780 Participants Needed

Technology-Enabled Team Care for High Blood Pressure

Recruiting at 1 trial location
CK
DM
Overseen ByDoyle M Cummings, Pharm.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: East Carolina University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.678910

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.1241112

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.

Research Team

DC

Doyle Cummings, Pharm.D.

Principal Investigator

East Carolina University Brody School of Medicine

Eligibility Criteria

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.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Technology enabled Team CareExperimental Treatment1 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 CareActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

Blood Pressure Control and Associated Factors in a Real-World Team-Based Care Center. [2021]
The potency of team-based care interventions for hypertension: a meta-analysis. [2022]
Improved blood pressure control with a physician-nurse team and home blood pressure measurement. [2013]
Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. [2018]
Team-based care and improved blood pressure control: a community guide systematic review. [2022]
Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. [2023]
The TeamSTEPPS Approach to Safety and Quality. [2022]
Implementation of TeamSTEPPS at a Level-1 Military Trauma Center: The San Antonio Military Medical Center Experience. [2022]
Building a culture of safety through team training and engagement. [2022]
Republished: Building a culture of safety through team training and engagement. [2022]
Determining the frequency and level of task-sharing for hypertension management in LMICs: A systematic review and meta-analysis. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness and Cost-Effectiveness of Team-Based Care for Hypertension: A Meta-Analysis and Simulation Study. [2023]
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