Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach
Improving Colorectal Cancer Screening Uptake Through Patient-Centered Education and Mailed Stool-Based Testing Outreach in the Primary Care Medicine Clinic
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Darren Nix
- 전화번호: 314-362-3201
- 이메일: nixd@wustl.edu
연구 연락처 백업
- 이름: Cassandra Fritz, MD, MPHS
- 전화번호: 314-454-8165
- 이메일: cfritz@wustl.edu
연구 장소
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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연락하다:
- Darren Nix
- 전화번호: 314-362-3201
- 이메일: nixd@wustl.edu
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연락하다:
- Cassandra Fritz, MD, MPHS
- 전화번호: 314-454-8165
- 이메일: cfritz@wustl.edu
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부수사관:
- Kamilah Scales, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Phase 1 Education Arm Inclusion Criteria:
- Previously enrolled in prior study IRB #202202059 who agreed to participate in future research
Phase 1 Education Arm Exclusion Criteria:
- Not enrolled in prior study IRB #202202059
Phase 2 (All Other Arms) Inclusion Criteria:
- Primary Care Medicine Clinic patient (PRMC)
- Eligible for CRC screening
- Between age 45-75 years old
- Have eligible health insurance
Phase 2 (All Other Arms) Exclusion Criteria:
- Prior history of colorectal cancer
- Diagnosis of inflammatory bowel disease
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 |
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실험적: Education
Participants will complete the Assessment of Colon Cancer Literacy (ACCL) as a pre-test prior to receiving education materials.
After the pre-test, participants will be provided with ACCL education materials.
Three months after being provided education materials, participants will repeat ACCL testing.
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Education materials are compiled from the American College of Gastroenterology (ACG) and the City of Hope.
The education materials are at a 6th grade reading level.
Materials detail digestive system and polyp background, colorectal cancer (CRC) risk factors, warning signs, screening options, recommended initial screening age, and stool-based screening and colonoscopy processes.
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실험적: Mailed FIT
Participants will receive a mailed package including 1 FIT test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. |
The Fecal immunochemical test (FIT) will be mailed to the participants.
Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
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실험적: Mailed Cologuard
Participants will receive a mailed package including 1 Cologuard test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants will have 3 months to return the kit. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient. |
The Cologuard test will be mailed to the participants.
Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
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활성 비교기: Usual Care
Participants will receive usual care from provider after enrollment with no intervention.
Usual care includes providers offering standard screening options including FIT, Cologuard, and colonoscopy at the initial visit with no default option or structured follow-up.
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Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in CRC knowledge (Education Arm only)
기간: At enrollment and 3 months after educational intervention (total estimated time is 3 months)
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Change in CRC knowledge will be measured by changes in the score of the Assessment of Colon Cancer Literacy (ACCL) test.
The ACCL consists of 10-items with True/False/Unsure.
The ACCL score ranges from 0 to 10 with a score of 7-10 indicating adequate literacy and scores of 0-6 indicating limited literacy.
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At enrollment and 3 months after educational intervention (total estimated time is 3 months)
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Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)
기간: At 3 months after receiving kit (total estimated time 3 months)
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At 3 months after receiving kit (total estimated time 3 months)
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Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)
기간: At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
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Acceptability will be assessed using the 3-item Customer Service Questionnaire (CSQ-3).
The 3-items are rated on a 4-point Likert scale as follows: 1=Poor, 2=Fair, 3=Good, and 4=Excellent.
Generally, the higher the score indicates greater customer satisfaction.
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At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
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CRC screening completion rate (All arms)
기간: From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
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CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.
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From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Cassandra Fritz, MD, MPHS, Washington University School of Medicine
간행물 및 유용한 링크
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
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 202606027
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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