Cancer Clinical Trial
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.
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.
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.
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