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Cardiovascular Risk FactorsPRxOACTNCT06405880

Pharmacist Case Finding and Intervention for Vascular Prevention Trial

A study testing Pharmacist-led care pathway in people with Cardiovascular Risk Factors and Blood Pressure, run by University of Alberta at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pharmacist-led care pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,003 participants
Where
1 siteCanada
Study dates
4 Nov 2024to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • Hypertension,
  • Obesity (defined as body mass index greater than 30),
  • Current tobacco or vape use

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The University of Alberta

    Edmonton, Alberta

Other trials in Canada

About this study

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

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.

Being tested
Pharmacist-led care pathway
Keywords
cardiovascular, blood pressure, diabetes, dyslipidemia
Medical subject headings
Cardiovascular Diseases, Diabetes Mellitus, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist-led care pathwayOther

    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.

Study groups in NCT06405880
Study groupRoleWhat they receive
Pharmacist-led care pathwayExperimentalParticipants 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.
Receives: Other: Pharmacist-led care pathway
Usual CareNo interventionThe control group will involve facilitated relay of information to participants' family physician. Participants in the control group will have their pharmacist collect information informing the patient's CV risk. Participants will then be given a letter that contains their values for CV risk factors (including blood pressure, HbA1c, and lipid panel), and they will be advised to present it to their family physician. No specific suggestions for CV risk reduction will be detailed in the letter. In the case where the patient does not have a family physician, they can be referred to a physician walk-in clinic. A follow-up appointment in 6-months' time will be booked for with all participants in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated cardiovascular risk

    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.

    Measured: Up to 6 months.

Secondary outcomes (12)

  1. A1c in those who have diabetes

    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

    Measured: Up to 6 months.

  2. Blood pressure

    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

    Measured: Up to 6 months.

  3. LDL Cholesterol Concentration

    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

    Measured: Up to 6 months.

  4. Tobacco use or vaping

    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.

    Measured: Up to 6 months.

  5. Yield of enrolment approaches

    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)

    Measured: Up to 6 months.

  6. Yield of enrollment by pharmacy type

    Yield of enrollment by clinic or non-clinic pharmacy type

    Measured: Up to 6 months.

  7. Shared-decision making uptake

    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.

    Measured: Up to 6 months.

  8. Previous cardiovascular risk assessment

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

    Measured: Up to 6 months.

  9. Proportion categorized as having high cardiovascular risk

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

    Measured: Up to 6 months.

  10. Patient satisfaction

    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.

    Measured: Up to 6 months.

  11. Types of intervention delivered by the pharmacist

    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.

    Measured: Up to 6 months.

  12. Quality of life reported by study participants

    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.

    Measured: Up to 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start4 Nov 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,003 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06405880
Sponsor's protocol ID
Pro00139142
Acronym
PRxOACT
Status last verified
Jan 2026
First submitted
1 May 2024
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu S, Tsuyuki RT, Graham MM, Nelson D, Semeniuk G, Al Hamarneh YN. Implementation of Pharmacist Case-Finding and Care Pathway Intervention for Vascular Prevention (PRxOACT): Protocol for a Randomized Controlled Trial. CJC Open. 2025 Mar 20;7(6):821-831. doi: 10.1016/j.cjco.2025.03.011. eCollection 2025 Jun.

    PubMed 40586019

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist-led care pathway in people with Cardiovascular Risk Factors and Blood Pressure, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated cardiovascular risk (time frame: Up to 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06405880, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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