Scaling CRC Screening Through Outreach, Referral, and Engagement (SCORE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE): A State-Level Program to Reduce Colorectal Cancer Burden in Vulnerable Populations

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Trial Mailed FIT Intervention - Age Group 50-75
* Behavioral: Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49
* Behavioral: Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Trial (Age Group 50-75) Using a randomized controlled trial study design, subjects are assigned to one of two arms: Arm 1: Trial Mailed FIT Intervention; or Arm 2: Trial Usual Care. Arm 1 (intervention) receives a mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the study (i.e., two annual rounds of mailed FIT). Sub-study (Age Group 45-49) Subjects, ages 45-49, are randomly assigned to one of two arms: Arm 3: Sub-Study Mailed FIT Intervention - Enhanced Envelope; or Arm 4: Sub-study Mailed FIT Active Comparator Plain Envelope. Subjects in both Arm 3 and Arm 4 receive mailed FIT plus up to two reminder letters. Subjects are randomized 1:1 at baseline and remain in their assigned arm for the duration of the sub-study (i.e., one annual round of mailed FIT).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Mailed FIT Intervention - Age Group 50-75<br>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. | Behavioral: Trial Mailed FIT Intervention - Age Group 50-75<br>* Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.<br>|
| No Intervention: Trial Usual Care - Age Group 50-75<br>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. | |
| Experimental: Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49<br>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. | Behavioral: Sub-Study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49<br>* Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in an enhanced envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The enhanced envelope is a yellow padded envelope with a USPS tracking label and sticker message: Important information from your doctor. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.<br>|
| Active Comparator: Sub-study Mailed FIT Comparator Plain Envelope - Age Group 45-40<br>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. | Behavioral: Sub-Study Mailed FIT Active Comparator Plain Envelope - Age Group 45-49<br>* Subjects are mailed an introductory letter advising them that they will receive a FIT kit in the mail. Next, subjects are mailed a FIT packet in plain envelope that contains a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit with a pre-paid return envelope. The plain envelope is a white envelope without a USPS tracking label or sticker message. Subjects receive up to two mailed letters reminding them to complete and return the FIT. Subjects receive FIT results via letter or phone call.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects, ages 50-75, who complete CRC screening within 6 months (Trial - Age Group 50-75) | Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete CRC screening using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review. | 18 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who return a completed mailed FIT at 60 days (Trial - Age Group 50-75) | Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) who return a completed FIT per electronic health record review. | 60 days after randomization | 
| Proportion of subjects who complete a follow-up (diagnostic) colonoscopy at 6 months (Trial - Age Group 50-75) | Proportion of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review. | 6 months after diagnostic colonoscopy result date | 
| Number of CRCs and advanced adenomas detected at 12 months (Trial - Age Group 50-75) | Number of CRCs and advanced adenomas detected among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who complete a screening or follow-up (diagnostic) colonoscopy per electronic health record review. | 12 months after screening or diagnostic colonoscopy result date | 
| Number of days from CRC diagnosis to the date of evaluation for CRC treatment (Trial - Age Group 50-75) | Number of days from CRC diagnosis to the date of evaluation for CRC treatment among subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) using electronic health record data to ascertain the dates of CRC diagnosis and evaluation for CRC treatment. | Up to 12 months after CRC diagnosis | 
| Number of subjects who receive referral for cancer treatment (Trial - Age Group 50-75) | Number of subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) who receive referral for cancer treatment among individuals diagnosed with CRC per electronic health record review. | 6 months after cancer diagnosis date | 
| Number of mailed FITs completed after two rounds of annual FIT outreach (Trial - Age Group 50-75) | Number of mailed FITs completed (0, 1, or 2) by subjects in Arm 1 (Trial Mailed FIT Intervention - Age Group 50-75) and Arm 2 (Trial Usual Care - Age Group 50-75) after two rounds of annual FIT outreach, per electronic health record review. | Up to 18 months after randomization | 
| Incremental cost of each additional patient screened in the intervention arm compared to usual care (Trial - Age Group 50-75) | Comparison of the programmatic costs incurred and number of subjects screened in Arm 1(Trial Mailed FIT Intervention - Age Group 50-75) compared to Arm 2 (Trial Usual Care - Age Group 50-75), measured as cost of intervention minus the cost of usual care, divided by the number screened in Arm 1 minus the number screened in Arm 2. Intervention costs will be assessed using periodic episodes of direct observation of mailed FIT outreach activities, time logs maintained by the intervention team, and assembly of administrative data capturing non-personnel/non-labor expenditures, such as costs associated with materials printing, FIT processing, and mailing costs. Usual care costs will be assessed using a combination of clinic observations and interviews with staff. | Through study completion, up to 36 months after randomization | 
| Proportion of subjects, ages 45-49, who are current with CRC screening (Sub-study - Age Group 45-49) | The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who who are current with any CRC screening compared to baseline, using any of the screening modalities recommended by the United States Preventive Services Task Force (FIT, fecal occult blood test [FOBT], FIT-DNA, colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, CT colonography) per electronic health record review. | 6 months after randomization | 
| Proportion of subjects, ages 45-49, who completed mailed FIT at 60 days (Sub-study - Age Group 45-49) | The proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) compared to subjects in Arm 4 (Sub-study Mailed FIT Active Comparator Envelope - Age Group 45-49) who return a completed FIT. | 60 days after randomization | 
| Proportion of subjects who complete a follow-up diagnostic colonoscopy at 60 days (Sub-study - Age Group 45-49) | Proportion of subjects in Arm 3 (Sub-study Mailed FIT Intervention Enhanced Envelope - Age Group 45-49) and Arm 4 (Sub-study Mailed FIT Active Comparator Plain Envelope - Age Group 45-40) with a positive (abnormal) FIT/FOBT result for whom colonoscopy is deemed to be clinically appropriate by the subject's provider who complete a follow-up (diagnostic) colonoscopy per electronic health record review. | 60 days after abnormal FIT result date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Screening, Colonoscopy, Community Health Centers, Implementation Science, Patient Navigation