Technology-Enabled Team Care for High Blood Pressure

Recruiting 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

780 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to compare a new model of care that uses cellular-enabled home blood pressure (BP) telemonitoring and combines it with team-based BP control using a pharmacist to help manage BP medications and to give patients advice on diet and exercise, to an enhanced usual care group that only receives the monitoring device and basic instructions, in individuals with a history of uncontrolled hypertension. The main question\[s\] it aims to answer are: 1. Among patients with a history of uncontrolled hypertension, evaluate the impact of team-based care using technology-enabled monitoring on improving goal-directed systolic blood pressure (SBP) levels relative to enhanced usual care (primary). 2. Assess the potential for heterogeneity of treatment effects by race, age, sex, and social deprivation index (secondary). 3. Examine the impact of the intervention on hypertension self-efficacy, medication adherence, timeliness of medication change, satisfaction with care, adoption of home BP monitoring, and the change in mean BP in diverse patients, many of whom have adverse social determinants of health (SDOH) (secondary/exploratory). Both groups will be asked to check their BP at home using a cellular-enabled home BP monitoring device that's provided. Patients in the Technology enabled Team Care (TTC) intervention group will have regular phone calls from a clinically trained and experienced pharmacist that works with their doctor/provider and who has reviewed their home BP readings. This pharmacist will help them adjust their medicines, provide brief nutrition and physical activity advice, and may refer them for help with any social challenges (not enough proper food, transportation problems, etc.) that they may be experiencing. An enhanced usual care group will serve as the comparison group and will receive the BP cuff monitoring device and basic instructions but will not receive ongoing monitoring or team care as described above. Researchers will compare the effect of the TTC intervention model to enhanced usual care to assess the impact on SBP levels at 6 and 12 months follow-up, as well as on a variety of patient-reported outcomes.

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.

Is Technology-Enabled Team Care for High Blood Pressure safe for humans?

The TeamSTEPPS program, which is similar to Technology-Enabled Team Care, has been shown to improve patient safety by enhancing teamwork and communication among healthcare providers. This approach has been implemented in various healthcare settings, leading to better safety outcomes. ^{1 2 3 4 5}

How is the Technology-enabled Team Care treatment for high blood pressure different from other treatments?

Technology-enabled Team Care is unique because it involves a team of healthcare professionals, like nurses and pharmacists, working together to manage high blood pressure, rather than relying on a single doctor. This collaborative approach aims to improve blood pressure control more effectively than traditional methods. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Technology-enabled Team Care for High Blood Pressure?

Research shows that team-based care, which involves healthcare professionals like nurses and pharmacists working together, is effective in improving blood pressure control. This approach has been shown to enhance the management of high blood pressure compared to usual care. ^{6 7 8 11 12}

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

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 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]

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]

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]

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]

Citations

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

Blood Pressure Control and Associated Factors in a Real-World Team-Based Care Center. [2021]

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

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

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

Improved blood pressure control with a physician-nurse team and home blood pressure measurement. [2013]

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Team-based care and improved blood pressure control: a community guide systematic review. [2022]

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

Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. [2023]

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

The TeamSTEPPS Approach to Safety and Quality. [2022]

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

Implementation of TeamSTEPPS at a Level-1 Military Trauma Center: The San Antonio Military Medical Center Experience. [2022]

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

Building a culture of safety through team training and engagement. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Republished: Building a culture of safety through team training and engagement. [2022]

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

Determining the frequency and level of task-sharing for hypertension management in LMICs: A systematic review and meta-analysis. [2022]

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

Effectiveness and Cost-Effectiveness of Team-Based Care for Hypertension: A Meta-Analysis and Simulation Study. [2023]