Implementation of a New Strategy to Identify HNPCC Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer

Conditions
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Colorectal Neoplasms, Hereditary Nonpolyposis Colorectal Cancer

Intervention / Treatment
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* Behavioral: Education for professionals
* Behavioral: Distribution of educational materials
* Behavioral: Feedback for professionals
* Behavioral: Reminders for professionals


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education for professionals|nan|
|Behavioral: Distribution of educational materials|nan|
|Behavioral: Feedback for professionals|nan|
|Behavioral: Reminders for professionals|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists. |  |  | 
| Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experiences with and acceptance of changed physician practice roles by patients and clinicians. |  |  | 
| Cost efficacy of the implementation procedures. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hereditary colorectal cancer, Microsatellite instability, Physician roles, Health care implementation, Intervention