Practice Facilitation for High Blood Pressure

(CIRCL-Chicago Trial)

Recruiting at 3 trial locations

Overseen By Jennifer Heinrich, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Children under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine the best way to use a proven blood pressure control method, known as the Kaiser bundle (a comprehensive treatment approach), in under-resourced urban communities. It focuses on neighborhoods in South Side Chicago, where high blood pressure and related health problems are common. Researchers will test this method in churches and health clinics to assess its effectiveness in controlling blood pressure. Individuals with high blood pressure who attend participating clinics or churches in this community might be suitable candidates for the trial.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance health outcomes in their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adapting existing interventions to community settings, so it's best to consult with the trial coordinators for specific guidance.

What prior data suggests that this method is safe for controlling high blood pressure?

Research has shown that the Kaiser Bundle, which includes tools like a list of people with high blood pressure and regular blood pressure checks, effectively controls blood pressure in various locations. One study found that using this bundle in Northern California significantly improved blood pressure management.

The bundle emphasizes system improvements rather than new medications or procedures, generally reducing risks for participants. It includes standard healthcare practices, such as using combined medications and taking accurate blood pressure readings. No serious side effects have been directly linked to these methods. Therefore, past experiences consider the Kaiser Bundle safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Practice Facilitation approach for managing high blood pressure because it offers a fresh method for implementing the Kaiser Blood Pressure Control Bundle. Unlike traditional methods that might not provide ongoing support, Practice Facilitation involves dedicated assistance to healthcare providers, ensuring the bundle's strategies are effectively integrated into practice. This hands-on approach could enhance adherence to treatment protocols and improve patient outcomes. By focusing on the practical application of proven strategies, this method has the potential to make a real difference in blood pressure management.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Studies have shown that the Kaiser Bundle, a set of proven methods, greatly improves blood pressure control. Research indicates that its use in Northern California helped more patients maintain healthy blood pressure levels. This success stems from features like maintaining a list of patients with high blood pressure, using a consistent method to measure blood pressure, and following a research-based treatment plan. This trial will compare two approaches: one arm will implement the Kaiser Bundle with Practice Facilitation, while the other will implement it without Practice Facilitation. Early results suggest that applying this approach in under-resourced areas, such as South Side Chicago, could also effectively manage high blood pressure. By involving community health workers and utilizing local resources, the bundle is expected to be both practical and beneficial in these communities. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 living in Chicago's South and West Sides, who are patients within participating clinics or churches. It aims to help those affected by high blood pressure and cardiovascular disease, especially minority populations.

Inclusion Criteria

Community: patients within participating clinics (by clinic location in community) OR within participating churches (by location in community)

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Exploration and Preparation

Convene community stakeholders to adapt implementation strategies using the Dynamic Adaptation Process model.

2-4 months

Implementation

Design, implement, and evaluate pilot projects to optimize implementation strategies within the target community.

3-6 months

Regular visits by community health workers and ministry facilitators

Sustainment

Implement, test, and evaluate an adapted implementation strategy to control hypertension through faith-based organizations.

2 years

Follow-up

Participants are monitored for safety and effectiveness after the main intervention.

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Kaiser Bundle

Trial Overview The study tests a community-centered health intervention adapted from Kaiser Permanente's model. It includes simplified treatment regimens and support from local health workers, with the goal of improving blood pressure control through faith-based organizations.

How Is the Trial Designed?

Group I: Practice Facilitation Experimental Treatment 1 Intervention

Practice Facilitation to support implementation of the Kaiser Blood Pressure Control Bundle

Group II: Non-Practice Facilitation Active Control 1 Intervention

implementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Pastors 4 PCOR

Collaborator

Trials

1

Recruited

5,800+

Published Research Related to This Trial

Benefis Medical Group implemented a series of interventions that significantly improved hypertension management, increasing the percentage of patients with documented blood pressure from 67% to 80% over a period from December 2012 to September 2013.

The percentage of patients diagnosed with hypertension rose from 16% to 36%, and those achieving controlled blood pressure increased from 41% to 64%, demonstrating the efficacy of their multifaceted approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Strategies to Recognize and Control Hypertension in a Multispecialty Clinic, Montana, 2012-2013. Wall, J., McLaury, MM., Gohdes, D., et al.[2023]

A study involving 380 Korean American individuals with hypertension found that both mailed and in-class culturally tailored education interventions significantly reduced blood pressure, with systolic BP reductions of 13.3 mm Hg and 16.1 mm Hg, respectively.

Both intervention groups achieved similar improvements in blood pressure control rates, indicating that mailed education can be as effective as in-class sessions, making it a practical option for busy individuals and other immigrant populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mail education is as effective as in-class education in hypertensive Korean patients. Kim, MT., Kim, EY., Han, HR., et al.[2022]

This study will evaluate the effectiveness of combining practice facilitation with hypertension-focused clinical decision support (CDS) in improving blood pressure control among patients in small primary care practices, involving 46 practices in New York City.

The trial aims to determine whether this combined approach can enhance the implementation of CDS and ultimately lead to better management of hypertension, addressing a significant gap in care where only half of patients achieve adequate blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial. Blecker, S., Gannon, M., De Leon, S., et al.[2023]

Practices that received more coaching-based strategies from facilitators were more successful in implementing quality improvement (QI) interventions, with those receiving over 6 coaching activities implementing a median of 17 out of 35 interventions.

The study found no significant link between the number of strategies used by facilitators and the overall number of QI interventions implemented, suggesting that the type of facilitation strategy, particularly coaching, is more critical than the quantity of strategies employed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does coaching matter? Examining the impact of specific practice facilitation strategies on implementation of quality improvement interventions in the Healthy Hearts in the Heartland study. Walunas, TL., Ye, J., Bannon, J., et al.[2022]

The 2014 Kaiser Permanente Hypertension Guideline recommends that adults aged 60 and older aim for a systolic blood pressure of less than 150 mmHg when treating uncomplicated hypertension, which is a significant change in practice.

This guideline is designed to help primary care physicians provide better outpatient care for hypertension, particularly for older patients without diabetes or chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2014 Hypertension Guideline: Recommendation for a Change in Goal Systolic Blood Pressure. Handler, J.[2018]

Kaiser Permanente Southern California (KPSC) has achieved hypertension control rates exceeding 85% among its diverse population of over 3.6 million, significantly higher than the national average of approximately 50%.

This success is attributed to an integrated health system model that includes a hypertension registry, standardized blood pressure measurements, evidence-based treatment algorithms, and a multidisciplinary team approach, all supported by continuous performance feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic implementation strategies to improve hypertension: the Kaiser Permanente Southern California experience. Sim, JJ., Handler, J., Jacobsen, SJ., et al.[2022]

The Kaiser Permanente Southern California health care system significantly improved hypertension control from 54% to 86% between 2004 and 2012, demonstrating effective health care delivery changes.

Hypertension control improvements were consistent across all demographic subgroups, achieving over 80% control regardless of race, ethnicity, or insurance type, indicating that systematic changes can effectively enhance health outcomes in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving blood pressure control in a large multiethnic California population through changes in health care delivery, 2004-2012. Shaw, KM., Handler, J., Wall, HK., et al.[2022]

The University of California Davis Health initiative significantly improved accurate blood pressure screening from 14% to 87% and increased blood pressure control from 62% to 75% among patients aged 18-85 through a series of evidence-based interventions.

Key strategies for success included staff training, workflow modifications, and a team-based approach, highlighting the importance of collaboration and communication in managing high blood pressure effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving blood pressure screening and control at an academic health system. Shaikh, U., Petray, J., Wisner, DH.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12054222/

Community intervention to reduce cardiovascular disease in ... To test the effectiveness of the adapted Kaiser bundle on BP control, participants will be recruited into the hypertension registry from the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11895547/

Process of Engaging Community and Scientific Partners in the ... Kaiser Permanente demonstrated that a “bundle” of evidence-based interventions significantly increased blood pressure control rates. This paper describes a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04755153

Study Details | NCT04755153 | Community Intervention to ... The overall study outcomes reach (implementation) and blood pressure (clinical effectiveness) ... implementation of the Kaiser Blood Pressure Control Bundle ...

4. divisionofresearch.kaiserpermanente.org divisionofresearch.kaiserpermanente.org/publications/improved-blood-pressure-control-associated-with-a-large-scale-hypertension-program/

Improved blood pressure control associated with a large- ... RESULTS: The KPNC hypertension registry included 349,937 patients when established in 2001 and increased to 652,763 by 2009. The NCQA HEDIS commercial ...

5. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-025-01452-5

Protocol for a Type 3 hybrid effectiveness-implementation ... The Kaiser Bundle includes a hypertension registry, standardization of blood pressure measurements, an evidence-based treatment protocol ...

6. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000232

Implementation Strategies to Improve Blood Pressure ... This scientific statement provides information on the implementation strategies to optimize hypertension management and to improve BP control among adults in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4270203/

Improved Blood Pressure Control Associated With a Large ... The central management team reviewed data related to practice patterns including staffing support, medication prescription patterns, encounter rates, and other ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11895538/

Planning the Implementation of a Multilevel Blood Pressure ... 15 In 2008, the Kaiser BP bundle was adapted and implemented in a network of safety-net clinics in Northern California. While the essential components of the ...

9. ahrq.gov ahrq.gov/sites/default/files/wysiwyg/evidencenow/heart-health/abcs-toolkit-2016.pdf

ABCS: Toolkit for the Practice Faciliatator This toolkit references two specific EHRs: eClinical Works (eCW) and MDLand. • The practice facilitator should have an understanding of the quality data that ...

10. researchgate.net researchgate.net/figure/Changes-in-Guideline-Concordant-Practice-Patterns-in-Hypertension-Treatment-at-SFHN_tbl2_326348878

Changes in Guideline-Concordant Practice Patterns ... The Kaiser Bundle includes a hypertension registry, standardization of blood pressure measurements, an evidence-based treatment protocol using fixed-dose ...