Pharmacist Case Finding and Intervention for Vascular Prevention Trial

Diabetes Clinical Trial

— PRxOACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405880
• Other study ID #: Pro00139142
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: Yazid Al Hamarneh
• Phone: 780-492-9608
• Email: yazid.alhamarneh[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 982
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Disease
• Cardiovascular Diseases
• Cardiovascular Risk Factors
• Diabetes
• Dyslipidemia
• Dyslipidemias

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months.
Secondary	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	Up to 6 months.
Secondary	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	Up to 6 months.
Secondary	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	Up to 6 months.
Secondary	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.	Up to 6 months.
Secondary	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)	Up to 6 months.
Secondary	Yield of enrollment by pharmacy type	Yield of enrollment by clinic or non-clinic pharmacy type	Up to 6 months.
Secondary	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.	Up to 6 months.
Secondary	Previous cardiovascular risk assessment	Proportion of participants who never had their cardiovascular risk assessed before the study.	Up to 6 months.
Secondary	Proportion categorized as having high cardiovascular risk	Proportion of participants who are categorized as having high cardiovascular risk.	Up to 6 months.
Secondary	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.	Up to 6 months.
Secondary	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.	Up to 6 months.
Secondary	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.	Up to 6 months.