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Open Access Study protocol

The RISAP-study: a complex intervention in risk communication and shared decision-making in general practice

Pia Kirkegaard1*, Adrian GK Edwards2, Bo Hansen1, Mette D Hansen1, Morten SA Jensen1, Torsten Lauritzen1, Mette B Risoer3 and Janus L Thomsen14

Author Affiliations

1 School of Public Health, Dept. of General Practice, Aarhus University, Bartholins Alle 2, DK-8000 Aarhus C, Denmark

2 Department of Primary Care and Public Health, Cardiff University, 2nd Floor Neuadd, Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK

3 Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, Norway

4 Institute of Public Health, Research Unit for General Practice, University of Southern Denmark, J.B. Winsløws Vej 9, DK-5000 Odense C, Denmark

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BMC Family Practice 2010, 11:70  doi:10.1186/1471-2296-11-70

Published: 22 September 2010

Abstract

Background

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 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/Design

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 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.

Discussion

This 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 registration

ClinicalTrials.gov Protocol Registration System NCT01187056