Clinical trial NCT01414751: Influence of Intervention Methodologies on Patient Choice of Therapy
Official title: Interventions for Chronic Diseases: Effect of Patient Values and Effectiveness Information on Patients' Choice of Therapy, Adherence to Therapy and Satisfaction With Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Communication
Hypercholesterolemia
Keywords: Risk communication
Shared decision making
Cardiovascular diseases
Hypercholesterolemia
Prevention
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2011-08-11
Enrollment: 248
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

GPs are randomized to one of two groups, being taught in informing their patients by means of either absolute risk reduction, ARR or life extension, LE.

The setting is the preventive talk in the GP's clinic. From a measured total-cholesterol the GP informs his patient about the individual risk of getting a cardiovascular disease and the possible effectiveness of a cholesterol-lowering drug. This is done by means of either ARR or LE. After the talk the patient is invited to answer a questionnaire concerning personal experience with the information given (deadline 2 weeks after the talk), and again after 3 months will receive a questionnaire concerning satisfaction with the decision made and reflections. Patients' redemption of prescriptions during the following week and the first year are recorded through Odense PharmacoEpidemiological Database, OPED. The GPs' opinions, experiences and concerns about risk communication, prevention, and usage of statins are explored by means of questionnaires.

Eligibility criteria: 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

Primary outcomes:
measure: Patient's satisfaction and confidence with the information given.
timeFrame: Within two weeks after receiving the information and after 3 months.
Secondary outcomes:
measure: Influence of effectiveness format on patients' consent or refusal to a therapy offer
timeFrame: Within the first week after receiving the information and during the following year.
Other outcomes:
Locations:
Study officials:
affiliation: Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
name: Dorte E Jarbol, MD PhD
role: STUDY_DIRECTOR
References:
citation: Harmsen CG, Kristiansen IS, Larsen PV, Nexoe J, Stovring H, Gyrd-Hansen D, Nielsen JB, Edwards A, Jarbol DE. Communicating risk using absolute risk reduction or prolongation of life formats: cluster-randomised trial in general practice. Br J Gen Pract. 2014 Apr;64(621):e199-207. doi: 10.3399/bjgp14X677824.
citation: Harmsen CG, Jarbol DE, Nexoe J, Stovring H, Gyrd-Hansen D, Nielsen JB, Edwards A, Kristiansen IS. Impact of effectiveness information format on patient choice of therapy and satisfaction with decisions about chronic disease medication: the "Influence of intervention Methodologies on Patient Choice of Therapy (IMPACT)" cluster-randomised trial in general practice. BMC Health Serv Res. 2013 Feb 25;13:76. doi: 10.1186/1472-6963-13-76.