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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Charlotte Gry Harmsen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01414751
First received: August 5, 2011
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Communication
Hypercholesterolemia
Behavioral: Absolute risk reduction
Behavioral: Prolongation of life

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Patient's satisfaction and confidence with the information given. [ Time Frame: Within two weeks after receiving the information and after 3 months. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 248
Study Start Date: November 2009
Estimated Study Completion Date: August 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: POL

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

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01414751

Sponsors and Collaborators
University of Southern Denmark
Danish Heart Foundation
Investigators
Study Director: Dorte E Jarbol, MD PhD Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charlotte Gry Harmsen, MD PhD fellow, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01414751     History of Changes
Other Study ID Numbers: CGH001
Study First Received: August 5, 2011
Last Updated: January 9, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Risk communication
Shared decision making
Cardiovascular diseases
Hypercholesterolemia
Prevention

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2014