The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice
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Purpose
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 | Intervention |
|---|---|
|
High Cholesterol Cardiovascular Disease |
Behavioral: Training programme |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice |
- The primary patient outcome is adherence to treatment choice. [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
- satisfaction with decision. [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
- self-rated health [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
- anxiety [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
- enablement [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
- satisfaction with communication, [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
- satisfaction and confidence in decision [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
- number of contacts to health services [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]
| Enrollment: | 179 |
| Study Start Date: | November 2007 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations More Information
No publications provided by University of Aarhus
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01187056 History of Changes |
| Other Study ID Numbers: | 2007-41-1446 |
| Study First Received: | August 20, 2010 |
| Last Updated: | October 29, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University of Aarhus:
|
Shared decision-making Risk information Decision aids |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypercholesterolemia Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013