Practice Support and Community Engagement for High Blood Pressure

Overseen By Laurette Espinoza-Hernandez, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Antihypertensives

Disqualifiers: Psychiatric, Substance abuse, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to explore a new strategy to control high blood pressure in Black patients through community support and healthcare guidance. It combines three approaches: nurse case management, remote blood pressure monitoring, and support for social factors affecting health, creating a comprehensive care model. This model includes practice facilitation, which provides structured support to improve healthcare practices. The trial seeks participants who are Black, have been diagnosed with high blood pressure, and are taking medication but still have blood pressure above 130/80 mmHg. Participants will receive usual care before transitioning to the new integrated care approach. As an unphased trial, this study offers participants the chance to contribute to innovative healthcare solutions tailored to their community.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, since it involves managing high blood pressure, you may need to continue your antihypertensive medication.

What prior data suggests that this practice facilitation is safe for high blood pressure management?

Research shows that practice facilitation safely manages blood pressure. Studies have demonstrated that it helps clinics implement effective changes, such as improving blood pressure control. For instance, one study found that blood pressure control improved from 54% to 61% in groups using practice facilitation. Another study showed improvements from 68% to 75%, even during the COVID-19 pandemic. These findings suggest that practice facilitation is well-tolerated and poses no significant risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Practice Facilitation approach for high blood pressure because it goes beyond traditional medication and lifestyle advice. Unlike standard care, which typically involves prescriptions and general guidelines, this method uses practice facilitators to actively engage with healthcare sites and tailor the hypertension management process to each community's specific needs. This personalized strategy aims to improve treatment adherence and outcomes by integrating community-specific resources and support, potentially leading to more sustainable blood pressure control.

What evidence suggests that the Practice Facilitation strategy is effective for controlling high blood pressure in Black patients?

Research has shown that practice facilitation, provided to participants during the PACE implementation period, can improve blood pressure control. One study found that the number of people with well-controlled blood pressure increased from 54% to 61% with practice facilitation. This method helps implement changes in healthcare practices, leading to better management of high blood pressure. It aims to make healthcare more effective in treating hypertension. These findings suggest that practice facilitation is a promising approach for helping patients manage their blood pressure. ^{1 2 4 6 7}

Who Is on the Research Team?

Nadia Islam, PhD

Principal Investigator

NYU Langone Health

Antoinette Schoenthaler, EdD

Principal Investigator

NYU Langone Health

Gbenga Ogedegbe, MD, MPH

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

The ADDRESS-BP trial is for Black individuals with uncontrolled high blood pressure, documented on at least two visits in the past year. Participants must have had a routine non-emergent primary care appointment within the last 12 months at one of the participating NYU Langone Health practices in NYC.

Inclusion Criteria

Patients who identify as Black (through EHR code or self-report)

Patients with a clinic BP > 130/80 mmHg

I am between 18 and 85 years old.

Exclusion Criteria

Patients deemed unable to comply with the study protocol

Patients participating in other hypertension-related clinical trials

Patients with significant psychiatric comorbidity or reports of substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care (UC) Period

Patients receive standard hypertension care and printed treatment guidelines

3 months

Practice Capacity Assessment

Practice facilitators conduct a capacity assessment at each site

3 months

PACE Implementation

Implementation of PACE with practice facilitators working to implement components

12 months

Follow-up

Participants are monitored for outcome assessment after PACE implementation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Practice Facilitation

Trial Overview This trial tests an integrated community-clinic model called PACE, which includes nurse case management, remote blood pressure monitoring, and support for social determinants of health to improve hypertension control among Blacks across 25 primary care practices.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Thus, each cluster will belong successively to the control group and the intervention group. During the control period (UC) patients at the sites will receive standard HTN care delivered by their primary care providers and standard printed HTN treatment guidelines. This period is then followed by the implementation of PACE. Clusters are randomly assigned to cross over at different times with all clusters eventually receiving PACE. During the PACE implementation period, which will last 12 months, practice facilitators will work with each site to implement the components of PACE.

Group II: Usual care (UC) Group Active Control 1 Intervention

The study design is a randomized stepped wedge cluster trial whereby all clusters (practice sites) begin as part of the Usual Care (UC) control condition. Clusters are then randomly assigned to cross over at different times with all clusters eventually receiving PACE. The study will involve each site starting with the UC, followed by a period of 3 months during which practice facilitators will train NCMs and CHWs, and finally followed by the PACE intervention for 12 months with a 6-month follow-up for outcome assessment. During the UC Period, patients at the sites will receive standard HTN care and standard printed HTN treatment guidelines. Immediately following this period, prior to implementation of PACE, we will conduct a practice capacity assessment at each site for 3 months. This period is then followed by the implementation of PACE.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10871131/

Practice facilitation for scale up of clinical decision support ... Practice facilitation is an implementation strategy that has been shown to support process changes. Our objective is to evaluate whether practice facilitation ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2816426

Practice Facilitation and Peer Coaching for Uncontrolled ... Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001003

Practice facilitation for scale up of clinical decision support ... We will conduct a cluster randomized control trial to compare the effect of hypertension-focused CDS plus practice facilitation on BP control, as compared to ...

4. 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10949149/

Practice Facilitation and Peer Coaching for Uncontrolled ... Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11178242/

Practice Facilitation and Clinical Performance Feedback ... Despite disruptions from the COVID-19 pandemic, practices demonstrated significant improvements in BP (68% to 75%, p<0.001) and cholesterol management (72% to ...

7. journals.lww.com journals.lww.com/jphmp/fulltext/2024/07001/practice_facilitation_and_clinical_performance.14.aspx

Practice Facilitation and Clinical Performance Feedback... Despite disruptions from the COVID-19 pandemic, practices demonstrated significant improvements in BP (68%-75%, P < .001) and cholesterol management (72%-78%, P ...