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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01187056
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : May 9, 2017
TrygFonden, Denmark
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
High Cholesterol Cardiovascular Disease Behavioral: Training programme Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice
Study Start Date : November 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Behavioral: Training programme
2 x 2 hours of training (workshops)
Other Name: decision making, decision aids

Active Comparator: Training, usual practice
The control group GPs will receive 2 hours of training in the primary care guideline for prevention of cardiovascular disease
Behavioral: Training programme
2 x 2 hours of training (workshops)
Other Name: decision making, decision aids

Primary Outcome Measures :
  1. The primary patient outcome is adherence to treatment choice. [ Time Frame: 2010-08-01 - 2011-04-01 ]

Secondary Outcome Measures :
  1. satisfaction with decision. [ Time Frame: 2010-08-01 - 2011-04-01 ]
  2. self-rated health [ Time Frame: 2010-08-01 - 2011-04-01 ]
  3. anxiety [ Time Frame: 2010-08-01 - 2011-04-01 ]
  4. enablement [ Time Frame: 2010-08-01 - 2011-04-01 ]
  5. satisfaction with communication, [ Time Frame: 2010-08-01 - 2011-04-01 ]
  6. satisfaction and confidence in decision [ Time Frame: 2010-08-01 - 2011-04-01 ]
  7. number of contacts to health services [ Time Frame: 2010-08-01 - 2011-04-01 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01187056

Sponsors and Collaborators
University of Aarhus
TrygFonden, Denmark
Principal Investigator: Janus L Thomsen, MD, PhD University of Aarhus

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT01187056     History of Changes
Other Study ID Numbers: 2007-41-1446
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: October 2012

Keywords provided by University of Aarhus:
Shared decision-making
Risk information
Decision aids

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases