Patient Activation After DXA Result Notification (PAADRN)

November 6, 2020 updated by: Fredric D Wolinsky
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

7749

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1A1
        • University of Toronto
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Georgia
      • Atlanta, Georgia, United States, 30305
        • Kaiser Permanente Georgia
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMD Result Letter and Brochure
Patients who receive the intervention - BMD result letter with brochure.
Behavioral: 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.
No Intervention: Control
Those who received usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guideline Concordant Osteoporosis Therapy
Time Frame: 12 weeks after DXA
Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine ≤-2.5 or FRAX ≥20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between -1.0 and -2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture ≥20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between -1 and -2.5) and FRAX <20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis.
12 weeks after DXA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fredric D Wolinsky

Collaborators

University of Alabama at Birmingham
University of Pittsburgh
University of Toronto
Kaiser Permanente

Investigators

  • Principal Investigator: Fredric Wolinsky, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201107758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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