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A Trial of the Implementation of iFOBT in General Practice

NCT02308384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2017-04-27

No results posted yet for this study

Summary

Background

Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. The faecal marker of human globin, iFOBT, could play an important role in aiding the general practitioner in detecting CRC.

Hypothesis

It will be possible to implement iFOBT in general practice as a test performed on patients who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose symptoms could indicate an undiagnosed colorectal cancer.

Aim

To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications.

Materials and methods

The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18 municipalities in the central Denmark Region, and these are randomised when to receive a continuous medical education (CME). The date of inclusion is defined as the first working day in the month the CME is planned to be conducted. The CME is part of an intervention aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention consist of a start package (iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The inclusion period is during the first 7 month of the study period, the study lasts for one year.

Perspectives

This study will provide important knowledge on how to improve CRC diagnostics in general practice.

Conditions

Interventions

BEHAVIORAL

Intervention

CME, Start-package and status mail

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Peter Vedsted, Professor · Research Unit of General Practice, Odense

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308384 on ClinicalTrials.gov