Abstract
BackgroundGeneral 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 training are needed. 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.Methods/DesignThe 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 will receive a questionnaire at baseline and after 6 months about 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 (Provider Decision Process Assessment Instrument). The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment (Morisky Compliance Scale), self-rated health (SF-12), enablement (Patient Enablement Instrument), and risk communication and decision-making effectiveness (COMRADE Scale). Prescriptions, contacts to the health services, and cholesterol level will be drawn from the registers.In each group, 12 consultations will be observed and tape-recorded. 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 analyse adaptation of the intervention model to the specific context.DiscussionThis study aims at providing GPs and patients with a firm basis for active deliberation about preventive treatment options, with a view to optimising adherence to chosen treatment.Trial registrationClinicalTrials.gov Protocol Registration System NCT01187056
Highlights
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
This study aims at providing general practitioner (GP) and patients with a firm basis for active deliberation about preventive treatment options, with a view to optimising adherence to chosen treatment
It has been argued that preventive treatment to lower the risk of cardiovascular disease is underused as a result of both general practitioners’ low adherence to clinical guidelines and patients’ low adherence to preventive treatment [4,5,6]
Summary
Much attention has been given to how risk information should be communicated to patients with established conditions requiring treatment or specific surveillance strategies [1,2,3]. Further studies in these areas of risk communication for disease prevention are needed as are studies about risk communication training for GPs and the use of decision aids These studies need to develop and evaluate interventions that address a range of likely difficulties - in training and adoption of SDM and risk communication skills, use of decision aids with real patients, and follow-up of their effectiveness as patients try to adapt treatment plans to their everyday lives. By nature these are ‘complex interventions’ [37] and will benefit from multi-faceted evaluation [38]
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