optimization of Calcium/Vitamin D intake, enhance use of pharmacotherapy when indicated, will improve patient satisfaction with their bone-related healthcare, and improve patients' osteoporosis specific knowledge when compared with usual care

Conditions

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Osteoporosis Bone Diseases, Metabolic

Keywords

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Bone Density Absorptiometry, Photon Osteoporosis Bone, Diseases, Metabolic Patient Education as Topic Fractures, Bone/Prevention and Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BMD Result Letter and Brochure

Patients who receive the intervention - BMD result letter with brochure.

Group Type EXPERIMENTAL

Bone Mineral Density Result Letter and Bone Health Brochure

Intervention Type BEHAVIORAL

Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Control

Those who received usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bone Mineral Density Result Letter and Bone Health Brochure

Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. patients presenting for DXA
2. age 50 years of age or older

Exclusion Criteria

1. non-English speakers
2. prisoners
3. people who have mental disabilities
4. individuals younger than age 50 years
5. individuals who do not have access to a telephone
6. deaf patients

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Fredric D Wolinsky

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fredric Wolinsky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

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201107758

Identifier Type: -

Identifier Source: org_study_id

Patient Activation After DXA Result Notification

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

BMD Result Letter and Brochure

Bone Mineral Density Result Letter and Bone Health Brochure

Control

Interventions

Bone Mineral Density Result Letter and Bone Health Brochure

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University of Alabama at Birmingham

Kaiser Permanente

University of Toronto

University of Pittsburgh

Fredric D Wolinsky

Responsible Party

Fredric D Wolinsky

Principal Investigators

Fredric Wolinsky, PhD

Locations

University of Alabama at Birmingham

Kaiser Permanente Georgia

University of Iowa

University of Toronto

Countries

References

Edmonds SW, Solimeo SL, Lu X, Roblin DW, Saag KG, Cram P. Developing a bone mineral density test result letter to send to patients: a mixed-methods study. Patient Prefer Adherence. 2014 Jun 5;8:827-41. doi: 10.2147/PPA.S60106. eCollection 2014.

Edmonds SW, Cram P, Lu X, Roblin DW, Wright NC, Saag KG, Solimeo SL; PAADRN Investigators. Improving bone mineral density reporting to patients with an illustration of personal fracture risk. BMC Med Inform Decis Mak. 2014 Nov 25;14:101. doi: 10.1186/s12911-014-0101-y.

Edmonds SW, Solimeo SL, Nguyen VT, Wright NC, Roblin DW, Saag KG, Cram P. Understanding Preferences for Osteoporosis Information to Develop an Osteoporosis Patient Education Brochure. Perm J. 2017;21:16-024. doi: 10.7812/TPP/16-024. Epub 2016 Nov 18.

Roblin DW, Cram P, Lou Y, Edmonds SW, Hall SF, Jones MP, Saag KG, Wright NC, Cromwell LF, Robinson BE, Wolinsky FD; PAADRN Investigators. The Contribution of Patient, Primary Care Physician, and Primary Care Clinic Factors to Good Bone Health Care. Perm J. 2021 Jan;25:1-3. doi: 10.7812/TPP/20.095.

Solimeo SL, Nguyen VT, Edmonds SW, Lou Y, Roblin DW, Saag KG, Cram P, Wolinsky FD. Sex differences in osteoporosis self-efficacy among community-residing older adults presenting for DXA. Osteoporos Int. 2019 May;30(5):1033-1041. doi: 10.1007/s00198-019-04854-6. Epub 2019 Jan 30.

Hall SF, Wright NC, Wolinsky FD, Lou Y, Edmonds S, Roblin D, Jones M, Saag K, Cram P. The prevalence of overtreatment of osteoporosis: results from the PAADRN trial. Arch Osteoporos. 2018 Sep 28;13(1):103. doi: 10.1007/s11657-018-0517-6.

Other Identifiers

201107758