Practice Facilitation for High Blood Pressure
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
678910How 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.
111121314Eligibility 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
+4 more
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.
+2 more
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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYUMC LangoneNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
References
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]Poor adherence to antihypertensive medications is a significant contributor to the racial gap in rates of blood pressure (BP) control among Latino adults, as compared to Black and White adults. While multi-level interventions (e.g., those aiming to influence practice, providers, and patients) have been efficacious in improving medication adherence in underserved patients with uncontrolled hypertension, the translation of these interventions into routine practice within "real world" safety-net primary care settings has been inadequate and slow. This study will fill this evidence-to-practice gap by evaluating the effectiveness of practice facilitation (PF) as a practical and tailored strategy for implementing Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA), a multi-level approach to improving medication adherence and BP control in 10 safety-net practices in New York that serve Latino patients.
Adherence and persistence with taking medication to control high blood pressure. [2011]Nonadherence and poor or no persistence with taking antihypertensive medications results in uncontrolled high blood pressure, poor clinical outcomes and preventable health care costs. Factors associated with nonadherence are multilevel and relate not only to the patient, but also to the provider, health care system, health care organization, and community. National guideline committees have called for more aggressive approaches to implement strategies known to improve adherence and technologies known to enable changes at the systems level including improved communication among providers and patients. Improvements in adherence and persistence are likely to be achieved by supporting patient self-management, a team approach to patient care, technology-supported office practice systems, better methods to measure adherence, and less clinical inertia. Integrating high blood pressure control into health care policies that emphasize and improve prevention and management of chronic illness remains a challenge. Four strategies are proposed: focusing on clinical outcomes; empowering informed, activated patients; developing prepared proactive practice teams; and advocating for health care policy reform. With hypertension remaining the most common reason for office visits, the time is now.
ASH position paper: Adherence and persistence with taking medication to control high blood pressure. [2021]Nonadherence and poor or no persistence in taking antihypertensive medications results in uncontrolled high blood pressure, poor clinical outcomes, and preventable health care costs. Factors associated with nonadherence are multilevel and relate not only to the patient, but also to the provider, health care system, health care organization, and community. National guideline committees have called for more aggressive approaches to implement strategies known to improve adherence and technologies known to enable changes at the systems level, including improved communication among providers and patients. Improvements in adherence and persistence are likely to be achieved by supporting patient self-management, a team approach to patient care, technology-supported office practice systems, better methods to measure adherence, and less clinical inertia. Integrating high blood pressure control into health care policies that emphasize and improve prevention and management of chronic illness remains a challenge. Four strategies are proposed: focusing on clinical outcomes; empowering informed, activated patients; developing prepared proactive practice teams; and advocating for health care policy reform. With hypertension remaining the most common reason for office visits, the time is now.
The effects of lay counseling on medication adherence and blood pressure: adjunctive treatment for hypertension. [2019]Ten noncompliant hypertensive patients were monitored and received counseling from trained aides. Monitoring and lay counseling was associated with a reduction of -10 mmHg in systolic blood pressure and of -7 mmHg in diastolic pressure (P less than 0.05). Medication adherence increased from 69% to 84%. Counseling resulted in pressure decreases equal to those obtained by usual care for similar but compliant patients. This analysis provides a model for paraprofessional adjunctive counseling of patients thought to be adhering poorly to their medication regimen, which may improve control of hypertension.
Increasing compliance. Patient-operated hypertension groups. [2019]Compliance was compared in 52 previously noncompliant hypertensive patients randomly assigned for eight weeks to either a nurse-operated hypertension clinic (control) or a patient-operated hypertension group] (experimental). Control patients listened to audiotapes on hypertension and its management and met individually with a nurse who adjusted their drug regimens. Experimental patients were trained to take their own blood pressure (BP) and select their own drugs in a group program emphasizing informed self-help. After the eight-week training period and at two- and six-month follow-up visits, both groups had significantly lower BPs. Compared with control patients, experimental patients had lower diastolic BPs, better pill counts, and better attendance (all P
Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. [2022]To estimate the incidence and describe characteristics of preventable adverse drug events (pADEs) in ambulatory care.
Frequency of ambulatory care adverse events in Latin American countries: the AMBEAS/PAHO cohort study. [2016]Determine the frequency and preventability of adverse events (AEs) from available information sources in selected ambulatory care (AC) sites in Latin America (LA).
Adverse drug reactions during treatment of hypertension. [2018]Adverse drug reactions (ADRs) can be broadly classified as either "a nuisance" or "life-threatening". Voluntary reporting systems gradually accumulate a quite impressive list of suspected ADRs with antihypertensive drugs as their use becomes widespread. Such data gives no clue to true or relative incidence. The absolute and comparative incidence of ADRs can only be determined fairly by a system of unbiased general data collection of ADRs from which the data for antihypertensive drugs is then selected. The Boston Collaborative Drug Surveillance Program provides such a source of information. Data from the Boston Program reveals that most of the listed ADRs with antihypertensive drugs occur very infrequently, that "nuisance" ADRs occur in 10 to 29% of patients in whom they are used, and that "life-threatening" ADRs occur in less than 1%. ADRs tend to discourage patient compliance with medication aims. In selecting specific antihypertensive therapy the clinician should be mindful not only of the severity of the hypertension to be treated, but also of the nature, type, and severity of potential ADRs, the personality and likely complicance of the patient, and the need for patient education regarding drug effects, possible unwanted effects, and what measures should be taken when ADRs occur.
[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. [2014]Antihypertensive drugs are thought to be responsible for adverse drug events in 25% of patients, with severe consequences in 13% of cases. The purpose of this study was to develop an interactive booklet designed to inform and involve patients with a view to preventing adverse drug events.
Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial. [2021]About 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs.
Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial. [2023]Only half of patients with hypertension have adequately controlled blood pressure. Clinical decision support (CDS) has the potential to overcome barriers to delivering guideline-recommended care and improve hypertension management. However, optimal strategies for scaling CDS have not been well established, particularly in small, independent primary care practices which often lack the resources to effectively change practice routines. Practice facilitation is an implementation strategy that has been shown to support process changes. Our objective is to evaluate whether practice facilitation provided with hypertension-focused CDS can lead to improvements in blood pressure control for patients seen in small primary care practices.
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]Practice facilitation is a multicomponent implementation strategy used to improve the capacity for practices to address care quality and implementation gaps. We sought to assess whether practice facilitators use of coaching strategies aimed at improving self-sufficiency were associated with improved implementation of quality improvement (QI) interventions in the Healthy Hearts in the Heartland Study.
Cardiovascular Disease Guideline Adherence: An RCT Using Practice Facilitation. [2022]Practice facilitation is a promising practice transformation strategy, but further examination of its effectiveness in improving adoption of guidelines for multiple cardiovascular disease risk factors is needed. The objective of the study is to determine whether practice facilitation is effective in increasing the proportion of patients meeting the Million Hearts ABCS outcomes: (A) aspirin when indicated, (B) blood pressure control, (C) cholesterol management, and (S) smoking screening and cessation intervention.
Self-Measured Blood Pressure Monitoring: Program Planning, Implementation, and Lessons Learned From 5 Federally Qualified Health Centers in Hawai'i. [2021]Self-measured blood pressure monitoring programs (BPMPs) are effective at controlling hypertension. We examined implementation of self-measured BPMPs at 5 Hawai'i-based Federally Qualified Health Centers (FQHCs). In a process evaluation of these programs, we found that FQHCs developed protocols for self-measured BPMP recruitment and enrollment and provided additional supports to account for their patients' psychosocial needs to achieve blood pressure control, such as lifestyle change education and opportunities through referrals either to on-site or other programs (eg, on-site gym, tobacco cessation program). Common barriers across sites included insufficient material support for blood pressure monitors and data collection; funding, which affects program sustainability; and the lack of an "off-the-shelf" self-measured BPMP intervention. Policy makers and funding organizations should address these issues related to self-measured BPMPs to ensure implementation success.