- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07639554
Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners (OPTIDEC COLO)
Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners: A Randomized Controlled Cluster Trial
The goal of this randomized trial is to assess the effectiveness of a targeted telephone reminder strategy, implemented by the patient's general practitioner, in enhancing participation in colorectal cancer screening among individuals who are not up to date . The participants are patients between 50 to 74 years old as they are the target for colorectal cancer screening. The main questions are:
- What is the percentage of patients who completed the colorectal cancer screening test during the intervention year , within the patient population of general practitioners participating in the study and identified as non-up-to-date for their screening status ?
- Identifying potential factors influencing the effectiveness of the intervention based on various characteristics of the patient, the geographical area, the general practitioner, and the caller
Researchers will compare with other patients who are not up to date without the intervention of their general practionner with a telephone reminder.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: José-philippe MORENO, MD
- Número de telefone: +33686663181
- E-mail: jose_philippe.moreno@univ-fcomte.fr
Locais de estudo
-
-
Franche-comté
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Champlitte, Franche-comté, França
- MSPU des 3 provinces
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Investigador principal:
- José-Philippe MORENO, MD
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria for general practionners :
- Practise in one of the four departments of the Franche-Comté region; ractise in a solo practice, group practice, multidisciplinary primary care centre , or community health centre;
- Are engaged in general medical practice.
- Have agreed to participate in the study.
Inclusion Criteria for patients :
- patients within the practice population of general practitioners selected to participate in the study;
- aged between 50 and 75 years inclusive;
- affiliated with the French general health insurance scheme or the agricultural social insurance scheme
Exclusion Criteria for general practionners:
- practise exclusively in a specialty other than general practice (e.g. osteopathy, allergology, vascular medicine).
Non inclusion Criteria for patients :
- Objection expressed by the patient to the change in the purpose of data processing for research purposes
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention Arm : phone-based outreach to promote colorectal cancer screening
In year n, the 50 selected general practitioners will receive from the national health insurance a list of patients who are not up to date with colorectal cancer screening.
Each patient's screening status will be verified by the clinical research associate through a review of the medical records.
A telephone call will be made by a member of the patient's primary care team.
|
A telephone call will be made by a member of the patient's primary care team (general practitioner, medical secretary, public health nurse, or care coordinator), with priority given to a call by the patient's general practitioner.
The call should preferably be made to the patient's mobile phone.
If the call is unsuccessful, a voicemail message will be left, and a second call will be attempted within the following seven days.
The voicemail message will include the name of the patient's general practitioner, the purpose of the call regarding colorectal cancer screening, and notification that a further attempt will be made to reach the patient.
If the telephone exchange is successful, an appointment at the healthcare facility will be offered to the patient, during which the screening test will be offered to the patient, during which the screening test will be handed over and explained by one of the healthcare professionals from the same facility.
|
|
Sem intervenção: Control arm
In year n, the 50 selected general practitioners will receive from the national health insurance a list of patients who are not up to date with colorectal cancer screening.
Each patient's screening status will be verified by the clinical research associate through a review of the medical records.
There will not be an intervention.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of patients who completed the colorectal cancer screening in each arms
Prazo: 6 months after inclusion
|
Patients who completed the colorectal cancer screening test during the intervention year (year n), within the patient population of general practitioners participating in the study, and who were identified from the national health insurance list as not up to date with screening - a status that was confirmed by reviewing their medical records. Completion of the screening will be confirmed by the presence of the test result in the patient's medical record within the General practionner's practice software, no later than three months after the end of the intervention. This mesure will be done in each arm. |
6 months after inclusion
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database
Prazo: 1 year after enrollment
|
Patients whose colorectal cancer screening status changed between the list received from National Health in year n and the list received in year n+1. A change in status will be confirmed by the absence of the patient from the n+1 list, among those still registered within the general practitioner's patient panel. |
1 year after enrollment
|
|
Number of patients who completed the colorectal cancer screening in the intervention arm according differents variables
Prazo: 3 months after the end of enrollment
|
Patients who completed the colorectal cancer screening (CRC) test during the intervention year , within the patient population of general practitioners participating in the study, and who were identified from the national health insurance list as not up to date with screening. This proportion will be analysed according to the following stratification variables:
|
3 months after the end of enrollment
|
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Number of participants per stage of the intervention process
Prazo: 3 months after the end of enrollment
|
In both study arms, identification of patients incorrectly included in the national health insurance list (i.e. patients already up to date with screening, those excluded from CRC screening, those under or awaiting colonoscopic follow-up, or currently undergoing treatment for colorectal cancer). For the intervention arm, classification of all patients according to the following outcomes:
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3 months after the end of enrollment
|
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quantifying the time required to carry out the intervention
Prazo: 3 months after the end of the enrollment
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In the intervention arm, time spent on all stages of the intervention:
|
3 months after the end of the enrollment
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-A01370-49
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