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Models of Primary Osteoporosis Screening in Male Veterans (MOPS)

Primary Purpose

Osteoporosis, Osteopenia, Osteoporotic Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bone Health Service Model
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Osteoporosis focused on measuring Osteoporosis, Osteopenia, Osteoporotic fracture, Age-Related Osteoporosis, Bone Loss, Age-Related

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham VA Medical Center, Durham, NCRecruiting
  • VA Salt Lake City Health Care System, Salt Lake City, UT
  • Hunter Holmes McGuire VA Medical Center, Richmond, VARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bone Health Service arm

Usual care (control) arm

Arm Description

Interventional arm

This arm represents a "no practice management support" control group.

Outcomes

Primary Outcome Measures

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
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
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
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.
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
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.
PACT Provider Time
Collected during nominal group qualitative interview

Secondary Outcome Measures

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.
DXA volume (DEXA rate per year)
Data collected at the facility level measuring change in DXA referrals
Bone Disease Clinic Volume (Consults per year)
Data collected at the facility level measuring change in bone clinic referral.

Full Information

First Posted
August 28, 2019
Last Updated
June 14, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04079868
Brief Title
Models of Primary Osteoporosis Screening in Male Veterans
Acronym
MOPS
Official Title
Models of Primary Osteoporosis Screening in Male Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia, Osteoporotic Fracture
Keywords
Osteoporosis, Osteopenia, Osteoporotic fracture, Age-Related Osteoporosis, Bone Loss, Age-Related

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be masked to the group assignment
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone Health Service arm
Arm Type
Experimental
Arm Description
Interventional arm
Arm Title
Usual care (control) arm
Arm Type
No Intervention
Arm Description
This arm represents a "no practice management support" control group.
Intervention Type
Behavioral
Intervention Name(s)
Bone Health Service Model
Intervention Description
Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.
Primary Outcome Measure Information:
Title
Screening Rates (%)
Description
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
Time Frame
Datapull at year 2
Title
Medication Discontinuation (days)
Description
Obtained from pharmacy dispensing records, the mean number of days until a gap in medication prescription of >=90 days among men prescribed osteoporosis medication
Time Frame
Year 2
Title
Medication Initiation (%)
Description
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
Time Frame
Intervention period year 2
Title
Medication Implementation (% of days covered with medication)
Description
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.
Time Frame
Year 2
Title
Bone Mineral Density (gram/sq centimeter)
Description
Chart abstraction of completed DXA of a random sample of n=900 patients within the 39 enrolled PACT teams
Time Frame
Year 5
Title
Harms (%)
Description
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.
Time Frame
Year 3
Title
PACT Provider Time
Description
Collected during nominal group qualitative interview
Time Frame
Year 2
Secondary Outcome Measure Information:
Title
Fractures (% with fracture in last 2 years)
Description
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.
Time Frame
Year 4
Title
DXA volume (DEXA rate per year)
Description
Data collected at the facility level measuring change in DXA referrals
Time Frame
Year 2
Title
Bone Disease Clinic Volume (Consults per year)
Description
Data collected at the facility level measuring change in bone clinic referral.
Time Frame
Year 2

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathleen S Colon-Emeric, MD
Phone
(919) 286-0411
Ext
176777
Email
Cathleen.Colon-Emeric@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Robert A Adler, MD
Phone
(804) 675-5424
Email
Robert.Adler@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathleen S Colon-Emeric, MD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathleen S Colon-Emeric, MD
Phone
919-286-0411
Ext
176777
Email
Cathleen.Colon-Emeric@va.gov
First Name & Middle Initial & Last Name & Degree
Robert A Adler, MD
Phone
(804) 675-5424
Email
Robert.Adler@va.gov
First Name & Middle Initial & Last Name & Degree
Carl Pieper, PhD
First Name & Middle Initial & Last Name & Degree
Cathleen S Colon-Emeric, MD
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148-0001
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert A Adler, MD
Phone
804-675-5424
Email
Robert.Adler@va.gov
First Name & Middle Initial & Last Name & Degree
Robert A Adler, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Models of Primary Osteoporosis Screening in Male Veterans

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