Pharmacist Intervention for Cardiovascular Disease Prevention

(PRxOACT Trial)

Overseen By Yazid Al Hamarneh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

982 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a pharmacist-led care plan can help reduce heart disease risk. Heart disease poses a major health concern, and the trial seeks new prevention methods by having pharmacists guide patients through lifestyle changes or medication. Participants will either follow a pharmacist-led plan (Pharmacist Case Finding and Intervention for Vascular Prevention Trial) or continue their usual care. The trial seeks adults with conditions such as diabetes, high blood pressure, or those who use tobacco or vape. As an unphased trial, it offers participants the chance to contribute to innovative heart disease prevention strategies.

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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this pharmacist-led intervention is safe for cardiovascular disease prevention?

Research has shown that programs led by pharmacists are generally safe and well-received. Studies have demonstrated that these programs can significantly lower heart disease risk factors, such as high blood pressure and cholesterol, without major safety concerns.

For example, one study found that pharmacist-led care resulted in significant reductions in blood pressure, LDL cholesterol (often called "bad" cholesterol), and body mass index (a measure of body fat based on height and weight). These results suggest that pharmacist-led care can effectively and safely manage heart health.

A 2023 analysis noted that pharmacist-led programs have also been linked to a lower risk of heart attacks, indicating their potential to greatly improve heart health without introducing new safety issues.

Overall, current evidence supports the safety of pharmacist-led programs for managing heart disease risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a pharmacist-led care pathway for preventing cardiovascular disease, which could be a game-changer compared to current options. Unlike usual care, where patients rely on their family physicians for guidance, this new approach involves pharmacists directly in the risk reduction process. Using a computer-based program, pharmacists work with patients to evaluate and manage cardiovascular risks through shared decision-making. This empowers patients to actively participate in their health management and could lead to more personalized and effective lifestyle changes and treatments.

What evidence suggests that this pharmacist-led intervention is effective for reducing heart disease risk?

Research has shown that pharmacists play a key role in reducing heart disease risk. In the RxEACH study, pharmacists helped patients lower their risk of heart problems by advising on lifestyle changes and medication use. This trial will test a similar approach, where participants in the pharmacist-led care pathway arm will receive guidance to manage risk factors like high blood pressure and cholesterol. The aim is to empower patients to make informed choices and improve their heart health. Strong evidence supports this method, which could help many people lower their heart disease risk. ^{1 6 7 8 9}

Who Is on the Research Team?

Ross Tsuyuki

Principal Investigator

University of Alberta

Yazid Al Hamarneh

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults over 18 with conditions like chronic kidney disease, diabetes, heart-related issues (atherosclerotic vascular disease), high blood pressure, obesity, tobacco or vape use, and chronic inflammatory diseases. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

Clinical diagnosis of at least one of the following conditions: Diabetes, Chronic kidney disease, Chronic inflammatory condition (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, systemic lupus erythematosus or psoriasis), Atherosclerotic vascular disease, Hypertension, Obesity (defined as body mass index greater than 30), Current tobacco or vape use

Exclusion Criteria

Pregnant

I am not willing to sign the consent form.

I cannot commit to regular follow-up visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a pharmacist-led intervention to reduce cardiovascular risk, involving shared decision-making and lifestyle or pharmacological management

6 months

Regular visits with pharmacists for intervention and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist Case Finding and Intervention for Vascular Prevention Trial

Trial Overview The study tests a pharmacist-led care pathway to see if it can help reduce the risk of heart disease. Pharmacists will provide more frequent support to patients in managing their cardiovascular health.

How Is the Trial Designed?

Group I: Pharmacist-led care pathway Experimental Treatment 1 Intervention

Participants in the intervention arm will receive the care using a shared decision-making pharmacist-led care pathway designed to guide the cardiovascular (CV) risk reduction process. The pharmacist-led care pathway is modelled after the largest CV risk reduction randomized controlled trial in a community pharmacy setting (RxEACH Study), and based upon the latest CV risk reduction guidelines, such as C-CHANGE. This pathway will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to calculate the participant's estimated CV risk. The participant and pharmacist will be guided by the care pathway to review the participant's estimated CV risk and contributing CV risk factors and engage in shared decision-making to manage the participant's CV risk factors using lifestyle changes and/or pharmacological treatment as clinically appropriate.

Group II: Usual Care Active Control 1 Intervention

The control group will involve facilitated relay of information to participants' family physician. Participants in the control group will have their pharmacist collect information informing the patient's CV risk. Participants will then be given a letter that contains their values for CV risk factors (including blood pressure, HbA1c, and lipid panel), and they will be advised to present it to their family physician. No specific suggestions for CV risk reduction will be detailed in the letter. In the case where the patient does not have a family physician, they can be referred to a physician walk-in clinic. A follow-up appointment in 6-months' time will be booked for with all participants in the control group.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

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]

Community pharmacist interventions have shown significant improvements in managing key cardiovascular disease (CVD) risk factors like hypertension and dyslipidemia, although very few trials have directly measured clinical outcomes such as cardiovascular events or mortality.

There is a need for more evidence on pharmacist interventions, especially in developing countries, to address the growing burden of CVD, and future research should focus on collecting clinical outcomes data through clinical registry trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular disease as a leading cause of death: how are pharmacists getting involved? Mc Namara, K., Alzubaidi, H., Jackson, JK.[2023]

A pharmacist-led protocol aimed at reducing cardiovascular risk did not significantly lower the 10-year Framingham risk score or individual risk factors among 176 patients over 6 months.

However, the protocol did improve statin utilization, with a higher percentage of patients in the follow-up group continuing statin therapy (85.2%) compared to the single-contact group (67.0%), and more patients initiated statin therapy in the follow-up group (75.0% vs 48.9%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Collaborative Cardiovascular Risk Reduction in Primary Care (CCARP) study. Evans, CD., Eurich, DT., Taylor, JG., et al.[2010]

A community pharmacist-led intervention for 70 at-risk participants aged 50-74 resulted in a significant 25% reduction in overall cardiovascular disease (CVD) risk over 6 months, demonstrating the potential effectiveness of pharmacists in primary prevention.

Participants also experienced notable improvements in blood pressure and waist circumference, indicating that comprehensive risk factor management by pharmacists can lead to better cardiovascular health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study evaluating multiple risk factor interventions by community pharmacists to prevent cardiovascular disease: the PAART CVD pilot project. McNamara, KP., O'Reilly, SL., Dunbar, JA., et al.[2022]

In a study involving 105 elderly vascular patients, 138 drug-related problems (DRPs) were identified, averaging 1.3 DRPs per patient, highlighting the prevalence of medication errors in this population.

Pharmacists played a crucial role in improving medication safety by making 100 interventions, with 56 leading to specific recommendations for prescription changes, particularly in commonly affected drug classes like antihypertensives and antithrombotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the pharmacotherapy of vascular surgery patients by medication reconciliation. Hohn, N., Langer, S., Kalder, J., et al.[2016]

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]

The RxEACH trial showed that community pharmacist prescribing can reduce cardiovascular events by 21%, and implementing this care in Canada could save the healthcare system over $4.4 billion over 30 years.

Pharmacist care is projected to provide significant health benefits, including gaining 576,689 quality-adjusted life years and preventing over 8.9 million cardiovascular events, making it both more effective and cost-saving compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist prescribing and care improves cardiovascular risk, but is it cost-effective? A cost-effectiveness analysis of the RxEACH study. Al Hamarneh, YN., Johnston, K., Marra, CA., et al.[2022]

In a study involving 566 patients screened in a primary care clinic, 32.9% were found to have moderate to high cardiovascular risk with at least one uncontrolled risk factor, highlighting the prevalence of unmanaged cardiovascular issues.

The pharmacist intervention led to significant improvements, with 65.5% of patients showing at least a 50% reduction in their risk factor levels, demonstrating the effectiveness of systematic case-finding and collaborative management in controlling cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Cardiovascular Risk Reduction in Primary Care II (CCARP II): Implementation of a systematic case-finding process for patients with uncontrolled risk factors. Yakiwchuk, EM., Jorgenson, D., Mansell, K., et al.[2023]

Pharmacists in the UK and Greece recognize their potential role in cardiovascular disease (CVD) prevention, with UK pharmacists adopting a patient-centered approach while Greek pharmacists tend to use a more paternalistic style.

Both groups primarily focus on secondary prevention through medication dispensing, but Greek pharmacists see opportunities for primary prevention and early screening, highlighting the need for better training and interprofessional collaboration to enhance their effectiveness in CVD prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Pharmacists in Cardiovascular Disease Prevention: Qualitative Studies from the United Kingdom and Greece. Peletidi, A., Nabhani-Gebara, S., Kayyali, R.[2022]

In a study involving 714 patients with cardiovascular disease, pharmacist-led interventions significantly improved the achievement of blood pressure and cholesterol treatment goals compared to usual care, with 52.5% of the intervention group reaching BP goals versus 43.0% in the control group.

The intervention also led to a higher proportion of patients achieving total cholesterol goals (56.5% vs. 44.1%) and combined BP/TC goals (37.1% vs. 21.8%), demonstrating the effectiveness of collaborative pharmaceutical care in managing cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Dader Method for pharmaceutical care on control of blood pressure and total cholesterol in outpatients with cardiovascular disease or cardiovascular risk: EMDADER-CV randomized controlled trial. Amariles, P., Sabater-Hernández, D., García-Jiménez, E., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06405880

Pharmacist Case Finding and Intervention for Vascular ... The potential impact of this project is to empower people to understand how to reduce their risk of heart disease and reduce the burden of heart disease on the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25001271

Implementation of Pharmacist Case-Finding and Care ... The aim of this trial is to determine the impact of the pharmacist-led Care Pathway intervention on participants' estimated risk for major CV events.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40586019/

Implementation of Pharmacist Case-Finding and Care ... The aim of this trial is to determine the impact of the pharmacist-led Care Pathway intervention on participants' estimated risk for major CV events.

4. jacc.org jacc.org/doi/10.1016/j.jacc.2016.03.528

The Effectiveness of Pharmacist Interventions on ... The study sought to evaluate the effectiveness of a community pharmacy-based case finding and intervention on cardiovascular risk. Methods: The RxEACH (Alberta ...

5. researchgate.net researchgate.net/publication/390062358_Implementation_of_Pharmacist_Case-Finding_Care_Pathway_Intervention_for_Vascular_Prevention_PRxOACT_protocol_for_a_randomized_controlled_trial

Implementation of Pharmacist Case-Finding and Care ... The aim of this trial is to determine the impact of the pharmacist-led Care Pathway intervention on participants' estimated risk for major CV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3507563/

Pharmacist Interventions to Improve Cardiovascular Disease ... Pharmacist interventions were associated with significant reductions in systolic and diastolic BP, TC, LDL cholesterol, and BMI compared with the usual care ...

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

Effectiveness of pharmacist's intervention in the ... A good deal of randomised controlled studies documented a positive impact of pharmacist-directed care, including measurement of cardiovascular ...

8. pharmacist.com pharmacist.com/Blogs/CEO-Blog/pharmacists-are-essential-to-improve-cardiovascular-health

Pharmacists are essential to improve cardiovascular health A recent 2023 analysis published in JAMA Network Open found that pharmacist-led interventions could prevent 15 million heart attacks in America.

9. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/jac5.70108

Outcomes of the Pharmacist and Community Health Worker ... Pharmacist-led interventions have demonstrated success in managing cardiovascular risk factors; addressing social drivers of health (SDOH) ...