Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06405880

Pharmacist Case Finding and Intervention for Vascular Prevention Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Risk Factors Blood Pressure Cardiovascular Disease Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alberta

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Pharmacist-led care pathway

Other

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 outcomes

  1. Estimated cardiovascular risk

    Time frame: 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 outcomes

  1. A1c in those who have diabetes

    Time frame: 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

  2. Blood pressure

    Time frame: 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

  3. LDL Cholesterol Concentration

    Time frame: 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

  4. Tobacco use or vaping

    Time frame: 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.

  5. Yield of enrolment approaches

    Time frame: 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)

  6. Yield of enrollment by pharmacy type

    Time frame: Up to 6 months.

    Yield of enrollment by clinic or non-clinic pharmacy type

  7. Shared-decision making uptake

    Time frame: 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.

  8. Previous cardiovascular risk assessment

    Time frame: Up to 6 months.

    Proportion of participants who never had their cardiovascular risk assessed before the study.

  9. Proportion categorized as having high cardiovascular risk

    Time frame: Up to 6 months.

    Proportion of participants who are categorized as having high cardiovascular risk.

  10. Patient satisfaction

    Time frame: 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.

  11. Types of intervention delivered by the pharmacist

    Time frame: 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.

  12. Quality of life reported by study participants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Implementation of Pharmacist Case Finding and Intervention for Vascular Prevention (PRxOACT) Study

Acronym: PRxOACT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 9, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.