The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH (RxEACH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01979471|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : October 30, 2017
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.
The research study will assess if a community pharmacy cardiovascular risk reduction intervention can help reduce cardiovascular risk.
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Chronic Kidney Disease Established Atherosclerotic Vascular Disease Framingham Risk Score More Than 20 Percent||Other: Advanced Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||723 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
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)
Other: Advanced Care
The pharmacist will complete a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA), which will include:
No Intervention: Usual Care
Patients randomized to the usual care group will receive:
- The difference in change in estimated cardiovascular risk between advanced care and usual care groups [ Time Frame: 3 months ]The difference in change in estimated cardiovascular risk between advanced care and usual care groups
- Difference in change in individual cardiovascular risk factors between advanced care and usual care groups [ Time Frame: 3 months ]Difference in change in individual cardiovascular risk factors between advanced care and usual care groups, including LDL-cholesterol, systolic and diastolic blood pressure, HbA1c, lifestyle (diet and exercise) and smoking cessation.
- Achievement of individual and the "triple target" [ Time Frame: 3 months ]Achievement of individual and the "triple target" of LDL-cholesterol ≤ 2.0 mmol/L, blood pressure control BP <140/90 mmHg (<130/80 in those with diabetes) and glycemic control (HbA1c ≤ 7.0) in advanced care compared to usual care group patients in those with diabetes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979471
|Edmonton, Alberta, Canada, T6G 2M8|
|Principal Investigator:||Charlotte A Jones, MD, PhD||University of British Columbia - Southern Medical Program|
|Principal Investigator:||Brenda Hemmelgarn, MD, PhD||Department of Medicine, University of Calgary|
|Principal Investigator:||Ross T Tsuyuki, PharmD, MSc||Department of Medicine, University of Alberta|