The Effect of CME on Early Cancer Diagnosis in General Practice
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|ClinicalTrials.gov Identifier: NCT02069470|
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : May 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Continuing Medical Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||689 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Continuing Medical Education (CME) on Early Cancer Diagnosis in General Practice|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
Experimental: Continuing Medical Education
Continuing Medical Education
Behavioral: Continuing Medical Education
3-hour after work meeting. Multifaceted form. Content: Cancer symptoms positive predictive values, pit falls, reflections on barriers and attitudes towards early cancer diagnosis.
Other Name: CME in early cancer diagnosis
No Intervention: Usual care
- 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.
- Use of fast track referrals [ Time Frame: 8 months ]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.
- GP knowledge, attitude and likely behavior pre CME [ Time Frame: Average 1 month before CME ]GP knowledge and attitude are measured by ad hoc questions from an online questionaire. The answers will be dichotomized
- Risk assessment [ Time Frame: 8 months ]Risk assessment is measured as a risk of cancer (0%-100%) each time a GP refers a patient to a fast track pathway
- The concrete patient´s use of general practice half year prior to diagnosis [ Time Frame: 6 months ]Patients use of general practice prior to diagnosis is measured as a ratio. The denominator is the amount of visits to general practice half year prior to diagnosis. The nominator is an average use of general practice over a half year based on the last years. The data is registered in health care registry.
- GP cancer hit rate [ Time Frame: 8 months ]GP Cancer hit rate per is measured as a proportion between patients referred to a fast track pathway diagnosed with cancer related to the total amount of referred patients. Civil registration numbers of all referred patients per GP from the MedCom data will be merge with National Registry of Cancer (NRC).
- Tumor stage [ Time Frame: 8 months ]Cancer patients´ tumor stage at treatment is measured by TNM-stage from Danish Cancer Registry.
- GP knowledge, attitude and likely behavior after CME [ Time Frame: Average 7 months after CME ]GP knowledge and attitude are measured by ad hoc questions from an online questionaire. The answers will be dichotomized
- 1 year survival [ Time Frame: 1 year ]Cancer patients´ 1 year survival is measured by merging their Civil Registration Numbers with the Cause of Death Register.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069470
|Research Centre for Cancer Diagnosis in Primary Care, Research Unit for General Practice, Aarhus University|
|Aarhus, Aarhus C, Denmark, 8000|
|Study Director:||Peter Vedsted, PhD, Prof.||Research centre for Cancer Diagnosis in Primary Care (CaP), Research Unit for general practice, Aarhus University|
|Study Director:||Flemming Bro, DrMed, Prof||Research Unit for General Practice, Aarhus University|