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

NCT03965104 | Completed

• 1 other identifier: Pro00090012
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Consultant Satisfaction Questionnaire

  6 months following follow up

Study Arms (2)

Intervention pharmacists

EXPERIMENTAL

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

Control pharmacists

NO INTERVENTION

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).

Interventions

Hypertension Canada Professional Certification Program: HC-PCP BEHAVIORAL

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.

Intervention pharmacists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead
• Hypertension Canada: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ross Tsuyuki, PharmD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: By necessity, pharmacists in the intervention groups cannot be blinded. However, pharmacists will not be told about the cluster randomization, just that they will be contacted about when they will receive the HC-PCP. During the control period, pharmacists will be told that their patients will be enrolled in an observational hypertension registry to prepare for the intervention phase.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized trial with the unit of randomization being the pharmacy

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: September 15, 2020
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)