Development and validation of a patient decision aid to assist pharmaceutical care in the prevention of cardiovascular d

1. Development and validation of a patient decision aid to assist pharmaceutical care in the prevention of cardiovascular disease L Lalonde B Pharm, PhD Faculty of Pharmacy University of Montreal Équipe de recherche en soins de première ligne Cité de la Santé de Laval Canadian Stroke Network

2. CVD prevention • Dyslipidemia and anti-hypertensive pharmacotherapy reduce CVD morbidity and mortality • Treatment guidelines are available • Adherence and persistence to treatment is low

3. Hypertension • Canadian Heart Health Surveys: • 16% are treated and controlled • 23% are treated and not controlled • 19% are not treated and not controlled • 42% are unaware of their hypertension AJH 1997; 10:1097-1102

4. Dyslipidemia • Low persistence to lipid-lowering medication • Two-year adherence in elderly: • Recent acute coronary syndrome: 40% • Chronic coronary artery disease: 36% • Primary prevention: 25% JAMA 2002; 288:462-467 • US-Canadian study: • Persistence: 50% after 5 years • Adherence: 66% of the time JAMA 1998;279(18):1458-1462

5. Pharmaceutical care improves: Risk-factor control Adherence to pharmacotherapy Patient satisfaction Process of care DYSLIPIDEMIA ImPACT J Am Pharm Assoc 2000; 40(2):157-165 IMPROVE Pharmacotherapy 2000:20(12):1508-1516 SCRIP Arch Intern Med 2002;162:1149-1155 HYPERTENSION Circulation 1973:XLVIII:1104-11 J Am Pharma Assoc1996;36(7): 443-451 J Occup Med 1994;36(7):743-6 Pharmacotherapy 1997;17(1):140-147 J Am Pharma Assoc 1998;38:574-585 Pharmaceutical care

6. Pharmaceutical care • Patient education • Evaluation of CVD risk • Development of a treatment plan • Patient follow-up Complex, time consuming, and therefore not easily implemented. The development of decision support tools for facilitating pharmaceutical care is important.

7. Objective Development of a Decision Aid for patients with hypertension and dyslipidemia

8. Development Developed by a panel of five researchers and clinicians Reviewed by experts in the field and linguistic specialist Pretest among patients with hypertension or dyslipidemia Pilot studies with pharmacists

9. Description of the DECISION AID

10. Decision Aid Includes: 1) Booklet 2) Personal worksheet

11. Booklet Provides general information • CVD • Risk factors • Treatment options • Four steps decision-making strategy • Examples of patients

12. Booklet The language is adapted to a grade-six level

13. Booklet Provides general evidence-based information

14. Worksheet Provides personal information to apply the four step strategy

15. Step One: To evaluate current cardiovascular health

16. Step One: • Modifiable CVD risk factors

17. Step One: • Current CVD risk • CVD age

18. Step Two: To evaluate the benefits of lifestyle changes and medication

19. Step Two: Estimates of the potential changes in CVD risk with lifestyle changes and medication Lifestyle changes: LDL:  5% HDL:  5% BP (syst/dias):  10 / 5 mm Medication: LDL:  35% HDL:  10% BP (syst/dias):  15 / 10 mm

20. Step Two: Net reduction in CVD risk if all modifiable risk factors are modified

21. Step Two: Patient's preferences

22. Step Three: To define a plan of action for the next three months with their health professional

23. Step Four: To follow progress over time

24. PRE-TESTING

25. Development and Preliminary Testing of a Patient Decision Aid to Assist Pharmaceutical Care in the Prevention of Cardiovascular Disease. L Lalonde, AM O'Connor, SA Grover, P Duguay, A Kayal, E Drake Pharmacotherapy, July 2004

26. Methods • Convenience sample of hypertensive and dyslipidemic patients from an hypertension clinic and CVD-prevention clinic. • Interviews before and after the decision aid

27. Participant characteristics

28. Acceptability of the Decision Aid

29. Participants knowledge p=0.001* p=0.014* p=0.016* * Wilcoxon signed-rank test

30. Perception of CVD risk Risk Category 10-year CVD Risk p = 0.031* p = 0.000* * McNemar test (exact versus inexact estimation)

31. Decisional Conflict p=0.027* p=0.012* p=0.028* p=0.011* p=0.007*

32. PILOT STUDY

33. Evaluation of a decision aid to help patients considering treatment options to reduce their cardiovascular risk: OPTION randomized controlled pilot study L Lalonde, AM O'Connor, SA Grover, P Duguay, A Kayal, E Drake

34. Mélanie Lauzon Evelyne Maher Andrée Martineau Jocelyne Mercier Isabelle Morneau Mélanie Pelletier Francine Perreault-Blake Julie Rousseau Isabelle Salomon Mélina Tsoumis Krystel Beaucage Pierre-Charles Boucher Dominique Chatel Chantal Desgroseillers Anne Drolet Marie Dubois Mélanie Gareau Normand Gauthier Vincent Landry Patrick Lapointe Véronique Laporte Community pharmacists

35. Objective • To assess the feasibility, relevance and clinical usefulness of using a decision aid or a simpler educational tool (personalized risk profile) to assist pharmaceutical care in community pharmacies.

36. Patients initiating anti-hypertensive or lipid-lowering medication(< 12 months) Randomisation Telephone interview Decision aid and pharmacist intervention Personal risk profile and pharmacist intervention Telephone interview 3-month follow-up Telephone interview

37. Personal RiskProfile • Risk factors identification • CVD risk estimate • Benefit of treatment

38. Patients sollicited by pharmacistsn = 42 Patients refused to participate (n = 10) Patients involved in another study (n = 1) Pharmacotherapy discontinued (n = 2) Never sent their medical information to the research nurse (n = 3) Pre-intervention interview n = 26 Intervention Post-intervention interview n = 24 3 month follow-up interview n = 23

39. Analysis • No differences were observed between the DA and the PRP groups. • We combined the results of patients in the DA and the PRP groups • We assessed the differences before and after the intervention.

40. Patients characteristics

41. Patients characteristics

42. Patients characteristics

43. Acceptability

44. Knowledge of personal risk factors Proportion of adequate assessment before and after the intervention

45. Perception of CVD risk Risk category 10-year CVD risk Benefits of treatment

46. Decisional conflict Median decision conflict score before and after the intervention p=0.028 p=0.028 p=0.055

47. Decisional conflict Proportion of participants with score > 2.5 units 7 / 24 (29%) 15/26 (58%) P = 0.07

48. Satisfaction pharmacist intervention Median score The Decision Satisfaction Inventory Scale (Barry MJ, Cherkin DC, Chang YC, Fowler FJ, SkatesS. Disease Management and Clinical Outcomes 1997;1:5-12)

49. Initiation of treatment (n = 15) Continuation of treatment (n = 8)

50. Stage of change Reducing salt in diet Smoking cessation Physical activity Reducing fat in diet Reducing alcohol Loosing weight