Bone Diseases, Metabolic, Osteoporosis
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Guideline Concordant Osteoporosis Therapy | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 7,749 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 26 | 18 |
| Overall Study | Lost to Follow-up | 498 | 523 |
| Overall Study | Proxy interview done | 2 | 3 |
| Overall Study | Withdrawal by Subject | 290 | 287 |
Baseline characteristics
| Characteristic | BMD Result Letter and Brochure | Total | Control |
|---|---|---|---|
| Age, Continuous | 66.5 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 Participants | 151 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3824 Participants | 7598 Participants | 3774 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 37 Participants | 80 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 842 Participants | 1656 Participants | 814 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants | 70 Participants | 36 Participants |
| Race (NIH/OMB) White | 2981 Participants | 5935 Participants | 2954 Participants |
| Region of Enrollment United States | 3898 participants | 7749 participants | 3851 participants |
| Sex: Female, Male Female | 3259 Participants | 6489 Participants | 3230 Participants |
| Sex: Female, Male Male | 639 Participants | 1260 Participants | 621 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 26 / 3,898 | 18 / 3,851 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMD Result Letter and Brochure | Guideline Concordant Osteoporosis Therapy | 2537 Participants |
| Control | Guideline Concordant Osteoporosis Therapy | 2477 Participants |