CommunicationIMPACTNCT01414751
Influence of Intervention Methodologies on Patient Choice of Therapy
A study testing Absolute risk reduction and Prolongation of life in people with Communication and Hypercholesterolemia, run by University of Southern Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Communication, Hypercholesterolemia
- What is being tested?
- Absolute risk reduction and Prolongation of life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-69 year-olds
- Patients with a measured total-cholesterol of > 4 MMol/Litre
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Communication, Hypercholesterolemia
- Being tested
- Absolute risk reduction, Prolongation of life
- Keywords
- Risk communication, Shared decision making, Cardiovascular diseases, Hypercholesterolemia, Prevention
- Medical subject headings
- Communication, Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absolute risk reductionBehavioural
Also called ARR
Patients receive effectiveness information concerning cholesterol lowering therapy by means of absolute risk reduction
Prolongation of lifeBehavioural
Also called POL
Patients receive effectiveness information concerning cholesterol lowering therapy by means of prolongation of life/life extension.
| Study group | Role | What they receive |
|---|---|---|
| Absolute risk reduction information | Active comparator | 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. Receives: Behavioral: Absolute risk reduction |
| Prolongation of life information | Active comparator | 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. Receives: Behavioral: Prolongation of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction and confidence with the information given.
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.
Measured: Within two weeks after receiving the information and after 3 months.
Secondary outcomes (1)
Influence of effectiveness format on patients' consent or refusal to a therapy offer
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.
Measured: Within the first week after receiving the information and during the following year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Principal investigator, Charlotte Gry Harmsen, University of Southern Denmark
- Investigators
- Dorte E Jarbol, MD PhD, Study director, Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414751
- Sponsor's protocol ID
- CGH001
- Acronym
- IMPACT
- Status last verified
- Jan 2013
- First submitted
- 5 Aug 2011
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24686884Harmsen 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.
PubMed 23442351
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01414751
- Acronym / sponsor ID
- IMPACT / CGH001
- Conditions
- Communication, Hypercholesterolemia
- Keywords
- Risk communication, Shared decision making, Cardiovascular diseases, Hypercholesterolemia, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2013 (estimated)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absolute risk reduction information | Active comparator | Behavioral: Absolute risk reductionPatients 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. |
| Prolongation of life information | Active comparator | Behavioral: Prolongation of lifePatients 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. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 40-69 year-olds
- Patients with a measured total-cholesterol of > 4 MMol/Litre
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absolute risk reductionAlso: ARRPatients receive effectiveness information concerning cholesterol lowering therapy by means of absolute risk reduction | Behavioural | Absolute risk reduction information |
| Prolongation of lifeAlso: POLPatients receive effectiveness information concerning cholesterol lowering therapy by means of prolongation of life/life extension. | Behavioural | Prolongation of life information |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- Derived from this study: PubMed 24686884Harmsen 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.
- Derived from this study: PubMed 23442351Harmsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorte E Jarbol, MD PhD study director
Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Absolute risk reduction and Prolongation of life in people with Communication and Hypercholesterolemia, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's satisfaction and confidence with the information given. (time frame: Within two weeks after receiving the information and after 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414751, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.