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Patient Activation After DXA Result Notification

Patient Activation After DXA Result Notification

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01507662
Acronym
PAADRN
Enrollment
7749
Registered
2012-01-11
Start date
2012-02-29
Completion date
2015-11-30
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, Metabolic, Osteoporosis

Keywords

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

Brief summary

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

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

Interventions

BEHAVIORALBone 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.

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
Kaiser Permanente
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
Fredric D Wolinsky
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Guideline Concordant Osteoporosis Therapy12 weeks after DXAGuideline 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.

Countries

Canada, United States

Participant flow

Recruitment details

Patients presenting for DXA centers were recruited through February 2012 to August 2014 at three health centers-the University of Iowa (UI), the University of Alabama at Birmingham (UAB), and Kaiser Permanente of Georgia (KPGA).

Participants by arm

ArmCount
BMD Result Letter and Brochure
Patients who receive the intervention - BMD result letter with brochure 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.
3,898
Control
Usual care
3,851
Total7,749

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath2618
Overall StudyLost to Follow-up498523
Overall StudyProxy interview done23
Overall StudyWithdrawal by Subject290287

Baseline characteristics

CharacteristicBMD Result Letter and BrochureTotalControl
Age, Continuous66.5 years
STANDARD_DEVIATION 8.4
66.6 years
STANDARD_DEVIATION 8.3
66.7 years
STANDARD_DEVIATION 8.2
Ethnicity (NIH/OMB)
Hispanic or Latino
74 Participants151 Participants77 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3824 Participants7598 Participants3774 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants7 Participants3 Participants
Race (NIH/OMB)
Asian
37 Participants80 Participants43 Participants
Race (NIH/OMB)
Black or African American
842 Participants1656 Participants814 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
34 Participants70 Participants36 Participants
Race (NIH/OMB)
White
2981 Participants5935 Participants2954 Participants
Region of Enrollment
United States
3898 participants7749 participants3851 participants
Sex: Female, Male
Female
3259 Participants6489 Participants3230 Participants
Sex: Female, Male
Male
639 Participants1260 Participants621 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
26 / 3,89818 / 3,851
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Guideline Concordant Osteoporosis Therapy

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.

Time frame: 12 weeks after DXA

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BMD Result Letter and BrochureGuideline Concordant Osteoporosis Therapy2537 Participants
ControlGuideline Concordant Osteoporosis Therapy2477 Participants

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026