Clinical trial NCT04079868: Models of Primary Osteoporosis Screening in Male Veterans
Official title: Models of Primary Osteoporosis Screening in Male Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Osteopenia
Osteoporotic Fracture
Keywords: Osteoporosis
Osteopenia
Osteoporotic fracture
Age-Related Osteoporosis
Bone Loss, Age-Related
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-09-06
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Screening Rates (%)
timeFrame: Datapull at year 2
measure: Medication Discontinuation (days)
timeFrame: Year 2
measure: Medication Initiation (%)
timeFrame: Intervention period year 2
measure: Medication Implementation (% of days covered with medication)
timeFrame: Year 2
measure: Bone Mineral Density (gram/sq centimeter)
timeFrame: Year 5
measure: Harms (%)
timeFrame: Year 3
measure: PACT Provider Time
timeFrame: Year 2
Secondary outcomes:
measure: Fractures (% with fracture in last 2 years)
timeFrame: Year 4
measure: DXA volume (DEXA rate per year)
timeFrame: Year 2
measure: Bone Disease Clinic Volume (Consults per year)
timeFrame: Year 2
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Cathleen S Colon-Emeric, MD
role: PRINCIPAL_INVESTIGATOR
References: