Cardiovascular Disease Clinical Trial
Official title:
The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice
General practitioners (GPs) and patients find it difficult to talk about risk of future
disease, especially when patients have asymptomatic conditions, and treatment options are
unlikely to cause immediate perceptible improvements in well-being. Further studies in risk
communication for disease prevention are needed, as are studies about risk communication
training for GPs. Aim: 1) to systematically develop, describe and evaluate a complex
intervention comprising a training programme for GPs in risk communication and shared
decision-making, 2) to evaluate the effect of the training programme on real-life
consultations between GPs and patients with high cholesterol levels, and 3) to evaluate
patients' reactions during and after the consultations. Hypothesis: 1) patients have better
adherence to chosen treatment.
The effect of the complex intervention, based around a training programme, will be evaluated
in a cluster-randomised controlled trial with an intervention group and an active control
group with 40 GPs and 280 patients in each group.
The GPs receive a questionnaire at baseline and after 6 months about their attitudes towards
risk communication and cholesterol-reducing medication. After each consultation with a
participating high cholesterol-patient, the GPs will complete a questionnaire about decision
satisfaction.
The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes
questions about adherence to chosen treatment, self-rated health, patient enablement, and
risk communication and decision-making effectiveness. Prescriptions, contacts to the health
services, and cholesterol level will be drawn from the register of the National Health
Service of Denmark at baseline and at 6 months.
In both intervention group and active control group, 12 consultations will be observed and
tape-recorded. The consultations will be divided between 4 GPs with each 3 patients. The
patients from these 24 consultations will be interviewed immediately after the consultation
and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention
group will be interviewed in a focus group 6 months after participation in the training
programme. The process and context of the RISAP-study will be investigated in detail using
an action research approach, in order to describe and analyse research choices, adaptation
of intervention model to the specific context, and GPs' and patients' reactions to trial
participation.
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