The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH
The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH
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.
Cardiovascular disease (CVD) is the leading cause of death worldwide accounting for nearly
 one third of the total deaths. The majority (90%) of the CVD cases are caused by modifiable
 risk factors. These factors include tobacco smoking, hypertension, hyperlipidemia, diabetes,
 physical inactivity, high fat diet and obesity.

 In Canada CVD rates have decreased drastically over the last few decades, yet it is still one
 of the leading causes of death. It also carries a financial burden on the Canadian economy
 with a cost close to $ 21 billion every year divided between loss of productivity and
 healthcare costs.

 Despite the risks associated with the major CVD risk factors and the treatment advancement,
 their prevalence is still substantial in North America. Treatment gaps were also reported
 amongst such factors. Al Hamarneh and colleagues (2012) reported that almost 50% of the
 community dwelling patients with type 2 diabetes were not at their HbA1c target. Leiter and
 colleagues (2013) reported that almost half of the patients with type 2 diabetes did not
 achieve their HbA1c or cholesterol target, slightly more than one third achieved their blood
 pressure targets and only 13% achieved the composite triple target.

 The guidelines recommend using cardiovascular risk assessment equations to guide CVD
 prevention and management. Despite being recommended by the guidelines, it has not been
 integrated in the clinicians' daily routine; in fact the majority of the patients attending
 physicians' clinics reported that they have never had a cardiovascular risk assessment. This
 indicates the need for new avenues for the patients to get their cardiovascular risk
 assessed.

 Community pharmacists are front-line primary healthcare professionals who see patients with
 chronic diseases more frequently than family physicians; as such, they are well positioned to
 identify patients at high risk for CVD, determine their CVD risk and assist in their disease
 management. The efficacy of pharmacists' intervention in chronic disease has been well
 demonstrated in the literature. Two of the largest randomized controlled trials in community
 pharmacy setting were conducted by our group. Both studies reported positive impact of the
 pharmacist intervention on the patients' lipid panel and blood pressure.

 Objectives

 Primary objective

 To evaluate the effect of a community pharmacy-based case finding and intervention program in
 patients at high risk for cardiovascular events on reduction in estimated risk for major
 cardiovascular events.

 Secondary objectives

 Clinical:

 -  Improvements in individual risk factors: LDL-cholesterol, blood pressure, HbA1c (among
 patients with diabetes), and smoking cessation

 -  Achievement of recommended cholesterol, blood pressure and glycemic control targets

 -  Increase in proportion of patients receiving appropriate BP, cholesterol and diabetes
 medication

 Process:

 -  Increase in number of high risk patients screened for cardiovascular risk

 -  Assess the efficacy of various case-finding mechanisms and vulnerable patient population
 reach

 -  Assure sustainability by exploring enabling and barrier forces.

 Methods

 Design: Randomized controlled trial with patients as the unit of randomization

 Setting: Community pharmacists in Alberta for recruitment and follow up, engaging both
 patients and family physicians

 Patients/Population:

 Inclusion criteria:

 Adults (≥18 years of age) at high risk for cardiovascular events, including:

 -  Patients with diabetes

 -  Patients with chronic kidney disease [eGFR <60 ml/min/1.73m2 and/or (ACR >= 30 mg/mmol
 or two consecutive ACR tests which are >= 3 mg/mmol)]

 -  Patients with established atherosclerotic vascular disease including cerebrovascular
 disease (prior stroke or transient ischemic attack), cardiovascular disease (myocardial
 infarction, acute coronary syndrome, stable angina, or revascularization), or peripheral
 arterial disease (symptomatic and/or ankle brachial index <0.9).

 -  Primary prevention patients with multiple risk factors and Framingham risk score >20%

 -  In order to qualify for inclusion, all patients must have at least one uncontrolled risk
 factor (i.e., blood pressure, LDL-cholesterol, HbA1c, or current smokers.

 Exclusion criteria:

 -  Unwilling to participate/sign consent form

 -  Unwilling or unable to participate in regular follow-up visits

 -  Pregnancy

 Recruitment:

 Pharmacists and pharmacy staff are going to use the following methods to recruit patients in
 the study:

 · Proactive recruitment by case-finding facilitators (trained pharmacy technicians,
 assistants or pharmacy/medical/nursing students who focus on target prescriptions for oral
 hypoglycemic, anti-hypertensive and lipid lowering medications). Pharmacists will check the
 most recent lab results for those patients in the course of routine care. If the patient has
 not had an eGFR or proteinuria test done over the last 12 months he/she will be given a
 request to do those tests with a copy sent to his/her family physician.

 If the Patient meets the inclusion criteria for the study the patient will be asked if he/she
 wants to participate in the study. If the patient agrees on participating he/she will be
 asked to sign a written informed consent form. After signing the consent form the patient
 will be enrolled in the study.

 The patient's family physician is going to receive a letter from the pharmacist to inform
 him/her that his/her patient agreed to participate in this study.

 Randomization:

 Once informed written consent is obtained, the patients will be randomized (via a centralized
 secure website to ensure allocation concealment) in a 1:1 ratio to either advanced care or
 usual care groups

 Intervention:

 For all the patients randomized to the advanced care group the pharmacist will complete a
 Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA),
 which will include:

 -  Patient assessment (blood pressure measurement according to CHEP guidelines, waist
 circumference, weight and height measurements)

 -  Laboratory assessment of HbA1c and lipids (if not done within 3 months)

 -  Individual assessment of CVD risk and education about this risk

 -  Calculation of cardiovascular risk will be facilitated by an online tool in which
 the pharmacist enters patient demographics such as age, gender, cholesterol, blood
 pressure, smoking status, diabetes, etc and the system will use the appropriate
 risk engine based on the patient's medical history. UKPDS, International model to
 predict recurrent cardiovascular disease and Framingham will be used for patients
 with diabetes, previous vascular disease, CKD or high Framingham risk (>20%)
 respectively (see appendix for risk engines score sheets). In the case where a
 patient has more than one co-morbidity the risk engine estimating the highest risk
 will be used

 -  Discussion of CVD risk with the patient using the interactive online tool which
 explains his/her individual cardiovascular risk and targets for intervention

 -  Proving the patient with education on cardiovascular risk factors and healthy
 lifestyle options

 -  Providing treatment recommendations (C-CHANGE and up to date Canadian clinical practice
 guidelines)

 -  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 using the physician contact form which will be developed by the research team

 -  Regular follow-up with all patients a minimum of every 3-4 weeks for 3 months (Interim
 telephone follow-up may be performed at the discretion of the pharmacist; however
 telephone follow-up cannot be used for 2 consecutive visits or for the final visit (3
 months).

 Usual care:

 Patients randomized to the usual care group will receive:

 -  Usual pharmacy care with no specific interventions for 3 months

 -  At the end of the 3 months of the usual care period, all patients will cross over to
 receive the advanced care outlined above for 3 months

 The analysis of the results from patients who cross over from the usual care group into the
 advanced care group will be conducted separately on before and after design basis.
Inclusion Criteria:

 -  Adults (≥18 years of age) at high risk for cardiovascular events, including:

 -  Patients with diabetes

 -  Patients with chronic kidney disease [eGFR <60 ml/min/1.73m2 and/or (ACR >= 30
 mg/mmol or two consecutive ACR tests which are >= 3 mg/mmol)]

 -  Patients with established atherosclerotic vascular disease including
 cerebrovascular disease (prior stroke or transient ischemic attack),
 cardiovascular disease (myocardial infarction, acute coronary syndrome, stable
 angina, or revascularization), or peripheral arterial disease (symptomatic and/or
 ankle brachial index <0.9).

 -  Primary prevention patients with multiple risk factors and Framingham risk score
 >20%

 -  In order to qualify for inclusion, all patients must have at least one
 uncontrolled risk factor (i.e., blood pressure, LDL-cholesterol, HbA1c, or
 current smoking)

 Exclusion Criteria:

 -  Unwilling to participate/sign consent form

 -  Unwilling or unable to participate in regular follow-up visits

 -  Pregnancy