A randomized controlled trial in Norwegian pharmacies on effects of risk alert and advice in people with elevated cardiovascular risk

Abstract

We investigated if alerting subjects to elevated total cholesterol (TC), hemoglobin A1c (HbA1c) and blood pressure (BP) (cardiovascular disease (CVD) risk factors that are usually asymptomatic), and if providing advice would result in reduced risk. We conducted a multicenter (50 community pharmacies) parallel three-arm 8-week randomized controlled trial (RCT) with a 52-week follow-up visit. During six days of screening, TC, HDL- and LDL-cholesterol, triglycerides, HbA1c, BP and body mass index (BMI) were assessed in 1318 individuals. Of these, 582 with a measured and predefined elevated ad hoc CVD risk score were randomized to either Alert/advice (n = 198) (immediately alerted of their screening result and received healthy lifestyle-advice), Advice-only (n = 185) (received only advice) or Control (n = 199) (not alert, no advice). Changes in risk score and self-reported health-related behaviors (diet, alcohol, physical activity) were assessed in pharmacies after 8 weeks (N = 543; 93%). Although the primary analysis showed no significant difference between groups, the Control group had the largest reduction in risk score of 14%. The total (uncontrolled) sample (N = 543) reduced the risk score by 3.2% beyond estimated regression towards the mean and improved their health-related behaviors. Among the 65% (n = 377) who returned 52 weeks after baseline, 14% reported started using CVD preventive medication after the screening. The study demonstrated that while assessing risk factors and behaviors in pharmacies proved efficient and possibly led to a small risk decrease, alerting people to their screening result did not seem to be more effective than a self-directed approach. ClinicalTrials.gov identifier: NCT02223793.

Evaluating the use of the heart age tool in community pharmacies: a 4-week cluster-randomized controlled trial

“…This 4-week intervention study was initiated in unison with the 1year follow-up of participants in the À52-weeks RCT 6 within the Vascular lifestyle-intervention and screening in pharmacies (VISA) study between September and November 2015. 3 In total, 48 community pharmacies (carefully chosen due to their size and widespread distribution in Norway) were clusterrandomized (1:1) prior to the beginning of study visits to intervention or control.…”

“…6 The aim was to study if alerting subjects to their elevated CVD risk through conventional risk communication would result in participants adopting to a healthier lifestyle and consequently present favorable risk-factor levels after 8 weeks. 6 Conventional risk communication included comparing assessed CVD risk-factor levels to predefined color-marked cut-off levels followed by risk-factor targeted diet and lifestyle advice. 6 However, this approach was not effective in reducing risk-factor levels.…”

“…6 Conventional risk communication included comparing assessed CVD risk-factor levels to predefined color-marked cut-off levels followed by risk-factor targeted diet and lifestyle advice. 6 However, this approach was not effective in reducing risk-factor levels. 6 Such numeric risk presentation can be perceived as technical and vague.…”

“…6 However, this approach was not effective in reducing risk-factor levels. 6 Such numeric risk presentation can be perceived as technical and vague. [7][8][9] How risk is communicated and consequently understood is often vital to how risk is acted upon.…”

“…11 Hence, using a similar simplistic, real-life approach, our aim was to investigate the 4-week changes (as it is generally accepted that steady state occur after 4 weeks) in wholeblood cholesterol, fatty acids and physical activity level after using heart age þ conventional risk communication (intervention) or only conventional risk communication (control) in subjects reinvited to pharmacies after attending the À52-weeks RCT. 6 In addition, pharmacy-staff's rated perceived utility of the heart age tool was investigated, in order to have multiple measures to evaluate the heart age tool for future applications.…”