Implementation of a New Strategy to Identify HNPCC Patients

Sponsor
Radboud University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00141466
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
360
13
21.9
27.7
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education for professionals
  • Behavioral: Distribution of educational materials
  • Behavioral: Feedback for professionals
  • Behavioral: Reminders for professionals
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Official Title:
Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer
Study Start Date :
Sep 1, 2005
Anticipated Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists. []

  2. Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons. []

Secondary Outcome Measures

  1. Experiences with and acceptance of changed physician practice roles by patients and clinicians. []

  2. Cost efficacy of the implementation procedures. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
2 Meander Medisch Centrum Amersfoort Netherlands
3 Ziekenhuis Rijnstate Arnhem Netherlands
4 HagaZiekenhuis Den Haag Netherlands
5 Pathologie laboratorium voor Dordrecht Dordrecht Netherlands
6 Stichting laboratoria voor pathologische anatomie en medische microbiologie Eindhoven Netherlands
7 Laboratorium voor pathologie Oost-Nederland Enschede Netherlands
8 Martini Ziekenhuis Groningen Netherlands
9 Elkerliek Ziekenhuis Helmond Netherlands
10 Laboratorium Volksgezondheid Friesland Leeuwarden Netherlands
11 Canisius Wilhelmina Ziekenhuis Nijmegen Netherlands
12 Medisch Centrum Rijnmond Zuid Rotterdam Netherlands
13 St. Elisabeth Ziekenhuis Tilburg Netherlands

Sponsors and Collaborators

  • Radboud University Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Nicoline Hoogerbrugge, MD PhD, Department of Human Genetics, Radboud University Nijmegen Medical Center
  • Principal Investigator: Rosella P Hermens, MSc PhD, Center of Quality of Care Research, Radboud University Nijmegen Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00141466
Other Study ID Numbers:
  • MIPA-2005
  • ZonMw nr. 945-14-107
First Posted:
Sep 1, 2005
Last Update Posted:
Apr 23, 2008
Last Verified:
Feb 1, 2007

Study Results

No Results Posted as of Apr 23, 2008