Rural RxAction (Rural Alberta Clinical Trial in Optimizing HypertensioN)
Improving Hypertension Management Through Use of Community Pharmacists with Prescriptive Authority – A Randomized Trial Design
Ross T. Tsuyuki, PharmD, MSc; Theresa L. Charrois, BSc(Pharm), MSc; Finlay A. McAlister, MD, MSc, Dale Cooney, BSP, MBA, Richard Z. Lewanczuk, MD, PhD, Norn RC Campbell, MD.
Background: Patients with hypertension continue to be poorly controlled. In a recently completed study, SCRIP-HTN, a community pharmacist and nurse intervention produced a 5.6 mmHg greater decrease in systolic blood pressure (BP) over 24 weeks compared to usual care in patients with diabetes and poorly controlled BP. Despite the improved BP, the intervention did not show an improvement in number or dosing of antihypertensive agents, and only half of the patients reached their BP goal. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique experience to measure outcomes in patients who are prescribed anti-hypertensive therapy by pharmacists.
Primary Objective: To evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, and prescribing/titration of antihypertensive medications) on systolic blood pressure reduction in patients with poorly controlled hypertension.
Design: Randomized controlled trial with patients allocated to enhanced pharmacist care or usual care in a 2:1 ratio.
Patients: Patients with BP above target levels on 2 occasions 2 weeks apart.
Setting: Rurally based pharmacists in Alberta.
Intervention: Enhanced pharmacist care including patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up every 4 weeks until achievement of target BP.
Patients in the enhanced care group will be further randomized to the sub-study of remuneration models: fee for visit payment vs. payment for performance model.
Control: Usual pharmacist and physician care, plus a wallet card for BP readings and pamphlet on BP.
Outcomes: The primary outcome will be a comparison of difference in change in systolic blood pressure between enhanced care and usual care at 24 weeks follow-up. For the sub-study of remuneration models, we will compare change in systolic blood pressure between the flat fee-for-visit group and payment-for-performance groups. We will also evaluate patient and pharmacist satisfaction.
Sample size: A sample size of 340 (250 intervention, 90 control) will provide 80% power to detect a difference of 8mmHg difference in change in systolic BP between intervention and usual care, and 6mmHg between the 2 remuneration strategies.
Implications: This will be the first randomized trial of pharmacist prescribing and an opportunity to evaluate 2 different payment models.
Study Status: We currently have 15 pharmacies who will participate. Training, prescribing applications and patient recruitment will begin in Spring 2009.
Funding: CIHR New Emerging Team Grant and Canadian Foundation for Pharmacy