- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07636174
Colorectal Cancer Screening Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (CRC PROACTIVE)
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. A substantial portion of the United States population remains overdue for screening, despite availability and insurance coverage of preventive health services. Barriers for completion and remaining up to date with screening include patients not remaining actively engaged with their care team, time constraints during office visits, and operational strain. This project aims to implement and evaluate a primary care visit-based outreach program that improves patient follow through on completion of overdue CRC screening.
This will be a 6 month, stepped-wedge, pragmatic trial conducted at Penn Medicine.
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Health System
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
All patients must meet the following criteria to be eligible:
- Age 18 years or older
- A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
- Overdue for colorectal cancer screening by health maintenance
- Ordered for FIT or Colonoscopy at the eligible visit
Exclusion Criteria:
As this trial is integrated with routine clinical operations, there will be no exclusion criteria other than already having an eligible visit at some point during the trial duration with an order for FIT or Colonoscopy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control Condition
During the control condition, clinics will receive standard of care.
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실험적: Active Intervention
During the active intervention, clinics will receive patient facing nudges.
Patient nudges will be post-visit text message reminders about their overdue CRC screening.
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All patients who complete their primary care visit and whose provider signed a colonoscopy or FIT order at their office visit will be sent post-visit text messages 7 and 14 days after visit completion, if they have not yet scheduled or completed their overdue CRC screening.
The messages delivered at 7 and 14 days will remind patients that appointments for their colonoscopy are available for them and provide phone number(s) to call for scheduling, or the messages will remind patients to return their FIT kit in the mail.
We will translate patient text messages into Spanish for patients who require an interpreter according to their language preferences in the EHR.
Patients will also have the option to engage with a bi-directional support menu via text message.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Colonoscopy Completion (6 months)
기간: Within 6 months after first eligible primary care visit.
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The primary outcome is completion of a colonoscopy within 6 months of the first eligible primary care visit at which a colonoscopy was ordered by the PCP.
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Within 6 months after first eligible primary care visit.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Colonoscopy Completion (12 months)
기간: Within 12 months after the first eligible primary care visit.
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The secondary outcome is completion of a colonoscopy within 12 months of the first eligible primary care visit with an order for colonoscopy.
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Within 12 months after the first eligible primary care visit.
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FIT Completion (6 months)
기간: Within 6 months after the first eligible primary care visit.
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The secondary outcome is completion of a fecal immunochemical test (FIT) within 6 months of the first eligible primary care visit with an order for a FIT.
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Within 6 months after the first eligible primary care visit.
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FIT Completion (12 months)
기간: Within 12 months after the first eligible primary care visit.
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The secondary outcome is completion of FIT within 12 months of the first eligible primary care visit with an order for a FIT.
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Within 12 months after the first eligible primary care visit.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shivan Mehta, University of Pennsylvania
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .