Health plan-based mailed fecal testing for colorectal cancer screening among dual-eligible Medicaid/Medicare enrollees: Outcomes of 2 program models.

BACKGROUND: Health insurance plans are increasingly offering mailed fecal immunochemical test (FIT) programs for colorectal cancer (CRC) screening, but few studies have compared the outcomes of different program models (eg, invitation strategies). METHODS: This study compares the outcomes of 2 health plan-based mailed FIT program models. In the first program (2016), FIT kits were mailed to all eligible enrollees; in the second program (2018), FIT kits were mailed only to enrollees who opted in after an outreach phone call. Participants in this observational study included dual-eligible Medicaid/Medicare enrollees who were aged 50 to 75 years and were due for CRC screening (1799 in 2016 and 1906 in 2018). Six-month FIT completion rates, implementation outcomes (eg, mailed FITs sent and reminders attempted), and program-related health plan costs for each program are described. RESULTS: All 1799 individuals in 2016 were sent an introductory letter and a FIT kit. In 2018, all 1906 were sent an introductory letter, and 1905 received at least 1 opt-in call attempt, with 410 (21.5%) sent a FIT. The FIT completion rate was 16.2% (292 of 1799 [95% CI, 14.5%-17.9%]) in 2016 and 14.6% (278 of 1906 [95% CI, 13.0%-16.2%]) in 2018 (P = .36). The overall implementation costs were higher in 2016 ($40,156) than 2018 ($34,899), with the cost per completed FIT slightly higher in 2016 ($138) than 2018 ($126). CONCLUSIONS: An opt-in mailed FIT program achieved FIT completion rates similar to those of a program mailing to all dual-eligible Medicaid/Medicare enrollees. LAY SUMMARY: Health insurance plans can use different program models to successfully mail fecal test kits for colorectal cancer screening to dual-eligible Medicaid/Medicare enrollees, with nearly 1 in 6 enrollees completing fecal testing.

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

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach.

BACKGROUND & AIMS: Mailing fecal immunochemical test (FITs) to individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening. Little is known about how phone-based advance notifications (primers) affect the effectiveness of mailed FIT outreach programs. METHODS: We performed a prospective study of patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT. Participants were randomly assigned to groups that received a live phone call primer (n = 1203) or a text message primer (n = 1622), from June through December 2018. The participants were then mailed a FIT kit, followed by 2 automated calls, and live reminder calls delivered by the care team. The main outcome was completion of FIT within 3 months of assignment to the live phone call or text message group. RESULTS: Participants had a FIT completion rate of 16.8%, a mean age of 58 years, and 80% were Latino. In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%). Between-group differences increased to 7.3% points (95% CI, 3.6%-11.0%) in the per-protocol analysis of 2144 participants reached by the text message (1320/1622, 81%), live call (438/1203, 36%), or voice message (386/1203, 32%). This rate increased to 14.9% points (95% CI; 9.6%-20.1%) in the per-protocol analysis of 1758 participants reached by the text message or reached by the live call. CONCLUSIONS: In a randomized trial, advance notification live phone calls outperformed text messages in prompting health center patients who had not previously completed a FIT to complete a mailed FIT. Clinicaltrials.gov no: NCT03167125.

The influence of multi-morbidities on colorectal cancer screening recommendations and completion.

PURPOSE: Patients' chronic disease burden can influence the likelihood that providers will recommend cancer screening and that patients will participate in it. Using data from the STOP CRC pragmatic study, we examined associations between chronic disease burden and colorectal cancer screening recommendation and use. METHODS: Participating STOP CRC clinics (n = 26) received either usual care or training to implement a mailed fecal immunochemical test (FIT) outreach program. Selected clinic patients (n = 60,187 patients) were aged 50-74 and overdue for colorectal cancer screening. We used logistic regression to examine the associations between FIT recommendations and completion and patients' chronic disease burden, calculated using the Charlson Comorbidity Index and the Chronic Illness and Disability Payment System. RESULTS: For each index, FIT recommendation odds were 8-9% higher among individuals with minimal chronic disease burden and 13-23% lower among individuals with high chronic disease burden (inverted U-shaped association). Among adults who were ordered a FIT, FIT completion odds were 20% lower for individuals with any, versus no, chronic condition and diminished with increasing disease burden (inverse linear association). CONCLUSIONS: Analysis showed an inverted U-shaped association between patients' chronic disease burden and providers' recommendation of a FIT and an inverse linear association between patients' chronic disease burden and FIT completion. ClinicalTrials.gov registration: NCT01742065.

Follow-up colonoscopy after an abnormal stool-based colorectal cancer screening result: analysis of steps in the colonoscopy completion process.

BACKGROUND: Delays in receiving follow-up colonoscopy after an abnormal fecal immunochemical test (FIT) result are associated with increased colorectal cancer incidence and mortality. Little is known about patterns of follow-up colonoscopy completion in federally qualified health centers. METHODS: We abstracted the medical records of health center patients, aged 50-75 years, who had an abnormal FIT result between August 5, 2017 and August 4, 2018 (N = 711). We assessed one-year rates of colonoscopy referral, pre-procedure visit completion, colonoscopy completion, and time to colonoscopy; associations between these outcomes and patient characteristics; and reasons for non-completion found in the medical record. RESULTS: Of the 711 patients with an abnormal FIT result, 90% were referred to colonoscopy, but only 52% completed a pre-procedure visit, and 43% completed a colonoscopy within 1 year. Median time to colonoscopy was 83 days (interquartile range: 52-131 days). Pre-procedure visit and colonoscopy completion rates were relatively low in patients aged 65-75 (vs. 50-64), who were uninsured (vs. insured) or had no clinic visit in the prior year (vs. ≥ 1 clinic visit). Common reasons listed for non-completion were that the patient declined, or the provider could not reach the patient. DISCUSSION: Efforts to improve follow-up colonoscopy rates in health centers might focus on supporting the care transition from primary to specialty gastroenterology care and emphasize care for older uninsured patients and those having no recent clinic visits. Our findings can inform efforts to improve follow-up colonoscopy uptake, reduce time to colonoscopy receipt, and save lives from colorectal cancer. TRIAL REGISTRATION: National Clinical Trial (NCT) Identifier: NCT03925883.

Direct-to-member mailed colorectal cancer screening outreach for Medicaid and Medicare enrollees: Implementation and effectiveness outcomes from the BeneFIT study.

BACKGROUND: Colorectal cancer screening uptake is low, particularly among individuals enrolled in Medicaid. To the authors' knowledge, little is known regarding the effectiveness of direct-to-member outreach by Medicaid health insurance plans to raise colorectal cancer screening use, nor how best to deliver such outreach. METHODS: BeneFIT is a hybrid implementation-effectiveness study of 2 program models that health plans developed for a mailed fecal immunochemical test (FIT) intervention. The programs differed with regard to whether they used a centralized approach (Health Plan Washington) or collaborated with health centers (Health Plan Oregon). The primary implementation outcome of the current study was the percentage of eligible enrollees to whom the plans delivered each intervention component. The primary effectiveness outcome was the rate of FIT completion within 6 months of mailing of the introductory letter. RESULTS: The health plans identified 12,000 eligible enrollees (8551 in Health Plan Washington and 3449 in Health Plan Oregon). Health Plan Washington mailed an introductory letter and FIT kit to 8551 enrollees (100%) and delivered a reminder call to 839 (10.3% of the 8132 attempted). Health Plan Oregon mailed an introductory letter, and a letter and FIT kit plus a reminder postcard to 2812 enrollees (81.5%) and 2650 enrollees (76.8%), respectively. FIT completion rates were 18.2% (1557 of 8551 enrollees) in Health Plan Washington. In Health Plan Oregon, completion rates were 17.4% (488 of 2812 enrollees) among enrollees who were mailed an introductory letter and 18.3% (484 of 2650 enrollees) among enrollees who also were mailed a FIT kit plus reminder postcard. CONCLUSIONS: The implementation of mailed FIT outreach by health plans may be effective and could reach many individuals at risk of developing colorectal cancer.

Factors Influencing Implementation of a Colorectal Cancer Screening Improvement Program in Community Health Centers: an Applied Use of Configurational Comparative Methods.

BACKGROUND: Evidence-based programs such as mailed fecal immunochemical test (FIT) outreach can only affect health outcomes if they can be successfully implemented. However, attempts to implement programs are often limited by organizational-level factors. OBJECTIVES: As part of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) pragmatic trial, we evaluated how organizational factors impacted the extent to which health centers implemented a mailed FIT outreach program. DESIGN: Eight health centers participated in STOP CRC. The intervention consisted of customized electronic health record tools and clinical staff training to facilitate mailing of an introduction letter, FIT kit, and reminder letter. Health centers had flexibility in how they delivered the program. MAIN MEASURES: We categorized the health centers' level of implementation based on the proportion of eligible patients who were mailed a FIT kit, and applied configurational comparative methods to identify combinations of relevant organizational-level and program-level factors that distinguished among high, medium, and low implementing health centers. The factors were categorized according to the Consolidated Framework for Implementation Research model. KEY RESULTS: FIT tests were mailed to 21.0-81.7% of eligible participants at each health center. We identified a two-factor solution that distinguished among levels of implementation with 100% consistency and 100% coverage. The factors were having a centralized implementation team (inner setting) and mailing the introduction letter in advance of the FIT kit (intervention characteristics). Health centers with high levels of implementation had the joint presence of both factors. In health centers with medium levels of implementation, only one factor was present. Health centers with low levels of implementation had neither factor present. CONCLUSIONS: Full implementation of the STOP CRC intervention relied on a centralized implementation team with dedicated staffing time, and the advance mailing of an introduction letter. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01742065 Registered 05 December 2012-Prospectively registered.

Development of a multivariable prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test in community clinics.

BACKGROUND: Colorectal cancer (CRC) is the 3rd leading cancer killer among men and women in the US. The Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) project aimed to increase CRC screening among patients in Federally Qualified Health Centers (FQHCs) through a mailed fecal immunochemical test (FIT) outreach program. However, rates of completion of the follow-up colonoscopy following an abnormal FIT remain low. We developed a multivariable prediction model using data available in the electronic health record to assess the probability of patients obtaining a colonoscopy following an abnormal FIT test. METHODS: To assess the probability of obtaining a colonoscopy, we used Cox regression to develop a risk prediction model among a retrospective cohort of patients with an abnormal FIT result. RESULTS: Of 1596 patients with an abnormal FIT result, 556 (34.8%) had a recorded colonoscopy within 6 months. The model shows an adequate separation of patients across risk levels for non-adherence to follow-up colonoscopy (bootstrap-corrected C-statistic > 0.63). The refined model included 8 variables: age, race, insurance, GINI income inequality, long-term anticoagulant use, receipt of a flu vaccine in the past year, frequency of missed clinic appointments, and clinic site. The probability of obtaining a follow-up colonoscopy within 6 months varied across quintiles; patients in the lowest quintile had an estimated 18% chance, whereas patients in the top quintile had a greater than 55% chance of obtaining a follow-up colonoscopy. CONCLUSIONS: Knowing who is unlikely to follow-up on an abnormal FIT test could help identify patients who need an early intervention aimed at completing a follow-up colonoscopy. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov ( NCT01742065 ) on December 5, 2012. The protocol is available.

First-year implementation of mailed FIT colorectal cancer screening programs in two Medicaid/Medicare health insurance plans: qualitative learnings from health plan quality improvement staff and leaders.

BACKGROUND: Colorectal cancer screening rates remain low, especially among certain racial and ethnic groups and the uninsured and Medicaid insured. Clinics and health care systems have adopted population-based mailed fecal immunochemical testing (FIT) programs to increase screening, and now health insurance plans are beginning to implement mailed FIT programs. We report on challenges to and successes of mailed FIT programs during their first year of implementation in two health plans serving Medicaid and dual eligible Medicaid/Medicare enrollees. METHODS: This qualitative descriptive study gathered data through in-depth interviews with staff and leaders at each health plan (n = 10). The Consolidated Framework for Implementation Research, field notes from program planning meetings between the research team and the health plans, and internal research team debriefs informed interview guide development. Qualitative research staff used Atlas.ti to code the health plan interviews and develop summary themes through an iterative content analysis approach. RESULTS: We identified first-year implementation challenges in five thematic areas: 1) program design, 2) vendor experience, 3) engagement/communication, 4) reaction/satisfaction of stakeholders, and 5) processing/returning of mailed kits. Commonly experienced challenges by both health plans related to the time-consuming nature of the programs to set up, and complexities and delays in working with vendors. We found implementation successes in the same five thematic areas as well as four additional areas of: 1) leadership support, 2) compatibility with the health plan, 3) broader impacts, and 4) collaboration with researchers. Commonly experienced successes included the ability to adapt the mailed FIT program to the individual health plan culture and needs, and the synchronicity between the programs and their organizational missions and goals. CONCLUSIONS: Both health plans successfully adapted mailed FIT programs to their own culture and resources and used their strong quality management resources to maximize success in overcoming the time demands of setting up the program and working with their vendors. Mailed FIT programs administered by health plans, especially those serving Medicaid- and dual eligible Medicaid/Medicare-insured populations, may be an important resource to support closing gaps in colorectal cancer screening among traditionally underserved populations.

Factors Affecting Adherence in a Pragmatic Trial of Annual Fecal Immunochemical Testing for Colorectal Cancer.

BACKGROUND: Colorectal cancer screening by fecal immunochemical test (FIT) reduces the burden of colorectal cancer. However, effectiveness relies on annual adherence, which presents challenges for clinic staff and patients. OBJECTIVE: Describe FIT return rates and identify factors associated with FIT adherence over 2 years in a mailed FIT outreach program in federally qualified health centers. DESIGN: Observational study nested in the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) trial. Five thousand one hundred ninety-five patients had an initial FIT order and were followed for ≥ 2 years (3574 also had a FIT order in the second year). MAIN MEASURES: FIT return percent in each year and patient- and neighborhood-level characteristics associated with FIT adherence. KEY RESULTS: Overall, the proportion of FIT orders that were completed was 46% in the patients' first year and 41% in the patients' second year. Of the 5195 patients with a FIT order in year 1, 3574 (69%) also had a FIT order in year 2 (71% of year 1 adherers and 67% of year 1 non-adherers, p = 0.009). Among those with a FIT order in the second year, the FIT return rate was about twice as high among those who were adherent in the first year (952/1674, or 57%) as among those who were not (531/1900, or 28%, p < 0.0001). Patient-level characteristics associated with higher odds of FIT return were a history of FIT screening at baseline, age over 65 (vs 50-65), no current tobacco use, recent receipt of a mammogram or flu vaccine, Asian ancestry (compared to non-Hispanic white), and non-English preference. The only neighborhood factor associated with lower FIT return rate was patient's larger residential city size. CONCLUSION: Our findings can inform the customization of programs to promote FIT return among patients who receive care at federally qualified health centers. TRIAL REGISTRATION: http://www.clinicaltrials.gov.

A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics.

STOP CRC is a cluster-randomized pragmatic study of a colorectal cancer (CRC) screening program within eight federally-qualified health centers (FQHCs) in Oregon and California promoting fecal immunochemical testing (FIT) with appropriate colonoscopy follow-up. Results are presented of a cost-effectiveness analysis of STOP CRC. Organization staff completed activity-based costing spreadsheets, assigning labor hours by intervention activity and job-specific wage rates. Non-labor costs were from study data. Data were collected over February 2014-February 2016; analyses were performed in 2016-2017. Incremental cost-effectiveness ratios (ICERs) using completed FITs adjusted for number of screening-eligible patients (SEPs), as the effectiveness measure were calculated overall and by organization. Intervention delivery costs totaled $305 K across eight organizations (range: $10.2 K-$110 K). Overall delivery cost per SEP was $14.43 (range: $10.37-$19.10). The largest cost category across organizations was implementation, specifically mailing preparation. The overall ICER was $483 per SEP-adjusted completed FIT (range: $96-$1021 among organizations with positive effectiveness). Lagged data accounting for implementation delay produced comparable results. The costs of colonoscopies following abnormal FITs decreased the overall ICER to S409 because usual care clinics generated more such colonoscopies than intervention clinics. Using lagged data, follow-up colonoscopies increase the ICER by 4.3% to $460. Results indicate the complex implications for cost-effectiveness of implementing standard CRC screening within a pragmatic setting involving FQHCs with varied patient populations, clinical structures, and resources. Performance variation across organizations emphasizes the need for future evaluations that inform the introduction of efficient CRC screening to underserved populations.

Effect of Reminding Patients to Complete Fecal Immunochemical Testing: A Comparative Effectiveness Study of Automated and Live Approaches.

BACKGROUND: The Community Preventive Services Task Force recommends multi-component interventions, including patient reminders, to improve uptake of colorectal cancer screening. OBJECTIVE: We sought to compare the effectiveness of different forms of reminders for a direct-mail fecal immunochemical test (FIT) program. DESIGN: Patient-randomized controlled trial. PARTICIPANTS: 2772 adults aged 50-75, not up to date with colorectal cancer screening recommendations, with a clinic visit in the previous year at any of four participating health center clinics. INTERVENTION: Participants were mailed an introductory letter and FIT. Those who did not complete their FIT within 3 weeks were randomized to receive (1) a reminder letter, (2) two automated phone calls, (3) two text messages, (4) a live phone call, (5) a reminder letter and a live phone call, (6) two automated phone calls and a live phone call, or (7) two text messages and a live phone call. Patients with a patient portal account were sent two email reminders, but were not randomized. MAIN MEASURES: FIT return rates for each group, 6 months following randomization. KEY RESULTS: A total of 255 (10%) participants returned their FIT within 3 weeks of the mailing. Among randomized participants (n = 2010), an additional 25.5% returned their FITs after reminders were delivered (estimated overall return rate = 32.7%). In intention-to-treat analysis, compared to the group allocated to receive a reminder letter, return rates were higher for the group assigned to receive the live phone call (OR = 1.51 [1.03-2.21]) and lower for the group assigned to receive text messages (OR = 0.66 [0.43-0.99]). Reminder effectiveness differed by language preference. CONCLUSIONS: Our data suggest that FIT reminders that included a live call were more effective than reminders that relied solely on written communication (a text message or letter). TRIAL REGISTRATION: ClinicalTrials.gov/ctc2/show/NCT01742065 .

Predictors of Colorectal Cancer Screening Prior to Implementation of a Large Pragmatic Trial in Federally Qualified Health Centers.

Colorectal cancer screening can prevent cancer deaths. Federally qualified health centers serve a unique patient population that often is not screened. Knowing who in this environment is getting screened via fecal testing and via colonoscopy can assist in tailoring intervention to raise rates of colorectal cancer screening. We examined patient-level and neighborhood-level characteristics associated with being up to date with colorectal cancer screening guidelines. We also examined associations between these factors and being screened with a fecal test. We observed an increase in colorectal cancer screening rates from 2010 to 2015. Adjusted analyses revealed that the following factors were significantly associated with colorectal cancer screening: aged 65 or older, having any type of insurance, previous outpatient visits, and current or other preventive screenings. Among adults aged 50-75 who were up to date with colorectal cancer screening, factors associated with use of fecal testing, as opposed to colonoscopy, were: being younger, speaking a non-English language, being uninsured, having prior office visits, and having had a flu shot in past year. Our findings may inform clinic-based effort to raise rates of colorectal cancer screening, especially in the community clinic setting. TRIAL REGISTRATION: ClinicalTrials.gov , NCT01742065.

Applying the Plan-Do-Study-Act (PDSA) approach to a large pragmatic study involving safety net clinics.

BACKGROUND: The Plan-Do-Study-Act (PDSA) cycle is a commonly used improvement process in health care settings, although its documented use in pragmatic clinical research is rare. A recent pragmatic clinical research study, called the Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), used this process to optimize the research implementation of an automated colon cancer screening outreach program in intervention clinics. We describe the process of using this PDSA approach, the selection of PDSA topics by clinic leaders, and project leaders' reactions to using PDSA in pragmatic research. METHODS: STOP CRC is a cluster-randomized pragmatic study that aims to test the effectiveness of a direct-mail fecal immunochemical testing (FIT) program involving eight Federally Qualified Health Centers in Oregon and California. We and a practice improvement specialist trained in the PDSA process delivered structured presentations to leaders of these centers; the presentations addressed how to apply the PDSA process to improve implementation of a mailed outreach program offering colorectal cancer screening through FIT tests. Center leaders submitted PDSA plans and delivered reports via webinar at quarterly meetings of the project's advisory board. Project staff conducted one-on-one, 45-min interviews with project leads from each health center to assess the reaction to and value of the PDSA process in supporting the implementation of STOP CRC. RESULTS: Clinic-selected PDSA activities included refining the intervention staffing model, improving outreach materials, and changing workflow steps. Common benefits of using PDSA cycles in pragmatic research were that it provided a structure for staff to focus on improving the program and it allowed staff to test the change they wanted to see. A commonly reported challenge was measuring the success of the PDSA process with the available electronic medical record tools. CONCLUSION: Understanding how the PDSA process can be applied to pragmatic trials and the reaction of clinic staff to their use may help clinics integrate evidence-based interventions into their everyday care processes. TRIAL REGISTRATION: Clinicaltrials.gov NCT01742065 . Registered October 31, 2013.

The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics.

BACKGROUND: While electronic health records (EHRs) play a key role in increasing colorectal cancer (CRC) screening by identifying individuals who are overdue, important shortfalls remain. OBJECTIVES: As part of the Strategies and Opportunities to STOP Colon Cancer (STOP CRC) study, we assessed the accuracy of EHR codes in identifying patients eligible for CRC screening. METHODS: We selected a stratified random sample of 800 study participants from 26 participating clinics, in the Pacific Northwest region of the USA. We compared data obtained through codes in the EHR to conduct a manual chart audit. A trained chart abstractor completed the abstraction of eligible and ineligible patients. RESULTS: Of 520 individuals in need of CRC screening, identified via the EHR, 459 were confirmed through chart review (positive predictive value = 88%). Of 280 individuals flagged as up-to-date in their screening per EHR data, 269 were confirmed through chart review (negative predictive value = 96%). Among the 61 patients incorrectly classified as eligible, 83.6% of disagreements were due to evidence of a prior colonoscopy or referral that was not captured in recognizable fields in the EHR. CONCLUSIONS: Our findings highlight importance of better capture of past screening events in the EHR. While the need for better population-based data is not unique to CRC screening, it provides an important example of the use of population-based data not only for tracking care, but also for delivering interventions.

Timeliness of Colonoscopy After Abnormal Fecal Test Results in a Safety Net Practice.

Fecal testing can only reduce colorectal cancer mortality if patients with an abnormal test result receive a follow-up colonoscopy. As part of the Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) project, we examined factors associated with adherence to follow-up colonoscopy among patients with abnormal fecal test results. As part of STOP CRC outreach, Virginia Garcia Memorial Health Center staff distributed 1753 fecal immunochemical tests (FIT), of which 677 (39 %) were completed, and 56 had an abnormal result (8 %). Project staff used logistic regression analyses to examine factors associated with colonoscopy referral and completion. Of the 56 patients with abnormal FIT results; 45 (80 %) had evidence of a referral for colonoscopy, 32 (57 %) had evidence of a completed colonoscopy within 18 months, and 14 (25 %) within 60 days of an abnormal fecal test result. In adjusted analysis, Hispanics had lower odds of completing follow-up colonoscopy within 60 days than non-Hispanic whites (adjusted OR 0.20; 95 % CI 0.04, 0.92). Colonoscopy within 60 days trended lower for women than for men (adjusted OR 0.25; 95 % CI 0.06-1.04). Among the 24 patients lacking medical record evidence of a colonoscopy, 19 (79 %) had a documented reason, including clinician did not pursue, patient refused, and colonoscopy not indicated. No reason was found for 21 %. Improvements are needed to increase rates of follow-up colonoscopy completion, especially among female and Hispanic patients.

Individuality of the plasma sodium concentration.

Older literature has suggested that the plasma sodium concentration is not individual, that it is neither intrinsic to an individual nor reproducible, longitudinally. We recently observed that the plasma sodium concentration is heritable. Because demonstrable heritability requires individuality of the relevant phenotype, we hypothesized that the plasma sodium concentration was substantially individual. In two large health plan-based cohorts, we demonstrated individuality of the plasma sodium concentration over a 10-yr interval; the intraclass correlation coefficient (ICC) averaged 0.4-0.5. The individuality of plasma sodium increased significantly with age. Plasma sodium individuality was equal to or only slightly less than that for plasma glucose but was less than the individuality for creatinine. The individuality of plasma sodium was further confirmed by comparing the Pearson correlation coefficient for within-individual versus between-individual pairs of sodium determinations and via application of the agreement index. Furthermore, the distribution of all sodium determinations for all participants within a population was similar to the distribution for the mean sodium concentration for individuals within that population. Therefore, the near-normal distribution of plasma sodium measurements within a population is likely not attributable to assay-specific factors but rather to genuine and durable biological variability in the osmotic set point. In aggregate, these data strongly support the individuality of the plasma sodium concentration. They further indicate that serial plasma sodium values for any given individual tend to cluster around a patient-specific set point and that these set points vary among individuals.

Strategies and opportunities to STOP colon cancer in priority populations: pragmatic pilot study design and outcomes.

BACKGROUND: Colorectal-cancer is a leading cause of cancer death in the United States, and Latinos have particularly low rates of screening. Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) is a partnership among two research institutions and a network of safety net clinics to promote colorectal cancer screening among populations served by these clinics. This paper reports on results of a pilot study conducted in a safety net organization that serves primarily Latinos. METHODS: The study assessed two clinic-based approaches to raise rates of colorectal-cancer screening among selected age-eligible patients not up-to-date with colorectal-cancer screening guidelines. One clinic each was assigned to: (1) an automated data-driven Electronic Health Record (EHR)-embedded program for mailing Fecal Immunochemical Test (FIT) kits (Auto Intervention); or (2) a higher-intensity program consisting of a mailed FIT kit plus linguistically and culturally tailored interventions delivered at the clinic level (Auto Plus Intervention). A third clinic within the safety-net organization was selected to serve as a passive control (Usual Care). Two simple measurements of feasibility were: 1) ability to use real-time EHR data to identify patients eligible for each intervention step, and 2) ability to offer affordable testing and follow-up care for uninsured patients. RESULTS: The study was successful at both measurements of feasibility. A total of 112 patients in the Auto clinic and 101 in the Auto Plus clinic met study inclusion criteria and were mailed an introductory letter. Reach was high for the mailed component (92.5% of kits were successfully mailed), and moderate for the telephone component (53% of calls were successful completed). After exclusions for invalid address and other factors, 206 (109 in the Auto clinic and 97 in the Auto Plus clinic) were mailed a FIT kit. At 6 months, fecal test completion rates were higher in the Auto (39.3%) and Auto Plus (36.6%) clinics compared to the usual-care clinic (1.1%). CONCLUSIONS: Findings showed that the trial interventions delivered in a safety-net setting were both feasible and raised rates of colorectal-cancer screening, compared to usual care. Findings from this pilot will inform a larger pragmatic study involving multiple clinics. TRIAL REGISTRATION: ClinicalTrial.gov: NCT01742065.

Advantages of wordless instructions on how to complete a fecal immunochemical test: lessons from patient advisory council members of a federally qualified health center.

Some patients face difficulty understanding instructions for completing the fecal immunochemical test (FIT), a self-administered test to screen for colorectal cancer. We sought to develop and test low-literacy instructions for completing the FIT. Working in partnership with a Latino-serving Federally Qualified Health Center (FQHC) in the Portland Metro area, we developed and tested low-literacy instructions for completing the FIT; the instructions contained seven words (mail within 3 days; Devolver dentro de 3 dias). We conducted focus groups of Spanish-speaking patients on the advisory council of our partnering FQHC organization, and we gathered feedback from the project's advisory board members and clinic staff. We mailed a FIT kit to each patient, along with either (a) instructions written in English and Spanish, consisting of 415 words; or (b) low-literacy "wordless" instructions. We asked patients to complete the test before providing feedback. Our qualitative assessment showed that the wordless instructions were preferred over instructions consisting of words. Wordless instructions might aid efforts to raise the rates of colorectal cancer screening among low-literacy and non-English-speaking populations.

The recalibration and redevelopment of a model to calculate patients' probability of completing a colonoscopy following an abnormal fecal test.

OBJECTIVES: Fecal immunochemical testing (FIT) is an effective screening tool for colorectal cancer. If an FIT is abnormal, a follow-up colonoscopy is necessary to remove polyps or find cancers. We sought to develop a usable risk prediction model to identify patients unlikely to complete a colonoscopy following an abnormal FIT test. METHODS: We recalibrated and then redeveloped a prediction model in federally qualified health centers (FQHCs), using a retrospective cohort of patients aged 50-75 with an abnormal FIT test and clinical data. Logistic and Cox regressions were used to recalibrate and then redevelop the model. RESULTS: The initial risk model used data from eight FQHCs (26 clinics) including 1723 patients. When we applied the model to a single large FQHC (34 clinics, 884 eligible patients), the model did not recalibrate successfully (c-statistic dropped more than 0.05, from 0.66 to 0.61). The model was redeveloped in the same FQHC in a cohort of 1401 patients with a c-statistic of 0.65. CONCLUSIONS: The original model developed in a group of FQHCs did not adequately recalibrate in the single large FQHC. Health system, patient characteristics or data differences may have led to the inability to recalibrate the model. However, the redeveloped model provides an adequate model for the single FQHC.