Clinical trial NCT00141466: Implementation of a New Strategy to Identify HNPCC Patients
Official title: Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Hereditary Nonpolyposis Colorectal Cancer
Keywords: Hereditary colorectal cancer
Microsatellite instability
Physician roles
Health care implementation
Intervention
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-09-01
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed.

Detailed description: The Radboud University Nijmegen Medical Centre developed a new method to identify patients with HNPCC. This method appeared cost-effective and feasible. Using this new method 70% of the HNPCC patients will be identified as compared to less than 30% when the current method is used. However, this new method does not implement itself; large gaps exists between best evidence and daily practice. This study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. The aim is to find the most cost-effective strategy to implement the new method to identify patients with HNPCC in the Netherlands.

Eligibility criteria: Inclusion Criteria:

* Colorectal cancer before the age of 50 years
* Second colorectal cancer at any age
* Colorectal cancer and other HNPCC associated extracolonic cancer irrespective of age at diagnosis
* Adenoma with high grade dysplasia diagnosed before the age of 40 years

Primary outcomes:
measure: Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.
measure: Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.
Secondary outcomes:
measure: Experiences with and acceptance of changed physician practice roles by patients and clinicians.
measure: Cost efficacy of the implementation procedures.
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Dordrecht
country: Netherlands
facility: Pathologie laboratorium voor Dordrecht
city: Eindhoven
country: Netherlands
facility: Stichting laboratoria voor pathologische anatomie en medische microbiologie
city: Enschede
country: Netherlands
facility: Laboratorium voor pathologie Oost-Nederland
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Laboratorium Volksgezondheid Friesland
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Medisch Centrum Rijnmond Zuid
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
Study officials:
affiliation: Department of Human Genetics, Radboud University Nijmegen Medical Center
name: Nicoline Hoogerbrugge, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of Quality of Care Research, Radboud University Nijmegen Medical Center
name: Rosella P Hermens, MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kievit W, de Bruin JH, Adang EM, Severens JL, Kleibeuker JH, Sijmons RH, Ruers TJ, Nagengast FM, Vasen HF, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Cost effectiveness of a new strategy to identify HNPCC patients. Gut. 2005 Jan;54(1):97-102. doi: 10.1136/gut.2004.039123.
citation: de Bruin JH, Kievit W, Ligtenberg MJ, Nagengast FM, Adang EM, Ruers TJ, Kleibeuker JH, Sijmons RH, van Krieken JH, Hoogerbrugge N. [More hereditary intestinal cancer can be detected if patients with colorectal carcinoma that are selected by the pathologist are examined for microsatellite instability]. Ned Tijdschr Geneeskd. 2005 Aug 6;149(32):1792-8. Dutch.
citation: Overbeek LI, Hermens RP, van Krieken JH, Adang EM, Casparie M, Nagengast FM, Ligtenberg MJ, Hoogerbrugge N; MIPA study group. Electronic reminders for pathologists promote recognition of patients at risk for Lynch syndrome: cluster-randomised controlled trial. Virchows Arch. 2010 Jun;456(6):653-9. doi: 10.1007/s00428-010-0907-7. Epub 2010 Apr 9.