The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH

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.