Jennifer Rivelli

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

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 registrationClinicaltrials.gov NCT01742065. Registered October 31, 2013.

Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial

The effectiveness of annual mailed fecal immunochemical testing (FIT) outreach is highest when return rates are optimized, which is aided by patient reminders. In a pilot patient-randomized controlled trial in two western Washington clinics of the Sea Mar Community Health Centers, we compared the effectiveness of two phone-based approaches to mailed FIT outreach reminders. In fall 2016, patients ages 50–75, due for colorectal cancer screening, and with a visit in the previous year at either of two clinics, were mailed an introductory letter and FIT. Those who did not return the FIT within 3 weeks (N = 427) were randomized to receive either: a) a series of up to 6 automated phone reminders; or b) the combination of automated and live phone reminders (up to 6 in total). The sole outcome was FIT return within 6 months after the FIT mailing. FIT completion rates were similar in the groups assigned to receive automated calls vs automated plus live calls (40% vs 39%; p = 0.89). The effectiveness of FIT reminder mode differed by language preference (p for interaction = 0.03): among Spanish-preferring patients (n = 106), FIT return rates were higher in the automated-only group than to the auto- plus live-call group (62% vs 39%, p = 0.02). Among English-preferring patients, no difference in modes was observed (n = 279, 32% vs 34%, p = 0.74). We observed no added benefit of live reminder calls in a mailed FIT plus automated call reminder program; our findings may inform efforts to efficiently optimize mailed-FIT outreach programs. ClinicalTrials.gov identifier NCT01742065

Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial

Annual fecal immunochemical testing (FIT) is cost‐effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false‐positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed‐FIT outreach, clinics delivered one of three FIT brands (InSure, OC‐Micro, and Hemosure). Patients who had a positive FIT result and a follow‐up colonoscopy were included in this analysis (N = 1130). Patients’ demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow‐up colonoscopy) were evaluated for FIT brand and patient factors using mixed‐effects multivariable logistic regression. The mean proportion of FIT‐positive results ranged from 8% in centers using the OC‐Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for χ2 = 0.08). In multivariable‐adjusted models, use of Hemosure was associated with greater odds of a FP result than OC‐Micro (OR = 2.00, 95% CI: 0.47‐8.56) or InSure (OR = 1.72, 95% CI: 0.44‐6.68). However, only female sex (OR = 1.58, 95% CI: 1.19‐2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13‐4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.

Abstract A13: Using boot camp translation to design a system-based intervention to improve rates of colon cancer screening using fecal immunochemical testing among Latino patients in community health centers

Introduction: Colon cancer is the second-leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. In 2015, only 63% of eligible adults, and 50% of Latinos, were up to date with colon cancer screening recommendations. One factor thought to contribute to the low screening rate is that patient-facing health information for Latinos is difficult to understand and patients face challenges in taking appropriate health action. As part of the Participatory Research to Advance Colon Cancer Prevention (PROMPT) study that seeks to raise rates of colon cancer screening in a Latino-serving community health center in California, we used boot camp translation (BCT), a validated community-based participatory strategy, to elicit input from diverse stakeholders and refine the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical test (FIT) program. Methods: We adapted BCT to engage Latino patients and clinic staff in this research. Eligible patient participants were Latino, aged 50 to 75 years, able to speak English or Spanish, and willing to participate in a 6-hour in-person meeting and three 30-minute follow-up phone calls. Materials were developed in English and Spanish, and separate sessions were held for English- and Spanish-speaking participants. As part of the in-person sessions, a national bilingual colon cancer expert delivered a presentation on colon health, cancer screening, and messages to improve screening participation, specific to Latino populations. Following the presentation, BCT experts facilitated brainstorming sessions to obtain feedback on the presented information, followed by an interactive small-group session where participants reviewed sample written materials and reminder messages using various modalities (e.g., text, letter, automated and live calls). We asked participants to consider what information about colon cancer screening is important to share with other patients, what the best methods are to share these messages, and the frequency with which these messages should be delivered to patients to encourage FIT completion. Participants then engaged in a hands-on exercise to share input about the timing and frequency of reminder delivery. Results from the exercise were used to define the intervention for the PROMPT pilot. Results: A total of 25 adults participated in an in-person session (12 in the English-language session; 13 in the Spanish-language session). Participants were mostly clinic patients (84%) and the majority were female (80%). Among the patient participants, 57% were enrolled in Medicaid, and 67% reported an annual household income of less than

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

20,000. Key themes from the sessions included increasing awareness about colon cancer and screening options, stressing the urgency of screening, and using personalized messages such as “I” statements in letters or human voices on automated phone call reminders. Both sessions noted the importance of receiving an alert (automated or live) before the FIT kit is mailed, and of receiving a reminder within 2 weeks of FIT kit mailing. Conclusions: Our BCT process allowed English- and Spanish-speaking Latino patients to directly inform which approaches get tested in the pilot study by refining message content and selecting their modality and timing to encourage patients who are mailed a FIT to complete it and mail it back. Using BCT, we successfully incorporated participant feedback to design culturally relevant health messages to promote FIT testing among patients served by community clinics. Citation Format: Jamie Thompson, Melinda Davis, LeAnn Michaels, Jennifer Rivelli, Marta Castro, Anne Escaron, Brittany Younger, Melissa Castillo, Sacha Reich, Gloria Coronado. Using boot camp translation to design a system-based intervention to improve rates of colon cancer screening using fecal immunochemical testing among Latino patients in community health centers [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A13.

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

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.