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NCT03818659: BP MAP

Improving BP Control in Diverse Populations Using BP MAP

Completed NA Results posted Last updated 3 March 2025
What this trial tests

NA trial testing Self-Guided M.A.P. BP Improvement Program in Hypertension in 1,238,835 participants. Completed in 30 June 2021.

Timeline
1 July 2019
Primary endpoint
28 February 2021
30 June 2021

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1,238,835
Start date1 July 2019
Primary completion28 February 2021
Estimated completion30 June 2021
Sites24 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 85, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Blood Pressure Control, % of Patients Primary · baseline and 6 months

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.

GroupValue95% CI
Full Support2.8-0.9 – 6.5
Self-Guided1.6-0.8 – 4.0
Usual Care-0.4-1.0 – 0.2
Change in Improvement in Blood Pressure, % of Patients Secondary · baseline and 12 months

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.

GroupValue95% CI
Full Support-3.4-10.3 – 3.5
Self-Guided-5.4-8.2 – -2.5
Usual Care-3.1-4.1 – -2.1
Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits Secondary · baseline and 6 months

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).

GroupValue95% CI
Full Support19.86.9 – 32.7
Self-Guided11.62.1 – 21.1
Usual Care0.1-0.0 – 0.2
Change in Medication Intensification, % of Visits Secondary · baseline and 6 months

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.

GroupValue95% CI
Full Support-1.6-6.1 – 3.0
Self-Guided-3.4-8.2 – 1.2
Usual Care-0.1-0.3 – 0.1
Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg Secondary · baseline and 6 months

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.

GroupValue95% CI
Full Support2.30.9 – 3.7
Self-Guided-1.6-5.6 – 2.4
Usual Care-1.1-1.5 – -0.8
Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits Secondary · baseline and 6 months

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

GroupValue95% CI
Full Support-0.8-3.2 – 1.7
Self-Guided-2.0-4.3 – 0.2
Usual Care-0.6-1.0 – -0.2
Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients Secondary · baseline and 6 months

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.

GroupValue95% CI
Full Support1.6-1.4 – 4.7
Self-Guided-0.1-1.8 – 1.7
Usual Care-0.7-0.8 – -0.6
Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients Secondary · baseline and 6 months

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.

GroupValue95% CI
Full Support-0.9-1.8 – 0.1
Self-Guided-0.1-1.5 – 1.2
Usual Care0.0-0.3 – 0.3
Change in Terminal Digit = Zero, % of Measurements Secondary · baseline and 6 months

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 woul

GroupValue95% CI
Full Support0.8-1.5 – 3.1
Self-Guided0.9-1.1 – 2.8
Usual Care-0.6-1.0 – -0.3
Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients Secondary · baseline and 6 months

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.

GroupValue95% CI
Full Support-1.5-2.6 – -0.3
Self-Guided-1.1-2.2 – 0.1
Usual Care-0.5-0.7 – -0.2

Sponsor's own description

BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Improvement in Blood Pressure Control in Safety Net Clinics Receiving 2 Versions of a Scalable Quality Improvement Intervention: BP MAP A Pragmatic Cluster Randomized Trial.
    Fontil V, Modrow MF, Cooper-DeHoff RM, Wozniak G, et al · · 2023 · cited 5× · PMID 36695297 · DOI 10.1161/jaha.121.024975

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Other recruiting trials for Hypertension

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03818659.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing