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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-07-31

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.

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Detailed Description

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Conditions

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High Cholesterol Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Training, decision making

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.

Group Type EXPERIMENTAL

Training programme

Intervention Type BEHAVIORAL

2 x 2 hours of training (workshops)

Training, usual practice

The control group GPs will receive 2 hours of training in the primary care guideline for prevention of cardiovascular disease

Group Type ACTIVE_COMPARATOR

Training programme

Intervention Type BEHAVIORAL

2 x 2 hours of training (workshops)

Interventions

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Training programme

2 x 2 hours of training (workshops)

Intervention Type BEHAVIORAL

Other Intervention Names

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decision making, decision aids

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No