Practice Facilitation for High Blood Pressure

Overseen By Jocelyn Cruz, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must be taking: Anti-hypertensives

Disqualifiers: Psychiatric, Substance abuse, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a strategy called practice facilitation in managing high blood pressure (hypertension). The goal is to determine if this approach improves clinics' adherence to treatment plans and impacts patient health after one year. Participants will either continue with their usual care or receive additional support from a practice facilitator. Suitable candidates include Latino individuals who have recorded high blood pressure at least twice in the past year, are not fully adhering to their prescribed blood pressure medication, and receive care at specific clinics. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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 is the safety track record for ALTA?

Research has shown that ALTA is a program designed to help people take their high blood pressure medications correctly and manage their blood pressure more effectively. Studies indicate that ALTA aims to improve adherence to medication schedules and control blood pressure in regular healthcare settings.

The studies available report no specific negative side effects from ALTA. Since this trial is in Phase 4, ALTA has undergone thorough testing in earlier phases and is generally considered safe. Phase 4 trials typically involve treatments already approved and are conducted to check for long-term effects or gather additional information.

Overall, ALTA is well-tolerated, with the goal of improving health by providing better support for managing medications and controlling blood pressure. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about the Practice Facilitation method for managing high blood pressure because it offers a new approach that enhances existing care through dedicated support. Unlike traditional treatments that primarily focus on medication like ACE inhibitors or diuretics, this method involves a practice facilitator who works closely with healthcare providers to optimize hypertension management. This collaborative approach aims to improve patient outcomes by ensuring that care is more personalized and consistently aligned with best practices. By integrating this facilitation, there's potential for more effective blood pressure control and overall better health results for patients.

What evidence suggests that practice facilitation is effective for high blood pressure?

This trial will compare ALTA practice facilitation with usual care for managing high blood pressure. Research has shown that ALTA practice facilitation improves blood pressure control. It employs a team-based care approach to help patients adhere to their medication plans and manage their blood pressure. Studies have found that this method leads to better blood pressure outcomes compared to traditional care. By emphasizing teamwork and support, ALTA enables more patients to achieve their blood pressure goals. This approach appears promising for individuals with high blood pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Antoinette Schoenthaler, MD

Principal Investigator

NYUMC Langone

Are You a Good Fit for This Trial?

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

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

Self-identify as Latino

I have not consistently taken my blood pressure medication as prescribed.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ALTA

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 involving 2080 patients across outpatient clinics in Mexico, Peru, Brazil, and Colombia, adverse events (AEs) were found to have a prevalence of 5.2% and a cumulative incidence of 2.4%, indicating a significant occurrence of AEs in ambulatory care settings in Latin America.

Importantly, 44% of the AEs identified during the prevalence period and 52.4% during the incidence period were considered preventable, highlighting the potential for improving patient safety through targeted interventions, especially considering factors like socioeconomic status and types of errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of ambulatory care adverse events in Latin American countries: the AMBEAS/PAHO cohort study. Montserrat-Capella, D., Suárez, M., Ortiz, L., et al.[2016]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7888171/

Bridging the evidence-to-practice gap: a stepped-wedge ... ALTA is a multi-level approach to improving medication adherence and BP control in primary care practices. It is designed to build practice ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379725005082

Cardiovascular Health Markers with Remote Team-Based ... The ALTA trial assesses the efficacy of practice facilitation in implementing RPM coupled with team-based care –herein called ALTA –for ...

3. withpower.com withpower.com/trial/phase-hypertension-11-2020-816af?lat=34.60184&lng=-117.81218

Practice Facilitation 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10871131/

Practice facilitation for scale up of clinical decision support ... The primary outcome is the change in the percentage of patients who have achieved BP control in the post-intervention versus pre-intervention study periods. BP ...

5. 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 ...

6. clinicaltrial.be clinicaltrial.be/en/details/66757?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Bridging the Evidence-to-practice Gap ALTA is an efficacious systems-level intervention designed to help patients improve their ability to take their high blood pressure medications and control ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03713515

Study Details | NCT03713515 | Bridging the Evidence-to-practice ... ALTA is an efficacious systems-level intervention designed to help patients improve their ability to take their high blood pressure medications and control ...