SCORE! Non-Physician Health Worker (NPHW) Implementation Protocol (SIP)

Rationale: The study has been created to help SCORE! Cohort participants with cardiovascular (CV) risk to receive medical guidance and adopt healthy lifestyle recommendations through NPHW under the direction of family physicians.

Objectives: To improve/maintain CV health (measured by blood pressure, glucose levels, lipids) through implementation of simplified treatment algorithm, connection to a NPWH and referrals to primary care physicians for pharmacological management, over 12 months.

Study Design: Implementation Study.

Population: All adults 18 years or older enrolled in the SCORE! Cohort who have the following uncontrolled CV risk factors: hypertension, elevated non-High density lipoprotein (HDL) cholesterol as per the Heart Outcomes Prevention Evaluation - 4 (HOPE-4) trial criteria, and/or elevated glucose as indicated by the random glucose level or the hemoglobin A1c (HbA1C) ≥ 6.5%.

Study procedures: Participants will be identified from the SCORE! Cohort study. If the participant has CV risk factors, they will be invited to the study. After the consent procedure, the NPHW will follow an algorithm validated in the HOPE-4 trial. There will be five follow-ups over 12 months.

Primary/Secondary outcomes: A change in Framingham Risk Score (FRS) after 12 months / A change in lipid panel, blood pressure, and glucose/HbA1c, medication adherence, smoking/tobacco cessation.

Data analysis: Descriptive and multivariate analysis will be conducted on the individual level. The overall participant population will be assessed for the proportion of participants with established cardiovascular disease (CVD), and in those without CVD, the proportion of individuals with CV risk factors and the percentage of people in low, moderate, and high FRS categories.

Participants will be identified from the SCORE! Cohort study who have previously received a letter indicating their cardiovascular risk score.

They are eligible if:

Uncontrolled CV risk factors will be defined as follows:

• Blood pressure measurements: systolic ≥ 140 or diastolic BP ≥ 90 mm Hg;
• Non-HDL cholesterol > 2.66 mmol/L;
• Random plasma glucose of ≥ 11.1 mmol/L or HbA1c% ≥ 6.5%

Exclusion criteria

include:

• Involvement in another study or program that would interfere with the study protocol,
• Known history of coronary artery disease or stroke;
• Severe co-morbid conditions with life expectancy < 1 year,
• Pregnancy or plans to become pregnant within 12 months;
• Other serious conditions or logistic factors likely to interfere with study participation