임상 레이더 AI | ||
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임상시험 NCT06376565은(는) 대장직장 암종에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps 1,680
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06376565은(는) 대장직장 암종에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2023년 11월 8일에 시작되어 1,680명의 참여자를 모집하고 있습니다. Jonsson Comprehensive Cancer Center이(가) 진행하며, 2027년 11월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 14일에 갱신되었습니다.
간단한 개요
This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increas...더 보기
상세한 설명
PRIMARY OBJECTIVE:
I. To increase completion of surveillance colonoscopy within 3.5 years of high risk neoplasia (HRN) diagnosis.
OUTLINE:
AIM 1: Participants complete an interview over 20-30 minutes.
AIM 2: Primary care clinics are randomized to 1 of 2 arms.
ARM I: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance po...
더 보기공식 제목
Multilevel Health System Intervention to Increase Guideline-Concordant Surveillance Colonoscopy for High Risk Colon Polyps
질환명
대장직장 암종출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
NCT 번호
실제 연구 시작일
2023-11-08
최신 업데이트 게시
2025-11-14
예상 연구 완료일
2027-11-30
계획된 등록 인원
1,680
연구종류
중재연구
단계/상
해당 없음
상태
모집중
주요 목적
스크리닝 (선별)
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Arm I(Multilevel intervention) Aim 1: Participants complete an interview over 20-30 minutes.
Aim 2: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records (EHR). Clinics also call patients to schedule their colonoscopy. Providers receive reminders and pending orders for the colonoscopy in the electronic health record...더 보기 | 의사소통 중재 Complete clinic EHR interventions 의사소통 중재 Receive scheduling reminders 의사소통 중재 Receive reminders and pending EHR orders 인터뷰 Complete interview |
활성 대조군Arm II (Standard follow up) Patients receive care according to the clinics' usual care practices. | 최고의 실습 Receive standard care 인터뷰 Ancillary studies |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Stakeholder perspectives on the multilevel intervention (Aim 1) | The Investigators will conduct 1-on-1 in-depth interviews with patients, advocates, providers, and administrators. these interviews will provide data in closer proximity to intervention implementation to optimize composition, timing, and acceptability of each component. Interview content is guided by the multiple health outcomes framework (MHOF) and addresses major barriers (patient, provider, system) to surveillance and challenges (patient, provider, system) to the planned implementation of intervention components. | At time of interview |
Completion of surveillance colonoscopy (Aim 2) | Will analyze rates during the study period using a generalized linear mixed model with a logit link that includes an indicator for study arm and random effects for clinic and primary care provider to account for the multilevel data structure. | At 3.5 years |
Implementation quality (Aim 3a) | The Investigators will assess implementation quality and outcomes through stakeholder interviews (patients, providers, administrators) and chart reviews. The information gained will guide adaptations of the intervention for future use so that clinicians maximize effectiveness, feasibility, acceptability, sustainability, and impact. Findings will also determine the resources needed to successfully scale the intervention to different settings | Up to 3 years |
Cost effectiveness (Aim 3b) | Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the natural language processing-based electronic health record intervention compared to usual care office outreach. | Up to 3 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2) | From HRN diagnosis to colonoscopy, up to 3 years |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
21 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- AIM 1 PATIENTS: Patients between age 45 and 75 with a HRN diagnosis in the past 5 years
- AIM 1 PATIENTS: 12 patients who did and 12 patients who did not have surveillance colonoscopy
- AIM 1 PROVIDERS: Primary care providers (PCPs) and gastroenterologists (GIs)
- AIM 1 ADMINISTRATORS: Administrators who are involved in care processes related to CRC screening, HRN surveillance, and/or colonoscopy scheduling
- AIM 2: Patients age 45 to 75 diagnosed with a HRN during the pre-specified two-year HRN diagnosis period
- AIM 2: Individuals with a personal history of colorectal carcinoma (CRC), inflammatory bowel disease (Crohn's, ulcerative colitis), or polyposis syndrome
- AIM 2: HRN cases not confirmed by chart review (human-in-the-loop)
Jonsson Comprehensive Cancer Center미국 국립암연구소3019개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Jenna Alarcon, 310-794-6197, [email protected]
1 1개국에 임상시험 장소
California
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States
Jenna Alarcon, 연락처, 310-794-6197, [email protected]
Folasade P. May, 책임연구자
모집중