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Improving BP Control in Diverse Populations Using BP MAP

Improving Blood Pressure Control in Diverse Populations by Measuring Accurately, Acting Rapidly, and Partnering With Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03818659
Acronym
BP MAP
Enrollment
1238835
Registered
2019-01-28
Start date
2019-07-01
Completion date
2021-06-30
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Detailed 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. 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.

Interventions

OTHERSelf-Guided M.A.P. BP Improvement Program

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.

OTHERFull Support 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.

Sponsors

OCHIN, Inc.
CollaboratorOTHER
Louisiana Public Health Institute
CollaboratorOTHER
American Medical Association
CollaboratorOTHER
American Heart Association
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

ACTIVE CLINICS For inclusion as an Active Clinic in this study, clinics may participate must be able to identify: * A Site Champion who works at the clinic and who is willing to take primary responsibility for implementing the M.A.P. intervention * A Physician Champion who works at the clinic and who is willing to advocate actively for the M.A.P. intervention * A Practice Change Facilitator willing to attend a 1-day training and help guide implementation of the M.A.P intervention for Full Support sites, with the support of AMA staff (may be the Site Champion or Physician Champion, or a person with regional responsibilities who can support multiple sites) Sites will be excluded if they: * Have implemented any high blood pressure quality improvement component from the M.A.P. BP improvement program as part of Target: BP or from the AMA or Target: BP websites * Are currently involved in an ongoing clinical trial or grant funded project related to high blood pressure or hypertension 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: * Datamarts with any Active Clinics participating in BP MAP will be excluded * Datamarts that obscure dates via date-shifting will be excluded, as this will not allow for control of concurrent secular trends 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: * Age 18-85 on the date of analysis * At least one outpatient encounter with a diagnosis of hypertension during the first six months of the measurement year (ending on the date of analysis) * No diagnosis or evidence of end-stage renal disease on or prior to the end of the measurement year * No pregnancy during the measurement year * No admission to an inpatient setting during the measurement year

Design outcomes

Primary

MeasureTime frameDescription
Change in Blood Pressure Control, % of Patientsbaseline and 6 monthsThe 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.

Secondary

MeasureTime frameDescription
Change in Confirmatory Repeated Blood Pressure Measurement, % of Visitsbaseline and 6 monthsThis 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).
Change in Medication Intensification, % of Visitsbaseline and 6 monthsThis 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.
Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHgbaseline and 6 monthsThis 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.
Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visitsbaseline and 6 monthsThis process measure captures the proportion of persons who had uncontrolled HTN who made a subsequent visit within the following 4 weeks.
Change in Improvement in Blood Pressure, % of Patientsbaseline and 12 monthsThis 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.
Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patientsbaseline and 6 monthsUse 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.
Change in Terminal Digit = Zero, % of Measurementsbaseline and 6 monthsInappropriate 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.
Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patientsbaseline and 6 monthsThis 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.
Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patientsbaseline and 6 monthsUse 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.

Countries

United States

Participant flow

Recruitment details

The unit of randomization was the participating clinical unit.

Pre-assignment details

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.

Participants by arm

ArmCount
Full Support
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. Full Support 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.
11,821
Full Support
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. Full Support 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.
12
Self-Guided
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. Self-Guided M.A.P. BP Improvement Program: 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.
14,454
Self-Guided
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. Self-Guided M.A.P. BP Improvement Program: 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.
12
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.
1,212,560
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.
18
Total1,238,877

Baseline characteristics

CharacteristicFull SupportSelf-GuidedUsual CareTotal
Age, Continuous57.1 Age in years
STANDARD_DEVIATION 2.49
57.1 Age in years
STANDARD_DEVIATION 2.61
63.47 Age in years
STANDARD_DEVIATION 1.76
63.46 Age in years
STANDARD_DEVIATION 1.78
Age, Customized
18-44 years
16.0 percentage of participants
STANDARD_DEVIATION 4.91
16.1 percentage of participants
STANDARD_DEVIATION 5.33
9.3 percentage of participants
STANDARD_DEVIATION 2.21
13.8 percentage of participants
STANDARD_DEVIATION 5.42
Age, Customized
45-64 years
56.5 percentage of participants
STANDARD_DEVIATION 4.5
56.5 percentage of participants
STANDARD_DEVIATION 6.07
38.1 percentage of participants
STANDARD_DEVIATION 4.58
50.4 percentage of participants
STANDARD_DEVIATION 10.06
Age, Customized
65+ years
27.5 percentage of participants
STANDARD_DEVIATION 8.03
27.4 percentage of participants
STANDARD_DEVIATION 8.38
52.6 percentage of participants
STANDARD_DEVIATION 6.14
35.8 percentage of participants
STANDARD_DEVIATION 14.09
COPD (%)6.6 percentage of participants
STANDARD_DEVIATION 4.18
4.4 percentage of participants
STANDARD_DEVIATION 2.43
5.7 percentage of participants
STANDARD_DEVIATION 1.51
5.7 percentage of participants
STANDARD_DEVIATION 1.51
Depression, %17.0 percentage of participants
STANDARD_DEVIATION 9.47
18.2 percentage of participants
STANDARD_DEVIATION 16.4
14.5 percentage of participants
STANDARD_DEVIATION 5.8
14.5 percentage of participants
STANDARD_DEVIATION 5.83
Diabetes, %29.9 percentage of participants
STANDARD_DEVIATION 3.43
33.8 percentage of participants
STANDARD_DEVIATION 9.89
26.7 percentage of participants
STANDARD_DEVIATION 2.74
26.7 percentage of participants
STANDARD_DEVIATION 2.78
Heart Failure, %2.9 percentage of participants
STANDARD_DEVIATION 1.51
2.6 percentage of participants
STANDARD_DEVIATION 1.36
6.8 percentage of participants
STANDARD_DEVIATION 1.3
6.8 percentage of participants
STANDARD_DEVIATION 1.31
Median total number of patients with hypertension517 number of participants1040 number of participants53266 number of participants2003 number of participants
Race/Ethnicity, Customized
Asian, %
1.6 percentage of participants
STANDARD_DEVIATION 2.34
3.8 percentage of participants
STANDARD_DEVIATION 5.69
1.7 percentage of participants
STANDARD_DEVIATION 0.67
2.3 percentage of participants
STANDARD_DEVIATION 3.72
Race/Ethnicity, Customized
Black, %
34.9 percentage of participants
STANDARD_DEVIATION 33.8
36.8 percentage of participants
STANDARD_DEVIATION 34.6
13.4 percentage of participants
STANDARD_DEVIATION 15.3
28.4 percentage of participants
STANDARD_DEVIATION 31.12
Race/Ethnicity, Customized
LatinX, %
10.3 percentage of participants
STANDARD_DEVIATION 5.9
26.3 percentage of participants
STANDARD_DEVIATION 28.3
3.1 percentage of participants
STANDARD_DEVIATION 2.01
13.2 percentage of participants
STANDARD_DEVIATION 19.36
Race/Ethnicity, Customized
Other, %
3.0 percentage of participants
STANDARD_DEVIATION 2.29
3.2 percentage of participants
STANDARD_DEVIATION 2.69
2.5 percentage of participants
STANDARD_DEVIATION 0.95
2.9 percentage of participants
STANDARD_DEVIATION 2.14
Race/Ethnicity, Customized
White, %
50.3 percentage of participants
STANDARD_DEVIATION 33.8
29.8 percentage of participants
STANDARD_DEVIATION 27.01
79.2 percentage of participants
STANDARD_DEVIATION 15.56
53.1 percentage of participants
STANDARD_DEVIATION 33.4
Sex/Gender, Customized
Female, %
57.2 percentage of participants
STANDARD_DEVIATION 5.8
60.7 percentage of participants
STANDARD_DEVIATION 5.75
51.4 percentage of participants
STANDARD_DEVIATION 3.08
56.4 percentage of participants
STANDARD_DEVIATION 6.35
Sex/Gender, Customized
Male, %
42.8 percentage of participants
STANDARD_DEVIATION 5.8
39.3 percentage of participants
STANDARD_DEVIATION 5.75
48.6 percentage of participants
STANDARD_DEVIATION 3.08
43.6 percentage of participants
STANDARD_DEVIATION 6.35

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Blood Pressure Control, % of Patients2.8 percentage of patients
Self-GuidedChange in Blood Pressure Control, % of Patients1.6 percentage of patients
Usual CareChange in Blood Pressure Control, % of Patients-0.4 percentage of patients
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the average reduction in patients with a recent medication intensification.

ArmMeasureValue (MEAN)
Full SupportChange in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg2.3 mmHg
Self-GuidedChange in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg-1.6 mmHg
Usual CareChange in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg-1.1 mmHg
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients-1.5 percentage of patients
Self-GuidedChange in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients-1.1 percentage of patients
Usual CareChange in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients-0.5 percentage of patients
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Confirmatory Repeated Blood Pressure Measurement, % of Visits19.8 percentage of visits
Self-GuidedChange in Confirmatory Repeated Blood Pressure Measurement, % of Visits11.6 percentage of visits
Usual CareChange in Confirmatory Repeated Blood Pressure Measurement, % of Visits0.1 percentage of visits
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Improvement in Blood Pressure, % of Patients-3.4 percentage of patients
Self-GuidedChange in Improvement in Blood Pressure, % of Patients-5.4 percentage of patients
Usual CareChange in Improvement in Blood Pressure, % of Patients-3.1 percentage of patients
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Medication Intensification, % of Visits-1.6 percentage of visits
Self-GuidedChange in Medication Intensification, % of Visits-3.4 percentage of visits
Usual CareChange in Medication Intensification, % of Visits-0.1 percentage of visits
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits-0.8 percentage of visits
Self-GuidedChange in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits-2.0 percentage of visits
Usual CareChange in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits-0.6 percentage of visits
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Terminal Digit = Zero, % of Measurements0.8 percentage of measurements
Self-GuidedChange in Terminal Digit = Zero, % of Measurements0.9 percentage of measurements
Usual CareChange in Terminal Digit = Zero, % of Measurements-0.6 percentage of measurements
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients-0.9 percentage of patients
Self-GuidedChange in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients-0.1 percentage of patients
Usual CareChange in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients0.0 percentage of patients
Secondary

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

Population: The unit of measure in this study is a clinic. All patients with hypertension at each of the included clinics were analyzed and used to evaluate the numerator and denominator for each metric.

ArmMeasureValue (MEAN)
Full SupportChange in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients1.6 percentage of patients
Self-GuidedChange in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients-0.1 percentage of patients
Usual CareChange in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients-0.7 percentage of patients

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026