BackgroundThe Community Preventive Services Task Force recommends multi-component interventions, including patient reminders, to improve uptake of colorectal cancer screening.ObjectiveWe sought to compare the effectiveness of different forms of reminders for a direct-mail fecal immunochemical test (FIT) program.DesignPatient-randomized controlled trial.Participants2772 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.InterventionParticipants 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 MeasuresFIT return rates for each group, 6 months following randomization.Key ResultsA 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.ConclusionsOur 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.

BackgroundThe 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.MethodsSTOP 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.ResultsClinic-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.ConclusionUnderstanding 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.

Little is known about the challenges faced by community clinics who must address clinical priorities first when participating in pragmatic studies. We report on implementation challenges faced by the eight community health centers that participated in Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), a large comparative effectiveness cluster-randomized trial to evaluate a directmail program to increase the rate of colorectal cancer (CRC) screening. We conducted interviews, at the onset of implementation and 1 year later, with center leaders to identify challenges with implementing and sustaining an electronic medical record (EMR)-driven mailed program to increase CRC screening rates. We used the Consolidated Framework for Implementation Research to thematically analyze the content of meeting discussions and identify anticipated and experienced challenges. Common early concerns were patients' access to colonoscopy, patients' low awareness of CRC screening, time burden on clinic staff to carry out the STOP CRC program, inability to accurately identify eligible patients, and incompatibility of the program's approach with the patient population or organizational culture. Once the program was rolled out, time burden remained a primary concern and new organizational capacity and EMR issues were raised (e.g., EMR staffing resources and turnover in key leadership positions). Cited program successes were improved CRC screening processes and rates, more patients reached, reduced costs, and improved patient awareness, engagement, or satisfaction. These findings may inform any clinic considering mailed fecal testing programs and future pragmatic research efforts in community health centers.

Background 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. Methods As part of STOP CRC outreach, Virginia Garcia Memorial Health Center staff distributed 1,753 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. Results 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%. Conclusion Improvements are needed to increase rates of follow-up colonoscopy completion, especially among female and Hispanic patients.

Screening rates for colorectal cancer (CRC) remain low, especially among certain populations. Mailed fecal immunochemical testing (FIT) outreach initiated by U.S. health plans could reach underserved individuals, while solving CRC screening data and implementation challenges faced by health clinics. We report the models and motivations of two health insurance plans implementing a mailed FIT program for age-eligible U.S. Medicaid and Medicare populations. One health plan operates in a single state with ~220,000 enrollees; the other operates in multiple states with ~2 million enrollees. We conducted in-depth qualitative interviews with key stakeholders and observed leadership and clinic staff planning during program development and implementation. Interviews were transcribed and coded using a content analysis approach; coded interview reports and meeting minutes were iteratively reviewed and summarized for themes. Between June and September 2016, nine participants were identified, and all agreed to the interview. Interviews revealed that organizational context was important to both organizations and helped shape program design. Both organizations were hoping this program would address barriers to their prior CRC screening improvement efforts and saw CRC screening as a priority. Despite similar motivations to participate in a mailed FIT intervention, contextual features of the health plans led them to develop distinct implementation models: a collaborative model using some health clinic staffing versus a centralized model operationalizing outreach primarily at the health plan. Data are not yet available on the models’ effectiveness. Our findings might help inform the design of programs to deliver mailed FIT outreach.

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. (J Am Board Fam Med 2019;32:307-317.)

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.

Programs that directly mail fecal immunochemical tests (FIT) to patients can increase colorectal cancer (CRC) screening, especially in low-income and Latino populations. Few studies have explored patient reactions to prompts or reminders that accompany such programs. As part of the Participatory Research to Advance Colon Cancer Prevention pilot study, which tested prompts and reminders to a direct-mail FIT program in a large, urban health center, we conducted telephone interviews among English- and Spanish-speaking participants who were assigned to receive a series of text message prompts, automated phone call reminders, and/or live phone call reminders. We analyzed interviews using a qualitative content analysis approach. We interviewed 41 participants, including 25 responders (61%) and 16 nonresponders (39%) to the direct-mail program. Participants appreciated program ease and convenience. Few participants recalled receiving prompts or automated/live reminders; nevertheless, the vast majority (95%, n = 39) thought reminders were acceptable and helpful and suggested that 2–3 reminders delivered starting 1 week after the mailed FIT would optimally encourage completion. Prompts and reminders used with mailed-FIT programs are accepted by patients, and my help boost response rates.