Improving BP Control in Diverse Populations Using BP MAP

NCT03818659 | Completed Results

• 1 other identifier: 18-25890
• Study Type: interventional
• Target: 1,238,835
• Locations: 1 country
• Sites: 24

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 6 months

Secondary Outcomes (9)

• Change in Improvement in Blood Pressure, % of Patients

  baseline and 12 months

• Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits

  baseline and 6 months

• Change in Medication Intensification, % of Visits

  baseline and 6 months

• Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg

  baseline and 6 months

• Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits

  baseline and 6 months

Study Arms (3)

Self-Guided

ACTIVE COMPARATOR

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

Full Support

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Self-Guided M.A.P. BP Improvement Program OTHER

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

Full Support M.A.P. BP Improvement Program OTHER

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• OCHIN, Inc.: collaborator
• Louisiana Public Health Institute: collaborator
• American Medical Association: collaborator
• American Heart Association: collaborator

Study Sites (24)

Open Door Del Norte CHC

Crescent City, California, 95531, United States

Location

Open Door Eureka Community Health & Wellness Center

Eureka, California, 95501, United States

Location

QueensCare Echo Park Clinic

Los Angeles, California, 90026, United States

Location

Monterey County Health Department Laurel Family Practice

Salinas, California, 93906, United States

Location

Belle Chasse Community Health Center

Belle Chasse, Louisiana, 70037, United States

Location

Daughters of Charity Carrollton

Carrollton, Louisiana, 70118, United States

Location

St. Bernard Community Health Center

Chalmette, Louisiana, 70043, United States

Location

Daughters of Charity Gretna

Gretna, Louisiana, 70056, United States

Location

Daughters of Charity Kenner

Kenner, Louisiana, 70065, United States

Location

Kenner Community Health Center

Kenner, Louisiana, 70065, United States

Location

St Charles Community Health Center- Paul Maillard

Luling, Louisiana, 70070, United States

Location

St. Charles Community Health Center

Luling, Louisiana, 70070, United States

Location

Daughters of Charity Metairie

Metairie, Louisiana, 70001, United States

Location

Daughters of Charity St. Cecilia

New Orleans, Louisiana, 700117, United States

Location

Daughters of Charity Higgins

New Orleans, Louisiana, 700126, United States

Location

Daughters of Charity New Orleans East

New Orleans, Louisiana, 700127, United States

Location

Access Health Louisiana Primary Care at the Pythian

New Orleans, Louisiana, 70112, United States

Location

Daughters of Charity Gentilly

New Orleans, Louisiana, 70122, United States

Location

Waterfall CHC

North Bend, Oregon, 97459, United States

Location

Tillamook CHC

Tillamook, Oregon, 97141, United States

Location

Public Health: Seattle & King County Eastgate Public Health Center

Bellevue, Washington, 98007, United States

Location

Public Health: Seattle & King County Primary Care at Navos

Burien, Washington, 98166, United States

Location

Cowlitz County Health Department Cowlitz County: North Beach Clinic

Longview, Washington, 98632, United States

Location

Public Health: Seattle & King County Downtown Public Health Center

Seattle, Washington, 98121, United States

Location

Related Publications (1)

• Fontil V, Modrow MF, Cooper-DeHoff RM, Wozniak G, Rakotz M, Todd J, Azar K, Murakami L, Sanders M, Chamberlain AM, O'Brien E, Lee A, Carton T, Pletcher MJ. 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. J Am Heart Assoc. 2023 Feb 7;12(3):e024975. doi: 10.1161/JAHA.121.024975. Epub 2023 Jan 25.

  PMID: 36695297 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Mark Pletcher
• Organization: University of California, San Francisco

mark.pletcher@ucsf.edu

415-514-8008

Study Officials

• Mark Pletcher, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 28, 2019
• Study Start: July 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: June 30, 2021
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)