Improving BP Control in Diverse Populations Using BP MAP
- Conditions
- Hypertension
- Interventions
- Other: Self-Guided M.A.P. BP Improvement ProgramOther: Full Support M.A.P. BP Improvement Program
- Registration Number
- NCT03818659
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1238835
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-Guided 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. Full Support 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.
- Primary Outcome Measures
Name Time Method Change in Blood Pressure Control, % of Patients 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.
- Secondary Outcome Measures
Name Time Method Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg 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.
Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits 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.
Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients 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.
Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients 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.
Change in Terminal Digit = Zero, % of Measurements 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 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 Patients 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.
Change in Improvement in Blood Pressure, % of Patients 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.
Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits 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).
Change in Medication Intensification, % of Visits 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.
Trial Locations
- Locations (24)
Public Health: Seattle & King County Downtown Public Health Center
🇺🇸Seattle, Washington, United States
QueensCare Echo Park Clinic
🇺🇸Los Angeles, California, United States
Monterey County Health Department Laurel Family Practice
🇺🇸Salinas, California, United States
Daughters of Charity Carrollton
🇺🇸Carrollton, Louisiana, United States
St Charles Community Health Center- Paul Maillard
🇺🇸Luling, Louisiana, United States
Kenner Community Health Center
🇺🇸Kenner, Louisiana, United States
Daughters of Charity Metairie
🇺🇸Metairie, Louisiana, United States
Daughters of Charity St. Cecilia
🇺🇸New Orleans, Louisiana, United States
Daughters of Charity Higgins
🇺🇸New Orleans, Louisiana, United States
Access Health Louisiana Primary Care at the Pythian
🇺🇸New Orleans, Louisiana, United States
Public Health: Seattle & King County Eastgate Public Health Center
🇺🇸Bellevue, Washington, United States
Cowlitz County Health Department Cowlitz County: North Beach Clinic
🇺🇸Longview, Washington, United States
Daughters of Charity New Orleans East
🇺🇸New Orleans, Louisiana, United States
Daughters of Charity Gentilly
🇺🇸New Orleans, Louisiana, United States
Public Health: Seattle & King County Primary Care at Navos
🇺🇸Burien, Washington, United States
Belle Chasse Community Health Center
🇺🇸Belle Chasse, Louisiana, United States
Open Door Del Norte CHC
🇺🇸Crescent City, California, United States
Open Door Eureka Community Health & Wellness Center
🇺🇸Eureka, California, United States
St. Bernard Community Health Center
🇺🇸Chalmette, Louisiana, United States
Daughters of Charity Gretna
🇺🇸Gretna, Louisiana, United States
Daughters of Charity Kenner
🇺🇸Kenner, Louisiana, United States
St. Charles Community Health Center
🇺🇸Luling, Louisiana, United States
Waterfall CHC
🇺🇸N. Bend, Oregon, United States
Tillamook CHC
🇺🇸Tillamook, Oregon, United States