Practice Facilitation for High Blood Pressure

Overseen by Antoinette Schoenthaler, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: NYU Langone Health

Must be taking: Anti-hypertensives

Disqualifiers: Psychiatric, Substance abuse, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants should have been prescribed at least one anti-hypertensive medication and be non-adherent to it.

What data supports the effectiveness of the treatment ALTA for high blood pressure?

The ALTA treatment, which focuses on improving medication adherence through a team-based care approach, has shown promise in improving blood pressure control among Latino patients in safety-net practices. Similar strategies, like lay counseling and patient-operated groups, have also been effective in increasing medication adherence and reducing blood pressure. ^{1 2 3 4 5}

Is the practice facilitation for high blood pressure treatment safe for humans?

The research does not provide specific safety data for practice facilitation for high blood pressure, but it mentions that adverse drug reactions (unwanted effects from medications) with antihypertensive drugs are generally infrequent and mostly mild, with serious reactions occurring in less than 1% of cases. ^{6 7 8 9 10}

How is the ALTA treatment for high blood pressure different from other treatments?

The ALTA treatment is unique because it uses a team-based care approach specifically designed to improve medication adherence among Latino patients with high blood pressure. It focuses on practice facilitation, which helps healthcare practices implement this multi-level intervention effectively in real-world settings, addressing the gap between evidence and practice. ^{1 11 12 13 14}

Research Team

Antoinette Schoenthaler, MD

Principal Investigator

NYUMC Langone

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

Self-identify as Latino

Exclusion Criteria

You plan to stop getting medical care at your current doctor's office within the next year.

I do not want to participate in the trial.

I am able to follow all study requirements.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care

All practice sites begin as part of the Usual Care control condition, receiving standard hypertension management without practice facilitation

Varies

Practice Facilitation

Implementation of the ALTA intervention with practice facilitation to improve medication adherence and blood pressure control

12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• ALTA (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Practice Faciliation Experimental Treatment 1 Intervention

Will be supported by a practice facilitator

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Findings from Research

This study aims to improve blood pressure control and medication adherence among Latino adults with hypertension by implementing a tailored practice facilitation strategy in 10 safety-net primary care practices in New York.

The effectiveness of this strategy will be evaluated through a rigorous stepped-wedge cluster randomized controlled trial, focusing on both the fidelity of implementing the intervention and clinical outcomes like blood pressure control and medication adherence over 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices. Schoenthaler, A., De La Calle, F., Soto, A., et al.[2021]

Nonadherence to antihypertensive medications leads to uncontrolled high blood pressure and negative health outcomes, highlighting the need for improved strategies to enhance medication adherence.

Four proposed strategies to improve adherence include focusing on clinical outcomes, empowering patients, developing proactive care teams, and advocating for health policy reform, which are essential for better management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence and persistence with taking medication to control high blood pressure. Hill, MN., Miller, NH., Degeest, S., et al.[2011]

Nonadherence to antihypertensive medications leads to uncontrolled high blood pressure and negative health outcomes, highlighting the need for improved strategies to enhance medication adherence.

Four key strategies are proposed to improve adherence: focusing on clinical outcomes, empowering patients, developing proactive care teams, and advocating for health care policy reform, which are essential for better management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ASH position paper: Adherence and persistence with taking medication to control high blood pressure. Hill, MN., Miller, NH., DeGeest, S.[2021]

In a study of 10 noncompliant hypertensive patients, monitoring and counseling led to significant reductions in blood pressure, with systolic pressure decreasing by 10 mmHg and diastolic pressure by 7 mmHg (P < 0.05).

Counseling also improved medication adherence from 69% to 84%, demonstrating that adjunctive support can effectively enhance treatment outcomes for patients struggling with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of lay counseling on medication adherence and blood pressure: adjunctive treatment for hypertension. Hovell, MF., Geary, DC., Black, DR., et al.[2019]

In a study of 52 previously noncompliant hypertensive patients, those trained to manage their own hypertension in a patient-operated group showed significantly better blood pressure control and medication adherence compared to those receiving traditional nurse-operated care.

The experimental group not only had lower diastolic blood pressure but also demonstrated better attendance and pill counts, suggesting that empowering patients through self-management can lead to improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing compliance. Patient-operated hypertension groups. Nessman, DG., Carnahan, JE., Nugent, CA.[2019]

Preventable adverse drug events (pADEs) occur at a median rate of 5.6 per 1000 person-months in ambulatory care, with cardiovascular drugs, analgesics, and hypoglycemic agents accounting for the majority of these events.

Many pADEs lead to hospitalization, highlighting the need for quality improvement programs that focus on reducing prescribing and monitoring errors, particularly for high-risk medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Thomsen, LA., Winterstein, AG., Søndergaard, B., et al.[2022]

A study from the Boston Collaborative Drug Surveillance Program found that while 'nuisance' adverse drug reactions (ADRs) from antihypertensive medications occur in 10 to 29% of patients, 'life-threatening' ADRs are very rare, occurring in less than 1%.

Clinicians should consider the potential severity and type of ADRs, along with patient compliance and education, when selecting antihypertensive therapies to ensure effective treatment and minimize negative impacts on patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions during treatment of hypertension. Kellaway, GS.[2018]

An interactive booklet was created to help patients understand the benefits and risks of antihypertensive drugs, aiming to prevent adverse drug events, which affect 25% of patients and can have severe consequences in 13% of cases.

The development process involved input from 27 experts and feedback from patients and healthcare providers, ensuring the booklet is user-friendly and addresses patient concerns about the expected benefits of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. Keriel-Gascou, M., Badet-Phan, A., Le Pogam, MA., et al.[2014]

A study involving 1095 patients and 60 general practitioners found that providing a booklet to patients significantly increased the reporting of adverse drug events (ADEs) related to antihypertensive medications, with patients in the intervention group being 3.5 times more likely to report ADEs compared to the control group.

The booklet not only enhanced ADE reporting but also improved patient satisfaction regarding communication with their general practitioners and management of high blood pressure, suggesting it could be a valuable tool in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial. Buchet-Poyau, K., Occelli, P., Touzet, S., et al.[2021]

This study will evaluate the effectiveness of combining practice facilitation with hypertension-focused clinical decision support (CDS) in improving blood pressure control among patients in small primary care practices, involving 46 practices in New York City.

The trial aims to determine whether this combined approach can enhance the implementation of CDS and ultimately lead to better management of hypertension, addressing a significant gap in care where only half of patients achieve adequate blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial. Blecker, S., Gannon, M., De Leon, S., et al.[2023]

Practices that received more coaching-based strategies from facilitators were more successful in implementing quality improvement (QI) interventions, with those receiving over 6 coaching activities implementing a median of 17 out of 35 interventions.

The study found no significant link between the number of strategies used by facilitators and the overall number of QI interventions implemented, suggesting that the type of facilitation strategy, particularly coaching, is more critical than the quantity of strategies employed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does coaching matter? Examining the impact of specific practice facilitation strategies on implementation of quality improvement interventions in the Healthy Hearts in the Heartland study. Walunas, TL., Ye, J., Bannon, J., et al.[2022]

Practice facilitation significantly improved smoking cessation interventions in primary care settings, with a notable increase in the proportion of smokers receiving counseling during the intervention period compared to the control period.

The study demonstrated that while practice facilitation enhanced the screening and cessation measures for smoking, further improvements in managing cardiovascular risk factors may require longer and more intensive interventions, as well as consideration of external policy influences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Guideline Adherence: An RCT Using Practice Facilitation. Shelley, DR., Gepts, T., Siman, N., et al.[2022]

Self-measured blood pressure monitoring programs (BPMPs) have been shown to effectively control hypertension, particularly when implemented with supportive protocols at Federally Qualified Health Centers in Hawaii.

Barriers to successful implementation included insufficient resources for blood pressure monitors, funding challenges affecting sustainability, and the absence of a standardized BPMP intervention, highlighting the need for policy and funding support to enhance these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Measured Blood Pressure Monitoring: Program Planning, Implementation, and Lessons Learned From 5 Federally Qualified Health Centers in Hawai'i. Stupplebeen, DA., Pirkle, CM., Sentell, TL., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices. [2021]

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

Adherence and persistence with taking medication to control high blood pressure. [2011]

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

ASH position paper: Adherence and persistence with taking medication to control high blood pressure. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

The effects of lay counseling on medication adherence and blood pressure: adjunctive treatment for hypertension. [2019]

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

Increasing compliance. Patient-operated hypertension groups. [2019]

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

Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Frequency of ambulatory care adverse events in Latin American countries: the AMBEAS/PAHO cohort study. [2016]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse drug reactions during treatment of hypertension. [2018]

9. France pubmed.ncbi.nlm.nih.gov

[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. [2014]

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

Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial. [2021]

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

Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Does coaching matter? Examining the impact of specific practice facilitation strategies on implementation of quality improvement interventions in the Healthy Hearts in the Heartland study. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Guideline Adherence: An RCT Using Practice Facilitation. [2022]

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

Self-Measured Blood Pressure Monitoring: Program Planning, Implementation, and Lessons Learned From 5 Federally Qualified Health Centers in Hawai'i. [2021]