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

prevention of cardiovascular disease

L Lalonde B Pharm, PhDFaculty of Pharmacy

University of MontrealÉquipe de recherche en soins de première ligne

Cité de la Santé de LavalCanadian Stroke Network

CVD prevention

• Dyslipidemia and anti-hypertensive pharmacotherapy reduce CVD morbidity and mortality

• Treatment guidelines are available

• Adherence and persistence to treatment is low

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

• 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

Dyslipidemia

Pharmaceutical care

Pharmaceutical care improves:

• Risk-factor control• Adherence to

pharmacotherapy• Patient satisfaction• Process of care

DYSLIPIDEMIAImPACT

J Am Pharm Assoc 2000; 40(2):157-165

IMPROVEPharmacotherapy 2000:20(12):1508-1516

SCRIPArch Intern Med 2002;162:1149-1155

HYPERTENSIONCirculation 1973:XLVIII:1104-11J Am Pharma Assoc1996;36(7): 443-451J Occup Med 1994;36(7):743-6Pharmacotherapy 1997;17(1):140-147J Am Pharma Assoc 1998;38:574-585

Pharmaceutical care

Complex, time consuming, and therefore not easily implemented. The development of decision support

tools for facilitating pharmaceutical care is important.

• Patient education• Evaluation of CVD risk• Development of a treatment plan• Patient follow-up

Objective

Development of a Decision Aid

for patients with

hypertension and dyslipidemia

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

Description of the DECISION AID

Decision Aid

Includes:

1) Booklet

2) Personal worksheet

Booklet

Provides general information

• CVD• Risk factors• Treatment options• Four steps decision-making

strategy• Examples of patients

Booklet

The language is adapted to a

grade-six level

Provides general evidence-based

information

Booklet

Worksheet

Provides personal information

to apply the

four step strategy

Step One:

To evaluate current cardiovascular health

Step One:

Modifiable CVD risk factors

Step One:

Current CVD risk CVD age

Step Two:

To evaluate the benefits of lifestyle

changes and medication

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

Step Two:

Net reduction in CVD risk if all modifiable risk

factors are modified

Step Two:

Patient's preferences

Step Three:

To define a plan of action for the next three months with

their health professional

Step Four:

To follow progress

over time

PRE-TESTING

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

Methods

• Convenience sample of hypertensive and dyslipidemic patients from an hypertension clinic and CVD-prevention clinic.

• Interviews before and after the decision aid

Participant characteristics

Number of participants (n)

Gender: n (%) Male

Age (year): mean ( sd)

Current treatment: n (%) Antihypertensive medication Lipid-lowering medication Both

10 year CVD risk: mean % ( sd)

Risk category: n (%) Below average (first tertile) Average (second tertile) Above average (third tertile)

16

10 (63%)

57 (10)

11 (69%)3 (19%)

2 (12.5%)

36% (28%)

4 (25%)3 (19%)9 (56%)

Acceptability of the Decision Aid

Way the information is presented in the booklet Excellent / very good Good / poorWay the information is presented in the worksheet Excellent / very good Good / poorAmount of information Too short Just right Too longObjectivity of the Decision Aid Slanted towards lifestyle options Slanted towards taking medications BalancedUsefulness Excellent / very good

14 (93%)1 (7%)

13 (87%)2 (13%)

1 (7%)14 (93%)

0 (0%)

2 (13%)1 (7%)

12 (80%)

15 (100%)

Participants knowledge

91%

73%

68%

100%

92%

99%

60%

65%

70%

75%

80%

85%

90%

95%

100%

Risk factors in general Personal risk factors Treatment options

Before

After

p=0.014* p=0.016* p=0.001*

* Wilcoxon signed-rank test

Perception of CVD risk

19%

0%

44%

7%

50%93%

0%

93%

31%

7%

56%

0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Before After Before After

Underestimation Exact estimation Overestimation

Risk Category 10-year CVD Risk

p = 0.031* p = 0.000*

* McNemar test (exact versus inexact estimation)

Decisional Conflict

2,3 2,3 2,3

2,1

2,3

2,0

1,9

2,0 2,0 2,0

1,5

1,75

2

2,25

2,5

Uncertainty Feelinguninformed

Feeling unclearabout values

Feelingunsupported in

decision

Overall score

p=0.027* p=0.012* p=0.028* p=0.011* p=0.007*

PILOT STUDY

Evaluation of a decision aid to help patients considering treatment

options to reduce their cardiovascular risk: OPTIONOPTION

randomized controlled pilot study

L Lalonde, AM O'Connor, SA Grover, P Duguay, A Kayal, E Drake

Community pharmacists

• 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

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.

Patients initiating anti-hypertensive or lipid-lowering medication

(< 12 months)

Randomisation

Decision aidDecision aidandand

pharmacist pharmacist interventionintervention

Personal risk Personal risk profile and profile and pharmacist pharmacist interventionintervention

3-month follow-up

Telephone interview

Telephone interview

Telephone interview

Personal Risk

Profile

• Risk factors identification

• CVD risk estimate

• Benefit of treatment

Patients sollicited by pharmacistsn = 42

Pre-intervention interview

n = 26

Post-intervention interview

n = 24

3 month follow-up interview

n = 23

Patients refused to participate(n = 10)

Patients involved in another study (n = 1)

Intervention

Pharmacotherapy discontinued (n = 2)Never sent their medical information to the

research nurse (n = 3)

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.

Decision aid Risk profile

Number of participants 13 13

Gender

Male 6 (46%) 8 (62%)

Female 7 (54%) 5 (38%)

Age (years) : median 55 57

Current treatment : n (%)

Dyslipidemia treatment only 12 (92%) 7 (54%)

Anti-hypertension treatment only 0 (0%) 3 (23%)

Anti-hypertension and dyslipidemia

treatment

1 (8%) 3 (23%)

Patients characteristics

Decision aid Risk profile

Blood pressure : median

Systolic/diastolic 130 / 80 135 / 85

Cholesterol level : median

LDL cholesterol (mmol/L) 3.62 3.84

HDL cholesterol (mmol/L) 1.25 1.18

Ratio total cholesterol/HDL cholesterol 4.68 4.89

Cardiovascular risk factors

Diabetes 1 (8%) 4 (31%)

Overweight and obesity 7 (54%) 10 (77%)

Previous cardiovascular disease 2 (15%) 4 (31%)

Sedentarity 8 (62%) 9 (69%)

Smoking 4 (31%) 1 (8%)

Patients characteristics

Decision aid Risk profile

Estimate cardiovascular risk : median

10-year cardiovascular risk (%) 16% 34%

Cardiovascular age (years) 54 59

Risk category : n (%)

Below average (first tertile) 5 (38%) 0 (0%)

Average (second tertile) 3 (23%) 6 (46%)

Above average (third tertile) 5 (38%) 7 (54%)

Patients characteristics

Decision aid Risk profileWay the information is presented in the booklet

Excellent / Very good 9 (75%) 10 (83%)Good / Poor 3 (25%) 2 (17%)

Way the information is presented in theworksheet

Excellent / Very good 7 (58%) 12 (100%)Good / Poor 5 (42%) 0 (0%)

Amount of informationToo short 2 (17%) 0 (0%)Just right 9 (75%) 12 (100%)Too long 1 (8%) 0 (0%)

Objectivity of the decision aidSlanted towards lifestyle options 3 (35%) 1 (8%)Slanted towards taking medications 0 (0%) 2 (25%)Balanced 9 (75%) 8 (67%)

UsefulnessVery usefull / Usefull 12 (100%) 12 (100%)

Helpfull to take decision regarding cholesterolor hypertension treatment

Yes 11 (92%) 12 (100%)No 1 (8%) 0 (0%)

Acceptability

Knowledge of personal

risk factors

35%

19%23%

81%

40%42%

21% 21%

79%

41%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

HDLcholesterol

LDLcholesterol

Blood pressure Body massindex

Overall

Before After

Proportion of adequate assessment before and after the intervention

35%42%

27%21%

42% 38%

31%

33%

35%54%

29%

58%

25%

39%

25% 29%

4%

35%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Before After Before After Before After

Underestimation Exact estimation Over estimation

Risk category 10-year CVD risk Benefits of treatment

Perception of CVD risk

2,3

2,7 2,7 2,7

2,5

2,0

2,3

2,7

2,5

2,4

1,5

1,75

2

2,25

2,5

2,75

Uncertainty Feelinguninformed

Feeling unclearabout values

Feelingunsupported in

decision

Overall score

Before After

Median decision conflict score before and after the intervention

p=0.028

p=0.028

p=0.055

Decisional conflict

Decisional conflict

0%

10%

20%

30%

40%

50%

60%

70%

Before After

Proportion of participants with score > 2.5 units

15/26 (58%)

7 / 24 (29%)

P = 0.07

Satisfaction pharmacist intervention

44

3,33

0

0,5

1

1,5

2

2,5

3

3,5

4

4,5

Patient's role Amount ofinformation

How pharmacisttreated patient

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)

Initiation of treatment (n = 15)

Continuation of treatment (n = 8)Before After

Lipids target reached : n (%) 4/7 (57%) 2/4 (50%)

Cholesterol concentration : mean (SD)Total Cholesterol (mmol/L) 5.42 (1.78) 4.75 (0.86)LDL Cholesterol (mmol/L) 2.83 (0.44) 2.57 (0.46)HDL Cholesterol (mmol/L) 1.17 (0.23) 1.19 (0.29)Total/HDL-Cholesterol 4.85 (1.93) 4.20 (1.50)

Before After

Lipids target reached : n (%) 7/14 (50%) 10/12 (83%)

Cholesterol concentration: mean (SD)Total Cholesterol (mmol/L) 6.46 (1.32) 4.70 (0.78)*LDL Cholesterol (mmol/L) 3.96 (0.73) 2.40 (0.86)*HDL Cholesterol (mmol/L) 1.36 (0.39) 1.44 (0.46)Total/HDL-Cholesterol 4.92 (0.96) 3.49 (0.99)*

0%

20%

40%

60%

80%

100%

Bef

ore

Aft

er

Bef

ore

Aft

er

Bef

ore

Aft

er

Bef

ore

Aft

er

Bef

ore

Aft

er

Bef

ore

Aft

er

Contemplation Preparation Action

Stage of change

Smoking cessation

Physical activity

Reducing fat in diet

Reducing salt in diet

Loosing weight

Reducing alcohol

Limits

• Pilot study without real control group

• Only one pharmacist visit

• Prevalent cases

• Lack of physician collaboration

Discussion

Feasibility:• Barriers to implementation

– perform research procedures– obtain previous laboratory test results– schedule patient's appointment– collaboration with treating physician

Discussion

Relevant:• Indication of low quality decision at baseline:

– little knowledge of CVD risk factors– inadequate perception of CVD risk and benefits of

treatment – relatively high level of decisional conflict

• High acceptability of both tools• High satisfaction toward pharmacist intervention• Current clinical practice practice guidelines

Discussion

• Effectiveness:– No impact on CVD knowledge– Reduction of decision conflict– Trends toward progression in the stage of

change for lifestyle changes– Trends toward improvement in lipid levels

TEAM cluster RCT

Patients admitted to cardiology unit

Usual Care Pharmaceutical Care

• Hospital pharmacists: • Complete and discuss DA

• Community pharmacists:• Review DA• Adjust statin dosage according to a prescription