Influence of Intervention Methodologies on Patient Choice of Therapy (IMPACT)

January 9, 2013 updated by: Charlotte Gry Harmsen, University of Southern Denmark

Interventions for Chronic Diseases: Effect of Patient Values and Effectiveness Information on Patients' Choice of Therapy, Adherence to Therapy and Satisfaction With Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Absolute risk reduction
Patients receive effectiveness information concerning cholesterol lowering therapy by means of absolute risk reduction
Other Names:
  • ARR
Active Comparator: 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.
Behavioral: Prolongation of life
Patients receive effectiveness information concerning cholesterol lowering therapy by means of prolongation of life/life extension.
Other Names:
  • POL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within two weeks after receiving the information and after 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of effectiveness format on patients' consent or refusal to a therapy offer
Time Frame: Within the first week after receiving the information and during the following year.
After patients have received the effectiveness information the secondary study focus will be on tendency to accept the offered therapy according to information format given. This will be studied by means of patients' redemptions of prescriptions, recorded through a pharmacoepidemilogical database, as well as background information about the patients.
Within the first week after receiving the information and during the following year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Danish Heart Foundation

Investigators

  • Study Director: Dorte E Jarbol, MD PhD, Research Unit of General Practice, Institute of Public Health, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGH001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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