Clinical trial NCT01581372: A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets
Official title: A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2012-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Proportion of participants achieving their target LDL-c in the intervention versus usual care group
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Safeway
state: Alberta
city: Lethbridge
country: Canada
facility: London Drugs
state: Alberta
Study officials:
affiliation: University of Alberta
name: Ross T Tsuyuki, PharmD
role: PRINCIPAL_INVESTIGATOR
References: