Interventions for Chronic Diseases: Effect of Patient Values and Effectiveness Information on Patients' Choice of Therapy, Adherence to Therapy and Satisfaction With Therapy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 248
- Primary Endpoint
- Patient's satisfaction and confidence with the information given.
Study Overview
Brief Summary
Few studies have explored how specific formats of effectiveness information effect on real patients' decisions. We only know little about what kind of format would be the optimal to help patients make well-informed real-life decisions corresponding to their preferences.
The trial is developed in a clinical randomised design to study risk communication in the shared decision making between general practitioners (GP) and their patients in primary prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about treatment effectiveness and their patients' values on patients' tendency to accept and adhere to the treatment as well as their feeling of content with the choice made. GPs are randomised to inform about risk and treatment effectiveness by means of either absolute risk reduction (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires concerning their content with decisions and reflections. Patients' redemption of prescriptions during the following week and the first year are recorded through an electronic database.
57 GPs and 248 patients have been enrolled in the trial.
Detailed Description
As chronic diseases are steadily increasing in the industrialized countries, there is a growing focus on preventive initiatives. This means that risk communication between the physician and his patients plays a central role.
Effective risk communication can enhance knowledge, involvement in decisions about tests or treatment, autonomy and empowerment of patients. Poor communication, however, can lead to anxiety, lack of confidence in health care professionals, and other adverse outcomes. It is vital that we identify the available evidence about how it should best be done.
The standard formats used to communicate intervention effectiveness are absolute risk reduction, relative risk reduction, number needed to treat, and life prolongation of life.
Few studies have explored the formats' influence on real patient decisions, implying that we only know little about what kind of format would be the optimal to help patients make well-informed real-life decisions corresponding to their preferences.
In a clinical randomized design risk communication is studied in the preventive talk between the general practitioner (GP) and his patients concerning cardiovascular diseases. Special focus is on influence of information format on patients' choice of therapy, adherence to therapy and satisfaction with therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •40-69 year-olds
- •Patients with a measured total-cholesterol of > 4 MMol/Litre
Exclusion Criteria
- •Patients with diabetes
- •Patients with known chronic cardiovascular diseases
- •Patients who are already being treated with cholesterol lowering therapy
- •Patients who are not familiar with the danish language
Arms & Interventions
Absolute risk reduction information
Patients belonging to this arm receive effectiveness information by means of absolute risk reduction when talking with their general practitioner concerning their cholesterol level and possible gain if starting therapy.
Intervention: Absolute risk reduction (Behavioral)
Prolongation of life information
Patients belonging to this arm receive effectiveness information by means of prolongation of life/life extension when talking with their general practitioner concerning their cholesterol level and possible gain if starting therapy.
Intervention: Prolongation of life (Behavioral)
Outcomes
Primary Outcomes
Patient's satisfaction and confidence with the information given.
Time Frame: Within two weeks after receiving the information and after 3 months.
After receiving information about effectiveness of a possible therapy, patients fill in a validated questionnaire ("COMRADE") concerning confidence and satisfaction with the information given. The questionnaire is handed out immediately after information has been given (deadline for answering being two weeks after receiving the effectuveness information), and again after three months to detect adherence with the decision made.
Secondary Outcomes
- Influence of effectiveness format on patients' consent or refusal to a therapy offer(Within the first week after receiving the information and during the following year.)
Investigators
Charlotte Gry Harmsen
MD PhD fellow
University of Southern Denmark