The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH

Summary

Cardiovascular disease (disease of the heart and blood vessels) is one of the leading causes of death in Canada. It also carries a financial burden on the Canadian economy with a yearly cost close to $21 billion divided between loss of productivity and healthcare costs. The majority of cardiovascular disease cases (90%) are caused by factors that can be controlled and modified. These factors include high blood pressure, high cholesterol, diabetes (high blood sugar), tobacco smoking, unhealthy diet, obesity, physical inactivity and high alcohol consumption. Such factors are very common and not very well controlled and so individuals who have any of these factors would be at risk of having cardiovascular disease. As such controlling these factors will reduce the risk of having cardiovascular disease and improve the individuals' quality of life. Pharmacists frequently work with patients and their family doctor to provide cardiovascular care. Having a pharmacist involved in cardiovascular care may help patients with cardiovascular disease or at risk of having the disease because they are more accessible and may have more opportunities to educate people about cardiovascular medications. This might lead to better prevention and control of cardiovascular disease.

Purpose:

The research study will assess if a community pharmacy cardiovascular risk reduction intervention can help reduce cardiovascular risk.

Procedure:

If the individual has an elevated blood pressure, cholesterol, blood sugar, waist circumference or body weight or is physically inactive, have an unhealthy diet, a smoker or taking medications for any of the previously mentioned conditions, the pharmacist will assess the cardiovascular disease risk \[risk of having a cardiovascular event (e.g. heart attack or a stroke)\] using a computer program. If the individual is at high risk s/he will be asked to take part in the study.

If the individual agrees to take part in the study s/he will be randomly assigned to either the Usual Care Group or the Advanced Care Group. All participants have an equal chance of being assigned to either group. If assigned to the Usual Care Group, the individual will receive the care and services that would normally be provided by the pharmacist. At 3 months, the pharmacist will see the individual who will be offered the Advanced Care at that time.

If assigned to the to Advanced Care Group, the individual will be asked to meet with the pharmacist every 3-4 weeks over a 3 month period. During these meetings, the pharmacist will conduct an assessment that may include blood pressure, waist circumference, height and weight measurements and talk to the individual about their cardiovascular risk and medications. The individual and the pharmacist will come up with a plan for how to try to lower his/her cardiovascular risk. The pharmacist will discuss this plan with their family doctor. The individual will be asked to conduct some laboratory tests before the 3 months visit; these tests may include HbA1c (a blood test to measure blood sugar control over the last 3 months) and cholesterol to assess the effect of the intervention on cardiovascular risk.

Conditions

• Diabetes
• Chronic Kidney Disease
• Established Atherosclerotic Vascular Disease
• Framingham Risk Score More Than 20 Percent

Interventions

OTHER

Advanced Care

The pharmacist will complete a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA), which will include: * Patient assessment * Laboratory assessment of HbA1c and lipids * Individual assessment of CVD risk and education about this risk * Calculation of cardiovascular risk will be facilitated by an online tool * Discussion of CVD risk with the patient using the interactive online tool which explains his/her individual cardiovascular risk and targets for intervention and providing the patient with education on cardiovascular risk factors and healthy lifestyle options * Treatment recommendations, Prescription adaptation(s), and/or prescribe 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.

Sponsors & Collaborators

• Alberta Health & Wellness

  collaborator OTHER_GOV

• Alberta Health services

  collaborator OTHER

• Merck Frosst Canada Ltd.

  collaborator INDUSTRY

• University of Alberta

  lead OTHER

Principal Investigators

• Charlotte A Jones, MD, PhD · University of British Columbia - Southern Medical Program

• Brenda Hemmelgarn, MD, PhD · Department of Medicine, University of Calgary

• Ross T Tsuyuki, PharmD, MSc · Department of Medicine, University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2015-09-30

Completion

2015-12-31

Countries

• Canada

Study Locations