Osteopenia, Osteoporosis, Osteoporotic Fracture
Conditions
Keywords
Osteoporosis, Osteopenia, Osteoporotic fracture, Age-Related Osteoporosis, Bone Loss, Age-Related
Brief summary
Models of Osteoporosis Screening in Male Veterans aims to test 1 distinct care model of primary osteoporosis screening in men within the VA healthcare setting. All care models deliver VA recommended osteoporosis screening and treatment to high-risk Veterans by appropriate Durham VA clinical staff. The MOPS project will evaluate patient, provider and facility outcomes to determine the effectiveness of each intervention.
Detailed description
Background/Purpose: Osteoporosis is under-recognized in older men. At age 50 years, 1 in 5 men can expect to suffer a major osteoporotic fracture in their remaining lifetime, comparable to the risk of prostate cancer. Men are more than twice as likely as women to experience complications after a fracture, and have greater excess mortality after hip fracture. Because risk factors are common in Veterans, osteoporosis is particularly prevalent in the Veterans Health Administration (VA) system. More than half of male Veterans over age 50 years have osteopenia or osteoporosis, a rate nearly double the non-Veteran population. Fractures resulting from osteoporosis have negative consequences on functional status, mortality, and quality of life, with high rates of pain, depression, and loss of independence. After a hip fracture, nearly 75% of patients spend time in a nursing facility, and only 20% regain their prior level of ambulation. Many fractures are associated with substantial excess mortality; men with a hip fracture have excess annual mortality of 20% that persists up to 10 years. Osteoporotic fractures also have an important economic impact. It is estimated that hip fractures result in 43 million dollars of excess cost to the VHA annually. Osteoporosis screening and treatment services within VA are ineffective overall. Overall, screening rates were 8% for men over age 65; far lower than expected based on the prevalence of osteoporosis risk factors in the population. Moreover, even among men in whom screening was completed, it was not associated with lower overall fracture rates because osteoporosis treatment and adherence following screening were extremely low. Attempts to improve osteoporosis screening using traditional quality improvement programs have been minimally effective. Electronic health record (EHR) alerts alone do not improve osteoporosis screening rates and do nothing to address adherence. However, one distinct osteoporosis screening paradigm has been suggested, and form the scientific premise for the models proposed in this application. A fracture Liaison Service (referred to here as Bone Health Service, BHS) represents a centralized model that has been successful in improving secondary osteoporosis screening and treatment adherence after a fracture has already occurred. In this model, a team of nurses led by a bone specialist identify patients with fracture within the entire health system, and arrange for evaluation and treatment. Such models have reduced 2-year fracture rates by 56% and are cost saving or highly cost-effective. Objectives: The investigators propose a pragmatic group randomized trial of PACT teams from both Durham and Richmond VAMC's. A PACT's will be randomized into 2 groups: a control group (no additional support), and a centralized Bone Health Service (BHS) model where teams will manage the screening and treatment of high-risk for fracture male Veterans. Outcomes for all patients eligible for osteoporosis screening within the randomized PACTs will be assessed by investigators masked to group assignment. Outcomes for PACT providers will be assessed using qualitative methods (nominal group technique). Patient-level outcomes: * Eligible proportion screened * Medication adherence * PACT fracture rates * Harms * Bone mineral density Provider and facility level outcomes: * Change in Dual-energy X-ray absorptiometry (DXA) volume * Bone mineral density (sub-sample of patients) * Change in metabolic bone disease clinic volume * PACT provider time and satisfaction (qualitative analyses) Health system and policy level outcomes * Program cost effectiveness Methodology: The investigators will compare the 1 screening models by enrolling, screening and randomizing PACT teams. 39 teams will be randomized, an estimated 24 teams at the Durham VA health care system and 15 at the Richmond VA medical center. Teams will be randomized to 1 of 2 arms: Bone Health Service or usual care (no additional support). A sub-set of providers will be recruited to complete a nominal group qualitative interview during year 3. Also a random sub-set of patients (900) will be recruited to complete a DXA scan to measure bone density beginning in year 4. Outcomes will be assessed at year 1, 2, 3, and 4.
Interventions
BEHAVIORALBone Health Service Model
Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be masked to the group assignment
Intervention model description
Stratified, block randomization will be used. A statistician unaware of team identity will randomize PACTs in blocks of 2 within strata to ensure similar distributions. If insufficient numbers of PACTs are recruited within small CBOCs, they will be combined with other similar CBOCs (rural vs. urban) for randomization.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
PACT Team inclusion criteria: * Provider with at least 0.75 FTE * Provider has completed training (i.e., PACT teams led by residents and fellows are excluded) * Care for male Veterans \>65 years (i.e., Women's Health PACTs are excluded) Patient Inclusion criteria: * No prior fracture or osteoporosis diagnosis * At least 1 VA Undersecretary Guideline risk factor (weight loss \>20% in 5 years; BMI \<25 kg/m2; diabetes; pernicious anemia; gastrectomy; anticonvulsants; glucocorticoids; androgen deprivation therapy; hyperthyroidism; hyperparathyroidism; rheumatoid arthritis; alcohol dependence; chronic lung disease; chronic liver disease; stroke; Parkinsonism; prostate cancer; and current smoking). Patients (enrolled in year 4/5 sub-sample) inclusion criteria: * Men aged 65-85 years * Enrolled in eligible PACT team for at least 2 years * Meet 1 or more criteria for osteoporosis screening as the protocol at PACT enrollment.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Screened for Osteoporosis | through study completion, an average of 1.5 years | Proportion of men who received DXA screening for for osteoporosis. Numerator is the number of men with a completed screening DXA, denominator is all patients meeting current osteoporosis screening criteria |
| Bone Mineral Density T-score at the Femoral Neck | 2 years after the primary care team's start date | Bone mineral density in gm/cm2 as measured by DXA, converted to T-score by the densitometer manufacturer. The T score reflects the number of standard deviations away from the mean bone density of young healthy women as defined in the National Health and Nutrition Survey. Lower T-scores reflect worse bone density, and T-scores \<= -1 are consistent with osteopenia or osteoporosis. This outcome was measured in a random subset of enrolled patients (target n=25 per primary care team), regardless of whether or not they had undergone osteoporosis screening during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Initiating Osteoporosis Medication (%) | through study completion, an average of 1.5 years | Numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications based on their DXA results |
| Gastrointestinal Medication Prescriptions | through study completion, an average of 1.5 years | This is a measure of potential harm from osteoporosis treatment. Numerator is number of men with new prescription for proton pump inhibitor or H2 blocker, denominator is all men eligible for osteoporosis screening |
| Proportion With Fractures | through study completion, an average of 1.5 years | Numerator is number of men with a confirmed fracture during study follow-up, denominator is all men eligible for osteoporosis screening at baseline |
| Osteoporosis Medication Persistence (Days) | through study completion, up to 2 years | Among participants who were prescribed an osteoporosis medication, the mean number of days between the first dispensing date until a gap in medication prescription of \>=90 days occurred |
| Osteoporosis Medication Adherence (Proportion of Days Covered) | through study completion, an average of 1.5 years | For patients started on osteoporosis medications, numerator is the total number of dispensed units, denominator is the number of days between the first medication prescription and medication discontinuation, death, or end of the study period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bone Health Service Arm Interventional arm
Bone Health Service Model: Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team. | 1,688 |
| Usual Care (Control) Arm This arm represents a no practice management support control group. | 1,424 |
| Total | 3,112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 100 | 200 |
| Overall Study | Physician Decision | 100 | 0 |
Baseline characteristics
| Characteristic | Usual Care (Control) Arm | Total | Bone Health Service Arm |
|---|---|---|---|
| Age, Continuous | 73.8 years STANDARD_DEVIATION 5.4 | 73.4 years STANDARD_DEVIATION 5.2 | 73.0 years STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 565 Participants | 1260 Participants | 695 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 41 Participants | 104 Participants | 63 Participants |
| Race (NIH/OMB) White | 818 Participants | 1748 Participants | 930 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1424 Participants | 3112 Participants | 1688 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 135 / 1,688 | 89 / 1,424 |
| other Total, other adverse events | 1 / 1,688 | 0 / 1,424 |
| serious Total, serious adverse events | 0 / 1,688 | 0 / 1,424 |
Outcome results
Primary
Bone Mineral Density T-score at the Femoral Neck
Bone mineral density in gm/cm2 as measured by DXA, converted to T-score by the densitometer manufacturer. The T score reflects the number of standard deviations away from the mean bone density of young healthy women as defined in the National Health and Nutrition Survey. Lower T-scores reflect worse bone density, and T-scores \<= -1 are consistent with osteopenia or osteoporosis. This outcome was measured in a random subset of enrolled patients (target n=25 per primary care team), regardless of whether or not they had undergone osteoporosis screening during the study period.
Time frame: 2 years after the primary care team's start date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Health Service Arm | Bone Mineral Density T-score at the Femoral Neck | -0.55 T score femoral neck | Standard Deviation 1.28 |
| Usual Care (Control) Arm | Bone Mineral Density T-score at the Femoral Neck | -0.70 T score femoral neck | Standard Deviation 1.25 |
Primary
Proportion of Participants Screened for Osteoporosis
Proportion of men who received DXA screening for for osteoporosis. Numerator is the number of men with a completed screening DXA, denominator is all patients meeting current osteoporosis screening criteria
Time frame: through study completion, an average of 1.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bone Health Service Arm | Proportion of Participants Screened for Osteoporosis | 830 participants |
| Usual Care (Control) Arm | Proportion of Participants Screened for Osteoporosis | 33 participants |
Secondary
Gastrointestinal Medication Prescriptions
This is a measure of potential harm from osteoporosis treatment. Numerator is number of men with new prescription for proton pump inhibitor or H2 blocker, denominator is all men eligible for osteoporosis screening
Time frame: through study completion, an average of 1.5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Health Service Arm | Gastrointestinal Medication Prescriptions | 562 Participants |
| Usual Care (Control) Arm | Gastrointestinal Medication Prescriptions | 473 Participants |
Secondary
Osteoporosis Medication Adherence (Proportion of Days Covered)
For patients started on osteoporosis medications, numerator is the total number of dispensed units, denominator is the number of days between the first medication prescription and medication discontinuation, death, or end of the study period
Time frame: through study completion, an average of 1.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Health Service Arm | Osteoporosis Medication Adherence (Proportion of Days Covered) | 0.92 proportion of days covered by meds | Standard Deviation 0.24 |
| Usual Care (Control) Arm | Osteoporosis Medication Adherence (Proportion of Days Covered) | 1.0 proportion of days covered by meds | Standard Deviation 0.13 |
Secondary
Osteoporosis Medication Persistence (Days)
Among participants who were prescribed an osteoporosis medication, the mean number of days between the first dispensing date until a gap in medication prescription of \>=90 days occurred
Time frame: through study completion, up to 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Health Service Arm | Osteoporosis Medication Persistence (Days) | 657 days | Standard Deviation 366 |
| Usual Care (Control) Arm | Osteoporosis Medication Persistence (Days) | 730 days | Standard Deviation 480 |
Secondary
Proportion of Patients Initiating Osteoporosis Medication (%)
Numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications based on their DXA results
Time frame: through study completion, an average of 1.5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Health Service Arm | Proportion of Patients Initiating Osteoporosis Medication (%) | 113 Participants |
| Usual Care (Control) Arm | Proportion of Patients Initiating Osteoporosis Medication (%) | 4 Participants |
Secondary
Proportion With Fractures
Numerator is number of men with a confirmed fracture during study follow-up, denominator is all men eligible for osteoporosis screening at baseline
Time frame: through study completion, an average of 1.5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bone Health Service Arm | Proportion With Fractures | 31 Participants |
| Usual Care (Control) Arm | Proportion With Fractures | 29 Participants |