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.

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.