Pre-implementation adaptation of primary care cancer prevention clinical decision support in a predominantly rural healthcare system.

BACKGROUND: Cancer is a leading cause of death in the United States. Primary care providers (PCPs) juggle patient cancer prevention and screening along with managing acute and chronic health problems. However, clinical decision support (CDS) may assist PCPs in addressing patients' cancer prevention and screening needs during short clinic visits. In this paper, we describe pre-implementation study design and cancer screening and prevention CDS changes made to maximize utilization and better fit a healthcare system's goals and culture. We employed the Consolidated Framework for Implementation Research (CFIR), useful for evaluating the implementation of CDS interventions in primary care settings, in understanding barriers and facilitators that led to those changes. METHODS: In a three-arm, pragmatic, 36 clinic cluster-randomized control trial, we integrated cancer screening and prevention CDS and shared decision-making tools (SDMT) into an existing electronic medical record-linked cardiovascular risk management CDS system. The integrated CDS is currently being tested within a predominately rural upper Midwestern healthcare system. Prior to CDS implementation, we catalogued pre-implementation changes made from 2016 to 2018 based on: pre-implementation site engagement; key informant interviews with healthcare system rooming staff, providers, and leadership; and pilot testing. We identified influential barriers, facilitators, and changes made in response through qualitative content analysis of meeting minutes and supportive documents. We then coded pre-implementation changes made and associated barriers and facilitators using the CFIR. RESULTS: Based on our findings from system-wide pre-implementation engagement, pilot testing, and key informant interviews, we made changes to accommodate the needs of the healthcare system based on barriers and facilitators that fell within the Intervention Characteristics, Inner Setting, and Outer Setting CFIR domains. Changes included replacing the expansion of medical assistant roles in one intervention arm with targeted SDMT, as well as altering cancer prevention CDS and study design elements. CONCLUSIONS: Pre-implementation changes to CDS may help meet healthcare systems' evolving needs and optimize the intervention by being responsive to real-world implementation barriers and facilitators. Frameworks like the CFIR are useful tools for identifying areas where pre-implementation barriers and facilitators may result in design changes, both to research studies and CDS systems. TRIAL REGISTRATION: NCT02986230.

Barriers and facilitators to implementing cancer prevention clinical decision support in primary care: a qualitative study.

BACKGROUND: In the United States, primary care providers (PCPs) routinely balance acute, chronic, and preventive patient care delivery, including cancer prevention and screening, in time-limited visits. Clinical decision support (CDS) may help PCPs prioritize cancer prevention and screening with other patient needs. In a three-arm, pragmatic, clinic-randomized control trial, we are studying cancer prevention CDS in a large, upper Midwestern healthcare system. The web-based, electronic health record (EHR)-linked CDS integrates evidence-based primary and secondary cancer prevention and screening recommendations into an existing cardiovascular risk management CDS system. Our objective with this study was to identify adoption barriers and facilitators before implementation in primary care. METHODS: We conducted semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR) with 28 key informants employed by the healthcare organization in either leadership roles or the direct provision of clinical care. Transcribed interviews were analyzed using qualitative content analysis. RESULTS: EHR, CDS workflow, CDS users (providers and patients), training, and organizational barriers and facilitators were identified related to Intervention Characteristics, Outer Setting, Inner Setting, and Characteristics of Individuals CFIR domains. CONCLUSION: Identifying and addressing key informant-identified barriers and facilitators before implementing cancer prevention CDS in primary care may support a successful implementation and sustained use. The CFIR is a useful framework for understanding pre-implementation barriers and facilitators. Based on our findings, the research team developed and instituted specialized training, pilot testing, implementation plans, and post-implementation efforts to maximize identified facilitators and address barriers. TRIAL REGISTRATION: clinicaltrials.gov , NCT02986230 , December 6, 2016.

Understanding primary care providers' perceptions of cancer prevention and screening in a predominantly rural healthcare system in the upper Midwest.

BACKGROUND: Cancer is the leading cause of death in the United States, with the burden expected to rise in the coming decades, increasing the need for effective cancer prevention and screening options. The United States Preventive Services Task Force has suggested that a shared decision-making process be used when clinicians and patients discuss cancer screening. The electronic medical record (EMR) often provides only reminders or alerts to primary care providers (PCPs) when screenings are due, a strategy with limited efficacy. METHODS: We administered a cross-sectional electronic survey to PCPs (n = 165, 53% response rate) at 36 Essentia Health primary care clinics participating in a large, National Cancer Institute-funded study on a cancer prevention clinical decision support (CDS) tool. The survey assessed PCP demographics, perceptions of the EMR's ability to help assess and manage patients' cancer risk, and experience and comfort level discussing cancer screening and prevention with patients. RESULTS: In these predominantly rural clinics, only 49% of PCPs thought the EMR was well integrated to help assess and manage cancer risk. Both advanced care practitioners and physicians agreed that cancer screening and informed discussion of cancer risks are important; however, only 53% reported their patients gave cancer screening a high priority relative to other health issues. CONCLUSIONS: The impact of EMR-linked CDS delivered to both patients and PCPs may improve cancer screening, but only if it is easy to use and saves PCPs time.

Validation of the ANSR® Listeria Method for Detection of Listeria spp. in Selected Foods.

ANSR® Listeria was previously certified as Performance Tested Method(SM) 101202 for detection of Listeria spp. on selected environmental surfaces. This study proposes a matrix extension to the method for detection of Listeria spp. in selected food matrixes. The method is an isothermal nucleic acid amplification assay based on the nicking enzyme amplification reaction technology. Following single-step sample enrichment for 16-24 h, the assay is completed in less than 50 min, requiring only simple instrumentation. Inclusivity testing was performed using a panel of 51 strains of Listeria spp., representing the species L. grayi, L. innocua, L. ivanovii, L. monocytogenes, L. seeligeri, and L. welshimeri. All strains tested were detected by the ANSR assay. Exclusivity testing of 30 strains representing non-Listeria Gram-positive bacteria yielded no evidence of cross-reactivity. Performance of the ANSR method for detection of Listeria spp. was compared to that of reference culture procedures for pasteurized liquid egg, pasteurized 2% milk, Mexican-style cheese, ice cream, smoked salmon, lettuce, cantaloupe, and guacamole. Data obtained in these unpaired studies and analyzed using a probability of detection model demonstrated that there were no statistically significant differences in results between the ANSR and reference culture methods, except for milk at 16 h and cantaloupe. In milk and smoked salmon, ANSR sensitivity was low at 16 h and therefore the recommended incubation time is 24 h. In cantaloupe, ANSR was found to be more sensitive than the reference culture method at both 16 and 24 h in independent laboratory testing. The ANSR Listeria method can be used as an accurate, rapid, and simple alternative to standard culture methods for detection of Listeria spp. in selected food types.

Validation of Modifications to the ANSR® Salmonella Method for Improved Ease of Use.

This paper describes the results of a study to validate minor reagent formulation and procedural changes to the ANSR® Salmonella method, AOAC Performance Tested Method™ 061203. In order to improve ease of use and diminish risk of amplicon contamination, the lyophilized reagent components were reformulated for increased solubility, thus eliminating the need to mix by pipetting. In the alternative procedure, an aliquot of the lysate is added to lyophilized ANSR reagents, immediately capped, and briefly mixed by vortex. Results of the validation study with ice cream, peanut butter, dry dog food, raw ground turkey, raw ground beef, and sponge samples from a stainless steel surface showed no statistically significant differences in performance between the ANSR method and the U.S. Food and Drug Administration Bacteriological Analytical Manual or U.S. Department of Agriculture-Food Safety and Inspection Services Microbiology Laboratory Guidebook reference culture procedures. Results of inclusivity and exclusivity testing were unchanged from those of the original validation study; exclusivity was 100% and inclusivity was 99.1% with only a single strain of Salmonella Weslaco testing negative. Robustness testing was also conducted, with variations to lysis buffer volume, lysis time, and sample volume having no demonstrable effect on assay results.