Technology-Enabled Team Care for High Blood Pressure

Enrolling by invitation at 1 trial location

Overseen By Doyle M Cummings, Pharm.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: East Carolina University

Disqualifiers: Severe kidney disease, Substance abuse, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with a history of uncontrolled high blood pressure (hypertension) manage their condition. It compares a team-based care approach, which includes home blood pressure monitoring and pharmacist support for medication and lifestyle advice, to regular care with basic instructions. Participants should have a history of uncontrolled high blood pressure, indicated by high readings despite treatment. The goal is to determine if the technology-enabled team care approach can better manage blood pressure and improve overall health outcomes. As an unphased trial, this study provides participants the chance to contribute to innovative care strategies that could enhance hypertension management for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, a pharmacist will work with you to adjust your medications as needed to manage your blood pressure.

What prior data suggests that this model of care is safe for managing high blood pressure?

Research shows that using technology in healthcare, as in this trial, is generally safe. Studies have found that technology for monitoring blood pressure can help patients manage their high blood pressure more effectively. For example, one study found that patients using telemonitoring were 2.69 times more likely to control their blood pressure. This suggests the technology helps maintain blood pressure without causing harm.

Other studies have highlighted benefits such as early detection of blood pressure issues, improved medication use, and better overall management of high blood pressure. Importantly, these studies did not report major safety problems, indicating that the technology is well-tolerated.

While specific safety data for this trial is unavailable, the absence of reported adverse events in previous studies is promising. The technology has proven safe in similar situations. Overall, evidence suggests this approach to managing high blood pressure is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Technology-Enabled Team Care for high blood pressure because it offers a comprehensive and personalized approach that goes beyond traditional treatments. Unlike standard care where patients primarily rely on their usual doctor, this method involves a team-based approach led by a pharmacist, integrating telephonic management. It utilizes cellular-enabled home blood pressure monitoring, which allows for more frequent and convenient tracking of blood pressure levels. This approach also emphasizes personalized interventions, including medication management, diet, and exercise adjustments, and even referrals for social issues, aiming for a holistic improvement in patient health.

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

This trial will compare Technology-enabled Team Care with Enhanced Usual Care for managing high blood pressure. Research has shown that technology in team care effectively lowers blood pressure in people with uncontrolled high blood pressure. In one study, patients using this method saw their blood pressure drop from an average of 156/85 mm Hg to 131/75 mm Hg over 12 months. Another study found that telemonitoring and remote medical advice improved blood pressure control and was more cost-effective than regular care. Additionally, a nationwide study reported a 70% increase in patients reaching their blood pressure goals. Team-based care, where healthcare professionals collaborate, has proven to improve blood pressure control. ^{1 3 6 7 8}

Who Is on the Research Team?

Doyle Cummings, Pharm.D.

Principal Investigator

East Carolina University Brody School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a history of uncontrolled high blood pressure, particularly Hispanic and non-Hispanic black (majority) and white individuals. Participants must have had an average systolic BP of at least 140 mmHg in the past year and speak English without needing an interpreter. Those with severe kidney disease, dementia, substance abuse issues, or pregnant women are excluded.

Inclusion Criteria

I am an adult with high blood pressure, and I am either Hispanic, non-Hispanic black, or white.

Your blood pressure has been consistently high (above 140 mmHg) during visits to your doctor in the past year.

Your blood pressure is consistently high at the time of screening.

Exclusion Criteria

Dementia, mental illness or any condition that would limit ability to give informed consent

You live in a very remote area where it's not possible to use a cell phone for monitoring.

I need an interpreter to communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ongoing team-based, pharmacist-led telephonic management of uncontrolled high blood pressure involving cellular-enabled home BP monitoring, medications, diet and exercise, and referral for social problems

6 months

Regular phone calls

Follow-up

Participants are monitored for changes in systolic blood pressure and other outcomes at 6 and 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Technology-enabled Team Care

Trial Overview The study compares two approaches to managing high blood pressure: one uses technology-enabled home monitoring plus team care including pharmacist support for medication management and lifestyle advice; the other provides just the monitor with basic instructions. The main goal is to see which method better controls systolic blood pressure.

How Is the Trial Designed?

Group I: Technology enabled Team Care Experimental Treatment 1 Intervention

Ongoing Team-based, Pharmacist led telephonic management of uncontrolled high blood pressure involving cellular-enabled home BP monitoring, medications, diet and exercise, and referral for social problems

Group II: Enhanced Usual Care Active Control 1 Intervention

Home BP monitoring device provided along with BP log, basic diet and exercise instruction, and care provided by the patient's usual doctor/provider

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

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]

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]

Team-based care (TBC) that includes nonphysician members who can adjust blood pressure medications leads to a greater reduction in systolic blood pressure (-10.5 mm Hg) compared to TBC with only physician titration (-5.0 mm Hg) after 12 months, based on a meta-analysis of 19 studies with 5993 participants.

TBC with nonphysician titration is not only more effective in managing hypertension but also cost-effective, gaining more quality-adjusted life years (0.022) compared to TBC with physician titration, making it a valuable strategy for reducing hypertension-related health issues in the U.S.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Cost-Effectiveness of Team-Based Care for Hypertension: A Meta-Analysis and Simulation Study. Bryant, KB., Rao, AS., Cohen, LP., et al.[2023]

Multidisciplinary care teams that include pharmacists are effective in preventing adverse drug events (ADEs), with the most common intervention being structured medication review meetings involving physicians, pharmacists, and nurses.

The majority of interventions targeted elderly patients, particularly those in nursing homes, highlighting the need for comprehensive medication assessments in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. Zaij, S., Pereira Maia, K., Leguelinel-Blache, G., et al.[2023]

The TeamSTEPPS program, inspired by safety practices from high-risk industries, aims to enhance patient safety in healthcare by promoting teamwork and effective communication among healthcare professionals.

Evidence shows that implementing TeamSTEPPS can improve safety and patient outcomes by shifting healthcare workers' focus from individual expertise to collaborative team performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The TeamSTEPPS Approach to Safety and Quality. Epps, HR., Levin, PE.[2022]

A physician-nurse team model, utilizing home blood pressure monitoring, significantly improved long-term hypertension control, with the percentage of patients achieving target blood pressure levels rising from 0% to 63% over 12 months.

The study involved 106 patients, and results showed a notable decrease in mean blood pressure from 156/85 mm Hg at baseline to 131/75 mm Hg at 12 months, indicating effective management and adjustment of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved blood pressure control with a physician-nurse team and home blood pressure measurement. Canzanello, VJ., Jensen, PL., Schwartz, LL., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10748448/

Effects of technology-enabled blood pressure monitoring in ... Telemonitoring with tele-consultation improved blood pressure control and was more cost-effective than usual care.

2. withpower.com withpower.com/trial/phase-hypertension-7-2023-714ee

Technology-Enabled Team Care for High Blood Pressure The study involved 106 patients, and results showed a notable decrease in mean blood pressure from 156/85 mm Hg at baseline to 131/75 mm Hg at 12 months, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25003126

Clinical and Engagement Results of a Nationwide ... There was a 70% relative increase in the number of patients at goal BP at follow-up (36.6% vs 21.5%; P < 0.001). Results among rural/underserved patients were ...

4. 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.

5. cdc.gov cdc.gov/high-blood-pressure/php/data-research/team-based-care/index.html

Team-Based Care to Improve Blood Pressure Control The CPSTF found that team-based care is a cost-effective intervention to improve blood pressure control.1 Uncontrolled high blood pressure is a preventable risk ...

6. dhcni.hscni.net dhcni.hscni.net/wp-content/uploads/2024/06/4.-Hypertension-TEC-Discovery-Sprint-Report.pdf?csrt=36984130259500765

Technology Enabled Care (TEC) Discovery - DHCNI Individuals may be better encouraged to engage in. TEC innovation for Hypertension management through increased awareness of benefits and impact.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03698890

Primary Technology Enhanced Care in Hypertension ... This study evaluates the impact of the use of a technology-enabled home blood pressure monitor amongst hypertensive patients in primary care.

8. healthsnap.io healthsnap.io/the-impact-of-virtual-care-management-programs-on-hypertension-outcomes-in-2024/

The Impact of Virtual Care Management Programs on ... The ability to monitor blood pressure remotely not only improves patient outcomes but also leads to significant cost savings for healthcare ...