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

This study has been completed.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01187056
First received: August 20, 2010
Last updated: October 29, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The primary patient outcome is adherence to treatment choice. [ Time Frame: 2010-08-01 - 2011-04-01 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187056

Sponsors and Collaborators
University of Aarhus
TrygFonden, Denmark
Investigators
Principal Investigator: Janus L Thomsen, MD, PhD University of Aarhus
  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 September 16, 2014