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Background: Fecal immunochemical testing (FIT) is a widely used first step for colorectal cancer (CRC) screening. Abnormal FIT results require a colonoscopy for screening completion and CRC diagnosis, but the rate of timely colonoscopy is low, especially among patients in safety-net settings. Multi-level factors at the clinic- and patient-levels influence colonoscopy completion after an abnormal FIT. Our study aims to implement a multi-level approach consisting of a clinic- and patient-level intervention to improve the completion of diagnostic colonoscopy after an abnormal FIT., Methods: We will test a multilevel intervention with one safety-net system across 12 primary care clinics - a clinic-level intervention using a stepped wedge design and a patient-level intervention with patient-level randomization. At the clinic level, we will implement a "best practices bundle" to improve workflow for primary care providers and staff using a stepped-wedge design. At the patient level, we will randomize 2000 patients to receive text messages and call reminders or usual care., Results: For the main analysis, we will use a mixed effects logistic model to assess the impact of the clinic intervention on the primary outcome (completion of colonoscopy within 180 days after abnormal FIT). Secondary outcomes include median days to colonoscopy completion, rate of referral to colonoscopy at 42 days, rate of scheduled colonoscopy at 56 days, and bowel preparation quality at colonoscopy., Discussion: This study will assess the extent to which a multi-level intervention can improve timely colonoscopy completion in a diverse patient population cared for in a safety-net setting., Trial Registration: NCT, NCT06191185. Registered 20 December 2023, https://clinicaltrials.gov/study/NCT06191185., Competing Interests: Declaration of competing interest Dr. Sarkar holds current research funding from the National Cancer Institute, California Healthcare Foundation, the Patient-Centered Outcomes Research Institute, and the National Institutes of Health. She has received prior grant funding from the Gordon and Betty Moore Foundation, the Blue Shield of California Foundation, the Agency for Healthcare Research and Quality, HopeLab, the US Food and Drug Administration, and the Commonwealth Fund. She received gift funding from The Doctors Company Foundation. She holds contract funding from InquisitHealth and RecoverX. Dr. Sarkar is a scientific/expert advisor for nonprofit organizations such as HealthTech 4 Medicaid (volunteer). She is a member of the American Medical Association's Equity and Innovation Advisory Group (honoraria) and is on the Board of Directors of the Collaborative for Accountability and Improvement (volunteer). She is an advisor for Waymark (shares) and Ceteri Capital I GP, LLC (shares). She has been a clinical advisor for Omada Health (honoraria) and an advisory board member for Doximity (honoraria)., (Copyright © 2024. Published by Elsevier Inc.)

Purpose: Colorectal cancer screening is recommended starting at age 45, but there has been little research on strategies to promote screening in patients younger than 50., Methods: An outreach program quasi-randomly assigned patients aged 45-50 without recent fecal immunochemical test (FIT), colonoscopy or contraindications to screening to two intervention arms: electronic outreach with email and text (electronic outreach only) versus electronic outreach plus mailed outreach with FIT, an instructional letter and a prepaid return envelope (mailed + electronic outreach). In response to known disparities in screening uptake, all Black patients were assigned to receive mailed + electronic outreach., Results: Among patients quasi-randomly assigned to an intervention (non-Black patients), the 180-day FIT completion rate was 18.8% in the electronic outreach only group (n = 1,318) and 25.0% in the mailed + electronic outreach group (n = 1,364) (difference 6.2% [95% CI 3.0, 9.4]). FIT completion was 16.6% among Black patients (n = 469), 8.4% (95% CI 4.1, 12.6) lower than among non-Black patients also assigned to mailed + electronic outreach., Conclusion: Among patients aged 45-50, mailed + electronic outreach had a greater effect on FIT completion than electronic outreach alone. Crossover between intervention groups likely lead to an underestimation of the effect of mailed outreach., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: Colorectal cancer (CRC) screening is recommended starting at age 45, but there has been little research on strategies to promote screening among patients younger than 50. This study assessed the effect of a multicomponent intervention on screening completion in this age group., Methods: The intervention consisted of outreach to patients aged 45 to 49 (n = 3,873) via mailed fecal immunochemical test (FIT) (sent to 46%), text (84%), e-mail (53%), and the extension to this age group of an existing standing order protocol allowing primary care nurses and medical assistants to order FIT at primary care clinics in an urban safety-net system. We used segmented linear regression to assess changes in CRC screening completion trends. Patients aged 51 to 55 were included as a comparison group (n = 3,943). Data were extracted from the EHR., Results: The percentage of patients aged 45 to 49 who were up-to-date with CRC screening (colonoscopy in 10 years or FIT in last year) increased an average of 0.4% (95% CI 0.3, 0.6)) every 30 days before intervention rollout and 2.8% (95% CI 2.5, 3.1) after (slope difference 2.3% [95% CI 2.0, 2.7]). This difference persisted after accounting for small changes in the outcome observed in the comparison group (slope difference 1.7% [95% CI 1.2, 2.2])., Conclusions: These results suggest that the intervention increased CRC screening completion among patients 45 to 49. Health care systems seeking to improve CRC screening participation among patients aged 45 to 49 should consider implementing similar interventions., Competing Interests: Conflict of interest: None., (© Copyright by the American Board of Family Medicine.)

Objective: Digital health care offers an opportunity to scale and personalize cancer screening programs, such as mailed outreach for colorectal cancer (CRC) screening. However, studies that describe the patient selection strategy and process for CRC screening are limited. Our objective was to evaluate implementation strategies for selecting patients for CRC screening programs in large health care systems., Methods: We conducted a systematic review of 30 studies along with key informant surveys and interviews to describe programmatic implementation strategies for selecting patients for CRC screening. PubMed and Embase were searched since inception through December 2018, and hand searches were performed of the retrieved reference lists but none were incorporated ( n  = 0). No language exclusions were applied., Results: Common criteria for outreach exclusion included: being up-to-date with routine CRC screening ( n  = 22), comorbidities ( n  = 20), and personal history ( n  = 22) or family history of cancer ( n  = 9). Key informant surveys and interviews were performed ( n  = 28) to understand data sources and practices for patient outreach selection, and found that 13 studies leveraged electronic medical care records, 10 studies leveraged a population registry (national, municipal, community, health), 4 studies required patient opt-in, and 1 study required primary care provider referral. Broad ranges in fecal immunochemical test completion were observed in community clinic ( n  = 8, 31.0-59.6%), integrated health system ( n  = 5, 21.2-82.7%), and national regional CRC screening programs ( n  = 17, 23.0-64.7%). Six studies used technical codes, and four studies required patient self-reporting from a questionnaire to participate., Conclusion: This systematic review provides health systems with the diverse outreach practices and technical tools to support efforts to automate patient selection for CRC screening outreach.

Background: Phone calls as part of multimodal fecal immunochemical test (FIT) outreach are effective but resource-intensive. Previous studies of advanced notification calls before FIT mailing have not differentiated patients' prior screening status., Objective: To determine the effectiveness of a phone call preceding mailing of a FIT kit on test completion rate for patients who have completed a prior FIT., Design: Randomized controlled trial nested within a larger study. All patients were assigned to receive organized mailed FIT outreach in the larger study., Participants: Patients in a safety-net health setting ages 50-75 years old with a previously negative FIT., Interventions: Patients were assigned to either receive an advanced notification phone call or no phone call preceding a mailed FIT kit. Both groups received an informational postcard prior to the mailed FIT., Main Measures: The primary outcome was FIT completion rate at 1 year. The secondary outcomes were FIT completion rates at 60, 90, and 180 days, rates stratified by demographic subgroups, and rates according to outcome of the phone call., Key Results: A total of 1645 patients were assigned to advanced notification calls and 1595 were assigned to no call preceding the FIT mailing. Although FIT completion rate was higher at day 60 (55.5% vs. 50.8%, p < 0.01), an advanced notification call did not significantly improve FIT completion at 1 year (70.9% vs. 69.9%, p = 0.52). Of the patients assigned to receive an advanced notification call, 90.5% were spoken with or left a voicemail; patients who were spoken with were more likely to complete a FIT at 1 year compared with patients who were only left a voicemail or could not be left a voicemail (79.9% vs. 69.2% vs. 49.6%, p < 0.01)., Conclusions: Advanced notification phone calls prior to FIT mailing did not improve rates at 1 year for patients with a previously negative FIT.

INTRODUCTION: We examined the utility of the International Classification of Disease, Tenth Revision (ICD-10) code, R19.5, for a positive or abnormal fecal immunochemical test (FIT) and its association with colonoscopy completion. METHODS: We identified all patients in a safety-net health system who underwent FITs from January 1, 2020, to August 31, 2021, and extracted the FIT date, FIT result, and ICD-10 code (R19.5) and colonoscopy procedures for each patient. RESULTS: FIT-positive patients who had an R19.5 designation within 90 days (n = 383) were significantly more likely than all other FIT-positive patients (n = 273) to complete a colonoscopy within 6 months (40.9% vs 16.8%, P