Identifying the Risk of Hereditary and Familial Colorectal Cancer in Colorectal Cancer Patients by Using an Online Risk Tool: An Evaluation Based on a Stepped Wedge Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Percentage of all included patients who have received a recommendation for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical geneticist.
研究概览
简要总结
In this trial the investigators will evaluate the effectiveness of the implementation of a digital familial risk questionnaire in the detection of CRC patients with hereditary or familial CRC. This will be done using a stepped wedge design with 5 participating hospitals for a duration of 1.5 years. A comparison is made between an intervention phase (offering the online risk assessment questionnaire) and a control phase (hospital-based standard practice for the detection of CRC patients with hereditary or familial CRC, informed by the referral criteria that are being used in the intervention group). All patients with a diagnosis of CRC who have a first appointment at the CRC outpatient clinic will be included. The primary outcome is the percentage of all included patients who receive a recommendation for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical geneticist. Data from clinical geneticists is being used to answer this question.
详细描述
Design: This is a multicenter prospective comparative cohort study, using a stepped-wedge design. All clusters (hospitals) start with the control strategy and switch, one by one, to the intervention strategy. Every 9 weeks a hospital will start implementing the questionnaire after a short training period of 1 week. As a referral to a clinical geneticist can take up to several months, we allow at least 6 months for the collection of the results of the genetic tests.
Control strategy: Each hospital starts with the control strategy. Just before the start of this study, all hospitals will be sent a list with the clinical genetics referral criteria that will be used for this study. Each hospital can decide on how to use these criteria.
Intervention strategy: Before the start of the study, all hospitals will be informed when the use of the online questionnaire will be implemented. They will also receive a manual on how to use the online CRF and questionnaire. The online CRF will be used to send out invitations for the questionnaire, to report baseline characteristics (age, sex, nationality, educational level, native language), reasons for non-participation, the number of changes that need to be made when verifying completed questionnaires and to calculate referral advice. In the training week, a researcher from the AMC will present the study to all involved persons and he will facilitate the implementation of the online CRF and questionnaire. All nurses and doctors participating in this study will be provided with their own login codes for the online CRF. Patients included in the training week will not be included in the analysis. All consecutive patients with CRC that have a first appointment at the outpatient clinic will be invited to complete the online questionnaire and they receive a record number. In case patients decline to complete the questionnaire, this will be reported by a nurse or gastroenterologist in the online CRF. If the patient consents, an email will be sent to the patient with a link to the questionnaire and the question to complete it before the next visit to the outpatient clinic. The online CRF will automatically result in a check for indications for referral to a clinical geneticist. The nurse or gastroenterologist can report this advice in the patient file and can decide on referring the patient.
Checking referrals to a clinical geneticist: Every two months, all patients included in the study will be tracked by searching for reports on clinical genetics consultation in their medical files and a check with local genetic centers will be done.
Statistical analysis of the primary outcome measure: The difference between the control group and intervention group in the proportion of patients who receive surveillance advice by a clinical geneticist will be calculated. A nonlinear mixed model will be used for testing the hypothesis of no difference. We will model the probability of receiving surveillance advice as a linear function, after a logit transformation, with as explanatory variables the hospital, the time interval, and the questionnaire effect: Logit(pijk)=μ+αi+βj+Χijθ, Where Logit(pijk) is the natural logarithm of the odds of a referral to a clinical geneticist for individuals (k) in cluster i at time j. μ is the overall mean, αi is a random effect for hospital i, βj is a fixed effect corresponding to time interval j, and Χij is an indicator variable for implementation of the questionnaire in hospital i at time j and θ is the questionnaire effect. Time effects will be analyzed in a discrete way (season, month) in case a primary effect is found. If no time effect is present, time function will be excluded from the model. For the primary outcome measures, we will use the intention-to-treat principle, including all eligible patients in the analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of CRC who have a first appointment at the outpatient clinic (before treatment has started). If a patient undergoes surgery before going to an outpatient clinic (in case of an acute surgery indication), this patient will not be included in our study
排除标准
- •Patients who have received a CRC treatment before their intake visit will be excluded
结局指标
主要结局
Percentage of all included patients who have received a recommendation for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical geneticist.
时间窗: After 1.5 years (study completion)
次要结局
- Percentage of referred patients fulfilling referral criteria for a Lynch syndrome suspicion(After 1.5 years (study completion))
- Percentage of referred patients fulfilling FCC criteria(After 1.5 years (study completion))
- Percentage of patients not adhering to referral advice(After 1.5 years (study completion))
- Percentage of all included patients with a referral to a clinical geneticist(After 1.5 years (study completion))
- Percentage of all included patients with confirmed other hereditary CRC syndromes (such as polyposis syndromes)(After 1.5 years (study completion))
- Percentage of all included patients with genetically confirmed Lynch syndrome(After 1.5 years (study completion))
- Percentage of all included patients who receive a surveillance advice per time period (month or season)(After 1.5 years (study completion))
- Percentage of referred patients not fulfilling referral criteria for FCC, a Lynch syndrome suspicion or other hereditary CRC syndromes(After 1.5 years (study completion))
- The number of changes in family history after verification of the completed questionnaire at the outpatient clinic(After 1.5 years (study completion))
- Patients' reasons for not filling out the questionnaire as reported by a nurse or gastroenterologist(After 1.5 years (study completion))
- Usability of the questionnaire for health care providers and patients by using a self-created online or paper questionnaire(After 1.5 years (study completion))
研究者
Prof. Evelien Dekker, MD, PhD
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)