A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT)
Recruitment status was Recruiting
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.
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.
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.
|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)|
- Proportion of participants achieving their target LDL-c in the intervention versus usual care group [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
|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)|
|Experimental: Pharmacist care||
Other: Pharmacist care
Pharmacist prescribing, education, drug management
|No Intervention: Usual care|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581372
|Contact: Meagen M Rosenthal, MAfirstname.lastname@example.org|
|Calgary, Alberta, Canada|
|Contact: Rita Bowron|
|Lethbridge, Alberta, Canada|
|Contact: Rick Seimens|
|Principal Investigator:||Ross T Tsuyuki, PharmD||University of Alberta|