Despite the cardiovascular disease (CVD) risk associated with hypertension, diabetes, dyslipidemia, and smoking, these risk factors remain poorly identified and controlled.
The RxEACH study was the first large randomized trial of CVD risk reduction by community pharmacists, demonstrating a significant reduction in risk for CVD events. Engagement of community pharmacists with an expanded scope of practice could have significant public health implications.
The purpose of the RxEACH study was to develop and implement a broad-based community pharmacist-initiated vascular risk reduction case-finding and intervention program in patients at high risk for cardiovascular disease and to evaluate its impact on risk for cardiovascular events.
Patients randomized to the intervention group received a Medication Therapy Management consultation from their pharmacist (in Alberta, called a Comprehensive Annual Care Plan or Standard Medication Management Assessment), which included:
• Patient assessment (blood pressure measurement according to Canadian Hypertension Education Program guidelines, waist circumference, weight and height measurements)
・Laboratory assessment of HbA1c, fasting cholesterol profile (if not done within the past 3 months) eGFR and ACR (if not done within the past 12 months)
・Individual assessment of CVD risk and education about this risk:
o The cardiovascular risk was calculated using an online tool. Our system used the
appropriate risk engine based on the patient’s medical history. The United Kingdom Prospective Diabetes Study (UKPDS) risk engine, the International model for prediction of recurrent cardiovascular disease and Framingham were used for patients with diabetes, previous vascular disease, CKD or primary prevention, respectively. In the case where a patient had more than one co-morbidity, the risk engine estimating the highest risk was used.
o Discussion of CVD risk with the patient using the interactive online tool to explain his/her individual cardiovascular risk and targets for intervention (see www.epicore.ualberta.ca/CVrisk) and healthy lifestyle options.
Providing treatment recommendations based upon the most up to date Canadian clinical practice guidelines for cardiovascular risk factors
Prescription adaptation(s), and/or de novo prescriptions where necessary to meet lipid, blood pressure and glycemic control targets and smoking cessation.
Regular communication with the patient’s family physician after each contact with the patient
Regular follow-up with all patients a minimum of every 3-4 weeks for 3 months Pharmacists in Alberta can bill the provincial health plan for providing such services.
Pharmacist training was based on the current Canadian guidelines. The research team developed an online training program that was reviewed internally and externally for content validity. The training program was hosted online at the Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta server and provided at face-to- face regional meetings. The training program included modules on case-finding, cardiovascular risk calculation and patient communication of cardiovascular risk, chronic kidney disease, hypertension, dyslipidemia, diabetes, smoking cessation, diet and lifestyle management, and documentation of care plans for remuneration by Alberta Health. A hotline was made available for participating pharmacists to connect them with experts in cardiovascular risk reduction and study procedures.
RxEACH was approved by the Health Research Ethics Boards of the University of Alberta and the University of Calgary and was registered on clinicaltrials.gov (NCT01979471).
The primary outcome
the difference in change in estimated cardiovascular risk between intervention and usual care groups at 3 months.