Pharmacist-Led Care for Cardiovascular Disease

(INCLUDE Trial)

Overseen By Kirk U Knowlton, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

Must be taking: Statins, LLT

Disqualifiers: Under 18, Palliative care, Pregnant

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study focuses on managing LDL-C levels, it might involve changes to your statin or lipid-lowering therapy (LLT) regimen.

What data supports the effectiveness of the treatment Clinical Pharmacy Team for cardiovascular disease?

Research shows that pharmacist-led care can lower blood pressure and reduce cardiovascular disease risk. Pharmacists also help improve medication use and patient outcomes by providing education, monitoring, and support, which can lead to better control of conditions like hypertension and diabetes. ^{1 2 3 4 5}

Is pharmacist-led care generally safe for humans?

Research shows that having a pharmacist as part of a healthcare team can help reduce medication errors and adverse drug events (harmful effects from medicines), which suggests that pharmacist-led care is generally safe for humans. ^{6 7 8 9 10}

How is the pharmacist-led care for cardiovascular disease treatment different from other treatments?

Pharmacist-led care for cardiovascular disease is unique because it involves pharmacists actively participating in patient education, medication management, and monitoring of cardiovascular risk factors, which can lead to better control of conditions like high blood pressure and diabetes. This approach emphasizes prevention and collaboration with other healthcare providers, making it a modern and efficient model for managing cardiovascular health. ^{1 3 11 12 13}

What is the purpose of this trial?

Patients who had an ASCVD event at an Intermountain hospital will be screened for eligibility to be randomized. Subjects who meet eligibility criteria will be randomized 1:1 to receive targeted care of their LDL-C through a pharmacist-driven management program or not. Patients may opt-out of receiving LDL-C management by the pharmacy team at any time. The purpose of this program is to increase the proportion of patients who achieve guideline-based recommendations of LDL-C levels of \<70 mg/dL by increasing statin and/or LLT adherence and LDL-C testing. Data collection as part of the study will continue until the last person randomized has had 1-year of follow-up.

Eligibility Criteria

This trial is for patients who have had an event related to atherosclerotic cardiovascular disease at an Intermountain hospital. They should be willing to potentially receive LDL-C management from a clinical pharmacy team and follow up for one year.

Inclusion Criteria

Value-based patient (as defined in the EDW)

I am over 18 years old.

Receives follow-up care with Intermountain Health

Exclusion Criteria

Pregnant or lactating women

I am receiving or will receive care to ease symptoms, not cure my disease.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive targeted care of their LDL-C through a pharmacist-driven management program or usual care

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Clinical Pharmacy Team

Trial Overview The study compares two approaches: one where patients get targeted care for managing their LDL cholesterol through a pharmacist-led program, versus usual care without this specialized intervention. The goal is to see if the pharmacy program helps more people reach ideal LDL levels.

Participant Groups

Group I: Clinical Pharmacy Team Experimental Treatment 1 Intervention

Patients will receive targeted care of their LDL-C through a pharmacist-driven management program.

Group II: Usual Care Active Control 1 Intervention

Patients will receive usual care for their LDL-C management.

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Findings from Research

Cardiovascular drugs have been shown to significantly improve patient outcomes, but they are often underutilized and prescribed at suboptimal doses, leading to reduced effectiveness.

Pharmacists can play a crucial role in enhancing patient care and survival rates by managing cardiovascular risks through dedicated clinics and better patient engagement, leveraging their access and expertise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ensuring that patients receive full cardiac pharmacotherapy services: a pharmacist's call to arms. White, CM.[2007]

Pharmacists can significantly improve the management of cardiovascular diseases through patient education, medication reviews, and monitoring of risk factors, leading to better control of conditions like hypertension and diabetes, as shown in systematic reviews of various studies.

A multidisciplinary approach that includes pharmacists in community settings is likely the most effective model for healthcare delivery, but more research is needed to fully understand the impact of pharmacists' interventions on cardiovascular health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of pharmacist's intervention in the management of cardiovascular diseases. Omboni, S., Caserini, M.[2022]

In a study involving 2,164 patients with left ventricular systolic dysfunction, a pharmacist-led intervention improved the prescribing of heart failure medications, with significant increases in treatment initiation and dose adjustments compared to usual care.

Despite these improvements in medication management, the intervention did not lead to better clinical outcomes, such as reduced death or hospital admissions for heart failure, indicating that the baseline treatment levels were already high among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. Lowrie, R., Mair, FS., Greenlaw, N., et al.[2022]

Multidisciplinary care teams that include pharmacists are effective in preventing adverse drug events (ADEs), with the most common intervention being structured medication review meetings involving physicians, pharmacists, and nurses.

The majority of interventions targeted elderly patients, particularly those in nursing homes, highlighting the need for comprehensive medication assessments in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. Zaij, S., Pereira Maia, K., Leguelinel-Blache, G., et al.[2023]

In a study involving 303 patients at Southampton Hospitals, pharmacist-led monitoring effectively identified 21 suspected adverse drug reactions (ADRs) associated with newly marketed drugs, demonstrating the feasibility of this approach in a hospital setting.

The study highlighted that while pharmacist monitoring was effective, the lack of electronic patient records (EPRs) limited efficiency; better-designed EPR systems could enhance the identification of patients on newly marketed drugs and improve monitoring outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group. Emerson, A., Martin, RM., Tomlin, M., et al.[2016]

The implementation of a pharmacist-led pediatrics medication safety team (PMST) in a pediatric critical care center resulted in a significant increase in reported medication errors, with reporting rates increasing sixfold from the initial phase to the final phase of the study.

Despite the increase in reported errors, the severity of these errors decreased dramatically, indicating that the PMST and educational interventions improved overall medication safety, with severe errors dropping from 46% to 0% over the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a pharmacist-led pediatrics medication safety team on medication-error reporting. Costello, JL., Torowicz, DL., Yeh, TS.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

e-Care for heart wellness: a feasibility trial to decrease blood pressure and cardiovascular risk. [2021]

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

Ensuring that patients receive full cardiac pharmacotherapy services: a pharmacist's call to arms. [2007]

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

Effectiveness of pharmacist's intervention in the management of cardiovascular diseases. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pharmaceutical services as a tool to improve outcomes in patients with cardiovascular diseases. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. [2022]

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

Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Effects of a pharmacist-led pediatrics medication safety team on medication-error reporting. [2022]

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

Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. [2021]

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

A clinical pharmacist-led integrated approach for evaluation of medication errors among medical intensive care unit patients. [2021]

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

Collaborative practice model between cardiologists and clinical pharmacists for management of patients with cardiovascular disease in an outpatient clinic. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Risk Reduction to Disease Management: Clinical Pharmacists as Cardiovascular Care Providers. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Improving medication optimisation in left ventricular systolic dysfunction after acute myocardial infarction. [2020]