Team-based Care for High Blood Pressure

Not currently recruiting at 1 trial location

Overseen By Dominique Brown, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Large practice, Insufficient staff, No EHR, others

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

Compensation: Varies

Number of Visits: 24

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 in small-to-medium primary care practices can improve high blood pressure management. It compares practices receiving coaching and support on teamwork (practice facilitation) with those maintaining their usual care methods. The trial seeks practices treating at least 200 patients with high blood pressure and using electronic records. Participants will help assess whether teamwork can significantly improve blood pressure control. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance patient care and outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Practice Facilitation is safe for hypertension management?

Research has shown that practice facilitation is generally safe in primary care. This method involves trained helpers assisting medical practices in making changes to better manage high blood pressure.

Studies have found that practice facilitation improves blood pressure control, with success rates increasing from 54% to 61% in some cases. Another study showed improvements from 68% to 75%, even during challenging times like the COVID-19 pandemic. These results suggest that both healthcare staff and patients handle the process well.

Importantly, practice facilitation does not involve medications or surgeries, so there are no typical medical side effects. It focuses on teamwork and support to enhance care. While no specific reports of negative effects exist, the emphasis on changing how care is delivered is generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Practice Facilitation" approach for managing high blood pressure because it offers a hands-on, team-based method to improve patient outcomes. Unlike traditional treatments that rely solely on medications or periodic doctor visits, this approach involves a trained facilitator who works directly with practice staff through 24 site visits. The facilitator helps implement system changes tailored to better manage hypertension, aiming to enhance the care process and patient engagement. By focusing on practice-level improvements, this method has the potential to create more sustainable and effective hypertension management compared to standard care.

What evidence suggests that Practice Facilitation is effective for high blood pressure?

Research has shown that practice facilitation, which participants in this trial may receive, can help people better control their blood pressure. Evidence suggests that using practice facilitation increased blood pressure control rates from 54% to 61% in some groups. Another study found that blood pressure management improved, with control rates rising from 68% to 75%. These findings indicate that coaching and support from a trained facilitator can significantly aid in managing high blood pressure. Overall, practice facilitation appears to help more people achieve healthier blood pressure levels. ^{1 2 3 5 6}

Who Is on the Research Team?

Donna Shelley, MD

Principal Investigator

NYU School of Global Public Health

Are You a Good Fit for This Trial?

This trial is for small-to-medium primary care practices with 1-5 healthcare providers and at least 2 non-physician staff. They must use an EHR system, have over 200 patients with hypertension, not be involved in other CVD initiatives, and agree to a 'physician champion' leading the intervention.

Inclusion Criteria

Have no plans to participate in another CVD-related quality improvement initiative during the study

My care team includes at least 2 non-physician staff members available.

Agree to study terms including randomization, data sharing, participation in PF, and completion of surveys

Exclusion Criteria

My doctor's practice manages fewer than 200 patients with high blood pressure.

You are currently involved in or planning to join another program to improve cardiovascular health during the study.

Unwilling to identify a "physician champion" or staff member to collaborate on all aspects of the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Practices receive practice facilitation to support the adoption of team-based care aimed at improving hypertension management and blood pressure control.

12 months

24 site visits

Follow-up

Sustainability of team-based care and blood pressure control is assessed.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Practice Facilitation

Trial Overview The study tests Practice Facilitation's impact on adopting team-based care for managing high blood pressure within independent primary care practices. It randomly assigns when each practice starts the intervention in a stepped-wedge design.

How Is the Trial Designed?

Group I: Practice Facilitation Active Control 1 Intervention

Practices review coaching and support from a trained practice facilitator. This includes 24 site visits in which facilitators meet with staff to work on implementing system changes to improve hypertension management.

Group II: Current Practice Active Control 1 Intervention

Practices will deliver care as usual and patients at these sites receive standard HTN care delivered.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

New York City Department of Health and Mental Hygiene

Collaborator

Trials

20

Recruited

19,400+

Published Research Related to This Trial

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]

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]

A 22-month observational study showed that integrating pharmacists into care for patients with hypertension and diabetes improved patient engagement, as those in the pharmacy group had more frequent visits with their primary care providers.

Despite increased engagement, there were no significant differences in achieving treatment goals for blood pressure and A1c levels between patients receiving collaborative care and those receiving standard care, indicating that managing diabetes may be more challenging than hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Pharmacist Team-Based Care in a Safety Net Medical Home: Facilitators and Barriers to Chronic Care Management. Price-Haywood, EG., Amering, S., Luo, Q., et al.[2023]

The Team Resource Management intervention, particularly when combined with Practice Enhancement Assistants, significantly reduced the overall rate of adverse drug events and moderate to severe preventable events in primary care settings over a 12-month period.

This study, which involved 12 practices and utilized a Trigger Tool chart review method, highlights the effectiveness of structured interventions in improving medication safety for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of self-empowered teams on rates of adverse drug events in primary care. Singh, R., Anderson, D., McLean-Plunkett, E., et al.[2021]

The Hypertension Management Program (HMP) was successfully adapted and implemented in a federally qualified health center in South Carolina, involving clinical pharmacists in managing hypertension for 316 patients through 758 visits, demonstrating its effectiveness in improving hypertension control.

The total cost of the HMP was $325,532, averaging $3.62 per patient per month, indicating that a team-based, patient-centered approach can be both cost-effective and beneficial in resource-limited settings for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Approach for Evaluating Implementation Processes and Program Costs for a Hypertension Management Program Implemented in a Federally Qualified Health Center. Tucker-Brown, A., Spafford, M., Wittenborn, J., et al.[2023]

The TBC-HTA study is evaluating a team-based care intervention involving nurses, pharmacists, and physicians to improve blood pressure control in 110 hypertensive outpatients over a 6-month period, compared to usual care.

The primary goal is to assess the difference in daytime ambulatory blood pressure between the team-based care group and the usual care group, with secondary outcomes including patient and healthcare professional satisfaction and long-term blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. Santschi, V., Wuerzner, G., Chiolero, A., et al.[2018]

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]

Citations

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

Practice facilitation for scale up of clinical decision support ... Only half of patients with hypertension have adequately controlled blood pressure. Clinical decision support (CDS) has the potential to overcome barriers to ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2816426

Practice Facilitation and Peer Coaching for Uncontrolled ... Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11178242/

Practice Facilitation and Clinical Performance Feedback ... Despite disruptions from the COVID-19 pandemic, practices demonstrated significant improvements in BP (68% to 75%, p<0.001) and cholesterol management (72% to ...

4. 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 ...

5. journals.lww.com journals.lww.com/jphmp/fulltext/2024/07001/practice_facilitation_and_clinical_performance.14.aspx

Practice Facilitation and Clinical Performance Feedback... Despite disruptions from the COVID-19 pandemic, practices demonstrated significant improvements in BP (68%-75%, P < .001) and cholesterol management (72%-78%, P ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02646488

NCT02646488 | Using Practice Facilitation in Primary Care ... The primary purpose of this study is to evaluate the effectiveness of practice facilitation as a quality improvement strategy for implementing the Million ...