The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH (RxEACH)
|First Received Date ICMJE||November 1, 2013|
|Last Updated Date||September 14, 2016|
|Start Date ICMJE||January 2014|
|Primary Completion Date||September 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01979471 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH|
|Official Title ICMJE||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.
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.
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.
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.
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
Adults (≥18 years of age) at high risk for cardiovascular events, including:
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.
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
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:
Patients randomized to the usual care group will receive:
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Intervention ICMJE||Other: Advanced Care
The pharmacist will complete a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA), which will include:
|Publications *||Tsuyuki RT, Al Hamarneh YN, Jones CA, Hemmelgarn BR. The Effectiveness of Pharmacist Interventions on Cardiovascular Risk: The Multicenter Randomized Controlled RxEACH Trial. J Am Coll Cardiol. 2016 Jun 21;67(24):2846-54. doi: 10.1016/j.jacc.2016.03.528. Epub 2016 Apr 4.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2015|
|Primary Completion Date||September 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT01979471|
|Other Study ID Numbers ICMJE||pro00041644|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Ross T. Tsuyuki, University of Alberta|
|Study Sponsor ICMJE||University of Alberta|
|PRS Account||University of Alberta|
|Verification Date||September 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP