Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines

Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines (RxPATH)

This study will assess the impact of a hypertension management certification program for community pharmacists on the blood pressure control of patients managed by the pharmacists enrolled. The investigators will compare the systolic blood pressure of patients identified to have hypertension in the community that are followed by pharmacists who have undergone the certification course, and compare their blood pressure outcomes to subjects managed by pharmacists who have not yet received the training.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Hypertension Canada Professional Certification Program: HC-PCP

Detailed Description

Hypertension Canada proposes the first "Hypertension Canada Professional Certification Program"(HC-PCP), specifically designed for Alberta pharmacists, to provide care and support to those at risk for or living with hypertension. Through this program, the investigators hope to help with prevention of the costly and chronic conditions to which hypertension often leads, like kidney failure, stroke, and heart disease.

The HC-PCP aims to provide training to pharmacists in the screening, prevention, and management of hypertension. It has been identified that the development and implementation of this certification program provides a unique opportunity to evaluate the impact of such a program on blood pressure reduction.

The investigators are aiming to assess the impact of pharmacist management on blood pressure control in patients with hypertension.

The development of the HC-PCP and the evaluation of its impact will occur in 2 phases. Phase 1 involves the development and implementation of the educational portion of the certification program. Phase 2 involves conducting a 1 year long study to assess the impact of the HC-PCP on blood pressure in patients with poorly controlled hypertension. This will be launched in pharmacies in Alberta.

• Study Type: Interventional
• Enrollment (Actual): 890
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with poorly controlled blood pressure (>140/90mmHg or >130/80mmHg if they have diabetes).

Exclusion Criteria:

• Unwilling to sign the consent form.
• Unwilling to participate in follow up visits.
• Current hypertension urgency or emergency (SBP > 180mmHg or DBP > 120mmHg).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention pharmacists; Will receive the HC-PCP prior to starting enrollment, and then will provide care to their patients, which will include risk assessment, prescribing of antihypertensive medications, and follow-up monthly according to the Hypertension Canada Guidelines.	Behavioral: Hypertension Canada Professional Certification Program: HC-PCP; The HC-PCP is a certification program which aims to provide training to generalist primary care providers in the screening, prevention, and management of hypertension.The competencies assessed in the program have been validated for their importance through a national survey of hypertension experts and primary care providers.
No Intervention: Control pharmacists; Will provide usual pharmacist care. All patients with blood pressure above target will be entered into the study database and serve as the control group. No specific interventions or follow-up will be mandated other than usual pharmacist care, although all patients will be assessed at 3 months to determine change in BP since enrollment (the primary outcome).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in change in systolic blood pressure between Intervention and Control patients.	To detect a 7 millimeters of mercury (mmHg) or greater difference in systolic blood pressure.	From baseline to 3 month follow-up, and up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consultant Satisfaction Questionnaire	patient satisfaction	6 months following follow up

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Hypertension Canada
• Investigators: Principal Investigator: Ross Tsuyuki, PharmD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Pro00090012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No