Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE): A State-Level Program to Reduce Colorectal Cancer Burden in Vulnerable Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,318
- 试验地点
- 4
- 主要终点
- Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)
研究概览
简要总结
This study will test the effectiveness of mailing fecal immunochemical tests (FITs) in increasing colorectal cancer (CRC) screening rates in U.S. adults ages 45-75. We are implementing this study in two age groups, 45-49 years and 50-75 years.
详细描述
Trial (Age Group 50-75) This randomized controlled trial assesses the effectiveness, feasibility, acceptability, and cost-effectiveness of mailing FITs from a central location to patients served by FQHCs. Subjects are randomly selected and assigned to receive either a mailed FIT intervention (Arm 1: Trial Mailed FIT Intervention - Age Group 50-75) or usual care (Arm 2: Trial Usual Care - Age Group 50-75). To assess United States Preventive Services Task Force recommendations for annual screening, we will mail subjects one round of FIT per year for up to two years.
Sub-study (Age Group 45-49) A sub-study assesses the effectiveness of mailing FITs from a central location to patients who are 45-49 years of age and newly eligible for CRC screening. The sub-study also assesses the impact of varying the appearance of the FIT packet mailing envelope on FIT return. All eligible patients from one FQHC clinic site are randomly assigned to receive either a mailed FIT intervention that includes an enhanced mailing envelope (Arm 3: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) or a plain envelope (Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49).
The Trial (Age Group 50-75) and the Sub-study (Age Group 45-49) also assess the effectiveness of delivering patient navigation from a central location to facilitate follow up colonoscopy for patients with a positive (abnormal) FIT result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-75 years
- •At average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative [father, mother, sister, brother], or diagnosis of inflammatory bowel disease)
- •No record of fecal occult blood test (FOBT)/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- •No record of any CRC diagnosis or total colectomy
- •No record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma)
- •Has a complete North Carolina mailing address in the EHR
- •Active patient of the clinic (seen within the past 18 months) at the time of randomization
- •No record of a positive (abnormal) FIT result in the first study round (Trial Ages 50-75 only)
排除标准
- •Age younger than 45 years or older than 75 years
- •Not at average risk for CRC ("average risk" is defined as those patients who do not have any of the following: documented history of CRC, colorectal neoplasms, colorectal polyps, colonic adenomas, family history of CRC among first degree relative [father, mother, sister, brother], or diagnosis of inflammatory bowel disease)
- •Record of FOBT/FIT within the past 12 months or colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or CT colonography within 10 years of the EHR query date
- •Record of any CRC diagnosis or total colectomy
- •Record of comorbidities or screening contraindications, including dementia, hospice care, assisted living, end-stage renal disease, and other cancers (glioblastoma, pancreatic cancer, lung cancer, esophageal cancer, liver and bile duct cancer, mesothelioma)
- •Does not have a complete North Carolina mailing address in the EHR
- •Not an active patient of the clinic (not seen within the past 18 months) at the time of randomization
- •Record of a positive (abnormal) FIT result reported during the first study round (Trial Ages 50-75)
研究组 & 干预措施
Trial Mailed FIT Intervention - Age Group 50-75
Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
干预措施: Trial Mailed FIT Intervention - Age Group 50-75 (Behavioral)
Trial Usual Care - Age Group 50-75
Subjects randomized to this arm are 50-75 years of age and eligible for CRC screening using FIT per electronic health record at either of two FQHCs. Only subjects who are 50-75 years of age are randomized to this arm. Subjects who are 50-75 cannot be randomized to Arm 3 or Arm 4.
Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.
干预措施: Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49 (Behavioral)
Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-49
Subjects randomized to this arm are 45-49 years of age and eligible for CRC screening using FIT per electronic health record at one FQHC. Only subjects who are 45-49 years of age are randomized to this arm. Subjects who are 45-49 years of age cannot be randomized to Arm 1 or Arm 2 of the main trial.
干预措施: Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49 (Behavioral)
结局指标
主要结局
Proportion of Subjects Who Completed Colorectal Cancer (CRC) Screening Within 6 Months (Trial - Age Group 50-75)
时间窗: Up to 6 months after randomization
"The proportion of subjects who received study Intervention (Age Group 50-75) and did not receive study intervention (Usual Care - Age Group 50-75 who completed CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force per electronic health record review. Fecal immunochemical test (FIT), fecal occult blood test \[FOBT\], fecal immunochemical test - deoxyribonucleic acid (FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography colonography."
次要结局
- Proportion of Subjects Who Completed a Follow-up (Diagnostic) Colonoscopy(Up to 6 months after diagnostic colonoscopy referral date)
- Number of Subject Colorectal Carcinoma (CRC) and Advanced Adenomas Detected at 12 Months(Up to 12 months after screening or diagnostic colonoscopy result date)
- Number of Subjects Who Received Referral for Cancer Treatment(Up to 6 months after cancer diagnosis date)
- Incremental Cost of Each Additional Patient Screened in the Intervention Arm Compared to Usual Care (Trial - Age Group 50-75)(Through study completion, up to 36 months after randomization)
- Proportion of Subjects Who Returned a Completed Mailed FIT at 60 Days(Up to 60 days after randomization)
- Proportion of Subjects Who Completed a Follow up (Diagnostic) Colonoscopy(Up to 6 months after abnormal FIT result date)
- Proportion of Subjects, Ages 45-49, Who Completed Mailed FIT at 60 Days(60 days after randomization)
- Number of Days From CRC Diagnosis to the Date of Evaluation for CRC Treatment(Up to 12 months after CRC diagnosis)
- Number of Subjects Mailed FITs Completed After Two Rounds of Annual FIT Outreach(Round 1 time frame: at 6 months after randomization; Round 2 time frame: at 6 months after determining eligibility for Round 2)
- The Proportion of Subjects, Ages 45-49, Who Are Current With CRC Screening(Up to 6 months after randomization)