A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Alberta.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ross T. Tsuyuki, University of Alberta
ClinicalTrials.gov Identifier:
NCT01581372
First received: March 5, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

Background:

Cardiovascular disease (CVD) is the cause of one-third of all deaths in Canada. One important risk factor for CVD is dyslipidemia. The Canadian Health Measures survey, which was conducted from 2007-2009, found that roughly 36% of Canadians had unhealthy levels of LDL. Despite strong evidence and clear practice guidelines for the management of this risk factor, it remains poorly treated.

Pharmacists are front-line primary care professionals who see patients at risk for cardiovascular disease more frequently than other healthcare professionals. As such, pharmacists have the opportunity to systematically and proactively identify patients with undertreated dyslipidemia, as one public health approach to chronic disease management.

The objective of this study is to evaluate the effect of enhanced pharmacist care (i.e., participant identification, assessment, care plan development, education/counseling, prescribing/titration of lipid-lowering medications and close follow-up) on the proportion of participants achieving target LDL-cholesterol levels.

Hypothesis: Enhanced pharmacist care will result in a more significant decrease in LDL-c levels, than that observed in the usual care patients.

Design:

This is a randomized controlled trial of enhanced pharmacist care. The study will be conducted in twelve community pharmacies in Alberta, including several Safeway Pharmacies. The participant population will be composed of adults with uncontrolled dyslipidemia as defined by the 2009 Canadian Dyslipidemia Guidelines. The primary intervention will be pharmacist directed dyslipidemia care. Participants randomized to usual care will receive usual care from their pharmacist and physician.

Study Implications:

To the investigators knowledge, this study is the first randomized trial of pharmacist prescribing in dyslipidemia. This study will have important implications for improving patients' access to care, especially as most provinces are proceeding with granting additional prescribing authority to pharmacists. The ability to conduct this study in a province where pharmacists already have the ability to prescribe is unique. The results will also encourage more pharmacists to get involved in cardiovascular prevention and will increase the number of prescribers in the area of dyslipidemia.


Condition Intervention
Dyslipidemias
Other: Pharmacist care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT Study)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Proportion of participants achieving their target LDL-c in the intervention versus usual care group [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmacist care Other: Pharmacist care
Pharmacist prescribing, education, drug management
No Intervention: Usual care

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adults >18 years of age
  • Suboptimal dyslipidemia control, defined as:
  • high risk (coronary disease (stroke/TIA), cerebrovascular disease, peripheral arterial disease, diabetes, or Framingham Risk Score >20%) and LDL-c >2.0 mmol/L
  • moderate risk (Framingham Risk Score 10-19%) and LDL-c >3.5 mmol/L
  • moderate risk (Framingham risk score 10-19%) in males >50 years or females >60 years with an LDL-c of ≤3.5 mmol/L and hs-CRP > 2.0 mg/L (measured twice 1-2 weeks apart)

Exclusion Criteria:

  • Participant unwilling to use statins,
  • Participant has a demonstrated intolerance to statins,
  • Participant is pregnant or nursing
  • Participant has renal impairment (defined as a creatinine ≤30 mL/min) or hepatic dysfunction
  • Participant is unwilling or unable to attend follow-up visits, or is unlikely to adhere to study procedures (due to cognitive limitations, severe psychiatric disorders or alcoholism)
  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: NCT01581372

Contacts
Contact: Meagen M Rosenthal, MA 1-780-492-8350 meagen.rosenthal@ualberta.ca

Locations
Canada, Alberta
Safeway Recruiting
Calgary, Alberta, Canada
Contact: Rita Bowron         
London Drugs Recruiting
Lethbridge, Alberta, Canada
Contact: Rick Seimens         
Sponsors and Collaborators
University of Alberta
AstraZeneca
Investigators
Principal Investigator: Ross T Tsuyuki, PharmD University of Alberta
  More Information

No publications provided

Responsible Party: Ross T. Tsuyuki, Director and Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT01581372     History of Changes
Other Study ID Numbers: Pro00020054
Study First Received: March 5, 2012
Last Updated: April 18, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014