- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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 and 74 years old, as they are the target population 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 not up to date with their screening?
- 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 these patients with other patients who are not up to date and did not receive the telephone reminder intervention from their general practitioner.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: José-philippe MORENO, MD
- 전화번호: +33686663181
- 이메일: jose_philippe.moreno@univ-fcomte.fr
연구 장소
-
-
Franche-comté
-
Champlitte, Franche-comté, 프랑스
- MSPU des 3 provinces
-
수석 연구원:
- José-Philippe MORENO, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for general practitioners:
- Practice in one of the four departments of the Franche-Comté region;
- Practice 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 practitioners:
- Practice 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention Arm : phone-based outreach to promote colorectal cancer screening
In year n, the 50 selected general practitioners will receive a list of patients who are not up to date with colorectal cancer screening from the national health insurance. Each patient's screening status will be verified by the clinical research associate through a review of the medical records. A telephone call will then 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 handed over and explained by one of the healthcare professionals from the same facility. |
|
간섭 없음: 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 be no intervention. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of patients who completed the colorectal cancer screening in each arms
기간: 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 practitioner's practice software, no later than three months after the end of the intervention. This measure will be applied in each arm |
6 months after inclusion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database
기간: 1 year after enrollment
|
Patients whose colorectal cancer screening status changed between the list received from the National Health Insurance in year n and the list received in year n+1. This 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
기간: 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
|
|
Number of participants per stage of the intervention process
기간: 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:
|
3 months after the end of enrollment
|
|
quantifying the time required to carry out the intervention
기간: 3 months after the end of the enrollment
|
In the intervention arm, time spent on all stages of the intervention:
|
3 months after the end of the enrollment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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