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

Sponsor

University of Alberta (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03965104

Collaborator

Hypertension Canada (Other)

1,000

Enrollment

Location

Arms

26.5

Anticipated Duration (Months)

37.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Hypertension Canada Professional Certification Program: HC-PCP	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Stepped wedge cluster randomized trial with the unit of randomization being the pharmacyStepped wedge cluster randomized trial with the unit of randomization being the pharmacy

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2020

Actual Primary Completion Date :

Feb 22, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Consultant Satisfaction Questionnaire [6 months following follow up]
patient satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

University of Alberta
Hypertension Canada

Investigators

Principal Investigator: Ross Tsuyuki, PharmD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alberta

ClinicalTrials.gov Identifier:

NCT03965104

Other Study ID Numbers:

Pro00090012

First Posted:

May 28, 2019

Last Update Posted:

Jul 8, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Jul 8, 2022