Pharmacist Intervention for Cardiovascular Disease Prevention
(PRxOACT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Heart disease is a common and serious medical condition which causes nearly one in every three deaths worldwide every year.
The factors which increase people's risk for heart disease are well-known, but there needs to be more support given to people to reduce their risk of heart disease. Pharmacists are front line primary healthcare providers who see patients more frequently than any other healthcare provider and can help people reduce their risk of heart disease.
This research project aims to see whether a pharmacist-led intervention can help people reduce their risk of heart disease. 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 community.
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 data supports the effectiveness of the treatment Pharmacist Case Finding and Intervention for Vascular Prevention Trial?
Research shows that pharmacist interventions, such as patient education and medication management, can improve control of high blood pressure, cholesterol, and diabetes, which are key risk factors for heart disease. These interventions have also been linked to reduced hospitalizations for heart failure, suggesting that pharmacists can play a crucial role in preventing cardiovascular diseases.
12345Is the pharmacist intervention for cardiovascular disease prevention safe for humans?
Pharmacist interventions have been shown to improve medication safety by reducing medication errors and managing drug safety, which suggests they are generally safe for humans.
13567How is the Pharmacist Case Finding and Intervention for Vascular Prevention Trial treatment different from other cardiovascular disease treatments?
This treatment is unique because it involves pharmacists actively identifying and managing patients with uncontrolled cardiovascular risk factors, focusing on education, medication review, and monitoring, which is different from traditional treatments that may not involve such direct pharmacist intervention.
138910Eligibility Criteria
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
I am 18 years old or older.
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
I am not willing to sign the consent form.
I cannot commit to regular follow-up visits.
Pregnant
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacist-led care pathwayExperimental Treatment1 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 CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of AlbertaEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
Collaborative Cardiovascular Risk Reduction in Primary Care II (CCARP II): Implementation of a systematic case-finding process for patients with uncontrolled risk factors. [2023]Previous pharmacist interventions to reduce cardiovascular (CV) risk have been limited by low patient enrolment. The primary aim of this study was to implement a collaborative pharmacist intervention that used a systematic case-finding procedure to identify and manage patients with uncontrolled CV risk factors.
The Collaborative Cardiovascular Risk Reduction in Primary Care (CCARP) study. [2010]To evaluate whether a simple pharmacist protocol, consisting of patient screening and cardiovascular risk stratification, identification and reminders about uncontrolled risk factors, and drug adherence support, can significantly reduce cardiovascular risk.
Effectiveness of pharmacist's intervention in the management of cardiovascular diseases. [2022]The pharmacist may play a relevant role in primary and secondary prevention of cardiovascular diseases, mainly through patient education and counselling, drug safety management, medication review, monitoring and reconciliation, detection and control of specific cardiovascular risk factors (eg, blood pressure, blood glucose, serum lipids) and clinical outcomes. Systematic reviews of randomised controlled and observational studies have documented an improved control of hypertension, dyslipidaemia or diabetes, smoking cessation and reduced hospitalisation in patients with heart failure, following a pharmacist's intervention. Limited proof for effectiveness is available for humanistic (patient satisfaction, adherence and knowledge) and economic outcomes. A multidisciplinary approach, including medical input plus a pharmacist, specialist nurse or both, and a greater involvement of community rather than hospital pharmacists, seems to represent the most efficient and modern healthcare delivery model. However, further well-designed research is demanded in order to quantitatively and qualitatively evaluate the impact of pharmacist's interventions on cardiovascular disease and to identify specific areas of impact of collaborative practice. Such research should particularly focus on the demonstration of a sensitivity to community pharmacist's intervention. Since pharmacy services are easily accessible and widely distributed in the community setting, a maximum benefit should be expected from interventions provided in this context.
Ensuring that patients receive full cardiac pharmacotherapy services: a pharmacist's call to arms. [2007]While clinical trials have proven that use of certain cardiovascular drugs improves morbidity and mortality, these drugs are not widely used, they are by and large prescribed in suboptimal doses, and their benefit is further diminished by nonadherence. Pharmacists have the ability to improve the survival of patients with cardiovascular risks. This can only be accomplished through the efforts of the individual pharmacist and the further development of health-system management services. Pharmacists need to leverage their access to patients, their large patient base, and their knowledge of refill dates to improve patient care. Support and development of more pharmacist-directed anticoagulation, hyperlipidemia, and hypertension clinics are also needed.
A pilot study evaluating multiple risk factor interventions by community pharmacists to prevent cardiovascular disease: the PAART CVD pilot project. [2022]There is insufficient evidence for the efficacy of comprehensive multiple risk factor interventions by pharmacists in the primary prevention of cardiovascular disease (CVD). Given the proven benefits of pharmacist interventions for individual risk factors, it is essential that evidence for a comprehensive approach to care be generated so that pharmacists remain key members of the health care team for individuals at risk of initial onset of CVD.
Optimizing the pharmacotherapy of vascular surgery patients by medication reconciliation. [2016]Medication errors may occur at any stage during the medication process and can lead to preventable adverse drug events and patients' harm. Pharmacists' support for reconcilable medication has been shown to be effective, rectifying errors and inaccuracies of the drug treatment and in the increase of medication safety. However, none of the previous studies focused on vascular patients. We investigated the nature and frequency of drug-related problems (DRPs) including the amount of potentially inappropriate medication (PIM) prescribed for elderly patients suffering from vascular diseases and the influence of pharmacists in the improvement of cardiovascular medication.
Pharmacist prescribing and care improves cardiovascular risk, but is it cost-effective? A cost-effectiveness analysis of the RxEACH study. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">The RxEACH randomized trial demonstrated that community pharmacist prescribing and care reduced the risk for cardiovascular (CV) events by 21% compared to usual care.
Cardiovascular disease as a leading cause of death: how are pharmacists getting involved? [2023]Cardiovascular diseases (CVDs) are a leading cause of death globally. This article explores the evidence surrounding community pharmacist interventions to reduce cardiovascular events and related mortality and to improve the management of CVD risk factors. We summarize a range of systematic reviews and leading randomized controlled trials and provide critical appraisal. Major observations are that very few trials directly measure clinical outcomes, potentially owing to a range of challenges in this regard. By contrast, there is an extensive, high-quality evidence to suggest that improvements can be achieved for key CVD risk factors such as hypertension, dyslipidemia, tobacco use, and elevated hemoglobin A1c. The heterogeneity of interventions tested and considerable variation of the context under which implementation occurred suggest that caution is warranted in the interpretation of meta-analyses. It is highly important to generate evidence for pharmacist interventions in developing countries where a majority of the global CVD burden will be experienced in the near future. A growing capacity for clinical registry trials and data linkage might allow future research to collect clinical outcomes data more often.
The Role of Pharmacists in Cardiovascular Disease Prevention: Qualitative Studies from the United Kingdom and Greece. [2022]In the United Kingdom (UK), cardiovascular disease (CVD) is the second main cause of death (27.4%) and the leading cause of death in Greece, accounting for 48% incidences. Pharmacists, the most accessible health-care professionals, can have a key role in all stages of CVD prevention. This study aimed to explore the current and future role of pharmacists in CVD prevention, focusing on two European countries, the United Kingdom and Greece.
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. [2023]Although some studies have demonstrated that pharmacist intervention can improve drug therapy among patients with cardiovascular disease (CVD), more evidence derived from randomized controlled trials (RCTs) is needed, including assessment of the effect of community pharmacist interventions in patients with CVD.