The primary objective is to compare differences between the communication strategies (personalized vs. standard, and personalized using iARR vs. personalized vs. CVD-free prognosis) on decisional certainty in patients with CVD at 1 month post-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Clinically manifest atherosclerotic disease
Research involving
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; Measured with the Brief Medication
Questionnaire (BMQ) 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; Measured with Patient Activation Measure (PAM)
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, Measured using the Short Form Survey 36 (SF-36)
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
A patient*s understanding of both prognosis and therapy effects is particularly
important in the prevention of cardiovascular disease (CVD). Prevention is
associated with (daily) life-long therapy and slowly accruing and unnoticed
benefits. Both patients and physicians have developed a preference for the
shared decision-making approach, which is believed to have a positive impact on
agreed-upon therapy adherence. However, in order to participate in sound
medical decision-making, both doctors and patients must understand the
reasoning behind preventative treatment. The translation from medical jargon to
readily understandable material can be challenging.
Current prevention guidelines often recommend treatment based on 10-year
cardiovascular risk, without directly considering an individual patient*s
expected benefits. In secondary prevention, all patients are usually assumed to
have both sufficient risk and potential benefit to prescribe preventative
therapy. Personalized approaches better identify individuals who could benefit
from preventative therapy, and therefore potentially represent both a more
medically responsible and cost-effective approach. But these approaches are
relatively new in secondary prevention. The REACH-SMART model is an
individualized model for secondary CVD prevention 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. The score has recently been
validated, and is based on readily available clinical predictors.
Statin medications are widely prescribed in secondary prevention. Therefore,
for this study we chose to investigate the effect of communicating different
individualized predictions on patient decision-making using statin therapy.
However, the results could be generalizable to different types of medications
used in secondary cardiovascular prevention. To date, the influence of various
communication strategies of personalized predictions on patient and physician
decision-making has not yet been studied.
Cardiovascular disease prevention is hampered by two issues: the simultaneous
over-treatment and under-treatment of different patient groups, and low therapy
adherence. The combination of shared decision-making and personalized
prevention strategies has the potential to attenuate both two issues.
Study objective
The primary objective is to compare differences between the communication
strategies (personalized vs. standard, and personalized using iARR vs.
personalized vs. CVD-free prognosis) on decisional certainty in patients with
CVD at 1 month post-communication intervention.
Study design
Hypothesis blinded, three-armed randomized controlled trial performed in
patients taking preventative therapy within the SMART-study.
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
Study burden and risks
During the 6-month duration of the trial, patients will receive three
questionnaires of varying length. These questionnaires take approximately 30
minutes to complete.
Complete participation in the intervention groups requires the patient to read
and interpret personalized predictions (to the best of their ability), watch
educational video's (approximately 10-20 minutes of length), and participate in
a short telephone conversation. Additionally patients give the study team
permission to contact the general practitioner to personalized predictions and
record request LDL-c concentrations. The burdens are thus low. Risks are
negligible. The study is performed in patients taking preventative therapy for
cardiovascular disease. The study results are expected to be applicable to the
domain of anyone taking preventative therapy.
Heidelberglaan 100
utrecht 3584 CX
NL
Heidelberglaan 100
utrecht 3584 CX
NL
Listed location countries
Age
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. 45-80 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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58608.041.16 |