No registrations found.
ID
Source
Brief title
Health condition
Personalized medicine
Communication
Cardiovascular Prevention
Shared decision-making
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient experience with decision-making, measured using the Decisional Conflict
Scale (DCS), 1 month post-intervention.
Secondary outcome
1. Prolonged Improved Patient Decision-Making; Measured with Decisional
Conflict Scale (DCS) questionnaire at 6 months
2. Self-reported medication adherence;
questionnaire at 1, and 6 months
3. Patients’ illness perceptions; Measured with Brief Illness Perception
Questionnaire (IPQ) questionnaire; at 1 and 6 months
4. Understanding of therapy-effects; Measured with Understanding of Therapy
questionnaire, designed for this study at 1 and 6 months
5. General practitioners’ assessment of the intervention; Measured with
questionnaire designed for this study at 1 month
6. Patient Activation
questionnaire at and 6 months
7. Patient Reported Shared Decision-Making, measured with the 9 -item
Shared Decision Making Questionnaire (SDMQ9), 1 month post intervention.
8. Patient Perception of Statin Efficacy, measured using a visual analog
scale at 1 and 6 months.
9. Quality of Life
questionnaire at 6 months.
10. Serum LDL-c (mmol/L) levels, 6 months after intervention, as documented
the primary Care Dossier (last observation carried forward)
Background summary
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.
Study design
Baseline, t=0; t=6 months
Intervention
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
Divisie Interne Geneeskunde en Dermatologie, Vasculaire Geneeskunde
Nicole N.M. Jaspers
Universitair Medisch Centrum Utrecht | Kamernummer D.01.229 | Huispostnummer F.02.126
Utrecht
The Netherlands
T: +31 88 75 556 50
N.E.M.Jaspers@umcutrecht.nl
Divisie Interne Geneeskunde en Dermatologie, Vasculaire Geneeskunde
Nicole N.M. Jaspers
Universitair Medisch Centrum Utrecht | Kamernummer D.01.229 | Huispostnummer F.02.126
Utrecht
The Netherlands
T: +31 88 75 556 50
N.E.M.Jaspers@umcutrecht.nl
Inclusion criteria
1. Inclusion in the SMART study (NL45885.041.13)
2. Clinically manifest cardiovascular disease, such as a confirmed diagnosis or strong clinical suspicion of one of the following: coronary artery disease, cerebrovascular disease, peripheral artery disease.
3. Use of statin medication at baseline
4. Between 18 and 80 years of age
5. Rankin Scale <3
Exclusion criteria
1. Pregnancy
2. Terminal malignancy or short life-expectancy
3. No follow-up possible
4. Inability to effectively communicate in Dutch
5. No informed consent (IC) signed
6. Baseline questionnaire not returned
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6080 |
| NTR-old | NTR6227 |
| CCMO | NL58608.041.16 |
| OMON | NL-OMON45689 |