Pharmacist Case Finding and Intervention for Vascular Prevention Trial

Not Applicable

Recruiting

• Conditions: Cardiovascular Disease; Cardiovascular Risk Factors; Blood Pressure; Dyslipidemia; Diabetes
• Interventions: Other: Pharmacist-led care pathway

• Registration Number: NCT06405880
• Lead Sponsor: University of Alberta

Brief Summary

Heart disease is a common and serious medical condition which causes nearly one in every three deaths worldwide every year.

The factors which increase people's risk for heart disease are well-known, but there needs to be more support given to people to reduce their risk of heart disease. Pharmacists are front line primary healthcare providers who see patients more frequently than any other healthcare provider and can help people reduce their risk of heart disease.

This research project aims to see whether a pharmacist-led intervention can help people reduce their risk of heart disease. The potential impact of this project is to empower people to understand how to reduce their risk of heart disease and reduce the burden of heart disease on the community.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-04
• Study First Posted: 2024-05-09
• Status Verified: 2024-11
• Study Start: 2024-11-04
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 982

Inclusion Criteria

• Adults (18 years or older)

• Clinical diagnosis of at least one of the following conditions:

  • Diabetes,
  • Chronic kidney disease,
  • Chronic inflammatory condition (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, systemic lupus erythematosus or psoriasis),
  • Atherosclerotic vascular disease,
  • Hypertension,
  • Obesity (defined as body mass index greater than 30),
  • Current tobacco or vape use

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Exclusion Criteria

• Unwilling to participate/sign consent form;
• Unwilling or unable to participate in regular follow-up visits; or
• Pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist-led care pathway	Pharmacist-led care pathway	Participants in the intervention arm will receive the care using a shared decision-making pharmacist-led care pathway designed to guide the cardiovascular (CV) risk reduction process. The pharmacist-led care pathway is modelled after the largest CV risk reduction randomized controlled trial in a community pharmacy setting (RxEACH Study), and based upon the latest CV risk reduction guidelines, such as C-CHANGE. This pathway will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to calculate the participant's estimated CV risk. The participant and pharmacist will be guided by the care pathway to review the participant's estimated CV risk and contributing CV risk factors and engage in shared decision-making to manage the participant's CV risk factors using lifestyle changes and/or pharmacological treatment as clinically appropriate.

Primary Outcome Measures

Name	Time	Method
Estimated cardiovascular risk	Up to 6 months.	The primary outcome is the difference in change in estimated CV risk (calculated using the EPI·RxISK™ calculator: https://www.epicore.ualberta.ca/epirxisk/) from baseline to the end of the study (up to six months) between the intervention and control groups.

Secondary Outcome Measures

Name	Time	Method
A1c in those who have diabetes	Up to 6 months.	The difference in change in serum A1c in those who have diabetes from baseline to the end of the study (up to six months) between the intervention and control groups
LDL Cholesterol Concentration	Up to 6 months.	The difference in change in serum LDL-cholesterol concentration from baseline to the end of the study (up to six months) between the intervention and control groups
Yield of enrolment approaches	Up to 6 months.	The yield from each enrolment approach used (active case-finding approach vs. passive approaches such as when the patient attends the pharmacy to collect a prescription medication or through patient self-identification)
Yield of enrollment by pharmacy type	Up to 6 months.	Yield of enrollment by clinic or non-clinic pharmacy type
Shared-decision making uptake	Up to 6 months.	Extent to which shared decision making was achieved in the intervention as measured by the validated Shared Decision Making 9-item Questionnaire (SDM-Q-9) tool. The minimum score is 0 and the maximum score is 45, where a higher score indicates a greater subjective level of shared decision making.
Proportion categorized as having high cardiovascular risk	Up to 6 months.	Proportion of participants who are categorized as having high cardiovascular risk.
Tobacco use or vaping	Up to 6 months.	The difference in the proportion of participants who report tobacco or vape use from baseline to the end of the study (up to six months) between the intervention and control groups.
Blood pressure	Up to 6 months.	The difference in change in blood pressure from baseline to the end of the study (up to six months) between the intervention and control groups
Types of intervention delivered by the pharmacist	Up to 6 months.	Types of interventions provided by the pharmacists, such as education on lifestyle factors (tobacco cessation, diet, exercise), prescribing or changing the dose of medications, education on new or changed medications, education on adherence to medications and/or lifestyle recommendations.
Patient satisfaction	Up to 6 months.	Patient satisfaction as measured by the Consultation Satisfaction Questionnaire. Minimum score is 18 and maximum score is 90, where a higher score indicates higher patient satisfaction.
Quality of life reported by study participants	Up to 6 months.	The difference in change in quality of life as measured using the validated EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Scale between the intervention and control groups. The EQ-5D-5L will be scored by collecting individuals' health state index value, which will be converted into an EQ 5D summary value according to the preferences of the general population of a country/region.
Previous cardiovascular risk assessment	Up to 6 months.	Proportion of participants who never had their cardiovascular risk assessed before the study.

Trial Locations

Locations (1)

The University of Alberta; 🇨🇦 Edmonton, Alberta, Canada