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 study aims to compare a multidisciplinary clinical hypertension and social needs intervention to enhanced standard of care for hypertension management in primary care clinics with regards to hypertension control outcomes.

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.

Is the E3 Multidisciplinary Team for High Blood Pressure treatment safe for humans?

The research articles do not provide specific safety data for the E3 Multidisciplinary Team for High Blood Pressure treatment or its other names. They focus on the safety of antihypertensive drug combinations, which generally have a low profile of serious side effects, but do not mention the E3 program specifically. ^{1 2 3 4 5}

How does the E3 Multidisciplinary Team treatment for high blood pressure differ from other treatments?

The E3 Multidisciplinary Team treatment for high blood pressure is unique because it involves a team-based approach, including doctors, nurses, pharmacists, and other healthcare professionals, working together to manage the condition. This collaborative method focuses on improving blood pressure control through coordinated care and patient education, which is different from traditional treatments that may rely solely on medication or individual healthcare providers. ^{6 7 8 9 10}

What data supports the effectiveness of the E3 Multidisciplinary Team for High Blood Pressure treatment?

Research shows that using a team-based approach, like the E3 Multidisciplinary Team, can significantly improve blood pressure control. Studies have found that such strategies increase the rate of blood pressure control and medication adherence, making them effective for managing high blood pressure. ^{6 7 10 11 12}

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 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]

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]

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]

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]

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 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]

Citations

1. Brazil pubmed.ncbi.nlm.nih.gov

Optimizing the treatment of hypertension in the primary care setting. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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

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

The potency of team-based care interventions for hypertension: a meta-analysis. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

[Multidisciplinary experience in the approach to the hypertensive patient]. [2010]

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

Effectiveness of a multidisciplinary intervention to improve hypertension control in an urban underserved practice. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adhering to the principles of clinical pharmacology - the correct fixed combinations of antihypertensive drugs. [2018]

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

Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse drug reactions during treatment of hypertension. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Initial combination therapy for rapid and effective control of moderate and severe hypertension. [2008]

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

Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. [2018]

12. Brazil pubmed.ncbi.nlm.nih.gov

[Nursing and the hypertensive patient. Report of experiences]. [2007]