NCT02069470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
689

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

January 29, 2014

Last Update Submit

May 8, 2017

Conditions

Keywords

Stepped wedged designEarly cancer diagnosisContinuing medical education

Outcome Measures

Primary Outcomes (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.

    8 months

Secondary Outcomes (1)

  • Use of fast track referrals

    8 months

Other Outcomes (7)

  • GP knowledge, attitude and likely behavior pre CME

    Average 1 month before CME

  • Risk assessment

    8 months

  • The concrete patient´s use of general practice half year prior to diagnosis

    6 months

  • +4 more other outcomes

Study Arms (2)

Continuing Medical Education

EXPERIMENTAL

Continuing Medical Education

Behavioral: Continuing Medical Education

Usual care

NO INTERVENTION

Usual care

Interventions

3-hour after work meeting. Multifaceted form. Content: Cancer symptoms positive predictive values, pit falls, reflections on barriers and attitudes towards early cancer diagnosis.

Also known as: CME in early cancer diagnosis
Continuing Medical Education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • GP should be a GP principal
  • The referring GP should complete the registration form

You may not qualify if:

  • Patients already registered with one cancer, diagnosed within 5 years
  • Patients self-inflicted in delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Centre for Cancer Diagnosis in Primary Care, Research Unit for General Practice, Aarhus University

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 24, 2014

Study Start

September 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations