A pharmacist-led follow-up program for patients with established coronary heart disease in North Norway – a randomized controlled trial

  • Beate H. Garcia
  • Trude Giverhaug
  • June U. Høgli
  • Frode Skjold
  • Lars Småbrekke
Keywords: Pharmaceutical Services, Medication Reconciliation, Pharmacists, Coronary Disease, Randomized Controlled Trials as Topic, Norway

Abstract

Objectives: The aim of the study was twofold; 1) to develop a clinical pharmacist-led 12 month lasting follow-up program for patients with established coronary heart disease (CHD) discharged from the University Hospital of North Norway, and 2) to explore the impact of the program with regards to adherence to a medication assessment tool for secondary prevention of CHD and change in biomedical risk factors.

Methods: A total of 102 patients aged 18-82 years were enrolled in a non-blinded randomized controlled trial with an intervention group and a control group. The intervention comprised medication reconciliation, medication review and patient education during three meetings; at discharge, after three months and after twelve months. The control group received standard care from their general practitioner. Primary outcomes were adherence to clinical guideline recommendations concerning prescription, therapy goal achievement and lifestyle education defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP). Secondary outcomes included changes in the biomedical risk factors cholesterol, blood pressure and blood glucose.

Results: Ninety-four patients completed the trial, 48 intervention group patients and 46 controls. Appropriate prescribing was high, but therapy goal achievement was low in both groups. Overall adherence to MAT-CHDSP criteria increased in both groups and was significantly higher in the intervention group at study end, 78.4% vs. 62.0%, p<0.001. The difference was statistically significant for the documented lifestyle advices in intervention group patients. No significant improvements in biomedical risk factors were observed in favor of the intervention group.

Conclusions: The study showed an increased guideline adherence in both study groups. This indicates that attention to clinical practice guideline recommendations in itself increases adherence – which may be a clinical pharmacist task. A larger adequately powered study is needed to show a significant difference in biomedical risk factor improvements in favor of the intervention. Amendments to the follow-up program are suggested before implementation in standard patient care can be recommended.

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References

1. Mackay J, Mensah G. Atlas of Heart Disease and Stroke. Geneve: WHO; 2004. ISBN: 9789241562768

2. Causes of deaths, 2010. Statistisk sentralbyrå (Eng: Statistics Norway) Available from: URL: http://www.ssb.no/ (accessed 2010 Jul 13).

3. Scottish Intercollegate Guideline Network. Available from: URL: http://www.sign.ac.uk/ (accessed 2010 Jul 13).

4. National Institute of Health and Clinical Excellence. Available from: URL: http://www.nice.org.uk/ (accessed 2010 Jul 13).

5. Nice Cardiovascular guidance. National Institute of Clinical Expertice (NICE) 2011Available from: URL: http://guidance.nice.org.uk/Topic/Cardiovascular (accessed 2010 Jul 13).

6. Horning KK, Hoehns JD, Doucette WR. Adherence to clinical practice guidelines for 7 chronic conditions in long-term-care patients who received pharmacist disease management services versus traditional drug regimen review. J Manag Care Pharm. 2007;13(1):28-36.

7. Libungan B, Stensdotter L, Hjalmarson A, From Attebring M, Lindqvist J, Bäck M, Herlitz J. Secondary prevention in coronary artery disease. Achieved goals and possibilities for improvements. Int J Cardiol. 2012;161(1):18-24. doi: 10.1016/j.ijcard.2011.04.025

8. Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil. 2009;16(2):121-137. doi: 10.1097/HJR.0b013e3283294b1d

9. Coma-Canella I. [Relationship between mortality due to acute myocardial infarction and adherence to clinical guidelines]. Rev Esp Cardiol. 2006;59(3):189-192.

10. Albert N. Improving medication adherence in chronic cardiovascular disease. Crit Care Nurse. 2008;28(5):54-64.

11. Nkansah N, Mostovetsky O, Yu C, Chheng T, Beney J, Bond CM, Bero L. Effect of outpatient pharmacists' non-dispensing roles on patient outcomes and prescribing patterns. Cochrane Database Syst Rev. 2010;(7):CD000336. doi: 10.1002/14651858.CD000336.pub2

12. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006;296(21):2563-2571.

13. Taveira TH, Wu WC, Martin OJ, Schleinitz MD, Friedmann P, Sharma SC. Pharmacist-led cardiac risk reduction model. Prev Cardiol. 2006;9(4):202-208.

14. Reilly V, Cavanagh M. The clinical and economic impact of a secondary heart disease prevention clinic jointly implemented by a practice nurse and pharmacist. Pharm World Sci. 2003;25(6):294-298.

15. Strand LM. Twenty Years of Pharmacuetical Care Practice: What Have We Learned? Lecture held on June 6 2011, Reykjavik, Iceland.

16. De Backer G; EUROASPIRE II Study Group. Evidence-based goals versus achievement in clinical practice in secondary prevention of coronary heart disease: findings in EUROASPIRE II. Atheroscler Suppl. 2002 Apr;2(4):13-16.

17. EuroAction - Demonstration Project in Preventive Cardiology. http://www.escardio.org/Policy/Pages/EuroAction.aspx (accessed November 7, 2011).

18. Garcia BH, Utnes J, Naalsund L, Giverhaug T. MAT-CHDSP, a novel medication assessment tool for evaluation of secondary prevention of coronary heart disease. Pharmacoepidemiol Drug Saf. 2011;20(3):249-257. doi: 10.1002/pds.2054

19. Garcia BH, Smabrekke L, Trovik T, Giverhaug T. Application of the MAT-CHDSP to assess guideline adherence and therapy goal achievement in secondary prevention of coronary heart disease after percutaneous coronary intervention. Eur J Clin Pharmacol. 2013;69(3):703-709. doi: 10.1007/s00228-012-1402-7

20. Kommuner og befolkning pr. helseforetak [Communities and inhabitants for each Health Trust]. Available from: URL: http://www.helse-nord.no/befolkning-pr-helseforetak/category22368.html (accessed 2010 Jul 13).

21. Bønaa K. Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis (NORSTENT). Clinicaltrials gov 2011 May 19 Available from: URL: http://clinicaltrials.gov/ct2/show/NCT00811772 (accessed November 7, 2011).

22. Randomisation at the Norwegian University of Science and Technology. http://www.ntnu.edu/dmf/akf/randomisering (accessed November 7, 2011).

23. Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care. New York: The Guilford Press; 2008.

24. Validated Blood Pressure Monitors by British Hypertension Society. http://www.bhsoc.org/blood_pressure_list.stm (accessed November 7, 2011).

25. Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Struijker Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Kjeldsen SE, Erdine S, Narkiewicz K, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Cifkova R, Dominiczak A, Fagard R, Heagerty AM, Laurent S, Lindholm LH, Mancia G, Manolis A, Nilsson PM, Redon J, Schmieder RE, Struijker-Boudier HA, Viigimaa M, Filippatos G, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Kiowski W, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Viigimaa M, Waeber B, Williams B, Zamorano JL, The task force for the management of arterial hypertension of the European Society of Hypertension, The task force for the management of arterial hypertension of the European Society of Cardiology. 2007 Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2007;28(12):1462-1536.

26. Robson C. Real world research. A resource for social scientists and practitioner-researchers. 2nd ed. Malden:Blackwell;2002.

27. Garcia BH, Storli SL, Smabrekke L. A pharmacist-led follow-up program for patients with coronary heart disease in North Norway--a qualitative study exploring patient experiences. BMC Res Notes. 2014;7:197. doi: 10.1186/1756-0500-7-197

28. Lalonde L, Hudon E, Goudreau J, Bélanger D, Villeneuve J, Perreault S, Blais L, Lamarre D. Physician-pharmacist collaborative care in dyslipidemia management: The perception of clinicians and patients. Res Social Adm Pharm. 2011;7(3):233-245. doi: 10.1016/j.sapharm.2010.05.003

29. Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management: 10 years of experience in a large integrated health care system. J Manag Care Pharm. 2010;16(3):185-195.

30. Wheeler A, Crump K, Lee M, Li L, Patel A, Yang R, Zhao J, Jensen M. Collaborative prescribing: A qualitative exploration of a role for pharmacists in mental health. Res Social Adm Pharm. 2012;8(3):179-192. doi: 10.1016/j.sapharm.2011.04.003

31. Till LT, Voris JC, Horst JB. Assessment of clinical pharmacist management of lipid-lowering therapy in a primary care setting. J Manag Care Pharm. 2003;9(3):269-273.

32. Neto PR, Marusic S, de Lyra Júnior DP, Pilger D, Cruciol-Souza JM, Gaeti WP, Cuman RK. Effect of a 36-month pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients. J Pharm Pharm Sci. 2011;14(2):249-263.

33. Ma Y, Ockene IS, Rosal MC, Merriam PA, Ockene JK, Gandhi PJ. Randomized Trial of a Pharmacist-Delivered Intervention for Improving Lipid-Lowering Medication Adherence among Patients with Coronary Heart Disease. Cholesterol. 2010;2010:383281. doi: 10.1155/2010/383281

34. Axtell SS, Ludwig E, Lope-Candales P. Intervention to improve adherence to ACC/AHA recommended adjunctive medications for the management of patients with an acute myocardial infarction. Clin Cardiol. 2001;24(2):114-118.

35. Bailey TC, Noirot LA, Blickensderfer A, Rachmiel E, Schaiff R, Kessels A, Braverman A, Goldberg A, Waterman B, Dunagan WC. An intervention to improve secondary prevention of coronary heart disease. Arch Intern Med. 2007;167(6):586-590.

36. Chapman NR, Fotis MA, Yarnold PR, Gheorghiade M. Pharmacist interventions to improve the management of coronary artery disease. Am J Health Syst Pharm. 2004;61(24):2672-2678.

37. Hawthorn effect. http://www.merriam-webster.com/dictionary/hawthorne%20effect (accessed November 7, 2011).

38. Reeve H, Baxter K, Newton P, Burkey Y, Black M, Roland M. Long-term follow-up in outpatient clinics. 1: The view from general practice. Fam Pract. 1997;14(1):24-28.

39. Geber J, Parra D, Beckey NP, Korman L. Optimizing drug therapy in patients with cardiovascular disease: the impact of pharmacist-managed pharmacotherapy clinics in a primary care setting. Pharmacotherapy. 2002;22(6):738-747.

40. Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5
Published
2015-06-18
Section
Original Research