The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Alberta
Sponsor:
Collaborators:
Alberta Health & Wellness
AHS Cancer Control Alberta
Merck Frosst Canada Ltd.
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Ross T. Tsuyuki, University of Alberta
ClinicalTrials.gov Identifier:
NCT01979471
First received: November 1, 2013
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Diabetes
Chronic Kidney Disease (eGFR <60 ml/Min/1.73m2)
Established Atherosclerotic Vascular Disease
Framingham Risk Score >20%
Other: Advanced Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The difference in change in estimated cardiovascular risk between advanced care and usual care groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The difference in change in estimated cardiovascular risk between advanced care and usual care groups


Secondary Outcome Measures:
  • Difference in change in individual cardiovascular risk factors between advanced care and usual care groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Difference in change in quality of life between advanced care and usual care groups


Estimated Enrollment: 1180
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other: Advanced Care

The pharmacist will complete a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA), which will include:

  • Patient assessment
  • Laboratory assessment of HbA1c and lipids
  • Individual assessment of CVD risk and education about this risk

    • Calculation of cardiovascular risk will be facilitated by an online tool
    • Discussion of CVD risk with the patient using the interactive online tool which explains his/her individual cardiovascular risk and targets for intervention and providing the patient with education on cardiovascular risk factors and healthy lifestyle options
  • Treatment recommendations, 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
  • Regular follow-up with all patients a minimum of every 3-4 weeks for 3 months.
No Intervention: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979471

Contacts
Contact: Ross T Tsuyuki, Pharm D, MSc 780- 492-8526 ross.tsuyuki@ualberta.ca
Contact: Yazid N Al Hamarneh, Bsc Pharmacy, PhD 780- 492-9608 yazid.alhamarneh@ualberta.ca

Locations
Canada, Alberta
EPICORE Centre Recruiting
Edmonton, Alberta, Canada, T6G 2M8
Contact: Ross T Tsuyuki, PharmD, Msc    780- 492-8526    ross.tsuyuki@ualberta.ca   
Contact: Yazid N Al Hamarneh, BSc Pharmacy, PhD    780- 492-9608    yazid.alhamarneh@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Alberta Health & Wellness
AHS Cancer Control Alberta
Merck Frosst Canada Ltd.
Public Health Agency of Canada (PHAC)
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Ross T. Tsuyuki, Professor of Medicine (Cardiology) and Director, EPICORE Centre University of Alberta, University of Alberta
ClinicalTrials.gov Identifier: NCT01979471     History of Changes
Other Study ID Numbers: pro00041644
Study First Received: November 1, 2013
Last Updated: November 15, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Cardiovascular risk reduction
Diabetes
Chronic Kidney Disease
Atherosclerotic vascular disease
Community Pharmacist
Randomized controlled trial

Additional relevant MeSH terms:
Atherosclerosis
Diabetes Mellitus
Kidney Diseases
Vascular Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 23, 2014