Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of CME on Early Cancer Diagnosis in General Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02069470
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
Danish Committee for Health Education
Danish College of General Practitioners
Information provided by (Responsible Party):
University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 689 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
Usual care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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.

  4. 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).

  5. Tumor stage [ Time Frame: 8 months ]
    Cancer patients´ tumor stage at treatment is measured by TNM-stage from Danish Cancer Registry.

  6. 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

  7. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients already registered with one cancer, diagnosed within 5 years
  • Patients self-inflicted in delay
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Research Centre for Cancer Diagnosis in Primary Care, Research Unit for General Practice, Aarhus University
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Danish Committee for Health Education
Danish College of General Practitioners
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02069470     History of Changes
Other Study ID Numbers: BST-5.2013-PV
BST040373-AAU ( Registry Identifier: Berit Skjoedeberg Toftegaard )
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Aarhus:
Stepped wedged design
Early cancer diagnosis
Continuing medical education