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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.

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slide1

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

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

dyslipidemia
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

pharmaceutical care
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
pharmaceutical care6
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.

objective
Objective

Development of a Decision Aid

for patients with

hypertension and dyslipidemia

development
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

decision aid
Decision Aid

Includes:

1) Booklet

2) Personal worksheet

booklet
Booklet

Provides general information

  • CVD
  • Risk factors
  • Treatment options
  • Four steps decision-making strategy
  • Examples of patients
booklet12
Booklet

The language is adapted to a grade-six level

slide13

Booklet

Provides general evidence-based information

worksheet
Worksheet

Provides personal information

to apply the

four step strategy

step one
Step One:

To evaluate current cardiovascular health

step one16
Step One:
  • Modifiable CVD risk factors
step one17
Step One:
  • Current CVD risk
  • CVD age
step two
Step Two:

To evaluate the benefits of lifestyle changes and medication

step two19
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 two20
Step Two:

Net reduction in CVD risk if all modifiable risk factors are modified

step two21
Step Two:

Patient's preferences

step three
Step Three:

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

step four
Step Four:

To follow progress

over time

slide25

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

p=0.001*

p=0.014*

p=0.016*

* Wilcoxon signed-rank test

perception of cvd risk
Perception of CVD risk

Risk Category

10-year CVD Risk

p = 0.031*

p = 0.000*

* McNemar test (exact versus inexact estimation)

decisional conflict
Decisional Conflict

p=0.027*

p=0.012*

p=0.028*

p=0.011*

p=0.007*

slide33

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

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

Community pharmacists
objective35
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
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

personal risk profile
Personal RiskProfile
  • Risk factors identification
  • CVD risk estimate
  • Benefit of treatment
patients sollicited by pharmacists n 42
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

analysis
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.
slide44

Knowledge of personal

risk factors

Proportion of adequate assessment before

and after the intervention

slide45

Perception of CVD risk

Risk category

10-year CVD risk

Benefits of treatment

slide46

Decisional conflict

Median decision conflict score before and after the intervention

p=0.028

p=0.028

p=0.055

slide47

Decisional conflict

Proportion of participants with

score > 2.5 units

7 / 24 (29%)

15/26 (58%)

P = 0.07

satisfaction pharmacist intervention
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)

slide49

Initiation of treatment (n = 15)

Continuation of treatment (n = 8)

slide50

Stage of change

Reducing salt in diet

Smoking cessation

Physical activity

Reducing fat in diet

Reducing alcohol

Loosing

weight

limits
Limits
  • Pilot study without real control group
  • Only one pharmacist visit
  • Prevalent cases
  • Lack of physician collaboration
discussion
Discussion

Feasibility:

  • Barriers to implementation
    • perform research procedures
    • obtain previous laboratory test results
    • schedule patient's appointment
    • collaboration with treating physician
discussion53
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
discussion54
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
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