The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice

Study Overview
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Brief Summary
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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.

Official Title
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The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice

Conditions
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High Cholesterol, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Training programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - GPs in Region Central and Region North, Denmark, are invited to the study. Patients are at least 18 years old, and have high cholesterol corresponding to a recommendation for cholesterol-reducing medication according to Danish clinical guideline for general practice. The patients are recruited after their high cholesterol has been detected and when treatment options are to be discussed. Exclusion Criteria: - Patients with CVD or DM are excluded from the study, as are patients already receiving cholesterol-reducing medication and patients unable to speak and read Danish.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training, decision making<br>General practitioners receive training in shared decision-making and risk communication, and use their newly acquired skills in real-life consultations with 7 patients with high cholesterol. | Behavioral: Training programme<br>* 2 x 2 hours of training (workshops)<br>* Other names: decision making, decision aids;|
| Active Comparator: Training, usual practice<br>The control group GPs will receive 2 hours of training in the primary care guideline for prevention of cardiovascular disease | Behavioral: Training programme<br>* 2 x 2 hours of training (workshops)<br>* Other names: decision making, decision aids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary patient outcome is adherence to treatment choice. |  | 2010-08-01 - 2011-04-01 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction with decision. |  | 2010-08-01 - 2011-04-01 | 
| self-rated health |  | 2010-08-01 - 2011-04-01 | 
| anxiety |  | 2010-08-01 - 2011-04-01 | 
| enablement |  | 2010-08-01 - 2011-04-01 | 
| satisfaction with communication, |  | 2010-08-01 - 2011-04-01 | 
| satisfaction and confidence in decision |  | 2010-08-01 - 2011-04-01 | 
| number of contacts to health services |  | 2010-08-01 - 2011-04-01 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared decision-making, Risk information, Decision aids