Telehealth vs Clinic Management for High Blood Pressure

(TEAMS-BP Trial)

Overseen By Kelsey Shore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Hypertension medications

Disqualifiers: Subdural hematoma, Terminal illness, Pregnancy, 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 compares two methods for managing high blood pressure in individuals who have had a stroke. One group will use Intensive Tailored Telehealth Management, receiving personalized plans and coaching through devices like smartphones. The other group will attend clinics for regular check-ups and receive advice via text messages through Intensive Clinic Management. Suitable participants have had a stroke, have uncontrolled high blood pressure, manage their care at home, and use a smartphone or tablet. As an unphased trial, this study provides a unique opportunity to explore innovative management strategies for this condition.

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 study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like Intensive Tailored Telehealth Management (ITTM) receive positive feedback from patients. Studies on telehealth models indicate that patients can safely monitor their blood pressure at home. Sending this information digitally allows doctors to manage treatment remotely, which patients find convenient and effective.

For Intensive Clinic Management (ICM), strong evidence supports that closely monitoring and controlling blood pressure is safe. Research has demonstrated that this approach can lower the risk of heart problems without significantly harming other organs, such as the kidneys.

Both treatments in this trial are based on proven methods, suggesting they are likely safe and well-tolerated. Participants in similar trials have generally experienced positive results with few issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for high blood pressure because they explore new ways to manage the condition beyond traditional in-person care. Intensive Tailored Telehealth Management (ITTM) offers a personalized approach by addressing individual barriers to care through remote monitoring and health coaching, which is more convenient for patients. On the other hand, Intensive Clinic Management (ICM) provides structured in-person follow-ups but incorporates digital health promotion to support lifestyle changes. These approaches aim to improve blood pressure control by integrating technology and personalized care, potentially making management more accessible and effective for patients.

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

This trial will compare Intensive Tailored Telehealth Management (ITTM) with Intensive Clinic Management (ICM) for controlling high blood pressure. Research has shown that ITTM, which participants in this trial may receive, can lower blood pressure in stroke patients by using technology for home monitoring and providing personalized advice. Early studies suggest that individuals who track their blood pressure and receive customized guidance can experience significant improvements.

In contrast, ICM, another treatment option in this trial, involves regular clinic visits to check and control blood pressure. This approach has proven effective in preventing strokes by maintaining healthy blood pressure levels. Research has shown that clinic visits, with close monitoring and regular check-ups, can effectively manage blood pressure. Both methods have shown promise in controlling high blood pressure. ^{1 2 6 7 8}

Who Is on the Research Team?

Cheryl Bushnell, MD

Principal Investigator

Wake Forest University Health Sciences

Wayne Rosamond, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is designed for individuals who have experienced a stroke and are now managing high blood pressure. Participants should be interested in using telehealth services or attending intensive clinic visits to manage their condition.

Inclusion Criteria

I have had a stroke confirmed by an MRI or CT scan.

Systolic Blood Pressure ≥ 130 mmHg

Able to read and understand English or Spanish

Exclusion Criteria

Transitioned to a facility such as skilled nursing or long-term care prior to enrollment

Mid upper arm circumference > 45 cm/17.7 inches or < 22 cm / 8.66 inches

Missing values for Systolic Blood Pressure or Privileged Access Management (PAM) score at baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Intensive Tailored Telehealth Management or Intensive Clinic Management for blood pressure control

6 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Bi-monthly visits (in-person or virtual)

Long-term follow-up

Participants are monitored for major adverse cardiovascular events and changes in cognitive function

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Clinic Management
• Intensive Tailored Telehealth Management

Trial Overview

The TEAMS-BP study compares two approaches: one where patients receive intensive management at clinics, and another where they get tailored support through telehealth technology to control their blood pressure after a stroke.

How Is the Trial Designed?

Group I: Intensive Tailored Telehealth Management (ITTM) Experimental Treatment 1 Intervention

ITTM is a novel adaptation of the Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink) model, based on the premise that patients have social and functional barriers to blood pressure management. In the ITTM arm, barriers to care are identified and addressed through Blood Pressure Care Plan messaging and referrals to needed resources. The ITTM intervention includes a tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT. INTERVENT services may be reimbursed using Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) insurance billing codes. Blood pressure monitors and wearable physical activity trackers will be provided to participants as part of the study.

Group II: Intensive Clinic Management (ICM) Experimental Treatment 1 Intervention

ICM is based on the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) model and includes blood pressure management at in-person follow-up visits occurring every 2 months when systolic blood pressures are at target (i.e., \< 130 mmHg), and monthly when systolic blood pressure is ≥ 130 mmHg. Participants will also receive low-touch health promotion messaging via text messaging, with reminders focused on medication adherence, healthy diet, and physical activity and a tailored Blood Pressure Care Plan for managing stroke recovery. Participants will be encouraged to monitor their blood pressure at home and record values in logs. Blood pressure monitors will be provided as part of the study.

Intensive Clinic Management is already approved in United States, European Union for the following indications:

Approved in United States as Intensive Clinic Management for:

• Blood Pressure Management Following Stroke

Approved in European Union as Intensive Clinic Management for:

• Blood Pressure Management Following Stroke

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Intensive blood pressure control is both effective and cost-effective, but implementing it in everyday clinical practice faces significant challenges.

Team-based care models for managing hypertension have proven to be more effective than standard care, highlighting the need for further research on their cost-effectiveness and the barriers to their implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness and Challenges of Implementing Intensive Blood Pressure Goals and Team-Based Care. Derington, CG., King, JB., Bryant, KB., et al.[2020]

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]

In a study involving 103 patients in tele-ICU services, a total of 210 drug-related problems (DRPs) were identified, highlighting the importance of telepharmaceutical consultations in improving medication safety.

The implementation of telepharmaceutical consultations led to the discussion of significant drug-drug interactions and dosage adjustments, demonstrating that tele-ICU services can enhance the quality of care in remote areas lacking access to clinical pharmacists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication safety in a German telemedicine centre: Implementation of a telepharmaceutical expert consultation in addition to existing tele-intensive care unit services. Amkreutz, J., Lenssen, R., Marx, G., et al.[2020]

The high-intensity intensivist staffing model in critical care has been associated with better patient outcomes, including reduced mortality and complications, while also potentially lowering costs.

Tele-ICU technology effectively extends this high-intensity staffing model to underserved areas, improving patient outcomes when implemented correctly, highlighting the need for further research on its optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine in the intensive care unit: state of the art. Scurlock, C., D'Ambrosio, C.[2015]

The quality of care for critically ill patients in intensive care units (ICUs) heavily relies on the performance of interprofessional and interdisciplinary teams.

Implementing effective quality management measures based on valid indicators is essential for optimizing workflows and enhancing patient safety in ICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality Management in Intensive Care Units]. Riessen, R., Haap, M.[2019]

The study demonstrated that telemedicine consultations for pediatric critical care in community hospitals are feasible, but neither telemedicine nor traditional telephone consultations significantly improved adherence to resuscitation guidelines, as only 37% of teams successfully defibrillated within the target time.

While telemedicine did not enhance defibrillation success rates, it did lead to a higher use of essential equipment like backboards during resuscitation efforts, indicating potential benefits in resource utilization even if overall outcomes did not improve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation. Yang, CP., Hunt, EA., Shilkofski, N., et al.[2018]

Implementing collaborative patient care rounds in three intensive care units led to significant improvements in the consideration of key practice items related to patient care, particularly in areas like delirium prevention and device use, with eight out of thirteen items showing increased attention (p < 0.05).

Nursing participation in care rounds increased from 83.9% to 91.8%, and the verbalization of daily goals rose dramatically from 59.8% to 89.1% (p < 0.0001), indicating enhanced collaboration and communication among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of collaborative patient care rounds in the intensive care unit. Chapman, LB., Kopp, KE., Petty, MG., et al.[2021]

Training tailored to the specific needs of different professional groups is essential for the successful implementation of coordinated care and telehealth services, as highlighted by both service managers and frontline staff.

Frontline staff expressed more concerns than managers regarding organizational responsiveness and the pace of change, indicating a gap in perceptions that could affect the overall effectiveness of integrated care initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How the Integration of Telehealth and Coordinated Care Approaches Impact Health Care Service Organization Structure and Ethos: Mixed Methods Study. Davidson, R., Barrett, DI., Rixon, L., et al.[2022]

A study involving 141 cardiovascular disease patients showed that synchronous telehealth services significantly reduced hospital admission rates and lengths of stay for both older (≥65 years) and younger (<65 years) patients, indicating improved management of their conditions.

The telehealth intervention also led to substantial cost savings, with inpatient costs and total monthly expenses decreasing significantly for both age groups, highlighting its potential as a cost-effective strategy for managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome and cost-effectiveness of a synchronous telehealth service for seniors and nonseniors with cardiovascular diseases: quasi-experimental study. Chen, YH., Lin, YH., Hung, CS., et al.[2022]

A telemedical program significantly improved adherence to seven key quality indicators in intensive care units, enhancing aspects like sedation management and infection control, based on a study of 1463 patients across 12 ICU clusters in Germany.

The intervention led to substantial improvements in patient care processes, with adjusted odds ratios indicating strong effectiveness in areas such as ventilation and patient communication, although no difference was found in adherence to daily clinical visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial. Spies, CD., Paul, N., Adrion, C., et al.[2023]

Telemedicine has the potential to address the shortage of intensivists and specialized nurses in intensive care units (ICUs) by improving adherence to best practice guidelines, which could enhance the quality of care.

Current evaluations of tele-critical care have primarily focused on mortality and length of stay, but future assessments should also include functional outcomes and quality of life measures, as these are often more important to patients than just survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine in the intensive care unit: A vehicle to improve quality of care? Weiss, B., Paul, N., Balzer, F., et al.[2021]

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]

Telemedicine has become essential in intensive care units (ICUs) to enhance patient safety and ensure constant monitoring, especially with limited staffing and high workloads.

Nurses play a crucial role in leveraging telemedicine technology to improve communication with physicians, which is vital for timely decision-making and achieving better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new era in the ICU: the case for telemedicine. Yeo, W., Ahrens, SL., Wright, T.[2018]

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