Models of Primary Osteoporosis Screening in Male Veterans

Osteoporosis Clinical Trial

— MOPS  

Official title:

Models of Primary Osteoporosis Screening in Male Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04079868
• Other study ID #: IIR 17-202
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Cathleen S Colon-Emeric, MD
• Phone: (919) 286-0411
• Email: Cathleen.Colon-Emeric[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis
• Osteoporotic Fracture
• Osteoporotic Fractures

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening Rates (%)	Proportion of men eligible men screened in last 12 months. Numerator is men receiving screening DXA, denominator is all patients meeting current osteoporosis screening criteria in the randomized PACT team	Datapull at year 2
Primary	Medication Discontinuation (days)	Obtained from pharmacy dispensing records, the mean number of days until a gap in medication prescription of >=90 days among men prescribed osteoporosis medication	Year 2
Primary	Medication Initiation (%)	Obtained from pharmacy dispensing records, numerator is number of patients prescribed osteoporosis medications, denominator is number of patients eligible for osteoporosis medications within each of the 39 randomized PACT teams	Intervention period year 2
Primary	Medication Implementation (% of days covered with medication)	Obtained from pharmacy dispensing records, for patients started on osteoporosis medications within prior year within the 39 PACT teams. Numerator is days covered by dispensed tablets, denominator is total number of days since the first medication prescription, censoring for death.	Year 2
Primary	Bone Mineral Density (gram/sq centimeter)	Chart abstraction of completed DXA of a random sample of n=900 patients within the 39 enrolled PACT teams	Year 5
Primary	Harms (%)	Data pull of ICD10 codes, numerator is number of men with new prescription for proton pump inhibitor or H2 blocker, denominator is all men eligible for osteoporosis screening within each of the 39 PACT teams.	Year 3
Primary	PACT Provider Time	Collected during nominal group qualitative interview	Year 2
Secondary	Fractures (% with fracture in last 2 years)	Data pull, confirmed by chart abstraction for all patients within the 39 PACTs. Numerator is number of men with fracture in last 2 years, denominator is all men eligible for osteoporosis screening within each of the 39 PACT teams.	Year 4
Secondary	DXA volume (DEXA rate per year)	Data collected at the facility level measuring change in DXA referrals	Year 2
Secondary	Bone Disease Clinic Volume (Consults per year)	Data collected at the facility level measuring change in bone clinic referral.	Year 2