An interventional study of Self-Guided M.A.P. BP Improvement Program and Full Support M.A.P. BP Improvement Program in Hypertension, sponsored by University of California, San Francisco. Completed at 24 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet) that enables distributed querying of electronic health record data in a common data model. The primary outcome will be change in clinic-level blood pressure (BP) control at 6 months. Secondary outcomes will include other blood pressure (BP) control metrics, other time points (12 and 18 months), and process measures such as BP measurement accuracy, medication intensification, and average systolic blood pressure (SBP) reduction after a medication intensification, and repeat visit within 4 weeks after a visit with elevated BP. The investigators hypothesize clinics randomized to the Full Support version will achieve a larger increase from baseline in the proportion of their hypertensive patients with controlled BP at 6 months as compared to clinics randomized to the Self-Guided version, and also as compared with usual care. The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet. This study was submitted to the IRB at UCSF, determined to be quality improvement and exempt from further review.
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ACTIVE CLINICS
For inclusion as an Active Clinic in this study, clinics may participate must be able to identify:
Sites will be excluded if they:
USUAL CARE CLINICS:
Usual Care Clinics will include PCORnet Datamarts participating in BP TRACK, a concurrently-running BP Control Registry within PCORnet that will provide quarterly datamart-level estimates of BP control and other aggregate metrics relevant to BP control. All participating datamarts will be included, with the following exceptions:
PATIENTS
Within clinics (Active or Usual Care), patients will be eligible (and identified from the electronic health record) if they meet National Quality Forum BP Control Metric (NQF 0018) criteria:
Active Clinics randomized to the Self-Guided Arm will receive access to an AHA/AMA web platform that includes the posted M.A.P. materials and limited access to AMA Staff who are available to answer questions. The study team will facilitate access to staff by hosting a kick-off webinar for program participants that will include an orientation to the materials on the website, general advice and practical tips about what works for implementation, and time for answering questions and discussion with the group.
Other: Self-Guided M.A.P. BP Improvement Program
Active Clinics randomized to the Full Support Arm will receive online access to M.A.P. materials and orientation webinar and also a Practice Change Facilitator who will lead the health center clinical staff, site champions and physician leads at each clinic over the course of 6 months to support the implementation of the MAP Program. With support from an AMA "Improvement Advisor", the Practice Change Facilitators will perform a baseline assessment of current workflows and assess each domain of M.A.P. The goal of the Full Support program is to help care teams develop skills and sustainable workflows that are effective at attaining and maintaining high levels of BP control.
Other: Full Support M.A.P. BP Improvement Program
The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet.
Active Clinics randomized to the Self-Guided Arm will receive access to an AHA/AMA web platform that includes the posted M.A.P. materials and limited access to AMA Staff who are available to answer questions. The study team will facilitate access to staff by hosting a kick-off webinar for program participants that will include an orientation to the materials on the website, general advice and practical tips about what works for implementation, and time for answering questions and discussion with the group.
Active Clinics randomized to the Full Support Arm will receive online access to M.A.P. materials and orientation webinar and also a Practice Change Facilitator who will lead the health center clinical staff, site champions and physician leads at each clinic over the course of 6 months to support the implementation of the MAP Program. With support from an AMA "Improvement Advisor", the Practice Change Facilitators will perform a baseline assessment of current workflows and assess each domain of M.A.P. The goal of the Full Support program is to help care teams develop skills and sustainable workflows that are effective at attaining and maintaining high levels of BP control.
Change in Blood Pressure Control, % of Patients
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.
Time frame: baseline and 6 months
Change in Improvement in Blood Pressure, % of Patients
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.
Time frame: baseline and 12 months
Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits
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).
Time frame: baseline and 6 months
Change in Medication Intensification, % of Visits
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.
Time frame: baseline and 6 months
Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg
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.
Time frame: baseline and 6 months
Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits
This process measure captures the proportion of persons who had uncontrolled HTN who made a subsequent visit within the following 4 weeks.
Time frame: baseline and 6 months
Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients
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.
Time frame: baseline and 6 months
Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients
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.
Time frame: baseline and 6 months
Change in Terminal Digit = Zero, % of Measurements
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.
Time frame: baseline and 6 months
Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients
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.
Time frame: baseline and 6 months
The unit of randomization was the participating clinical unit.
| Milestone | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Started | 11821 | 14454 | 1212560 |
| Completed | 11821 | 14454 | 1212560 |
| Not completed | 0 | 0 | 0 |
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.
| percentage of patients | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Blood Pressure Control, % of Patients | 2.8 (-0.9 to 6.5) | 1.6 (-0.8 to 4.0) | -0.4 (-1.0 to 0.2) |
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.
| percentage of patients | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Improvement in Blood Pressure, % of Patients | -3.4 (-10.3 to 3.5) | -5.4 (-8.2 to -2.5) | -3.1 (-4.1 to -2.1) |
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).
| percentage of visits | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits | 19.8 (6.9 to 32.7) | 11.6 (2.1 to 21.1) | 0.1 (-0.0 to 0.2) |
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.
| percentage of visits | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Medication Intensification, % of Visits | -1.6 (-6.1 to 3.0) | -3.4 (-8.2 to 1.2) | -0.1 (-0.3 to 0.1) |
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.
| mmHg | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg | 2.3 (0.9 to 3.7) | -1.6 (-5.6 to 2.4) | -1.1 (-1.5 to -0.8) |
This process measure captures the proportion of persons who had uncontrolled HTN who made a subsequent visit within the following 4 weeks.
| percentage of visits | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits | -0.8 (-3.2 to 1.7) | -2.0 (-4.3 to 0.2) | -0.6 (-1.0 to -0.2) |
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.
| percentage of patients | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients | 1.6 (-1.4 to 4.7) | -0.1 (-1.8 to 1.7) | -0.7 (-0.8 to -0.6) |
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.
| percentage of patients | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients | -0.9 (-1.8 to 0.1) | -0.1 (-1.5 to 1.2) | 0.0 (-0.3 to 0.3) |
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.
| percentage of measurements | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Terminal Digit = Zero, % of Measurements | 0.8 (-1.5 to 3.1) | 0.9 (-1.1 to 2.8) | -0.6 (-1.0 to -0.3) |
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.
| percentage of patients | Full Support | Self-Guided | Usual Care |
|---|---|---|---|
| Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients | -1.5 (-2.6 to -0.3) | -1.1 (-2.2 to 0.1) | -0.5 (-0.7 to -0.2) |
Collected over Not applicable: adverse events were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Full Support | — | — | — |
| Self-Guided | — | — | — |
| Usual Care | — | — | — |
The unit of measure in this study is a clinic.
| Age, Continuous(Age in years) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| Mean | 57.1 ± 2.49 | 57.1 ± 2.61 | 63.47 ± 1.76 | 63.46 ± 1.78 |
| Age, Customized(percentage of participants) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| 18-44 years | 16.0 ± 4.91 | 16.1 ± 5.33 | 9.3 ± 2.21 | 13.8 ± 5.42 |
| 45-64 years | 56.5 ± 4.50 | 56.5 ± 6.07 | 38.1 ± 4.58 | 50.4 ± 10.06 |
| 65+ years | 27.5 ± 8.03 | 27.4 ± 8.38 | 52.6 ± 6.14 | 35.8 ± 14.09 |
| Sex/Gender, Customized(percentage of participants) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| Female, % | 57.2 ± 5.80 | 60.7 ± 5.75 | 51.4 ± 3.08 | 56.4 ± 6.35 |
| Male, % | 42.8 ± 5.80 | 39.3 ± 5.75 | 48.6 ± 3.08 | 43.6 ± 6.35 |
| Race/Ethnicity, Customized(percentage of participants) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| White, % | 50.3 ± 33.8 | 29.8 ± 27.01 | 79.2 ± 15.56 | 53.1 ± 33.40 |
| LatinX, % | 10.3 ± 5.9 | 26.3 ± 28.3 | 3.1 ± 2.01 | 13.2 ± 19.36 |
| Black, % | 34.9 ± 33.8 | 36.8 ± 34.6 | 13.4 ± 15.3 | 28.4 ± 31.12 |
| Asian, % | 1.6 ± 2.34 | 3.8 ± 5.69 | 1.7 ± 0.67 | 2.3 ± 3.72 |
| Other, % | 3.0 ± 2.29 | 3.2 ± 2.69 | 2.5 ± 0.95 | 2.9 ± 2.14 |
| Median total number of patients with hypertension(number of participants) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| Median | 517 (299 to 1049) | 1040 (630 to 1623) | 53266 (26200 to 74379) | 2003 (596 to 46407) |
| Diabetes, %(percentage of participants) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| Mean | 29.9 ± 3.43 | 33.8 ± 9.89 | 26.7 ± 2.74 | 26.7 ± 2.78 |
| Heart Failure, %(percentage of participants) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| Mean | 2.9 ± 1.51 | 2.6 ± 1.36 | 6.8 ± 1.30 | 6.8 ± 1.31 |
| Depression, %(percentage of participants) | Full Support | Self-Guided | Usual Care | Total |
|---|---|---|---|---|
| Mean | 17.0 ± 9.47 | 18.2 ± 16.4 | 14.5 ± 5.80 | 14.5 ± 5.83 |
1 further baseline measures are reported on the registry.
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University of California, San Francisco