The Alberta Vascular Risk Reduction Community Pharmacy Project: RxEACH

NCT01979471 | Completed

• 1 other identifier: pro00041644
• Study Type: interventional
• Target: 723
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Chronic Kidney Disease; Established Atherosclerotic Vascular Disease; Framingham Risk Score More Than 20 Percent

Keywords

Cardiovascular risk reduction; Diabetes; Chronic Kidney Disease; Atherosclerotic vascular disease; Community Pharmacist; Randomized controlled trial; [eGFR <60 ml/min/1.73m2 and/or (ACR >= 30 mg/mmol or two consecutive ACR tests which are >= 3 mg/mmol)]

Outcome Measures

Primary Outcomes (1)

• The difference in change in estimated cardiovascular risk between advanced care and usual care groups

  The difference in change in estimated cardiovascular risk between advanced care and usual care groups

  3 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Advanced care

OTHER

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

Usual Care

NO INTERVENTION

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

Interventions

Advanced Care OTHER

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.

Advanced care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Unwilling to participate/sign consent form
• Unwilling or unable to participate in regular follow-up visits
• Pregnancy

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health & Wellness: collaborator
• Alberta Health services: collaborator
• Merck Frosst Canada Ltd.: collaborator

Study Sites (1)

EPICORE Centre

Edmonton, Alberta, T6G 2M8, Canada

Location

Related Publications (1)

• 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.

  PMID: 27058907 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic; Atherosclerosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiology) and Director, EPICORE Centre University of Alberta

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 8, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

CA (1)