The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 723
- 试验地点
- 2
- 主要终点
- The difference in change in estimated cardiovascular risk between advanced care and usual care groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Unwilling to participate/sign consent form
- •Unwilling or unable to participate in regular follow-up visits
- •Pregnancy
研究组 & 干预措施
Advanced care
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)
干预措施: Advanced Care (Other)
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
结局指标
主要结局
The difference in change in estimated cardiovascular risk between advanced care and usual care groups
时间窗: 3 months
The difference in change in estimated cardiovascular risk between advanced care and usual care groups
次要结局
- Difference in change in individual cardiovascular risk factors between advanced care and usual care groups(3 months)
- Achievement of individual and the "triple target"(3 months)
研究者
Ross T. Tsuyuki
Professor of Medicine (Cardiology) and Director, EPICORE Centre University of Alberta
University of Alberta