AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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 groups in NCT02069470
Study groupRoleWhat they receive
Continuing Medical EducationExperimentalContinuing Medical Education
Receives: Behavioral: Continuing Medical Education
Usual careNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted24 Feb 2014 (estimated)
  2. Study startSep 2012
  3. Primary completionDec 2015
  4. Study completionDec 2016

Resources

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)
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 28327100
  • Toftegaard 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 27460041
  • Toftegaard 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

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.

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