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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if pharmacist-led care can help individuals with cardiovascular disease manage their cholesterol levels more effectively. Participants will receive either standard care or specialized attention from a clinical pharmacy team to maintain their LDL-C (a type of cholesterol) below 70 mg/dL, a level recommended for better heart health. The trial targets individuals who have experienced a heart-related event, such as a heart attack or stroke, at an Intermountain hospital. Participants should already be receiving follow-up care through Intermountain Health. As an unphased trial, this study allows participants to contribute to innovative care strategies that could enhance heart health management.

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 prior data suggests that this pharmacist-driven management program is safe for patients with cardiovascular disease?

Research shows that pharmacist-led care is both safe and effective. In previous studies, programs run by pharmacists have helped patients adhere to their medication plans without causing significant side effects. For instance, one study found that pharmacist-led care helped patients manage their cholesterol levels safely, with no major problems reported.

Another study demonstrated that pharmacists play a crucial role in managing heart health by ensuring correct medication use. Patients have responded positively to this approach. Overall, these findings suggest that pharmacist-led care is safe for managing cholesterol and improving medication adherence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for cardiovascular disease, which typically involves doctor-led management of LDL cholesterol through medications and lifestyle changes, the pharmacist-led care approach offers something different. This method uses a clinical pharmacy team to provide targeted, pharmacist-driven management of LDL-C levels. Researchers are excited about this trial because it explores how involving pharmacists directly in patient care might enhance treatment outcomes. By leveraging the expertise of pharmacists, the goal is to offer more personalized care, potentially leading to better cholesterol management and overall heart health.

What evidence suggests that this pharmacist-driven management program is effective for managing LDL-C levels?

Research has shown that involving a pharmacist in patient care can significantly improve the management of "bad" cholesterol, known as LDL-C, which is linked to heart disease. In this trial, participants will receive either usual care or join a Clinical Pharmacy Team, where pharmacists assist in managing medications. Studies have found that pharmacist involvement leads to more effective reductions in LDL-C levels compared to standard care. Pharmacists ensure patients take their medications correctly and understand their condition. This approach not only improves cholesterol levels but also addresses other heart-related issues. These findings suggest that pharmacist involvement can enhance heart health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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

Receives follow-up care with Intermountain Health

Value-based patient (as defined in the EDW)

I am over 18 years old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12582718/

Impact of clinical pharmacist-led pharmacotherapy on long ... We found that pharmacist participation markedly improved prescription appropriateness and medication adherence, increased the proportion of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S193328742030074X

Effect of pharmacist interventions on reducing low-density ... Pharmacist interventions significantly reduce LDL-C when compared with usual care. · Pharmacist interventions also improve total cholesterol, triglycerides, and ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828305

Pharmacist-Led Management Model and Medication ... This randomized clinical trial found a modest improvement in medication adherence among patients with CHF who received the pharmacist-led management ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5761304/

Effectiveness of pharmacist's intervention in the ... The interventions of pharmacists included patient education, medication management, feedback to healthcare professionals and disease management.

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2018.24.5.423

The Effect of Clinical Pharmacist-Led Comprehensive ... The integration of pharmacists in primary care settings can have positive effects on patient outcomes relating to chronic disease state control.

6. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/jac5.70107

The Impact of a Pharmacist‐Driven, Interprofessional Lipid ... The objective of this study was to evaluate the clinical effectiveness of a pharmacist-driven, interprofessional lipid optimization workflow in ...

7. drugtopics.com drugtopics.com/view/pharmacist-led-care-leads-to-better-outcomes-in-ascvd-ashp-midyear

Pharmacist-Led Care Leads to Better Outcomes in ASCVD The primary outcome was average LDL reduction; the key secondary outcomes included the percentage of patients who achieved LDL less than 70 mg/ ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0735109715062750

The Role of the Clinical Pharmacist in the Care of Patients ... Team-based cardiovascular care, including the use of clinical pharmacists, can efficiently deliver high-quality care. This Joint Council Perspectives paper ...