Team-based Care for High Blood Pressure

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

90 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Practice Facilitation for high blood pressure?

Research shows that team-based care, which includes practice facilitation, is effective in improving blood pressure control. This approach involves healthcare professionals like nurses and pharmacists working together to help patients manage their blood pressure better. ^{1 2 3 4 5}

Is team-based care for high blood pressure safe for humans?

Team-based care, including practice facilitation and collaborative care models, has been used safely in various healthcare settings to manage conditions like hypertension and diabetes. These approaches often involve healthcare professionals working together to improve patient care and have shown improvements in medication safety and hypertension control without significant safety concerns. ^{5 6 7 8 9}

How is the treatment 'Practice Facilitation' for high blood pressure different from other treatments?

Practice Facilitation involves a team-based care approach where nurses, pharmacists, and physicians work together to manage high blood pressure, unlike traditional treatments that may rely solely on a single healthcare provider. This collaborative model aims to improve blood pressure control by leveraging the expertise of multiple healthcare professionals. ^{2 3 10 11 12}

What is the purpose of this trial?

The study is a stepped-wedge cluster randomized control trial to compare the effect of Practice Facilitation in 90 small-to-medium sized independent primary care practices on the adoption of team-based care.

Research Team

Donna Shelley, MD

Principal Investigator

NYU School of Global Public Health

Eligibility Criteria

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.

My practice manages hypertension for at least 200 patients.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Instrumental variable methods to assess quality of care the marginal effects of process-of-care on blood pressure change and treatment costs. [2021]

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

The potency of team-based care interventions for hypertension: a meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. [2018]

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

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

5. 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]

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

Clinical Pharmacist Team-Based Care in a Safety Net Medical Home: Facilitators and Barriers to Chronic Care Management. [2023]

7. 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]

8. Egypt pubmed.ncbi.nlm.nih.gov

Effects of self-empowered teams on rates of adverse drug events in primary care. [2021]

9. United States 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. [2023]

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

Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Team-based care and improved blood pressure control: a community guide systematic review. [2022]

12. Brazil pubmed.ncbi.nlm.nih.gov

Blood Pressure Control and Associated Factors in a Real-World Team-Based Care Center. [2021]