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

Cardiovascular Disease Clinical Trial

— RISAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187056
• Other study ID #: 2007-41-1446
• Status: Completed
• Phase: N/A
• First received: August 20, 2010
• Last updated: May 8, 2017
• Start date: November 2007
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• High Cholesterol
• Hypercholesterolemia

Intervention

Behavioral:
• Training programme
2 x 2 hours of training (workshops)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	TrygFonden, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary patient outcome is adherence to treatment choice.		2010-08-01 - 2011-04-01
Secondary	satisfaction with decision.		2010-08-01 - 2011-04-01
Secondary	self-rated health		2010-08-01 - 2011-04-01
Secondary	anxiety		2010-08-01 - 2011-04-01
Secondary	enablement		2010-08-01 - 2011-04-01
Secondary	satisfaction with communication,		2010-08-01 - 2011-04-01
Secondary	satisfaction and confidence in decision		2010-08-01 - 2011-04-01
Secondary	number of contacts to health services		2010-08-01 - 2011-04-01