BP REACH Intervention for High Blood Pressure

(BP-REACH Trial)

Recruiting at 3 trial locations

Overseen By Kassi Kronfeld, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Age < 35, Dementia, Aphasia, others

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

Compensation: Varies

Number of Visits: 4

546 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a team-based approach can more effectively help people lower their blood pressure compared to regular care. The BP REACH Intervention program includes support from a pharmacist and a health coach to manage medication and provide guidance. It targets individuals who have experienced a stroke or heart attack and are currently managing high blood pressure. Ideal candidates speak English or Spanish, receive care at one of the specified medical centers in Los Angeles, and have a systolic blood pressure of 130 or higher. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for managing high blood pressure.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this team-based program is safe for lowering blood pressure?

Research shows that team-based care, where pharmacists and nurses collaborate, effectively controls blood pressure. Studies have found that this approach can lower both systolic and diastolic blood pressure. Patients have tolerated this method well, with no major safety issues reported.

Similarly, the BP REACH Intervention involves a pharmacist and health coach assisting patients. It targets individuals who have had a stroke or heart attack to manage their blood pressure. Studies of similar programs have not reported significant side effects, suggesting that the BP REACH program is likely safe for participants.

Although this program is not a new drug or treatment, the involvement of healthcare professionals provides personalized support. This ensures that any medication side effects can be effectively managed by the healthcare team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BP REACH Intervention is unique because it combines several personalized elements to manage high blood pressure more effectively. Unlike standard treatments that typically focus on medication, this intervention includes educational materials, home blood pressure monitoring, coaching calls, and pharmacist-led medication management. Researchers are excited about this approach because it empowers patients with tools and support to take control of their health, potentially leading to better adherence and improved outcomes. This comprehensive strategy could offer a more holistic solution compared to traditional options.

What evidence suggests that the BP REACH Intervention is effective for lowering blood pressure?

Research has shown that a healthcare team, including a pharmacist and health coach, can help lower blood pressure. People receiving this support often manage their blood pressure better. Specifically, this team approach effectively reduces systolic blood pressure (the top number in a reading) for those with high blood pressure. The Centers for Disease Control and Prevention (CDC) notes that team-based care is cost-effective and helps prevent uncontrolled high blood pressure. In this trial, participants in the intervention arm will follow the BP REACH program, which may benefit those who have had a stroke or heart attack. ^{1 6 7 8 9}

Who Is on the Research Team?

Alejandra Casillas, MD

Principal Investigator

University of California, Los Angeles

Amytis Towfighi, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers over 35 years old with high blood pressure (SBP ≥ 130 mm Hg) who have had a stroke or heart attack and are patients at specific LA medical centers. It's not for those who can't consent due to conditions like dementia.

Inclusion Criteria

Your systolic blood pressure is 130 or higher.

I had a stroke or heart attack and am a patient at one of the specified medical centers.

Exclusion Criteria

Cannot provide informed consent due to dementia or aphasia

Your blood pressure is lower than 130 mm Hg.

I am under 35 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection including blood pressure, BMI, cholesterol, and other health metrics

1 week

1 visit (in-person)

Intervention

Participants receive a home blood pressure monitor, monthly coaching calls, and medication management by a pharmacist

12 months

Monthly phone calls

Follow-up

Participants are monitored for changes in blood pressure and other health metrics

12 months

3 visits (in-person) at Baseline, 3 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• BP REACH Intervention

Trial Overview The BP REACH Intervention, a team-based program involving pharmacists and health coaches, aims to lower blood pressure in people with past strokes or heart attacks. It will be compared to usual care over a period of 12 months.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants follow the intervention protocol, including receiving educational materials, a home blood pressure monitor, coaching calls from BP REACH coaches and medication management from a pharmacist.

Group II: Usual Care Active Control 1 Intervention

Participants receive the usual care received by patients of the medical center

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

Quality improvement strategies that effectively control blood pressure include team changes, patient education, and promoting self-management, highlighting the importance of a collaborative approach.

Barriers to blood pressure control can arise from patients, providers, and systems, suggesting that future research should focus on identifying the most effective components of these quality improvement interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing effective hypertension quality improvement strategies: barriers and potential solutions. Walsh, JM., Sundaram, V., McDonald, K., et al.[2021]

A study involving 3071 adults with moderately severe hypertension found that both clinic-based and telehealth care significantly reduced blood pressure over 12 months, with no significant difference in effectiveness between the two methods.

Patients receiving telehealth care reported higher satisfaction with their blood pressure management, including more frequent home monitoring and greater convenience, suggesting that telehealth is a safe and effective alternative to traditional clinic visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Margolis, KL., Bergdall, AR., Crain, AL., et al.[2023]

A community intervention targeting hypertension in predominantly racial/ethnic minority neighborhoods led to significant blood pressure improvements, especially in individuals with severely elevated blood pressure (≥160/100 mmHg), who saw a reduction from 165.4/98.3 mmHg to 150.4/90.8 mmHg.

After 3 months, 55.2% of participants with severely elevated blood pressure achieved controlled levels, demonstrating the effectiveness of education and empowerment strategies in managing hypertension in high-risk communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. Prendergast, HM., Escobar-Schulz, S., Del Rios, M., et al.[2022]

A telephonic outreach program significantly improved blood pressure control among patients with hypertension, with 32.5% of those receiving the intervention achieving control compared to 23.7% in the usual care group, based on a study involving over 64,000 participants.

Patients with pre-existing conditions like cardiovascular disease, chronic kidney disease, or diabetes benefited even more from the intervention, suggesting that targeted outreach could enhance BP management in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an automated telephone intervention to improve blood pressure control. Harrison, TN., Ho, TS., Handler, J., et al.[2021]

The Reach Out Cognition study will assess the acceptability and feasibility of using digital tools for self-administered cognitive assessments and blood pressure monitoring in hypertensive patients, extending data collection from 12 months to 18 months for better insights.

This study focuses on a predominantly working-age Black American population, aiming to inform future clinical trials and improve remote monitoring strategies for hypertension and cognitive health, potentially addressing health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition. Skolarus, LE., Dinh, M., Kidwell, KM., et al.[2021]

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]

The ongoing randomized controlled trial involves 294 veterans with hypertension receiving a nurse-administered, patient-tailored intervention aimed at improving blood pressure control over 2 years, with a high retention rate of 97% after the first year.

At 6 months, participants in the nurse intervention group showed a significant increase in confidence regarding their hypertension treatment compared to those receiving usual care, indicating the intervention's potential effectiveness in promoting medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. Bosworth, HB., Olsen, MK., Gentry, P., et al.[2015]

The American Heart Association's Check. Change. CONTROL (CCC) program, involving 4069 patients across 18 cities, showed that community-based blood pressure interventions can be effectively scaled and customized, leading to significant improvements in blood pressure.

High enrollment and engagement at various sites were linked to successful outcomes, with effective strategies including hypertension education classes, distribution of blood pressure cuffs, and active follow-up with participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a multi-community hypertension implementation study: the American Heart Association's Check. Change. Control. program. Anderson, ML., Peragallo Urrutia, R., O'Brien, EC., et al.[2021]

Currently, only about 31% of hypertensive patients in the U.S. have their blood pressure controlled to the target level of < 140/90 mm Hg, highlighting a significant gap in hypertension management since the Healthy People 2010 goal aims for 50%.

Improving awareness, treatment, and control rates could potentially resolve barriers to hypertension management, suggesting that achieving 80% awareness, 90% treatment of aware patients, and 70% control among treated patients could meet the national goal for blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling blood pressure in 50% of all hypertensive patients: an achievable goal in the healthy people 2010 report? Egan, BM., Basile, JN.[2016]

The Reach Out mHealth intervention, which uses SMS text messaging for self-measured blood pressure (SMBP) monitoring, was well-received by participants, indicating its potential effectiveness in engaging hypertensive patients in managing their blood pressure.

Participants with higher engagement levels had better understanding and social support, while those with lower engagement or who withdrew from the trial faced more health-related social needs, suggesting that addressing these needs could improve participation and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study. Hellem, AK., Whitfield, C., Casetti, A., et al.[2023]

In a study involving 139 African-American participants with chronic hypertension, 67% of those who completed the intervention achieved blood pressure control after 180 days, indicating a high overall success rate in managing hypertension.

Although the educational intervention did not significantly differ in effectiveness compared to the control group, factors like age and smoking status influenced the outcomes, suggesting that targeted approaches may be necessary for different patient demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced emergency department discharge for chronic hypertension management - Results of a randomized controlled trial. Gleason Comstock, J., Janisse, J., Streater, A., et al.[2022]

A 12-week salt reduction program significantly lowered blood pressure in adults, with an average decrease of -2.5 mm Hg in systolic blood pressure and -2.7 mm Hg in diastolic blood pressure, particularly benefiting those with high-normal blood pressure or hypertension.

While both the salt reduction and healthy lifestyle programs improved blood pressure, the salt reduction program was more effective, highlighting the importance of dietary quality in managing hypertension, especially through adherence to the Mediterranean diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. Moreira-Rosário, A., Ismael, S., Barreiros-Mota, I., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05937685

Study Details | NCT05937685 | Reducing Blood Pressure ... BP-REACH aims to test the impact of an intervention on systolic blood pressure (SBP) for individuals with a history of stroke or MI in a randomized controlled ...

2. withpower.com withpower.com/trial/phase-myocardial-infarction-6-2023-6b61f

BP REACH Intervention for High Blood Pressure The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with ...

3. 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.

4. 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S258975002300002X

Effectiveness, reach, uptake, and feasibility of digital health ... This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4672378/

Team-Based Care and Improved Blood Pressure Control Team-based care increased the proportion of people with controlled BP and reduced both systolic and diastolic BP, especially when pharmacists and nurses were ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10132961/

Randomized trial protocol for remote monitoring for equity in ... This study will design and test a digital health intervention for use in marginalized populations treated within safety net settings.

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.024975

BP MAP A Pragmatic Cluster Randomized Trial In this randomized trial, 2 methods of implementing a quality improvement intervention in 24 safety net clinics led to modest improvements in BP control.

9. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000232

Implementation Strategies to Improve Blood Pressure ... This scientific statement provides information on the implementation strategies to optimize hypertension management and to improve BP control among adults in ...