A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT)
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pharmacist care
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
Eligibility 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)
Sites / Locations
- Safeway
- London Drugs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmacist care
Usual care
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants achieving their target LDL-c in the intervention versus usual care group
Secondary Outcome Measures
Full Information
NCT ID
NCT01581372
First Posted
March 5, 2012
Last Updated
April 25, 2015
Sponsor
University of Alberta
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT01581372
Brief Title
A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets
Acronym
RxACT
Official Title
A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT Study)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist care
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Pharmacist care
Intervention Description
Pharmacist prescribing, education, drug management
Primary Outcome Measure Information:
Title
Proportion of participants achieving their target LDL-c in the intervention versus usual care group
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross T Tsuyuki, PharmD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Safeway
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
London Drugs
City
Lethbridge
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets
We'll reach out to this number within 24 hrs