Clinical trial NCT03818659: Improving BP Control in Diverse Populations Using BP MAP
Official title: Improving Blood Pressure Control in Diverse Populations by Measuring Accurately, Acting Rapidly, and Partnering With Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: Louisiana Public Health Institute
name: American Medical Association
name: American Heart Association
First posted: 2019-01-28
Enrollment: 1238835
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Blood Pressure Control, % of Patients
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Improvement in Blood Pressure, % of Patients
timeFrame: baseline and 12 months
measure: Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits
timeFrame: baseline and 6 months
measure: Change in Medication Intensification, % of Visits
timeFrame: baseline and 6 months
measure: Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg
timeFrame: baseline and 6 months
measure: Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits
timeFrame: baseline and 6 months
measure: Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients
timeFrame: baseline and 6 months
measure: Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients
timeFrame: baseline and 6 months
measure: Change in Terminal Digit = Zero, % of Measurements
timeFrame: baseline and 6 months
measure: Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Crescent City
country: United States
facility: Open Door Del Norte CHC
state: California
city: Eureka
country: United States
facility: Open Door Eureka Community Health & Wellness Center
state: California
city: Los Angeles
country: United States
facility: QueensCare Echo Park Clinic
state: California
city: Salinas
country: United States
facility: Monterey County Health Department Laurel Family Practice
state: California
city: Belle Chasse
country: United States
facility: Belle Chasse Community Health Center
state: Louisiana
city: Carrollton
country: United States
facility: Daughters of Charity Carrollton
state: Louisiana
city: Chalmette
country: United States
facility: St. Bernard Community Health Center
state: Louisiana
city: Gretna
country: United States
facility: Daughters of Charity Gretna
state: Louisiana
city: Kenner
country: United States
facility: Daughters of Charity Kenner
state: Louisiana
city: Kenner
country: United States
facility: Kenner Community Health Center
state: Louisiana
city: Luling
country: United States
facility: St Charles Community Health Center- Paul Maillard
state: Louisiana
city: Luling
country: United States
facility: St. Charles Community Health Center
state: Louisiana
city: Metairie
country: United States
facility: Daughters of Charity Metairie
state: Louisiana
city: New Orleans
country: United States
facility: Daughters of Charity St. Cecilia
state: Louisiana
city: New Orleans
country: United States
facility: Daughters of Charity Higgins
state: Louisiana
city: New Orleans
country: United States
facility: Daughters of Charity New Orleans East
state: Louisiana
city: New Orleans
country: United States
facility: Access Health Louisiana Primary Care at the Pythian
state: Louisiana
city: New Orleans
country: United States
facility: Daughters of Charity Gentilly
state: Louisiana
city: N. Bend
country: United States
facility: Waterfall CHC
state: Oregon
city: Tillamook
country: United States
facility: Tillamook CHC
state: Oregon
city: Bellevue
country: United States
facility: Public Health: Seattle & King County Eastgate Public Health Center
state: Washington
city: Burien
country: United States
facility: Public Health: Seattle & King County Primary Care at Navos
state: Washington
city: Longview
country: United States
facility: Cowlitz County Health Department Cowlitz County: North Beach Clinic
state: Washington
city: Seattle
country: United States
facility: Public Health: Seattle & King County Downtown Public Health Center
state: Washington
Study officials:
affiliation: University of California, San Francisco
name: Mark Pletcher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: