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

Karianne Svendsen, Vibeke H Telle-Hansen, Lisa T Mørch-Reiersen, Kjersti W Garstad, Kari Thyholt, Linda Granlund, Hege Berg Henriksen, Jon Michael Gran, David R Jacobs Jr, Kjetil Retterstøl, Karianne Svendsen, Vibeke H Telle-Hansen, Lisa T Mørch-Reiersen, Kjersti W Garstad, Kari Thyholt, Linda Granlund, Hege Berg Henriksen, Jon Michael Gran, David R Jacobs Jr, Kjetil Retterstøl

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.

Figures

Fig. 1
Fig. 1
CONSORT (2010) flow chart of participants in a pharmacy-based randomized controlled trial.

References

    1. Brown T.J., Todd A., O'Malley C.L. NIHR Journals Library; 2016. Community Pharmacy Interventions for Public Health Priorities: A Systematic Review of Community Pharmacy-delivered Smoking, Alcohol and Weight Management Interventions Southampton (UK)
    1. CONSORT Consort checklist. 2010.
    1. Eggen A.E., Mathiesen E.B., Wilsgaard T. The sixth survey of the Tromso Study (Tromso 6) in 2007–08: collaborative research in the interface between clinical medicine and epidemiology: study objectives, design, data collection procedures, and attendance in a multipurpose population-based health survey. Scand. J. Public Health. 2013;41:65–80.
    1. Estruch R., Ros E., Salas-Salvado J., Covas M.I., Corella D., Aros F. Retraction and Republication: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N. Eng. J. Med. 2013;368:1279–1290.
    2. N. Eng. J. Med. 2018;378(25):2441–2442.
    1. Ference B.A., Ginsberg H.N., Graham I. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur. Heart J. 2017;38:2459–2472.
    1. Global Burden of Disease Mortality Causes of Death Collaborators Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388:1459–1544.
    1. Goff D.C., Jr., Lloyd-Jones D.M., Bennett G. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J. Am. Coll. Cardiol. 2014;63:2935–2959.
    1. Hannan P.J., Jacobs D.R., Jr., McGovern P. Estimating the effect of regression toward the mean under stochastic censoring. Am. J. Epidemiol. 1994;139:422–431.
    1. Helitzer D.L., Lanoue M., Wilson B. A randomized controlled trial of communication training with primary care providers to improve patient-centeredness and health risk communication. Patient Educ. Couns. 2011;82:21–29.
    1. Henriksen H.B., Berntsen S., Paur I., Zucknick M., Skjetne A.J., Bohn S.K. Validation of two short questionnaires assessing physical activity in colorectal cancer patients. BMC Sports Sci. Med. Rehabil. 2018;10(8)
    1. Hjermann I., Velve Byre K., Holme I. Effect of diet and smoking intervention on the incidence of coronary heart disease. Report from the Oslo Study Group of a randomised trial in healthy men. Lancet. 1981;2:1303–1310.
    1. Hoskin M.A., Bray G.A., Hattaway K. Prevention of diabetes through the lifestyle intervention: lessons learned from the diabetes prevention program and outcomes study and its translation to practice. Curr. Nutr. Rep. 2014;3:364–378.
    1. IDRE Statistical Consulting Group Missing data techniques with SAS. 2016.
    1. Jeet G., Thakur J.S., Prinja S. Community health workers for non-communicable diseases prevention and control in developing countries: evidence and implications. PLoS ONE. 2017;12
    1. Kahan B.C., Morris T.P. Analysis of multicentre trials with continuous outcomes: when and how should we account for centre effects? Stat. Med. 2013;32:1136–1149.
    1. Kaplan H., Thompson R.C., Trumble B.C. Coronary atherosclerosis in indigenous South American Tsimane: a cross-sectional cohort study. Lancet. 2017
    1. Laake P., Hjartåker A., Thelle D.S. 1st ed. Gyldendal akademisk; Oslo: 2007. Epidemiologiske og kliniske forskningsmetoder; p. 551.
    1. Law M.R., Wald N.J., Thompson S.G. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994;308:367–372.
    1. Midttun L., Martinussen P.E. Hospital waiting time in Norway: what is the role of organizational change? Scand. J. Public Health. 2005;33:6.
    1. Mooney L.A., Franks A.M. Impact of health screening and education on knowledge of coronary heart disease risk factors. J. Am. Pharm. Assoc. 2011;51:713–718.
    1. National Health and Nutrition Examination Survey . 2004. Anthropometry Procedures Manual. (accessed 25.1 2018)
    1. Piepoli M.F., Hoes A.W., Agewall S. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: the Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR) Atherosclerosis. 2016;252:207–274.
    1. Pi-Sunyer X., Blackburn G., Brancati F.L. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007;30:1374–1383.
    1. Rohla M., Haberfeld H., Sinzinger H. Systematic screening for cardiovascular risk at pharmacies. Open Heart. 2016;3
    1. Rothman R.L., Montori V.M., Cherrington A. Perspective: the role of numeracy in health care. J. Health Commun. 2008;13:583–595.
    1. Santschi V., Chiolero A., Burnand B. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch. Intern. Med. 2011;171:1441–1453.
    1. Selmer R., Igland J., Ariansen I. NORRISK 2: a Norwegian risk model for acute cerebral stroke and myocardial infarction. Eur. J. Prev. Cardiol. 2017;24:773–782.
    1. Sialvera T.E., Papadopoulou A., Efstathiou S.P. Structured advice provided by a dietitian increases adherence of consumers to diet and lifestyle changes and lowers blood low-density lipoprotein (LDL)-cholesterol: the increasing adherence of consumers to diet & lifestyle changes to lower (LDL) cholesterol (ACT) randomised controlled trial. J. Hum. Nutr. Diet. 2017
    1. Statistics Norway GPs and emergency primary health care. 2015.
    1. Svendsen K., Jacobs D.R., Jr., Røyseth I.T. 2018. Pharmacies Offer a Potential High-yield and Convenient Arena for Total Cholesterol and CVD Risk Screening. Unpublished results (submitted to European Journal of Public Health)
    1. Svendsen K., Henriksen H.B., Østengen B. Evaluation of n a short food frequency questionnaire to assess cardiovascular disease-related diet and lifestyle factors. Food Nutr. Res. 2018;62
    1. Waldron C.A., van der Weijden T., Ludt S. What are effective strategies to communicate cardiovascular risk information to patients? A systematic review. Patient Educ. Couns. 2011;82:169–181.
    1. Whiting D.R., Guariguata L., Weil C. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res. Clin. Pract. 2011;94:311–321.
    1. World Health Organization . 2010. Global Status Report on Noncommunicable Diseases 2010: Description of the Global Burden of NCDs, Their Risk Factors and Determinants. (Genevé)
    1. World Health Organization . 2015. World Report on Ageing and Health.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅