What side effects are associated with this type of intervention?

Common treatments for high blood pressure include diuretics, ACE inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, and calcium channel blockers. Diuretics can cause electrolyte imbalances and dehydration. ACE inhibitors may lead to a persistent dry cough and elevated blood potassium levels. ARBs are generally well-tolerated but can also increase blood potassium. Beta-blockers might cause fatigue, cold extremities, and bradycardia. Calcium channel blockers can result in swelling of the lower extremities, dizziness, and constipation. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including ACE inhibitors (e.g., quinapril), angiotensin II receptor blockers (ARBs), and calcium channel blockers (CCBs). These medications have been shown to be effective in controlling blood pressure and reducing the risk of cardiovascular events. Practice facilitation, which supports healthcare practice processes and outcomes, aims to improve the implementation fidelity of these treatments and enhance clinical measures such as medication adherence and blood pressure control.

What other types of research exist?

Promising, novel alternatives to Practice Facilitation for high blood pressure patients include: 1) Risk-stratified population management dashboards, which use data analytics to identify and manage high-risk patients more effectively. 2) Telehealth interventions, which provide remote monitoring and support for blood pressure management. 3) Multicomponent quality improvement interventions (mQI) that combine various strategies such as patient education, self-monitoring, and clinical decision support tools. 4) Integration of behavioral health approaches, such as motivational interviewing and cognitive-behavioral therapy, to address lifestyle factors contributing to hypertension.

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Practice Facilitation for High Blood Pressure

Phase 4

Recruiting

Led By Antoinette Schoenthaler, EdD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be age 18 years or older

Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)

Must not have

Refuse to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial evaluates a method where a team helps healthcare providers improve how Latinx patients with high blood pressure take their medication and manage their health. Health coaches work with these patients to teach them about their medication, help them plan their care, and monitor their progress to achieve better health outcomes.

Who is the study for?

This trial is for adults over 18 who identify as Latino, speak English or Spanish, have high blood pressure not controlled by medication (less than 80% adherence), and are treated in a safety-net primary care practice. They must interact with healthcare staff regularly but can't join if they're in another hypertension study, have significant mental health or substance abuse issues, plan to leave their current clinic soon, or can't follow the study protocol.

What is being tested?

The trial is testing 'ALTA', an intervention facilitated by practice staff aimed at improving how well patients stick to their high blood pressure treatment plans. The main goal is to see if this approach helps patients better follow their treatment regimen and improve clinical measures like blood pressure after one year.

What are the potential side effects?

Since ALTA involves implementing a new practice facilitation method rather than a drug, traditional side effects aren't expected. However, there may be indirect effects related to changes in medication adherence or adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My blood pressure has been high (≥ 140/90 mmHg) on two visits in the past year.

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I am fluent in either English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not want to participate in the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Level of implementation fidelity

Secondary study objectives

Blood Pressure (BP) control

Medication adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Practice FaciliationExperimental Treatment1 Intervention

Will be supported by a practice facilitator

Group II: Usual CareActive Control1 Intervention

Using a stepped wedge design, all practice sites begin as part of the Usual Care (UC) control condition and will receive standard hypertension management that is part of the current clinic procedure. No practice facilitation will occur at this time.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include diuretics, which help the kidneys remove excess sodium and water from the body, reducing blood volume; ACE inhibitors and ARBs, which relax blood vessels by blocking the formation or action of angiotensin, a chemical that narrows blood vessels; calcium channel blockers, which prevent calcium from entering the cells of the heart and blood vessel walls, leading to more relaxed vessels; and beta-blockers, which reduce heart rate and the heart's output of blood. Understanding these mechanisms is crucial for patients as it helps them comprehend how their medications work to lower blood pressure, the importance of adherence, and the potential side effects, thereby improving their engagement and outcomes in treatment plans facilitated by healthcare practices.

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