SMART-INFORM

Rationale: In secondary cardiovascular disease (CVD) prevention, all patients are usually assumed to

have both sufficient risk and potential benefit to prescribe preventative therapy. But this has repeatedly

shown to be overly simplistic and may thus, result in over- and under-treatment for some patients.

Individualized approaches better identify individuals who could benefit from preventative therapy.



In order to participate in sound medical decision-making, both doctors and patients must understand

the reasoning behind preventative treatment. However, the translation from medical jargon to readily

understandable material can be challenging. The REACH-SMART model is an individualized predication

score for secondary CVD prevention and is capable of expressing prognosis both in terms of 10-year risk

of a recurrent event, and in terms of cardiovascular event free life-expectancy.

Study Design: Hypothesis blinded, three-armed, randomized controlled trial nested within the ongoing

SMART-study.

Study population: 1) Patients with clinical manifest vascular disease and using statins. 2) General

practitioners of the randomized patients in this study.



Intervention: Personalized information concerning prognosis and effect of statin-therapy will be

calculated using the REACH-SMART score. The personalized information described below will be given to

patients on a written leaflet, supplemented by an educational video, and a telephone consultation. The

general practitioners will receive the same written correspondence as the patients. Patients in the

standard (control) group will not receive any additional information. The three randomized groups are:



1. Standard-communication practices (control group)

2. Standard- communication practices and personalized information based on

a. Individualized 10-year absolute risk of a recurrent event


b. Change in individualized absolute risk associated with statin therapy.

3. Standard-communication practices and personalized information based on


a. Individualized recurrent cardiovascular event-free life expectancy

b. Change in recurrent cardiovascular event-free life-expectancy associated with statin

therapy.

Primary Endpoint: Inter-group differences in the Decisional Conflict Scale between groups at 1 month

post-randomization.

Baseline, t=0; t=6 months

The three-arms of this trial are:



1. Standard-communication practices only (Control Group)

2. Standard- communication practices plus personalized information on

a. Prediction passport: 10-year risk of recurrent event and change in
absolute risk associated with statin therapy.

b. Educational video’s

c. Telephone conversation

3. Standard-communication practices plus personalized information on

a. Prediction passport: Recurrent cardiovascular event-free life
expectancy and change in recurrent cardiovascular event-free life-expectancy
associated with statin therapy

b. Educational video’s

c. Telephone conversation