Practice Facilitation for High Blood Pressure

(CIRCL-Chicago Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: Children under 18

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to adapt a proven set of methods to manage high blood pressure for use in the South Side of Chicago. It focuses on minority residents who have high rates of hypertension. Community health workers and church facilitators will help manage blood pressure with support from local clinics and shared data.

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 data supports the effectiveness of the treatment Kaiser Bundle for high blood pressure?

The Kaiser Permanente Southern California health system improved high blood pressure control from 54% to 86% by using a comprehensive approach that included standardized blood pressure measurements, a treatment plan based on evidence, and a team of healthcare professionals. This success suggests that the Kaiser Bundle, which likely includes similar strategies, can effectively manage high blood pressure. ^{1 2 3 4 5}

How does the Kaiser Bundle treatment for high blood pressure differ from other treatments?

The Kaiser Bundle treatment for high blood pressure is unique because it uses an integrated health system model that includes a hypertension registry, standardized blood pressure measurements, an evidence-based treatment algorithm, and a multidisciplinary team approach. This comprehensive strategy has achieved high control rates by involving medical assistants, nurses, and pharmacists, and providing continuous performance feedback. ^{1 4 6 7 8}

Research Team

Eligibility Criteria

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

I am between 18 and 89 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• Kaiser Bundle (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Pastors 4 PCOR

Collaborator

Trials

1

Recruited

5,800+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Systemic implementation strategies to improve hypertension: the Kaiser Permanente Southern California experience. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Improving blood pressure control in a large multiethnic California population through changes in health care delivery, 2004-2012. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Improving blood pressure screening and control at an academic health system. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Mail education is as effective as in-class education in hypertensive Korean patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation of Strategies to Recognize and Control Hypertension in a Multispecialty Clinic, Montana, 2012-2013. [2023]

6. England 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. [2022]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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