Evaluating the Reach of a Patient Navigation Program for Follow-up Colonoscopy in a Large Federally Qualified Health Center.

Patient navigation (PN) has been shown to improve participation in cancer screening, including colorectal cancer screening, and the Community Preventive Services Task Force now recommends the practice. Despite the effectiveness of PN programs, little is known about the number of contacts needed to successfully reach patients or about the demographic and healthcare utilization factors associated with reach. PRECISE was an individual randomized study of PN vs. usual care conducted as a partnership between two large health systems in the Pacific Northwest. The navigation program was a six topic-area telephonic program designed to support patients with an abnormal fecal test result to obtain a follow-up colonoscopy. We report the number of contact attempts needed to successfully reach navigated patients. We used logistic regression to report the demographic and healthcare utilization characteristics associated with patients allocated to PN who were successfully reached. We identified 1200 patients with an abnormal FIT result, among whom 970 were randomized into the study (45.7% were female, 17.5% were Spanish-speaking, mean age was 60.8). Of the 479 patients allocated to the PN intervention, 382 (79.7%) were reached within 18 call attempts and nearly all (n = 356; 93.2%) were reached within six contact attempts. Patient characteristics associated with reach were race, county of residence, and body mass index. Our findings can guide future efforts to optimize the reach of PN programs.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: Text messages reached the most patients, yet effectiveness was highest in those who personally answered the live phone call. IMPACT: Despite the broad reach and low cost of text messages, personalized approaches may more successfully boost FIT completion.

Developing Patient-Refined Messaging for Follow-Up Colonoscopy After Abnormal Fecal Testing in Hispanic Communities: Key Learnings from Virtual Boot Camp Translation.

Colorectal cancer (CRC) is a leading cause of cancer death in the US. Screening by fecal immunochemical test (FIT) is a strategy to lower CRC rates. Unfortunately, only half of patients with an abnormal FIT result complete the follow-up colonoscopy, an essential component of screening. We used virtual Boot Camp Translation (BCT), to elicit input from partners to develop messaging/materials to motivate patients to complete a follow-up colonoscopy. Participants were Hispanic, ages 50 to 75 years, and Spanish-speaking. All materials were developed in English and Spanish. The first meeting included expert presentations that addressed colorectal health. The two follow-up sessions obtained feedback on messaging/materials developed based on themes from the first meeting. Ten participants attended the first meeting and eight attended the follow-up sessions. The two key barriers to follow-up colonoscopy after abnormal FIT noted by participants were (a) lack of colonoscopy awareness and (b) fear of the colonoscopy procedure. We learned that participants valued simple messaging to increase knowledge and alleviate concerns, patient-friendly outreach materials, and increased access to health information. Using virtual BCT, we included participant feedback to design culturally relevant health messages to promote follow-up colonoscopy after abnormal fecal testing among Hispanic patients served by community clinics.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. IMPACT: 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.

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.

Developing patient-refined colorectal cancer screening materials: application of a virtual community engagement approach.

INTRODUCTION: In partnership with a federally qualified health center (FQHC), an adapted virtual version of boot camp translation (BCT) was used to elicit input from Spanish-speaking Latino patients and staff to develop messaging and patient education materials for follow-up colonoscopy after abnormal fecal testing. We describe how we adapted an existing in-person BCT process to be delivered virtually and present evaluations from participants on the virtual format. METHODS: Three virtual BCT sessions were facilitated by bilingual staff and conducted via Zoom. These sessions included introductions and discussions on colorectal cancer (CRC), CRC screening, and gathered feedback from participants on draft materials. Ten adults were recruited from the FQHC. A research team member from the FQHC served as the point of contact (POC) for all participants and offered Zoom introductory sessions and/or technology support before and during the sessions. Following the third session, participants were invited to complete an evaluation form about their virtual BCT experience. Using a 5-point Likert Scale (where 5 = strongly agree), questions focused on session utility, group comfort level, session pacing, and overall sense of accomplishment. RESULTS: Average scores ranged from 4.3 to 5.0 indicating strong support towards the virtual BCT sessions. Additionally, our study emphasized the importance of a POC to provide technical support to participants throughout the process. Using this approach, we successfully incorporated feedback from participants to design culturally relevant materials to promote follow-up colonoscopy. CONCLUSION: We recommend ongoing public health emphasis on the use of virtual platforms for community engaged work.

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative.

BACKGROUND: Although patient navigation has shown promise for increasing participation in colorectal cancer screening and follow-up, little evidence is available to guide implementation of patient navigation in clinical practice. We characterize 8 patient navigation programs being implemented as part of multi-component interventions of the National Cancer Institute's Cancer Moonshot Accelerating Colorectal Cancer Screening and Follow-Up Through Implementation Science (ACCSIS) initiative. METHODS: We developed a data collection template organized by ACCSIS framework domains. The template was populated by a representative from each of the 8 ACCSIS research projects. We report standardized descriptions of 1) the socio-ecological context in which the navigation program was being conducted, 2) navigation program characteristics, 3) activities undertaken to facilitate program implementation (eg, training), and 4) outcomes used in program evaluation. RESULTS: ACCSIS patient navigation programs varied broadly in their socio-ecological context and settings, the populations they served, and how they were implemented in practice. Six research projects adapted and implemented evidence-based patient navigation programs; the remaining projects developed new programs. Five projects began navigation when patients were due for initial colorectal cancer screening; 3 projects began navigation later in the screening process, when patients were due for follow-up colonoscopy after an abnormal stool-test result. Seven projects relied on existing clinical staff to deliver the navigation; 1 hired a centralized research navigator. All project researchers plan to evaluate the effectiveness and implementation of their programs. CONCLUSIONS: Our detailed program descriptions may facilitate cross-project comparisons and guide future implementation and evaluation of patient navigation programs in clinical practice.

Colonoscopy Following an Abnormal Fecal Test Result from an Annual Colorectal Cancer Screening Program in a Federally Qualified Health Center.

OBJECTIVE: Individuals with an abnormal fecal immunochemical test (FIT) result have an elevated risk of colorectal cancer, and the risk increases if the follow-up colonoscopy is delayed. Of note, rates of follow-up colonoscopy are alarmingly low in federally qualified health centers (FQHCs), US health care settings that serve a majority racial and ethnic minority patient population. We assessed factors associated with colonoscopy after an abnormal FIT result and used chart-abstracted data to assess reasons (including process measures) for lack of follow-up as part of an annual, mailed-FIT outreach program within a large, Latino-serving FQHC. METHODS: As part of the National Institutes of Health-funded PROMPT study, we identified patients with an abnormal FIT result and used logistic regression to assess associations between patient demographics and receipt of follow-up colonoscopy, controlling for patients' preferred language. We report on time (days) to referral and time to colonoscopy. For charts with an abnormal FIT result but no evidence of colonoscopy, we performed a manual abstraction and obtained the reason for the absence of colonoscopy. When there was no evidence of colonoscopy in a patient's electronic health record (EHR), we performed an automated query of the administrative claims database to identify colonoscopy outcomes. RESULTS: We identified 324 patients with abnormal FIT results from July to October 2018. These patients were mostly publicly insured (Medicaid 53.1%, Medicare 14.5%), 81.8% were aged 50 to 64 years, 55.3% were female, 80.3% were Hispanic/Latino, and 67.3% preferred to speak Spanish. We found that 108/324 (33.3%) patients completed colonoscopy within 12 months, and the median time to colonoscopy was 94 days (IQR: 68-176). Common barriers to colonoscopy completion, obtained from chart-abstracted data, were: no documentation following referral to gastrointestinal (GI) specialist or GI consultation (41.6%), no referral to GI specialist following abnormal fecal test (34.2%), and absence of a valid insurance authorization (6.5%). CONCLUSIONS: Multi-level strategies are needed to provide optimal care across the cancer continuum for FQHC patients. In order to reduce the risk of CRC and realize the return on fecal testing investment, concerted system-level efforts are urgently needed to improve rates of follow-up colonoscopy among FQHC patients and redress racial and ethnic disparities in CRC screening outcomes.

Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial.

BACKGROUND: Screening reduces incidence and mortality from colorectal cancer (CRC), yet US screening rates are low, particularly among Medicaid enrollees in rural communities. We describe a two-phase project, SMARTER CRC, designed to achieve the National Cancer Institute Cancer MoonshotSM objectives by reducing the burden of CRC on the US population. Specifically, SMARTER CRC aims to test the implementation, effectiveness, and maintenance of a mailed fecal test and patient navigation program to improve rates of CRC screening, follow-up colonoscopy, and referral to care in clinics serving rural Medicaid enrollees. METHODS: Phase I activities in SMARTER CRC include a two-arm cluster-randomized controlled trial of a mailed fecal test and patient navigation program involving three Medicaid health plans and 30 rural primary care practices in Oregon and Idaho; the implementation of the program is supported by training and practice facilitation. Participating clinic units were randomized 1:1 into the intervention or usual care. The intervention combines (1) mailed fecal testing outreach supported by clinics, health plans, and vendors and (2) patient navigation for colonoscopy following an abnormal fecal test result. We will evaluate the effectiveness, implementation, and maintenance of the intervention and track adaptations to the intervention and to implementation strategies, using quantitative and qualitative methods. Our primary effectiveness outcome is receipt of any CRC screening within 6 months of enrollee identification. Our primary implementation outcome is health plan- and clinic-level rates of program delivery, by component (mailed FIT and patient navigation). Trial results will inform phase II activities to scale up the program through partnerships with health plans, primary care clinics, and regional and national organizations that serve rural primary care clinics; scale-up will include webinars, train-the-trainer workshops, and collaborative learning activities. DISCUSSION: This study will test the implementation, effectiveness, and scale-up of a multi-component mailed fecal testing and patient navigation program to improve CRC screening rates in rural Medicaid enrollees. Our findings may inform approaches for adapting and scaling evidence-based approaches to promote CRC screening participation in underserved populations and settings. TRIAL REGISTRATION: Registered at clinicaltrial.gov ( NCT04890054 ) and at the NCI's Clinical Trials Reporting Program (CTRP #: NCI-2021-01032) on May 11, 2021.

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.

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.

Physician adjudication of angioedema diagnosis codes in a population of patients with heart failure prescribed angiotensin-converting enzyme inhibitor therapy.

PURPOSE: Our objective was to calculate the positive predictive value (PPV) of the ICD-9 diagnosis code for angioedema when physicians adjudicate the events by electronic health record review. Our secondary objective was to evaluate the inter-rater reliability of physician adjudication. METHODS: Patients from the Cardiovascular Research Network previously diagnosed with heart failure who were started on angiotensin-converting enzyme inhibitors (ACEI) during the study period (July 1, 2006 through September 30, 2015) were included. A team of two physicians per participating site adjudicated possible events using electronic health records for all patients coded for angioedema for a total of five sites. The PPV was calculated as the number of physician-adjudicated cases divided by all cases with the diagnosis code of angioedema (ICD-9-CM code 995.1) meeting the inclusion criteria. The inter-rater reliability of physician teams, or kappa statistic, was also calculated. RESULTS: There were 38 061 adults with heart failure initiating ACEI in the study (21 489 patient-years). Of 114 coded events that were adjudicated by physicians, 98 angioedema events were confirmed for a PPV of 86% (95% CI: 80%, 92%). The kappa statistic based on physician inter-rater reliability was 0.65 (95% CI: 0.47, 0.82). CONCLUSIONS: ICD-9 diagnosis code of 995.1 (angioneurotic edema, not elsewhere classified) is highly predictive of angioedema in adults with heart failure exposed to ACEI.

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.

Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers.

BACKGROUND: Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own. OBJECTIVES: The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention). METHODS: PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum. DISCUSSION: This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. TRIAL REGISTRATION: National Clinical Trial (NCT) Identifier: NCT03925883.

A Survey of Provider Attitudes, Beliefs, and Perceived Barriers Regarding a Centralized Direct-Mail Colorectal Cancer Screening Approach at Community Health Centers.

Background: Colorectal cancer screening (CRC) rates are low, particularly among individuals with low socioeconomic status. Organized CRC screening programs have demonstrated success in increasing screening rates. Little is known about provider attitudes, beliefs, and practices related to CRC screening or how they are influenced by an organized CRC screening program. Methods: In 2014 and 2016, providers from 26 safety net clinics in Oregon and Northern California were invited to complete baseline and follow-up online surveys for the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study. The provider survey link was sent electronically to primary care providers serving adult patients. Providers were sent reminders every 2 weeks via email to complete the survey, up to 3 reminders total. In this article, we describe learnings about provider attitudes, beliefs, and practices related to CRC screening after implementation of the STOP CRC program. Results: A total of 166 unique providers completed baseline and/or follow-up surveys, representing 228 responses. Main themes included (1) favorable shifts in attitude toward fecal immunochemical test (FIT) and direct-mail cancer screening programs, (2) changes in provider perception of key barriers, and (3) growing interest in centralized automated systems for identifying patients due for CRC screening and eligible for population-based outreach. Discussion: Providers are interested in improved information systems for identifying patients due for CRC screening and delivering population-based outreach (ie, to distribute FIT kits outside of the clinic visit) to help reduce health system- and patient-level barriers to screening. Trial Registration: National Clinical Trial (NCT) Identifier NCT01742065.

Developing Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program in a Latino-Based Community Health Center.

INTRODUCTION: Colon cancer is the second leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. One factor thought to contribute to the low screening rate is the difficulty Latinos encounter in understanding health information, and therefore in taking appropriate health action. Therefore, we used Boot Camp Translation (BCT), a patient engagement approach, to engage Latino stakeholders (ie, patients, clinic staff) in refining the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical testing (FIT) program. METHODS: Patient participants were Latino, ages 50 to 75 years, able to speak English or Spanish, and willing to participate in the in-person kickoff meeting and follow-up phone calls over a 3-month period. We held separate BCT sessions for English- and Spanish-speaking participants. As part of the in-person meetings, a bilingual colon cancer expert presented on colon health and screening messages and BCT facilitators led interactive sessions where participants reviewed materials and reminder messages in various modalities (eg, letter, text). Participants considered what information about colon cancer screening was important, the best methods to share these messages, and the timing and frequency with which these messages should be delivered to patients to encourage FIT completion. We used follow-up phone calls to iteratively refine materials developed based on key learnings from the in-person meeting. RESULTS: Twenty-five adults participated in the in-person sessions (English [n = 12]; Spanish [n = 13]). Patient participants were primarily enrolled in Medicaid/uninsured (76%) and had annual household incomes less than $20,000 (67%). Key themes distilled from the sessions included increasing awareness that screening can prevent colon cancer, stressing the urgency of screening, emphasizing the motivating influence of family, and using personalized messages from the practice such as 'I' or 'we' statements in letters or automated phone call reminders delivered by humans. Participants in both sessions noted the importance of receiving an automated or live alert before a FIT kit is mailed and a reminder within 2 weeks of FIT kit mailing. DISCUSSION: Using BCT, we successfully incorporated participant feedback to adapt culturally relevant health messages to promote FIT testing among Latino patients served by community clinics. Materials will be tested in the larger Participatory Research to Advance Colon Cancer Prevention (PROMPT) trial.

Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study.

BACKGROUND: Improving uptake of colorectal cancer screening has the potential of saving thousands of lives. We compared the effectiveness of automated and live prompts and reminders as part of a mailed fecal immunochemical test (FIT) outreach program. DESIGN AND METHODS: Participants were 1767 adults aged 50 to 75 eyars who were not up-to-date with colorectal cancer screening recommendations at a participating community health center clinic. In addition to a mailed FIT kit, participants were randomized to receive (1) a text message prompt and 2 automated phone call reminders (automated condition); (2) up to 3 live call reminders (live condition); or (3) a text message prompt, 2 automated call reminders, and up to 3 live reminders (combined automated plus live condition). We assessed FIT completion rates in each group 6 months following randomization. KEY RESULTS: Nearly one-third of participants completed an FIT within 6 months. Compared with adults allocated to the automated condition, FIT completion rates were higher in adults allocated to the live condition (32.3% vs 26.0%; adjusted difference, 6.3 percentage points; 95% CI, 1.1-11.4) and in adults allocated to the combined automated plus live condition (35.7% vs 26.0%; adjusted difference, 9.7 percentage points; 95% CI, 4.4-14.9). The number of kits needed to mail to achieve a completed FIT ranged from 2.8 in the combined automated plus live condition to 3.8 in the automated condition. CONCLUSIONS: Among unscreened individuals in this population, live phone call reminders either alone or in combination with automated prompts and reminders outperformed automated approaches alone.

Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial.

BACKGROUND: Colon cancer is the second leading cause of cancer deaths in the United States. The Participatory Research to Advance Colon Cancer Prevention (PROMPT) study is a collaboration between two research institutions and a federally qualified health center (FQHC). The study seeks to raise colon cancer screening rates using a direct-mail fecal immunochemical testing (FIT) and reminder program in an FQHC serving a predominantly Latino population in California. METHODS: PROMPT is a pragmatic trial enrolling 16 clinics. The study will test automated and live prompts (i.e., alerts, reminders) to a direct-mail FIT program in two phases. In Phase I, we tailored and defined intervention components for the pilot using a community-based participatory research approach called boot camp translation. We then plan to conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts, 2) live prompts, and 3) a combination of automated plus live prompts to alert and remind patients to complete screening. In Phase II, the adapted best practice intervention will be spread to additional clinics within the FQHC (estimated population 27,000) and assessed for effectiveness. Patient and staff interviews will be conducted to explore receptivity to the program and identify barriers to implementation. DISCUSSION: This pragmatic trial applies innovative approaches to engage diverse stakeholders and will test the effectiveness and spread of a direct-mail plus reminder program. If successful, the program will provide a model for a cost-effective method to raise colon cancer screening rates among Latino patients receiving care in FQHCs. TRIAL REGISTRATION: National Clinical Trial (NCT) Identifier NCT03167125.

Preeclampsia Screening: Evidence Report and Systematic Review for the US Preventive Services Task Force.

IMPORTANCE: Preeclampsia is a complex disease of pregnancy with sometimes serious effects on maternal and infant morbidity and mortality. It is defined by hypertension after 20 weeks' gestation and proteinuria or other evidence of multisystem involvement. OBJECTIVE: To systematically review the benefits and harms of preeclampsia screening and risk assessment for the US Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMed, and Cochrane Central Register of Controlled Trials databases from 1990 through September 1, 2015. Surveillance for new evidence in targeted publications was conducted through October 5, 2016. STUDY SELECTION: English-language trials and observational studies, including externally validated prediction models, of screening effectiveness, benefits, and harms from routine preeclampsia screening during pregnancy. DATA EXTRACTION AND SYNTHESIS: Independent dual review of article abstracts and full texts against a priori inclusion criteria. Meta-analysis was not performed because of clinical and statistical heterogeneity of included studies. MAIN OUTCOMES AND MEASURES: Maternal and infant health outcomes, including eclampsia, stroke, stillbirth, preterm birth, and low birth weight; screening and risk prediction test performance; harms of screening and risk assessment. RESULTS: Twenty-one studies (13 982 participants) were included. No studies directly compared the effectiveness of preeclampsia screening in a screened population vs an unscreened population; 1 US trial (n = 2764) found no difference in benefits or harms with fewer prenatal visits but was underpowered for rare, serious outcomes. For harms, a before-after comparison cohort noninferiority study of urine protein screening for specific indications compared with routine screening (n = 1952) did not identify harms with fewer urine screening tests. Four studies (n = 7123) reported external validation performance of 16 risk prediction models, 5 of which had good or better discrimination (c statistic >0.80) for prediction of preeclampsia, and positive predictive values of 4% in the largest, most applicable validation cohorts. Calibration was not reported despite being a key model performance measure. There were no studies of urine screening test performance conducted in asymptomatic primary care populations; 14 studies of protein urine test performance among women being evaluated for suspected preeclampsia (n = 1888) had wide-ranging test accuracy (sensitivity, 22%-100%; specificity, 36%-100%) and high statistical and clinical heterogeneity in tests used, eligibility criteria, and proteinuria prevalence (8.7%-93.8%). CONCLUSIONS AND RELEVANCE: Evidence to estimate benefits and harms of preeclampsia screening and the test performance of different screening approaches over the course of pregnancy was limited. Externally validated risk prediction models had limited applicability and lacked calibration and clinical implementation data needed to support routine use. Further research is needed to better inform risk-based screening approaches and improve screening strategies, given the complex pathophysiology and clinical unpredictability of preeclampsia.