Improving BP Control in Diverse Populations Using BP MAP

Sponsor

University of California, San Francisco (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03818659

Collaborator

OCHIN, Inc. (Other), Louisiana Public Health Institute (Other), American Medical Association (Other), American Heart Association (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patient Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Other: Self-Guided M.A.P. BP Improvement Program Other: Full Support M.A.P. BP Improvement Program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Other: 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.
No Intervention: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Other: Self-Guided M.A.P. BP Improvement Program

Experimental: 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.

Other: Full Support M.A.P. BP Improvement Program

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Change in % Blood Pressure Control [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

Medication intensification, % of visits [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.
Confirmatory repeated blood pressure measurement, % of visits [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).
Average Systolic Blood Pressure (SBP) reduction after a medication intensification visit, mmHg [6 months]
This continuous metric describes the change in SBP observed between a visit with a medication intensification to the subsequent visit. Note that Metric 11 (added later) is the standard deviation of the same measurements.
Improvement in Blood Pressure, % of patients [6 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 10-12 of the measurement period, among hypertensive patients not previously controlled.
Use of fixed dose combination product among patients taking 2 or more classes of medications, % of patients [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.
Use of a CCB or thiazide or thiazide-like diuretic among African-American patients on at least one medication, % of patients [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.
Terminal digit = zero, % of measurements [6 months]
Inappropriate rounding of blood pressure measurements (usually to zero) leads to measurement error and worse treatment decisions. This metric is designed to catch this behavior, which would lead to a terminal digit of zero of 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). 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.
Repeat visit in 4 weeks after a visit with uncontrolled HTN, % of visits [6 months]
This process measure captures the proportion of persons who had uncontrolled HTN who made a subsequent visit within the following 4 weeks.
Blood Pressure Controlled to 2017 Guideline Goal, % of patients [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.
Standard deviation of SBP reduction after a medication intensification visit, mmHg [6 months]
This continuous metric describes the standard deviation of the change in SBP observed between a visit with a medication intensification to the subsequent visit. Note that Metric 4 is the average of the same measurements.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Open Door Del Norte CHC	Crescent City	California	United States	95531
2	Open Door Eureka Community Health & Wellness Center	Eureka	California	United States	95501
3	QueensCare Echo Park Clinic	Los Angeles	California	United States	90026
4	Monterey County Health Department Laurel Family Practice	Salinas	California	United States	93906
5	Belle Chasse Community Health Center	Belle Chasse	Louisiana	United States	70037
6	Daughters of Charity Carrollton	Carrollton	Louisiana	United States	70118
7	St. Bernard Community Health Center	Chalmette	Louisiana	United States	70043
8	Daughters of Charity Gretna	Gretna	Louisiana	United States	70056
9	Daughters of Charity Kenner	Kenner	Louisiana	United States	70065
10	Kenner Community Health Center	Kenner	Louisiana	United States	70065
11	St Charles Community Health Center- Paul Maillard	Luling	Louisiana	United States	70070
12	St. Charles Community Health Center	Luling	Louisiana	United States	70070
13	Daughters of Charity Metairie	Metairie	Louisiana	United States	70001
14	Daughters of Charity St. Cecilia	New Orleans	Louisiana	United States	700117
15	Daughters of Charity Higgins	New Orleans	Louisiana	United States	700126
16	Daughters of Charity New Orleans East	New Orleans	Louisiana	United States	700127
17	Access Health Louisiana Primary Care at the Pythian	New Orleans	Louisiana	United States	70112
18	Daughters of Charity Gentilly	New Orleans	Louisiana	United States	70122
19	Waterfall CHC	N. Bend	Oregon	United States	97459
20	Tillamook CHC	Tillamook	Oregon	United States	97141
21	Public Health: Seattle & King County Eastgate Public Health Center	Bellevue	Washington	United States	98007
22	Public Health: Seattle & King County Primary Care at Navos	Burien	Washington	United States	98166
23	Cowlitz County Health Department Cowlitz County: North Beach Clinic	Longview	Washington	United States	98632
24	Public Health: Seattle & King County Downtown Public Health Center	Seattle	Washington	United States	98121

Sponsors and Collaborators

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

Investigators

Principal Investigator: Mark Pletcher, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT03818659

Other Study ID Numbers:

18-25890

First Posted:

Jan 28, 2019

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Oct 26, 2021