MI-CARE Team Model for Hypertension

(MI-CARE Trial)

Overseen By Susan J Shaw, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Hypertension medications

Disqualifiers: Inability to consent, Hostility

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

230 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you will continue your current medications since the trial focuses on improving medication adherence for hypertension.

What data supports the effectiveness of the MI-CARE treatment for hypertension?

Research shows that team-based care, involving collaboration between different healthcare professionals, can significantly improve blood pressure control. For example, a study found that a multidisciplinary approach increased blood pressure control rates from 51.0% to 67.4% in an underserved urban practice. This suggests that the MI-CARE treatment, which involves an interprofessional care team, may also be effective in managing hypertension. ^{1 2 3 4 5}

Is the MI-CARE Team Model for Hypertension safe for humans?

The MI-CARE Team Model, which involves a team-based approach to managing hypertension, has been used in various studies to improve blood pressure control. These studies did not report any specific safety concerns, suggesting that the model is generally safe for human use. ^{1 2 6 7 8}

How is the MI-CARE treatment for hypertension different from other treatments?

The MI-CARE treatment is unique because it involves an interprofessional care team approach, focusing on patient engagement and adherence to treatment plans, which is different from traditional methods that often rely solely on medication. This model emphasizes collaboration among healthcare providers and empowers patients to manage their own health, potentially leading to better blood pressure control. ^{1 2 6 9 10}

What is the purpose of this trial?

MI-CARE is an innovative coordinated care team intervention to improve medication adherence and blood pressure derived from research findings that build on existing clinical practice. Designed with an eye toward sustainability, MI-CARE incorporates billable pharmacist and CHW services for patients with low medication adherence and high burdens of chronic illness and preventable consequences. MI-CARE offers interprofessional team care with comprehensive expertise and complementary skill sets that mitigate the silo effect of specialized medicine to deliver primary care to diverse, high-risk populations experiencing disparities in hypertension.

Research Team

Jeannie K Lee, PharmD

Principal Investigator

University of Arizona College of Pharmacy

Eligibility Criteria

This trial is for adults over 18 who identify as African-American, Latino, or Vietnamese and speak English, Spanish, or Vietnamese. They must have high blood pressure treated with medication, use 5 or more chronic medications and have less than 80% adherence to their hypertension medication.

Inclusion Criteria

I am taking medication for high blood pressure.

I often forget to take my blood pressure medication.

I take 5 or more medications regularly for chronic conditions.

Exclusion Criteria

I understand the details and implications of the clinical trial.

I am willing and able to follow the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MI-CARE intervention, which includes medication optimization and tailored case management by a pharmacist-CHW team. Pill counts and blood pressure measurements are conducted at each visit.

6 months

Regular visits with the pharmacist-CHW team

Booster

A booster session is conducted one month after the intervention visits to reinforce adherence and blood pressure control.

1 month

Follow-up

Participants are monitored for medication adherence, blood pressure, and other health outcomes post-intervention.

6 months

Treatment Details

Interventions

• My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)

Trial Overview The MI-CARE program is being tested; it's a coordinated care team approach designed to improve how well patients stick to their blood pressure medication regimen by providing comprehensive primary care through an interprofessional team.

Participant Groups

Group I: MI-CARE Intervention Experimental Treatment 1 Intervention

Pharmacist-community health worker team providing coordinated care tailored to high-risk patients with hypertension. MI-CARE intervention participants will meet with the pharmacist-CHW team for medication optimization and tailored case management. Pill counts will be completed to assess adherence and BP will be measured at each visit to guide antihypertensive medication optimization and provide feedback to participants about their adherence and BP control. Intervention visits will be followed by a booster one month later.

Group II: Waitlist Control Active Control 1 Intervention

Participants enrolled in this arm will receive usual medical care

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Findings from Research

A multidisciplinary approach involving nurses, pharmacists, and physicians significantly improved blood pressure control in an underserved urban practice, with rates increasing from 51.0% to 67.4% during the intervention phase.

While medication adherence improved during the intervention, it did not remain elevated after the study ended, highlighting the need for ongoing support to maintain adherence in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multidisciplinary intervention to improve hypertension control in an urban underserved practice. Fortuna, RJ., Nagel, AK., Rose, E., et al.[2022]

The Hypertension Management Initiative (HMI) significantly improved patient engagement and knowledge about hypertension management, with 199 out of 3934 enrolled patients reporting satisfaction with regular monitoring and goal-setting for their health.

Healthcare providers noted that the HMI enhanced their confidence in diagnosing and managing hypertension, improved interprofessional collaboration, and allowed nurses to take on more independent roles, ultimately reducing the workload for physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension management initiative: qualitative results from implementing clinical practice guidelines in primary care through a facilitated practice program. Tobe, SW., Moy Lum-Kwong, M., Von Sychowski, S., et al.[2013]

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]

The pharmacist-physician collaborative practice model (PPCPM) significantly improved long-term blood pressure control rates in an underserved urban population, with 68% of patients achieving their blood pressure goals by 2013, compared to only 17% at baseline.

This model demonstrated effectiveness despite challenges such as high obesity rates and smoking prevalence, ranking in the 90th percentile of national quality benchmarks for hypertension management, highlighting the importance of interprofessional collaboration and accessible care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Pharmacist-Physician Team-Based Collaboration to Improve Long-Term Blood Pressure Control at an Inner-City Safety-Net Clinic. Sisson, EM., Dixon, DL., Kildow, DC., et al.[2022]

In a 12-month study involving 463 patients with hypertension, those receiving collaborative management from primary care-pharmacist teams achieved significantly lower blood pressure levels compared to those receiving usual care, with systolic blood pressure at 137/75 mmHg versus 143/78 mmHg.

The intervention group also had a higher rate of achieving target blood pressure (<140/90 mmHg) at 62% compared to 44% in the control group, indicating that pharmacist involvement in hypertension management can enhance treatment effectiveness without negatively impacting quality of life or patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of team-based care: impact of physician-pharmacist collaboration on uncontrolled hypertension. Hunt, JS., Siemienczuk, J., Pape, G., et al.[2022]

A physician-nurse team model, utilizing home blood pressure monitoring, significantly improved long-term hypertension control, with the percentage of patients achieving target blood pressure levels rising from 0% to 63% over 12 months.

The study involved 106 patients, and results showed a notable decrease in mean blood pressure from 156/85 mm Hg at baseline to 131/75 mm Hg at 12 months, indicating effective management and adjustment of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved blood pressure control with a physician-nurse team and home blood pressure measurement. Canzanello, VJ., Jensen, PL., Schwartz, LL., et al.[2013]

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]

All 23 countries and regions surveyed reported integrating team-based care for basic hypertension management, but only 30% implemented it for more advanced tasks, highlighting a gap in comprehensive care.

Healthcare workers recognized the benefits of team-based hypertension care, but faced barriers such as inadequate training (83%) and regulatory issues (76%), suggesting that improving training and support systems is crucial for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Landscape of team-based care to manage hypertension: results from two surveys in low/middle-income countries. Ogungbe, O., Cazabon, D., Moran, AE., et al.[2023]

This study evaluates a collaborative care model involving physicians and pharmacists to improve blood pressure control across 27 diverse primary care offices, focusing on underrepresented minorities and varying levels of clinical pharmacy services.

The randomized trial will assess the effectiveness and sustainability of this model over 9 or 24 months, providing insights into its potential for widespread adoption in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control. Carter, BL., Clarke, W., Ardery, G., et al.[2021]

References

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

Effectiveness of a multidisciplinary intervention to improve hypertension control in an urban underserved practice. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Hypertension management initiative: qualitative results from implementing clinical practice guidelines in primary care through a facilitated practice program. [2013]

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

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

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

Effectiveness of a Pharmacist-Physician Team-Based Collaboration to Improve Long-Term Blood Pressure Control at an Inner-City Safety-Net Clinic. [2022]

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

A randomized controlled trial of team-based care: impact of physician-pharmacist collaboration on uncontrolled hypertension. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Improved blood pressure control with a physician-nurse team and home blood pressure measurement. [2013]

7. 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]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Landscape of team-based care to manage hypertension: results from two surveys in low/middle-income countries. [2023]

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

A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control. [2021]