E3 Multidisciplinary Team for High Blood Pressure

Overseen By Laura Zimmermann, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Organ transplant, Dialysis, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing high blood pressure using a team approach. The goal is to determine if a combination of a pharmacist, social worker, and nurse, along with a phone app for monitoring, can better control high blood pressure compared to usual care. The trial targets African American and Latinx adults with high blood pressure (140/90 or higher) who use a smartphone and visit specific primary care clinics. Participants will either receive assistance from the E3 Multidisciplinary Team or engage with educational materials through the E3 Self-Guided Hypertension Education Program. This study aims to identify which method more effectively maintains blood pressure control. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance hypertension management for diverse communities.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this multidisciplinary team approach is safe for hypertension management?

Research has shown that a team approach to managing high blood pressure is generally well-received. Most studies indicate that involving healthcare professionals like pharmacists and nurses can improve blood pressure control. However, specific safety data for the E3 Multidisciplinary Team treatment itself remains limited.

Since this approach emphasizes support and lifestyle changes rather than new medications, it is likely safe. Patients typically handle these interventions well, as they focus on education, monitoring, and guidance rather than medical procedures. For those considering joining the trial, it appears to prioritize safety through supportive care rather than introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the E3 Multidisciplinary Team's approach to high blood pressure because it offers a comprehensive, team-based approach that goes beyond traditional medication and lifestyle recommendations. Unlike standard care, which often relies on regular doctor visits and medication, this method integrates a pharmacist, social worker, and nurse who work together with patients through a tele-health platform. This team not only helps with medication adjustments and monitoring but also provides personalized diet and lifestyle education, plus referrals for social support needs. Another distinctive feature is the use of a self-monitoring blood pressure app, empowering patients to take an active role in managing their health. Through this innovative blend of technology and team support, researchers hope to improve blood pressure control more effectively than current methods.

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

This trial will compare two approaches for managing high blood pressure. One approach involves a multidisciplinary team, which participants in the "Hypertension Team Based Group" will experience. Research has shown that using a team of different health professionals can greatly improve blood pressure management. For example, a study from the University of California Davis Health found that this approach increased accurate blood pressure checks from 14% to 87%. Another study in Africa demonstrated that team-based care led to better blood pressure control in adults with high blood pressure. The team includes professionals like pharmacists, social workers, and nurses who provide comprehensive support. This setup aids in managing medications, making lifestyle changes, and addressing social needs, all crucial for effectively controlling high blood pressure. ^{1 2 4 5 6}

Who Is on the Research Team?

Kristen Pallok, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for African American and/or Latinx adults over 18 with uncontrolled stage 2 hypertension (BP ≥140/90), who see a Rush primary care provider, own a smartphone, and have an email. It's not for those in other remote hypertension programs, past E3 program participants, organ transplant recipients, or dialysis patients.

Inclusion Criteria

Patient is following with Rush primary care provider in eligible Rush primary care clinics

Patient has a smart phone (Android or iOS)

African American and/or Latinx

Exclusion Criteria

Patient is already participating in another remote hypertension monitoring program

Patient has already participated in the E3 Hypertension program or the E3 Diabetes program

I have received an organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multidisciplinary intervention including remote blood pressure monitoring, medication titration, and lifestyle education for hypertension control

6 months

Predominantly via tele-health

Follow-up

Participants are monitored for hypertension control and systolic blood pressure changes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• E3 Multidisciplinary Team
• E3 Self-Guided Hypertension Education Program

Trial Overview The study compares a team-based intervention including clinical management and social support to enhanced standard care in managing high blood pressure among primary care patients. The focus is on the effectiveness of this multidisciplinary approach.

How Is the Trial Designed?

Group I: Hypertension Team Based Group Experimental Treatment 1 Intervention

A multidisciplinary team composed of a pharmacist, social worker, and nurse coupled to a self-monitoring blood pressure phone app will provide hypertension monitoring, medication titration, diet and lifestyle education, and referrals for social needs. The team will interact with the patients predominantly via tele-health remotely for 6 months.

Group II: Hypertension Self-Guided Group Active Control 1 Intervention

A research assistant ensures patients in the self-guided group have a home blood pressure monitor on enrollment and will call patients at 3 and 6 months to ensure the blood pressure monitor is functioning correctly and to remind patients to check their blood pressure and follow-up with their primary care doctors. Patients will continue with standard clinical care for hypertension in addition to receiving timed, mailed educational materials on hypertension, remote monitoring, diet and lifestyle recommendations for 6 months.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

The TBC-HTA study is evaluating a team-based care intervention involving nurses, pharmacists, and physicians to improve blood pressure control in 110 hypertensive outpatients over a 6-month period, compared to usual care.

The primary goal is to assess the difference in daytime ambulatory blood pressure between the team-based care group and the usual care group, with secondary outcomes including patient and healthcare professional satisfaction and long-term blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. Santschi, V., Wuerzner, G., Chiolero, A., et al.[2018]

In the SPRINT trial, patients with higher baseline cardiovascular disease (CVD) risk benefited more from intensive blood pressure treatment, while those with lower risk experienced more harm than benefit, highlighting the importance of risk stratification in treatment decisions.

The study found that the number needed to treat to prevent primary outcomes decreased significantly with higher CVD risk, while the number needed to harm for serious adverse events increased, indicating a favorable benefit-to-harm ratio for intensive treatment in higher-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. Phillips, RA., Xu, J., Peterson, LE., et al.[2022]

A study from the Boston Collaborative Drug Surveillance Program found that while 'nuisance' adverse drug reactions (ADRs) from antihypertensive medications occur in 10 to 29% of patients, 'life-threatening' ADRs are very rare, occurring in less than 1%.

Clinicians should consider the potential severity and type of ADRs, along with patient compliance and education, when selecting antihypertensive therapies to ensure effective treatment and minimize negative impacts on patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions during treatment of hypertension. Kellaway, GS.[2018]

A multidisciplinary approach involving nurses, pharmacists, and physicians significantly improved blood pressure control in an underserved urban practice, with rates increasing from 51.0% to 67.4% during the intervention phase.

While medication adherence improved during the intervention, it did not remain elevated after the study ended, highlighting the need for ongoing support to maintain adherence in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary intervention to improve hypertension control in an urban underserved practice. Fortuna, RJ., Nagel, AK., Rose, E., et al.[2022]

Team-based care involving nurses and pharmacists significantly improves blood pressure control, with education about medications leading to an average reduction of -8.75/-3.60 mm Hg in blood pressure.

Pharmacist interventions showed the largest effect on systolic blood pressure, with an average reduction of -9.30 mm Hg, while both nurses and pharmacists demonstrated similar efficacy in managing hypertension, suggesting that integrating these roles into healthcare can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potency of team-based care interventions for hypertension: a meta-analysis. Carter, BL., Rogers, M., Daly, J., et al.[2022]

Less than 50% of patients in the U.S. with moderate to severe hypertension reach their blood pressure goals, highlighting the need for early and effective treatment to reduce cardiovascular risks.

Using initial combination therapy with a renin-angiotensin system (RAS) inhibitor and a diuretic can significantly improve blood pressure control and has a similar safety profile to single-drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial combination therapy for rapid and effective control of moderate and severe hypertension. Franklin, SS., Neutel, JM.[2008]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06899750

E3 Hypertension - A Team-based, Multidisciplinary Model ... This study aims to compare a multidisciplinary clinical hypertension and social needs intervention to enhanced standard of care for hypertension management ...

2. withpower.com withpower.com/trial/phase-hypertension-1-2025-a0966

E3 Multidisciplinary Team for High Blood Pressure The University of California Davis Health initiative significantly improved accurate blood pressure screening from 14% to 87% and increased blood pressure ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11284891/

Effectiveness of team-based care interventions in improving ... We evaluated the effectiveness of team-based care interventions in improving blood pressure (BP) outcomes among adults with hypertension in Africa.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425000382

A randomised controlled trial of a multidisciplinary TEAM ... The TEAM-PAD study aims to determine if a centralised virtual multidisciplinary team (MDT) model of care is effective in improving guideline-recommended ...

5. portailvasculaire.fr portailvasculaire.fr/sites/default/files/docs/2025_aha_guide_bp_hta.pdf

2025 AHA/ACC/AANP/AAPA/ABC/ACCP STRUCTURE: The focus of this clinical practice guideline is to create a living, working document updating current knowledge in the field of high ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25029452/

Multidisciplinary approaches to the management of high ... Recent findings: Multidisciplinary care for hypertension management, across the majority of studies identified, resulted in improved blood pressure (BP) ...