Mailed Fecal Immunochemical Test Research Articles

The Reach of Calls and Text Messages for Mailed FIT Outreach in the PROMPT Stepped-Wedge Colorectal Cancer Screening Trial.

Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening participation. We assessed the reach and effectiveness of adding notifications to mailed FIT programs. We conducted secondary analyses of a stepped-wedge evaluation of an enhanced mailed FIT program (n = 15 clinics). Patients were stratified by prior FIT completion. Those with prior FIT were sent a text message (Group 1); those without were randomized 1:1 to receive a text message (Group 2) or live phone call (Group 3). All groups were sent automated phone call reminders. In stratified analysis, we measured reach and effectiveness (FIT completion within 6 months) and assessed patient-level associations using generalized estimating equations. Patients (n = 16,934; 83% Latino; 72% completed prior FIT) were reached most often by text messages (78%), followed by live phone calls (71%), then automated phone calls (56%). FIT completion was higher in patients with prior FIT completion versus without [44% (Group 1) vs. 19% (Group 2 + Group 3); P < 0.01]. For patients without prior FIT, effectiveness was higher in those allocated to a live phone call [20% (Group 3) vs. 18% (Group 2) for text message; P = 0.04] and in those who personally answered the live call (28% vs. 9% no call completed; P < 0.01). Text messages reached the most patients, yet effectiveness was highest in those who personally answered the live phone call. Despite the broad reach and low cost of text messages, personalized approaches may more successfully boost FIT completion.

Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas

BackgroundMailed fecal immunochemical test (FIT) outreach and patient navigation are evidence-based practices shown to improve rates of colorectal cancer (CRC) and follow-up in various settings, yet these programs have not been broadly adopted by health systems and organizations that serve diverse populations. Reasons for low adoption rates are multifactorial, and little research explores approaches for scaling up a complex, multi-level CRC screening outreach intervention to advance equity in rural settings.MethodsSMARTER CRC, a National Cancer Institute Cancer Moonshot project, is a cluster-randomized controlled trial of a mailed FIT and patient navigation program involving 3 Medicaid health plans and 28 rural primary care practices in Oregon and Idaho followed by a national scale-up trial. The SMARTER CRC intervention combines mailed FIT outreach supported by clinics, health plans, and vendors and patient navigation for colonoscopy following an abnormal FIT result. We applied the framework from Perez and colleagues to identify the intervention’s components (including functions and forms) and scale-up dissemination strategies and worked with a national advisory board to support scale-up to additional organizations. The team is recruiting health plans, primary care clinics, and regional and national organizations in the USA that serve a rural population. To teach organizations about the intervention, activities include Extension for Community Healthcare Outcomes (ECHO) tele-mentoring learning collaboratives, a facilitation guide and other materials, a patient navigation workshop, webinars, and individualized technical assistance. Our primary outcome is program adoption (by component), measured 6 months after participation in an ECHO learning collaborative. We also assess engagement and adaptations (implemented and desired) to learn how the multicomponent intervention might be modified to best support broad scale-up.DiscussionFindings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings.Trial registrationRegistered at ClinicalTrials.gov (NCT04890054) and at the NCI’s Clinical Trials Reporting Program (CTRP no.: NCI-2021–01032) on May 11, 2021.

Implementing an Organized Colorectal Cancer Screening Program: Lessons Learned From an Academic–Community Practice

IntroductionThe effectiveness of mailed fecal immunochemical test (FIT) outreach might be enhanced through an organized colorectal cancer (CRC) screening program, yet published real-world experiences are limited. We synthesized the process of implementing a CRC screening program which used mailed FIT outreach in a large integrated academic-community practice. Materials and MethodsData from a pilot mailed FIT program were shared with healthcare system leadership which inspired the creation of a cross-institutional organized CRC Screening Program. In partnership with a centralized Population Health Team and Primary Care, we defined: 1) the institutional approach to CRC screening, 2) the target population and method for screening, 3) the team responsible for implementation, 4) the healthcare team responsible for decisions and care, 5) a quality assurance structure, and 6) a method for identifying cancer occurrence. ResultsThe Fred Hutch/UW Medicine Population Health CRC Screening Program began in September 2021. The workflow for mailed FIT outreach included a mailed postcard, a MyChart message from the patient's primary care provider (PCP), a FIT kit with a letter signed by the PCP and program director, and up to three bi-weekly reminders. Patients without a colonoscopy 3 months after an abnormal FIT result received navigation through the program. In the first program year, we identified 9,719 patients eligible for outreach and in an intention to treat analysis, 32% of patients completed CRC screening by FIT or colonoscopy. ConclusionsReal-world experiences detailing how to implement organized CRC screening programs might increase adoption. In our experience, broadly disseminating pilot data, early institutional support, robust data management and strong cross-departmental relationships were critical to successfully implementing a CRC screening program that benefits all patients.

Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol

BackgroundGuidelines recommend screening for colorectal cancer (CRC), but participation and abnormal test follow up rates are suboptimal, with disparities by demography. Evidence-based interventions exist to promote screening, but community adoption and implementation are limited. MethodsThe San Diego Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) program is an academic-community partnership testing regional implementation of a Hub-and-Spoke model for increasing CRC screening and follow-up. The “hub” is a non-academic, non-profit organization that includes 17 community health center (CHC) systems, serving over 190 rural and urban clinic sites. The “spokes” are 3 CHC systems that oversee 11–28 clinics each, totaling over 60 clinics. Using a cluster-randomized trial design, 9 clinics were randomized to intervention and 16 to usual care. Within intervention clinics, approximately 5000 eligible patients not up-to-date with CRC screening per year were identified for intervention. Interventions include an invitation primer, a mailed fecal immunochemical test with completion instructions, and phone and text-based reminders (hub) and patient navigation protocol to promote colonoscopy completion after abnormal FIT (spoke). Outcomes include: 1) proportion of patients up-to-date with screening after three years in intervention versus non-intervention clinics; 2) proportion of patients with abnormal FIT completing colonoscopy within six months of the abnormal result. Implementation science measures are collected to assess acceptability, intervention and usual care adaptations, and sustainability of the intervention strategies. ConclusionThis large-scale, regional cluster randomized trial among CHCs serving diverse populations is anticipated to accelerate progress in CRC prevention in underserved populations.Trial registration: NCT04941300

Effectiveness and Cost of an Enhanced Mailed Fecal Test Outreach Colorectal Cancer Screening Program: Findings from the PROMPT Stepped-Wedge Trial.

Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer screening rates, yet little is known about how to optimize these programs for effectiveness and cost. PROMPT was a pragmatic, stepped-wedge, cluster-randomized effectiveness trial of mailed FIT outreach. Participants in the standard condition were mailed a FIT and received live telephone reminders to return it. Participants in the enhanced condition also received a tailored advance notification (text message or live phone call) and two automated phone call reminders. The primary outcome was 6-month FIT completion; secondary outcomes were any colorectal cancer screening completion at 6 months, implementation, and program costs. The study included 27,585 participants (80% ages 50-64, 82% Hispanic/Latino; 68% preferred Spanish). A higher proportion of enhanced participants completed FIT at 6 months than standard participants, both in intention-to-treat [+2.8%, 95% confidence interval (CI; 0.4-5.2)] and per-protocol [limited to individuals who were reached; +16.9%, 95% CI (12.3-20.3)] analyses. Text messages and automated calls were successfully delivered to 91% to 100% of participants. The per-patient cost for standard mailed FIT was $10.84. The enhanced program's text message plus automated call reminder cost an additional $0.66; live phone calls plus an automated call reminder cost an additional $10.82 per patient. Adding advance notifications and automated calls to a standard mailed FIT program boosted 6-month FIT completion rates at a small additional per-patient cost. Enhancements to mailed FIT outreach can improve colorectal cancer screening participation. Future research might test the addition of educational video messaging for screening-naïve adults.

Uptake of colorectal cancer screening after mailed fecal immunochemical test (FIT) outreach in a newly eligible 45–49-year-old community health center population

PurposeWe assessed fecal immunochemical test (FIT) uptake following a mailed FIT intervention among 45–49-year-olds newly eligible for colorectal cancer (CRC) screening based on 2021 United States Preventive Services Task Force screening recommendations. We also tested the effect of an enhanced versus plain mailing envelope on FIT uptake.MethodsIn February 2022 we mailed FITs to eligible 45–49-year-olds at one Federally Qualified Health Center (FQHC) clinic. We determined the proportion who completed FITs within 60 days. We also conducted a nested randomized trial comparing uptake using an enhanced envelope (padded with tracking label and colored messaging sticker) versus plain envelope. Finally, we determined the change in CRC screening by any modality (e.g., FIT, colonoscopy) among all clinic patients in this age group (i.e., clinic-level screening) between baseline and 6 months post-intervention.ResultsWe mailed FITs to 316 patients. Sample characteristics: 57% female, 58% non-Hispanic Black, and 50% commercially insured. Overall, 54/316 (17.1%) returned a FIT within 60 days, including 34/158 (21.5%) patients in the enhanced envelope arm versus 20/158 (12.7%) in the plain envelope arm (difference 8.9 percentage points, 95% CI: 0.6–17.2). Clinic-level screening among all 45–49-year-olds increased 16.6 percentage points (95% CI: 10.9–22.3), from 26.7% at baseline to 43.3% at 6 months.ConclusionCRC screening appeared to increase following a mailed FIT intervention among diverse FQHC patients aged 45–49. Larger studies are needed to assess acceptability and completion of CRC screening in this younger population. Visually appealing mailers may improve uptake when implementing mailed interventions.Trial registration The trial was registered on May 28, 2020 at ClinicalTrials.gov (identifier NCT04406714).

Implementing an enhanced mailed FIT program to improve CRC screening at a federally qualified health center: experiences of patients and staff.

Colorectal cancer (CRC) is a leading cause of cancer death in the USA. Screening programs in federally qualified health centers (FQHCs) are essential to reducing CRC-related mortality and morbidity among underserved populations. Centralized, population-based mailed fecal immunochemical test (FIT) programs can improve CRC screening rates, but barriers to implementation remain. We qualitatively explored barriers and facilitators to implementation of a mailed FIT program at a large, urban FQHC that employed advance notification "primers" (live calls and texts) and automated reminders. We interviewed 25 patients and 45 FQHC staff by telephone about their experience with the program. Interviews were transcribed, coded, and content analyzed using NVivo.12. Patients and staff found advance notifications conveyed through live phone calls or text messages to be acceptable and motivational for FIT completion. Live phone primers were helpful in addressing patients' questions and misconceptions about screening, particularly for patients new to screening. Advance notifications sent by text were considered timely and useful in preparing patients for receipt of the FIT. Barriers to implementation included lack of receipt of primers, reminders, or the mailed FIT itself due to inaccurate patient contact information within the FQHC medical record; lack of systems for documenting mailed FIT outreach to coordinate with clinical care; and lack of local caller identification for primers and reminders. Our findings demonstrate that an enhanced mailed FIT program using primers and reminders was acceptable. Our findings can help other FQHCs implement and optimize their mailed FIT programs.

Reach and effectiveness of a centralized navigation program for patients with positive fecal immunochemical tests requiring follow-up colonoscopy

Completion rates for follow-up colonoscopies after an abnormal fecal immunochemical test (FIT) are suboptimal in federally qualified health center (FQHC) settings. We implemented a screening intervention that included mailed FIT outreach to North Carolina FQHC patients from June 2020 to September 2021 and centralized patient navigation to support patients with abnormal FITs in completing follow-up colonoscopy. We evaluated the reach and effectiveness of navigation using electronic medical record data and navigator call logs detailing interactions with patients. Reach assessments included the proportion of patients successfully contacted by phone and who agreed to participate in navigation, intensity of navigation provided (including types of barriers to colonoscopy identified and total navigation time), and differences in these measures by socio-demographic characteristics. Effectiveness outcomes included colonoscopy completion, timeliness of follow-up colonoscopy (i.e., within 9 months), and bowel prep adequacy. Among 514 patients who completed a mailed FIT, 38 patients had an abnormal result and were eligible for navigation. Of these, 26 (68%) accepted navigation, 7 (18%) declined, and 5 (13%) could not be contacted. Among navigated patients, 81% had informational needs, 38% had emotional barriers, 35% had financial barriers, 12% had transportation barriers, and 42% had multiple barriers to colonoscopy. Median navigation time was 48.5 min (range: 24–277 min). Colonoscopy completion differed across groups – 92% of those accepting navigation completed colonoscopy within 9 months, versus 43% for those declining navigation. We found that centralized navigation was widely accepted in FQHC patients with abnormal FIT, and was an effective strategy, resulting in high colonoscopy completion rates.

Using Text Messages and Fotonovelas to Increase Return of Home-Mailed Colorectal Cancer Screening Tests: Mixed Methods Evaluation

Background Colorectal cancer (CRC) is currently the second leading cause of cancer-related deaths in the United States; however, it is mostly preventable with appropriate screening and is often treatable when detected at early stages. Many patients enrolled in an urban Federally Qualified Health Center (FQHC) clinic were found to be past due for CRC screening. Objective This study described a quality improvement (QI) project to improve CRC screening rates. This project used bidirectional texting with fotonovela comics and natural language understanding (NLU) to encourage patients to mail fecal immunochemical test (FIT) kits back to the FQHC. Methods The FQHC mailed FIT kits to 11,000 unscreened patients in July 2021. Consistent with the usual care, all patients received 2 text messages and a patient navigator call within the first month of mailing. As part of a QI project, 5241 patients who did not return their FIT kit within 3 months, aged 50-75 years, and spoke either English or Spanish were randomized to either usual care (no further intervention) or intervention (4-week texting campaign with a fotonovela comic and remailing kits if requested) groups. The fotonovela was developed to address known barriers to CRC screening. The texting campaign used NLU to respond to patients’ texts. A mixed methods evaluation used data from SMS text messages and electronic medical records to understand the impact of the QI project on CRC screening rates. Open-ended text messages were analyzed for themes, and interviews were completed with a convenience sample of patients to understand barriers to screening and impact of the fotonovela. Results Of the 2597 participants, 1026 (39.5%) in the intervention group engaged with bidirectional texting. Participating in bidirectional texting was related to language preference (χ22=11.0; P=.004) and age group (χ22=19.0; P&lt;.001). Of the 1026 participants who engaged bidirectionally, 318 (31%) clicked on the fotonovela. Furthermore, 54% (32/59) of the patients clicked on the fotonovela and responded that they loved it, and 36% (21/59) of patients responded that they liked it. The intervention group was more likely to get screened (487/2597, 18.75%) than those in usual care (308/2644, 11.65%; P&lt;.001), and this pattern held, regardless of demographic subgroup (sex, age, screening history, preferred language, and payer type). Interview data (n=16) indicated that the text messages, navigator calls, and fotonovelas were well received and not unduly invasive. Interviewees noted several important barriers to CRC screening and offered suggestions for reducing barriers and increasing screening. Conclusions Texting using NLU and fotonovela is valuable in increasing CRC screening as observed by the FIT return rate for patients in the intervention group. There were patterns in which patients did not engage bidirectionally; future work should investigate how to ensure that populations are not left out of screening campaigns.

Using Text Messages and Fotonovelas to Increase Return of Home-Mailed Colorectal Cancer Screening Tests: Mixed Methods Evaluation.

Colorectal cancer (CRC) is currently the second leading cause of cancer-related deaths in the United States; however, it is mostly preventable with appropriate screening and is often treatable when detected at early stages. Many patients enrolled in an urban Federally Qualified Health Center (FQHC) clinic were found to be past due for CRC screening. This study described a quality improvement (QI) project to improve CRC screening rates. This project used bidirectional texting with fotonovela comics and natural language understanding (NLU) to encourage patients to mail fecal immunochemical test (FIT) kits back to the FQHC. The FQHC mailed FIT kits to 11,000 unscreened patients in July 2021. Consistent with the usual care, all patients received 2 text messages and a patient navigator call within the first month of mailing. As part of a QI project, 5241 patients who did not return their FIT kit within 3 months, aged 50-75 years, and spoke either English or Spanish were randomized to either usual care (no further intervention) or intervention (4-week texting campaign with a fotonovela comic and remailing kits if requested) groups. The fotonovela was developed to address known barriers to CRC screening. The texting campaign used NLU to respond to patients' texts. A mixed methods evaluation used data from SMS text messages and electronic medical records to understand the impact of the QI project on CRC screening rates. Open-ended text messages were analyzed for themes, and interviews were completed with a convenience sample of patients to understand barriers to screening and impact of the fotonovela. Of the 2597 participants, 1026 (39.5%) in the intervention group engaged with bidirectional texting. Participating in bidirectional texting was related to language preference (χ22=11.0; P=.004) and age group (χ22=19.0; P<.001). Of the 1026 participants who engaged bidirectionally, 318 (31%) clicked on the fotonovela. Furthermore, 54% (32/59) of the patients clicked on the fotonovela and responded that they loved it, and 36% (21/59) of patients responded that they liked it. The intervention group was more likely to get screened (487/2597, 18.75%) than those in usual care (308/2644, 11.65%; P<.001), and this pattern held, regardless of demographic subgroup (sex, age, screening history, preferred language, and payer type). Interview data (n=16) indicated that the text messages, navigator calls, and fotonovelas were well received and not unduly invasive. Interviewees noted several important barriers to CRC screening and offered suggestions for reducing barriers and increasing screening. Texting using NLU and fotonovela is valuable in increasing CRC screening as observed by the FIT return rate for patients in the intervention group. There were patterns in which patients did not engage bidirectionally; future work should investigate how to ensure that populations are not left out of screening campaigns.

Nudging to Increase Colorectal Cancer Screening Rates: A Cost-Benefit Analysis of a Medicare Mailed Fecal Immunochemical Test Program

This paper presents a cost-benefit analysis of the implementation of a mailed fecal immunochemical test (FIT) program for Medicare beneficiaries who have fallen behind on recommended colorectal cancer (CRC) screening. An ex-ante cost-benefit analysis was conducted to determine the total net benefits to US society of the implementation of a Medicare Mailed FIT program on one-year and 10-year timelines. Costs and benefits associated with the implementation of such a program were valued using Centers for Medicare and Medicaid Services (CMS) reimbursement rates and results from existing research. Analysis procedures followed Health and Human Services Guidelines for Regulatory Impact Analysis to the maximum extent possible. The base-case net benefits after program year one were estimated to be $9.6 billion with estimated 10-year net benefits of $74.5 billion. Best-case sensitivity analysis outcomes were estimated to be $22.7 billion in net benefits at the end of year one and $202.3 billion in net benefits on a 10-year timeline, while worst-case sensitivity analysis outcomes were estimated to be $1.4 billion in net benefits at the end of year one and $12.5 billion in net benefits on a 10-year timeline. Further sensitivity analyses all yielded positive net benefits on one and 10-year timelines indicating that the implementation of a mailed FIT program for Medicare beneficiaries who have fallen behind on CRC screening offers considerable net benefit to US society.

Modifications in Primary Care Clinics to Continue Colorectal Cancer Screening Promotion During the COVID-19 Pandemic.

COVID-19 caused significant declines in colorectal cancer (CRC) screening. Health systems and clinics, faced with a new rapidly spreading infectious disease, adapted to maintain patient safety and address the effects of the pandemic on healthcare delivery. This study aimed to understand how CDC-funded Colorectal Cancer Control Program recipients and their partner health systems and clinics may have modified evidence-based intervention (EBI) implementation to promote CRC screening during the COVID-19 pandemic; to identify barriers and facilitators to implementing modifications; and to extract lessons that can be applied to support CRC screening, chronic disease management, and clinic resilience in the face of future public health crises. Nine recipients were selected to reflect the diversity inherent among all CRCCP recipients. Recipient and clinic partner staff answered unique sets of pre-interview questions to inform tailoring of interview guides that were developed using constructs from the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) and Consolidated Framework for Implementation Research (CFIR). The study team then interviewed recipient, health system, and clinic partner staff incorporating pre-interview responses to focus each conversation. We employed a rapid qualitative analysis approach then conducted virtual focus groups with recipient representatives to validate emergent themes. Three modifications that emerged from thematic analysis include: (1) offering mailed fecal immunochemical test (FIT) kits for CRC screening with mail or drop off return; (2) increasing the use of patient education and engagement strategies; and (3) increasing the use of or improving automated patient messaging systems. With improved tracking and automated reminder systems, mailed FIT kits paired with tailored patient education and clear instructions for completing the test could help primary care clinics catch up on the backlog of missed screenings during COVID-19. Future research can assess the effectiveness and cost-effectiveness of offering mailed FIT kits on maintaining or improving CRC screening, especially among people who are medically underserved.

S255 Assessing the Impact of a Multi-Component Health System Intervention to Address Low Colorectal Cancer Screening Participation in Patients With a Family History of Colorectal Cancer

Introduction: In the United States, 3-10% of individuals have a family history of colorectal cancer (CRC). Population health strategies to increase CRC screening often exclude these individuals, and interventions to increase screening participation in this high-risk group are rare. We designed and implemented a multi-component health system intervention to increase CRC screening uptake among individuals with a family history of CRC that were excluded from mailed fecal immunochemical test (FIT) outreach in our health system. Methods: The study was performed in a large academic medical center with biannual mailed FIT outreach for individuals at average-risk for CRC. We included patients who did not receive mailed FIT outreach in 2021 due to a family history of CRC. We excluded patients with a personal history of inflammatory bowel disease, colectomy, or CRC. The intervention included both primary care provider (PCP) and patient components. The PCP component was sent via the electronic health record (EHR) and included CRC screening guidelines for patients with a family history of CRC and a pended colonoscopy order for each patient overdue for screening. The patient component was delivered via the EHR patient portal and a mailed letter and included education about familial risk and colonoscopy, and a prompt to schedule a colonoscopy. Preliminary outcomes were measured 2-months post-intervention and were whether: (1) the PCP signed the pended colonoscopy order and (2) the patient scheduled colonoscopy. We used descriptive statistics to describe the study cohort and paired t-tests to compare the study outcomes pre- and post-intervention. The primary outcome of colonoscopy completion will be measured 6 months post-intervention. Results: 152 patients received the intervention. The mean age was 61.3 years (s.d 7.0), 32.9% were male, and 42.1% were non-Hispanic White (Table). Colonoscopy orders increased from 32 (21.1%) to 92 (60.5%) from pre- to post-intervention (p< 0.0001) (Figure). Colonoscopies scheduled increased from 0 to 9 (5.9%) (p=0.002). Conclusion: We designed and evaluated the preliminary results of a health system intervention that aims to increase screening participation among individuals with a family history of CRC. There was a significant increase in both colonoscopies ordered and colonoscopies scheduled. This study demonstrates a successful population health strategy to increase provider and patient intention to screen in this high-risk population.Figure 1.: Screening colonoscopies ordered and screening colonoscopies scheduled pre- intervention versus post- intervention, n= 152 Table 1. - Intervention population characteristics, n= 152 Patient Characteristic Study Population (n=152) Age [years, mean (SD)] 61.3 (7.0) Male Sex [n (%)] 50 (32.9) White Race [n (%)] 72 (47.4) Non-Hispanic Ethnicity [n (%)] 116 (76.3) Private Insurance [n (%)] 149 (98.0) Married [n (%)] 83 (54.6) English Language Preference [n (%)] 147 (96.7) Social Vulnerability Index [median (IQR)] 25.9 (11.8-47.8) Current or Former Tobacco Use Disorder [n (%)] 38 (25.0) Current or Former Alcohol Use Disorder [n (%)] 13 (8.6) Body Mass Index ≥ 25 [n (%)] 100 (66.2) Hemoglobin A1c ≥ 5.7 [n (%)] 75 (52.8) Family Members with Documented CRC [median (IQR)] 1 (1-1) 1st Degree Family Members with Documented CRC [median (IQR)] 1 (1-1) Years since Last PCP Visit [median (IQR)] 1.01 (0.75-1.62) Years since Last GI Visit [median (IQR)] 2.3 (2.5-9.2) Breast Cancer Screening Up-To-Date [n (%)] 47 (47) Cervical Cancer Screening Up-To-Date [n (%)] 61 (83.6)

Improving colorectal cancer screening in rural primary care: Preliminary effectiveness and implementation of a collaborative mailed fecal immunochemical test pilot.

Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer (CRC) screening rates. We piloted a collaborative mailed FIT program with health plans and rural clinics to evaluate preliminary effectiveness and refine implementation strategies. We conducted a single-arm study using a convergent, parallel mixed-methods design to evaluate the implementation of a collaborative mailed FIT program. Enrollees were identified using health plan claims and confirmed via clinic scrub. The intervention included a vendor-delivered automated phone call (auto-call) prompt, FIT mailing, and reminder auto-call; clinics were encouraged to make live reminder calls. Practice facilitation was the primary implementation strategy. At 12 months post mailing, we assessed the rates of: (1) mailed FIT return and (2) completion of any CRC screening. We took fieldnotes and conducted postintervention key informant interviews to assess implementation outcomes (eg, feasibility, acceptability, and adaptations). One hundred and sixty-nine Medicaid or Medicare enrollees were mailed a FIT. Over the 12-month intervention, 62 participants (37%) completed screening of which 21% completed the mailed FIT (most were returned within 3 months), and 15% screened by other methods (FITs distributed in-clinic, colonoscopy). Enrollee demographics and the reminder call may encourage mailed FIT completion. Program feasibility and acceptability was high and supported by perceived positive benefit, alignment with existing workflows, adequate staffing, and practice facilitation. Collaborative health plan-clinic mailed FIT programs are feasible and acceptable for implementation in rural clinics and support CRC screening completion. Studies that pragmatically test collaborative approaches to mailed FIT and patient navigation follow-up after abnormal FIT and support broad scale-up in rural settings are needed.

Cost-effectiveness of mt-sDNA versus mailed FIT outreach for Medicare Advantage enrollees using the CRC-AIM microsimulation model.

e18827 Background: Despite proven effectiveness in reducing colorectal cancer (CRC) cases, screening for CRC remains underutilized, including those enrolled in Medicare Advantage. A mailed fecal immunochemical test (FIT) outreach program may increase CRC screening adherence. This study examined the cost-effectiveness of stool-based tests (FIT and multi-target stool DNA [mt-sDNA]), with FIT offered via a mailed outreach program, in a Medicare Advantage population. Methods: The validated CRC-AIM microsimulation model was used to simulate the costs and clinical outcomes of 2 million average-risk individuals, free of diagnosed CRC at age 40, who initiated CRC screening at age 65. Annual mailed FIT outreach and triennial mt-sDNA were assessed. Test sensitivity and specificity inputs were based on the 2021 United States Preventative Services Task Force modeling study. FIT outreach program cost ($25.92) and direct costs for screening tests, colonoscopies (COLs), complications, and CRC care were included. The model employed a lifetime horizon, 3% discount rates, and a Medicare Advantage perspective. The primary analysis used published real-world adherence rates for stool-based tests and follow-up COLs (FIT/COL: 29%/53%; mt-sDNA/COL: 69.8%/71.5%). Secondary analyses assumed 100% adherence for stool-based tests and/or follow-up COLs and 20% higher than primary analysis for FIT and the corresponding follow-up COLs. Results: In the primary analysis, mt-sDNA had the greatest life-years gained (LYG), incidence reduction (IR), and mortality reduction (MR) and was cost-effective at a willingness-to-pay threshold of $50,000/QALY compared to mailed FIT outreach (Table). This was true when 100% adherence was assumed for follow-up COL and when FIT had 20% higher adherence than the primary analysis. mt-sDNA had 64-129% greater LYG, 79-150% greater IR, and 68-146% greater MR than mailed FIT outreach. When assuming 100% adherence for both screening test and follow-up COL, mt-sDNA was dominated by mailed FIT outreach. Conclusions: Adherence to CRC screening modality and follow-up COL greatly impacts clinical and cost-effectiveness outcomes. Future analysis should consider evidence-based, health plan-specific data to accurately reflect outcomes that aid in payer decision making.[Table: see text]

Clinic Factors Associated With Mailed Fecal Immunochemical Test (FIT) Completion: The Difference-Making Role of Support Staff.

Mailed fecal immunochemical test (FIT) programs can facilitate colorectal cancer (CRC) screening. We sought to identify modifiable, clinic-level factors that distinguish primary care clinics with higher vs lower FIT completion rates in response to a centralized mailed FIT program. We used baseline observational data from 15 clinics within a single urban federally qualified health center participating in a pragmatic trial to optimize a mailed FIT program. Clinic-level data included interviews with leadership using a guide informed by the Consolidated Framework for Implementation Research (CFIR) and FIT completion rates. We used template analysis to identify explanatory factors and configurational comparative methods to identify specific combinations of clinic-level conditions that uniquely distinguished clinics with higher and lower FIT completion rates. We interviewed 39 clinic leaders and identified 58 potential explanatory factors representing clinic workflows and the CFIR inner setting domain. Clinic-level FIT completion rates ranged from 30% to 56%. The configurational model for clinics with higher rates (≥37%) featured any 1 of the following 3 factors related to support staff: (1) adding back- or front-office staff in past 12 months, (2) having staff help patients resolve barriers to CRC screening, and (3) having staff hand out FITs/educate patients. The model for clinics with lower rates involved the combined absence of these same 3 factors. Three factors related to support staff differentiated clinics with higher and lower FIT completion rates. Adding nonphysician support staff and having those staff provide enabling services might help clinics optimize mailed FIT screening programs.

Cost Effectiveness of Mailed Outreach Programs for Colorectal Cancer Screening: Analysis of a Pragmatic, Randomized Trial

Clinical guidelines for colorectal cancer (CRC) screening suggest use of either stool-based tests or colonoscopy - modalities that differ in recommended screening intervals, adherence, and costs. We know little about the long-term cost differences in population-health outreach strategies to promote these strategies. We conducted a cost-effectiveness analysis to compare 2 mailed outreach strategies to increase CRC screening from a pragmatic, randomized clinical trial: mailed fecal immunochemical test (FIT) kits vs invitations to complete a screening colonoscopy. We built a 10-year Markov chain Monte Carlo microsimulation model to account for differences in screening intervals, adherence, and costs. Mailed FIT kits had a lower 10-year average per-person cost of screening relative to colonoscopy invitations ($1139 vs $1725) but with 10.89 fewer months of compliance and 60 fewer advanced neoplasia detected (37 advanced adenomas and 23 CRC). Incremental cost effectiveness ratios for colonoscopy invitations compared with mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC, respectively. Although FIT was the preferred strategy at low willingness-to-pay thresholds, the 2 strategies were equal at a willingness-to-pay threshold of $41.31 per covered month gained. Mailed FIT or colonoscopy invitations are both options to improve CRC screening completion and advanced neoplasia detection, and the choice of outreach strategy may differ by a health system's willingness-to-pay threshold. Mailed FIT kits are less expensive than colonoscopy invitations but result in fewer months of screening compliance and advanced neoplasia detected.

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates

Colorectal cancer (CRC) screening reduces CRC mortality; however, screening rates remain well below the national benchmark of 80%. To determine whether an electronic primer message delivered through the patient portal increases the completion rate of CRC screening in a mailed fecal immunochemical test (FIT) outreach program. In this randomized clinical quality improvement trial at the University of California, Los Angeles Health of 2339 patients enrolled in a FIT mailing program from August 28, 2019, to September 20, 2020, patients were randomly assigned to either the control or intervention group, and the screening completion rate was measured at 6 months. Participants were average-risk managed care patients aged 50 to 75 years, with a valid mailing address, no mailed CRC outreach in the previous 6 months, and an active electronic health record (EHR) patient portal who were due for CRC screening. Data were analyzed on an intention-to-treat basis. Eligible patients were randomly assigned to receive either (1) the standard FIT mailed outreach (control group) or (2) the standard FIT mailed outreach plus an automated primer to notify patients of the upcoming mailed FIT sent through the electronic patient portal (intervention group). The primary outcome was the screening completion rate (ie, returning the FIT). Secondary outcomes were (1) were the time to CRC screening from the FIT mailing date, (2) screening modality completed, and (3) the effect of opening the electronic primer on screening completion rate. The study included 2339 patients (1346 women [57.5%]; mean [SD] age, 58.9 [7.5] years). The screening completion rate was higher in the intervention group than in the control group (37.6% [445 of 1182] vs 32.1% [371 of 1157]; P = .005). The time to screening was shorter in the intervention group than in the control group (adjusted hazard ratio, 1.24; 95% CI, 1.08-1.42; P = .003). The proportion of each screening test modality completed was similar in both groups. In a subanalysis of the 900 of 1182 patients (76.1%) in the intervention group who opened the patient portal primer message, there was a 7.3-percentage point (95% CI, 2.3-12.4 percentage points) increase in CRC screening (local mean treatment effect; P = .004). Implementation of an electronic patient portal primer message in a mailed FIT outreach program led to a significant increase in CRC screening and improvement in the time to screening completion. The findings provide an evidence base for additional refinements to mailed FIT outreach quality improvement programs in large health systems. ClinicalTrials.gov Identifier: NCT05115916.

Persistent Barriers to Colorectal Cancer Screening Completion Amid Centralized Outreach: A Mixed Methods Study.

To understand patient experiences and persistent barriers to colorectal cancer (CRC) screening amid centralized outreach at urban family medicine practices. Following a pragmatic trial assessing mailed fecal immunochemical test (FIT) outreach, we invited a subset of participants to complete a semi-structured qualitative interview and structured questionnaire. Single urban academic healthcare system. Sixty patients who were eligible and overdue for CRC screening at the time of trial enrollment. Using Andersen's Behavioral Model, we developed an interview guide to systematically assess factors shaping screening decisions and FIT uptake. Close-ended responses were analyzed using descriptive statistics. Qualitative data were analyzed using the constant comparative method. Most participants (82%) self-reported that they had ever completed any modality of CRC screening, and nearly half (43%) completed the mailed FIT during the trial. Most patients (60%) preferred FIT to colonoscopy due to its private, convenient, and non-invasive nature; however, persistent barriers related to screening beliefs including fear of test results and cancer treatment still prevented some patients from completing any form of CRC screening. Mailed FIT can overcome many structural barriers to CRC screening, yet clear communication and follow-up amid centralized outreach are essential. For some patients, tailored outreach or navigation to address screening-related fears or other screening beliefs may be needed to ensure timely completion of CRC screening.

Centralized colorectal cancer screening outreach and patient navigation for vulnerable populations in North Carolina: study protocol for the SCORE randomized controlled trial

BackgroundAlthough colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial.MethodsWe will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants.DiscussionThis hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations.Trial registrationThe trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).