Trial Outcomes & Findings for Improving BP Control in Diverse Populations Using BP MAP (NCT NCT03818659)

The unit of randomization was the participating clinical unit.

24 clinic leaders agreed to participate in a BP control quality improvement program and 24 clinics were randomized and assigned to one of the intervention arms. We included 18 PCORnet clinics in our Blood Pressure Control Laboratory Surveillance Program (BP Track) for our control arms. No individuals were consented. This study was exempt from IRB review as a quality improvement program not human subjects research.

Unit of analysis: Number of clinic

Improving BP Control in Diverse Populations Using BP MAP

The primary outcome will be clinic-level change in the proportion of patients with controlled BP from baseline to 6 months after the start of the intervention. BP control will be defined according to NQF 0018 as the percent of eligible patients (defined below) with SBP \<140 mmHg and DBP \< 90 mmHg, based on measurements obtained at the most recent ambulatory clinical encounter at baseline (using the lowest measures of SBP and DBP at that encounter) and similarly at the 6-month time point after initiation of the intervention.

This overall measure of BP improvement implements CMS065v4\[ref\], which defines BP improvement as either a reduction of 10 mmHg in SBP or achievement of SBP that is "adequately controlled" (SBP \< 140 mmHg) in months 12 of the measurement period, among hypertensive patients not previously controlled.

This process measure is designed to capture the practice of repeating a blood pressure measurement in the same visit when the first measurement done in clinic is high (SBP≥140 mmHg or DBP≥90 mmHg).

This process measure captures the proportion of visits where BP is uncontrolled where a medication is ordered that is of a different class of medication than had previously been used. Note that this explicitly does not give credit for ordering a simple refill or medication dose increase, or use of a different medication in the same class.

This continuous metric describes the change in SBP (+/- standard deviation) observed between a visit with a medication intensification to the subsequent visit occurring at least 10 days later.

This process measure captures the proportion of persons who had uncontrolled HTN who made a subsequent visit within the following 4 weeks.

Use of fixed dose combination medications helps with adherence, promotes rational combinations of medications, and increases likelihood of achieving BP control. This metric, which is limited to patients taking more than one medication class, describes the prevalence of fixed dose combination pill use.

Use of calcium channel blockers (CCB) OR a thiazide or thiazide-like diuretic medication classes is recommended to treat black or African American patients as first line monotherapy due to increased efficacy. This metric, which is limited to African-American patients with a diagnosis of hypertension taking at least one medication class, describes the prevalence of those receiving the recommended drug class.

Inappropriate rounding of blood pressure measurements (usually to zero) leads to measurement error and worse treatment decisions. This continuous metric is calculated for a clinic as the percent of measurements at that clinic (for hypertensive patients) where the terminal digit of the measurement is zero. A percent greater than 10% (if an automated BP monitor is used) or greater than 20% (if a manual BP monitor is used with recommended rounding to even digits) indicates evidence of inappropriate rounding. Unlike most of our metrics, lower is better, down to an ideal value of 10-20%, which would be expected if no rounding were occurring. For this study we calculated the change in this continuous metric for each clinic from baseline to 6 months, and then described the mean change across clinics by group. As with our other outcomes, the unit of analysis in the study is a clinic.

This alternative overall measure of BP control is identical to Metric 1, except that attainment of BP Control is defined by SBP \< 130 mmHg and DBP \< 80 mmHg, as per the goal stated in the 2017 ACC/AHA Hypertension Guideline\[ref\]. Note that while the treatment threshold varies in the Guideline, depending on cardiovascular risk, the goal applies to all patients.