Table 3.
Study outcome measures and the pre-specified clinically important difference.
| Outcome | Definition/Measure | Data Source/Timing | Important Difference |
|---|---|---|---|
| Patient (Panel) Level (Aim 1) | |||
| Screening Rates | Proportion of eligible men screened in last 12 months | EHR data warehouse at baseline, year 1 and year 2 | 25% increase from 6% Usual Care |
| Medication Initiation | Proportion of screened men meeting treatment threshold who receive at least 1 prescription | EHR, intervention period year 1 and year 2, non-VA medication lists by chart abstraction. | 30% increase from 55% Usual Care |
| Medication Implementation | Days of medication dispensed divided by follow-up days | Pharmacy dispensing records, for patients started within prior year at baseline, year 1 and 2. Non-VA medication lists by chart abstraction. | 20% increase in MPR≥80%40 from 30% Usual Care |
| Medication Discontinuation | Time between first prescription dispensing date and the date of first medication possession gap of ≥3 months | 20% difference | |
| Harms | Proportion of men started on oral medication for new GI distress in 3 months Subtrochanteric fractures or Osteonecrosis of the jaw | ICD10 codes, new prescription for proton pump inhibitor or H2 blocker | 15% increase from 30% Usual Care >expected 1/50,000 patient years treatment |
| Fractures (exploratory) | All clinical fractures excluding facial, digital | EHR, confirmed by chart abstraction | 10% decrease from 2.5/100 person years Usual Care |
| Provider/Facility Level (Aim 2) | |||
| DXA volume | DXA orders/ 1000 patients/year, by intervention group | EHR, year 2 | |
| Bone Disease clinic volume | Consults/ 1000 patients/year, by intervention group | EHR, year 2 | |
| Primary care team satisfaction, time | Nominal Group Technique at Routine Staff meeting | Measured at 2 years | |
| Health System/Policy Level (Aim 3) | |||
| Program Cost Effectiveness | Cost/quality adjusted life years (QALY) of the screening models compared to usual care | Markov model with above outcomes, fracture rates, cost and quality of life from VA and medical literature | Probability of cost/QALY >80% at thresholds of $50,000, $100,000, $200,00041 |
EHR = Electronic Health Record; MPR = Medication Possession Ratio