CancerNCT02069470
The Effect of CME on Early Cancer Diagnosis in General Practice
A study testing Continuing Medical Education in people with Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background Denmark has a lower survival of cancer compared to most European countries. Fast track pathways for organ specific cancers were established in the years 2008-2010. In 2011 further a fast track pathway for non-specific serious symptoms. Cancer in general practice is a low prevalence condition. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Continuing Medical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 689 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GP should be a GP principal
- The referring GP should complete the registration form
- Patients should be referred directly from practice to hospital on cancer suspicion in the inclusion period September 2012- May 2013
Who cannot join
- Patients already registered with one cancer, diagnosed within 5 years
- Patients self-inflicted in delay
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Centre for Cancer Diagnosis in Primary Care, Research Unit for General Practice, Aarhus University
Aarhus, Aarhus C, 8000
About this study
Official title: The Effect of Continuing Medical Education (CME) on Early Cancer Diagnosis in General Practice
Background Denmark has a lower survival of cancer compared to most European countries. Fast track pathways for organ specific cancers were established in the years 2008-2010. In 2011 further a fast track pathway for non-specific serious symptoms. Cancer in general practice is a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients per year. The investigators know that cancer patients have an increased use of general practice prior to diagnosis and that 25% of them wait for more than 20 days in general practice for referral according to the GPs. The latest Danish Cancer Plan therefore includes a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track pathways.
The aim of this study was to investigate the effect of this CME in early cancer diagnosis. This is measured by changes in GP knowledge, attitude and risk assessment. GP referral behavior assessed by primary care interval and use of fast track referrals. GP´s cancer hit rate, cancer patients´ tumor stage at treatment and 1 year survival.
Read more
Methods/Design The study is conducted as a stepped wedge controlled design based on a quasi-cluster randomization.
In august 2012 an invitation to participate in the present study were sent to 859 general Practitioners (GPs) from the Central Denmark Region. GPs completed a form for each patient they referred to a fast-track diagnostic pathway for cancer within an 8-month period.
Every other week, we received data from a regional database. We reminded the referring GP-practice about non included patients. The collected data will be linked to registries.
The CME-intervention The CME-course was a 3-hour meeting after work. Guided by the available evidence from the literature following the investigators ensured a multifaceted interactive teaching method including case-based education. The content included by other topics positive predictive values, false reassurance from negative testing and other pit-false.
Statistical analyses The outcomes will be analyzed in a generalized linear random-effects model with random effect of GPs. Based on data it will be assessed whether further modeling of inter correlation within practices and within clusters is required, and whether the intervention effects are assumed equal for all GPs, or in random interaction with them. Analyses will be performed both in the full GP-population ("intention to intervening ") and in the 3 subgroups of GPs.
Read the detailed description
Denmark has a lower survival of cancer compared to most European countries. This could be explained by an inadequate organization of cancer investigation. In order to improve this, 34 fast track pathways for organ specific cancer diseases were established in the years 2008-2010. In 2011 further a fast track pathway for non-specific serious symptoms.
Another reason could be delay in general practice. Cancer in general practice is a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients per year. 50 % of cancer patients presented non-specific symptoms and even when they had organ specific alarm symptoms the positive predictive value for cancer was most often lower than 5%.
The investigators know that cancer patients have an increased use of general practice prior to diagnosis and that 25% of them wait for more than 20 days in general practice for referral. A study showed that 20 % of Danish GPs assumed a hypothetical cancer risk higher than 50% when they refer a 50 year old man to a cancer fast-track pathway. The latest Danish Cancer Plan included a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track pathways.
The aim of this study is to investigate the effect of this CME in early cancer diagnosis. This is measured by changes in
- GP knowledge, attitude and risk assessment.
- GP referral behavior assessed by primary care interval and use of fast track referrals.
- GP´s cancer hit rate, cancer patients´ tumor stage at treatment and 1 year survival.
Methods/Design The study was conducted as a stepped wedge controlled design based on a quasi-cluster randomization. GPs from a cluster which had received CME were controlled by GPs from another cluster which had not yet received CME. GPs from each cluster were divided in an intervention group and a reference group depending on whether they participated in the CME or not.
In august 2012 an invitation to participate in the present study were sent to 859 general Practitioners (GPs) from the Central Denmark Region. GPs were asked to complete a form for each patient they referred to a fast-track diagnostic pathway for cancer within an 8-month period (September 2012 - May 2013). Data included presented symptoms, a GP-estimated cancer risk (predictive value) at referral time, date for referral and date for first presentation of a cancer related symptom to a general practitioner.
To increase the completeness of data, every other week, the investigators received data from a regional database on patients referred to a cancer diagnostic pathway. The referring GP-practice were reminded about non-included patients.
In order to link the collected data following registries were used:
- The Civil Registration Number (CRN), a unique 10-digit personal identification number assigned to every permanent and temporary Danish Residents
- The Hospital Discharge Registry that comprises The Patient Administrative System (PAS) which holds administrative information on hospital activities. Data includes dates of hospital admissions and type of admission.
- The Danish Cancer Registry (DCR) which holds information on all cancer diagnoses in Denmark.
- MedCom data from a web interface (referral hotel) that includes all electronic referral letters sent from general practice to hospital.
- Danish National Health Insurance Service Registry (NHSR) which holds information on all contacts to general practice and all services provided.
The CME-intervention The CME-course was a 3-hour meeting. Guided by the available evidence from the literature following issues were considered important.
- A multifaceted interactive teaching method.
- Knowledge transfer based on patient cases to create a close relation to every day practice.
- An emotional experience to facilitate change in attitude. An educational film was created for the occasion. The film illustrated a series of consultations between a GP and a patient.
Following topics were chosen:
- Faster investigation increases survival.
- Predictive positive values for cancer symptoms.
- False reassurance from a negative test and other pit falls.
- Delay in making an appropriate cancer referral.
- Difficulties in using fast track pathways for cancer.
- Difficulties in communicating cancer risk.
Statistical analyses The outcomes will be analyzed in a generalized linear random-effects model with random effect of GPs. Based on data it will be assessed whether further modeling of inter correlation within practices and within clusters is required, and whether the intervention effects are assumed equal for all GPs, or in random interaction with them. Analyses will be performed both in the full GP-population ("intention to intervening ") and in the 3 subgroups of GPs; GP participated in CME, Colleague participated, even GP neither colleagues participated in CME.
- Conditions
- Cancer
- Being tested
- Continuing Medical Education
- Keywords
- Stepped wedged design, Early cancer diagnosis, Continuing medical education
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuing Medical EducationBehavioural
Also called CME in early cancer diagnosis
3-hour after work meeting. Multifaceted form. Content: Cancer symptoms positive predictive values, pit falls, reflections on barriers and attitudes towards early cancer diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Continuing Medical Education | Experimental | Continuing Medical Education Receives: Behavioral: Continuing Medical Education |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary care interval
Primary care interval is the amount of days from the date where the patient first presented a cancer relevant symptom to the GP to the date of referral to a fast track pathway for cancer.
Measured: 8 months
Secondary outcomes (1)
Use of fast track referrals
Use of fast track referrals is measured by counting the relevant electronic referral letters sent to a web interface called referral hotel (MedCom data) from each individual GP in Central Denmark Region.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Committee for Health Education, Danish College of General Practitioners
- Responsible party
- Sponsor
- Investigators
- Peter Vedsted, PhD, Prof., Study director, Research centre for Cancer Diagnosis in Primary Care (CaP), Research Unit for general practice, Aarhus UniversityFlemming Bro, DrMed, Prof, Study director, Research Unit for General Practice, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069470
- Sponsor's protocol ID
- BST-5.2013-PV
- Other IDs
- BST040373-AAU
- Status last verified
- May 2017
- First submitted
- 29 Jan 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Toftegaard BS, Bro F, Falborg AZ, Vedsted P. Impact of a continuing medical education meeting on the use and timing of urgent cancer referrals among general practitioners - a before-after study. BMC Fam Pract. 2017 Mar 21;18(1):44. doi: 10.1186/s12875-017-0607-3.
PubMed 28327100Toftegaard BS, Bro F, Falborg AZ, Vedsted P. Impact of continuing medical education in cancer diagnosis on GP knowledge, attitude and readiness to investigate - a before-after study. BMC Fam Pract. 2016 Jul 26;17:95. doi: 10.1186/s12875-016-0496-x.
PubMed 27460041Toftegaard BS, Bro F, Vedsted P. A geographical cluster randomised stepped wedge study of continuing medical education and cancer diagnosis in general practice. Implement Sci. 2014 Nov 7;9:159. doi: 10.1186/s13012-014-0159-z.
PubMed 25377520
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuing Medical Education (CME) on Early Cancer Diagnosis in General Practice
- ClinicalTrials.gov ID
- NCT02069470
- Acronym / sponsor ID
- BST-5.2013-PV
- Conditions
- Cancer
- Keywords
- Stepped wedged design, Early cancer diagnosis, Continuing medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Committee for Health Education, Danish College of General Practitioners
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Feb 2014 (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.
Background Denmark has a lower survival of cancer compared to most European countries. Fast track pathways for organ specific cancers were established in the years 2008-2010. In 2011 further a fast track pathway for non-specific serious symptoms. Cancer in general practice is a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients per year. The investigators know that cancer patients have an increased use of general practice prior to diagnosis and that 25% of them wait for more than 20 days in general practice for referral according to the GPs. The latest Danish Cancer Plan therefore includes a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track pathways.
The aim of this study was to investigate the effect of this CME in early cancer diagnosis. This is measured by changes in GP knowledge, attitude and risk assessment. GP referral behavior assessed by primary care interval and use of fast track referrals. GP´s cancer hit rate, cancer patients´ tumor stage at treatment and 1 year survival.
Methods/Design The study is conducted as a stepped wedge controlled design based on a quasi-cluster randomization.
In august 2012 an invitation to participate in the present study were sent to 859 general Practitioners (GPs) from the Central Denmark Region. GPs completed a form for each patient they referred to a fast-track diagnostic pathway for cancer within an 8-month period.
Every other week, we received data from a regional database. We reminded the referring GP-practice about non included patients. The collected data will be linked to registries.
The CME-intervention The CME-course was a 3-hour meeting after work. Guided by the available evidence from the literature following the investigators ensured a multifaceted interactive teaching method including case-based education. The content included by other topics positive predictive values, false reassurance from negative testing and other pit-false.
Statistical analyses The outcomes will be analyzed in a generalized linear random-effects model with random effect of GPs. Based on data it will be assessed whether further modeling of inter correlation within practices and within clusters is required, and whether the intervention effects are assumed equal for all GPs, or in random interaction with them. Analyses will be performed both in the full GP-population ("intention to intervening ") and in the 3 subgroups of GPs.
Detailed description
Denmark has a lower survival of cancer compared to most European countries. This could be explained by an inadequate organization of cancer investigation. In order to improve this, 34 fast track pathways for organ specific cancer diseases were established in the years 2008-2010. In 2011 further a fast track pathway for non-specific serious symptoms.
Another reason could be delay in general practice. Cancer in general practice is a low prevalence condition. Each general practitioner (GP) will see 8-10 new cancer patients per year. 50 % of cancer patients presented non-specific symptoms and even when they had organ specific alarm symptoms the positive predictive value for cancer was most often lower than 5%.
The investigators know that cancer patients have an increased use of general practice prior to diagnosis and that 25% of them wait for more than 20 days in general practice for referral. A study showed that 20 % of Danish GPs assumed a hypothetical cancer risk higher than 50% when they refer a 50 year old man to a cancer fast-track pathway. The latest Danish Cancer Plan included a CME as a key strategy to lower the GP threshold to refer patients to cancer fast track pathways.
The aim of this study is to investigate the effect of this CME in early cancer diagnosis. This is measured by changes in
- GP knowledge, attitude and risk assessment.
- GP referral behavior assessed by primary care interval and use of fast track referrals.
- GP´s cancer hit rate, cancer patients´ tumor stage at treatment and 1 year survival.
Methods/Design The study was conducted as a stepped wedge controlled design based on a quasi-cluster randomization. GPs from a cluster which had received CME were controlled by GPs from another cluster which had not yet received CME. GPs from each cluster were divided in an intervention group and a reference group depending on whether they participated in the CME or not.
In august 2012 an invitation to participate in the present study were sent to 859 general Practitioners (GPs) from the Central Denmark Region. GPs were asked to complete a form for each patient they referred to a fast-track diagnostic pathway for cancer within an 8-month period (September 2012 - May 2013). Data included presented symptoms, a GP-estimated cancer risk (predictive value) at referral time, date for referral and date for first presentation of a cancer related symptom to a general practitioner.
To increase the completeness of data, every other week, the investigators received data from a regional database on patients referred to a cancer diagnostic pathway. The referring GP-practice were reminded about non-included patients.
In order to link the collected data following registries were used:
- The Civil Registration Number (CRN), a unique 10-digit personal identification number assigned to every permanent and temporary Danish Residents
- The Hospital Discharge Registry that comprises The Patient Administrative System (PAS) which holds administrative information on hospital activities. Data includes dates of hospital admissions and type of admission.
- The Danish Cancer Registry (DCR) which holds information on all cancer diagnoses in Denmark.
- MedCom data from a web interface (referral hotel) that includes all electronic referral letters sent from general practice to hospital.
- Danish National Health Insurance Service Registry (NHSR) which holds information on all contacts to general practice and all services provided.
The CME-intervention The CME-course was a 3-hour meeting. Guided by the available evidence from the literature following issues were considered important.
- A multifaceted interactive teaching method.
- Knowledge transfer based on patient cases to create a close relation to every day practice.
- An emotional experience to facilitate change in attitude. An educational film was created for the occasion. The film illustrated a series of consultations between a GP and a patient.
Following topics were chosen:
- Faster investigation increases survival.
- Predictive positive values for cancer symptoms.
- False reassurance from a negative test and other pit falls.
- Delay in making an appropriate cancer referral.
- Difficulties in using fast track pathways for cancer.
- Difficulties in communicating cancer risk.
Statistical analyses The outcomes will be analyzed in a generalized linear random-effects model with random effect of GPs. Based on data it will be assessed whether further modeling of inter correlation within practices and within clusters is required, and whether the intervention effects are assumed equal for all GPs, or in random interaction with them. Analyses will be performed both in the full GP-population ("intention to intervening ") and in the 3 subgroups of GPs; GP participated in CME, Colleague participated, even GP neither colleagues participated in CME.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuing Medical Education | Experimental | Behavioral: Continuing Medical EducationContinuing Medical Education |
| Usual care | No intervention | –Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- GP should be a GP principal
- The referring GP should complete the registration form
- Patients should be referred directly from practice to hospital on cancer suspicion in the inclusion period September 2012- May 2013
Key exclusion criteria (2 listed)
- Patients already registered with one cancer, diagnosed within 5 years
- Patients self-inflicted in delay
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 |
|---|---|---|
| Continuing Medical EducationAlso: CME in early cancer diagnosis3-hour after work meeting. Multifaceted form. Content: Cancer symptoms positive predictive values, pit falls, reflections on barriers and attitudes towards early cancer diagnosis. | Behavioural | Continuing Medical Education |
Primary outcome
Primary care interval
Time frame: 8 months
Primary care interval is the amount of days from the date where the patient first presented a cancer relevant symptom to the GP to the date of referral to a fast track pathway for cancer.
1 secondary outcome
Use of fast track referrals
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Derived from this study: PubMed 28327100Toftegaard BS, Bro F, Falborg AZ, Vedsted P. Impact of a continuing medical education meeting on the use and timing of urgent cancer referrals among general practitioners - a before-after study. BMC Fam Pract. 2017 Mar 21;18(1):44. doi: 10.1186/s12875-017-0607-3.
- Derived from this study: PubMed 27460041Toftegaard BS, Bro F, Falborg AZ, Vedsted P. Impact of continuing medical education in cancer diagnosis on GP knowledge, attitude and readiness to investigate - a before-after study. BMC Fam Pract. 2016 Jul 26;17:95. doi: 10.1186/s12875-016-0496-x.
- Derived from this study: PubMed 25377520Toftegaard BS, Bro F, Vedsted P. A geographical cluster randomised stepped wedge study of continuing medical education and cancer diagnosis in general practice. Implement Sci. 2014 Nov 7;9:159. doi: 10.1186/s13012-014-0159-z.
- Individual participant dataSharing planned: Undecided
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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.
Peter Vedsted, PhD, Prof. study director
Research centre for Cancer Diagnosis in Primary Care (CaP), Research Unit for general practice, Aarhus University
Flemming Bro, DrMed, Prof study director
Research Unit for General Practice, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuing Medical Education in people with Cancer, run by University of Aarhus at 1 site in 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary care interval (time frame: 8 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 NCT02069470, which also lists 3 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 9 May 2017.