An observational study of workflows to support fecal testing for colorectal cancer screening in primary care practices serving Medicaid enrollees.

BACKGROUND: Screening supports early detection and treatment of colorectal cancer (CRC). Provision of fecal immunochemical tests/fecal occult blood tests (FIT/FOBT) in primary care can increase CRC screening, particularly in populations experiencing health disparities. This study was conducted to describe clinical workflows for FIT/FOBT in Oregon primary care practices and to identify specific workflow processes that might be associated (alone or in combination) with higher (versus lower) CRC screening rates. METHODS: Primary care practices were rank ordered by CRC screening rates in Oregon Medicaid enrollees who turned age 50 years from January 2013 to June 2014 (i.e., newly age-eligible). Practices were recruited via purposive sampling based on organizational characteristics and CRC screening rates. Data collected were from surveys, observation visits, and informal interviews, and used to create practice-level CRC screening workflow reports. Data were analyzed using descriptive statistics, qualitative data analysis using an immersion-crystallization process, and a matrix analysis approach. RESULTS: All participating primary care practices (N=9) used visit-based workflows, and four higher performing and two lower performing used population outreach workflows to deliver FIT/FOBTs. However, higher performing practices (n=5) had more established workflows and staff to support activities. Visit-based strategies in higher performing practices included having dedicated staff identify patients due for CRC screening and training medical assistants to review FIT/FOBT instructions with patients. Population outreach strategies included having clinic staff generate lists and check them for accuracy prior to direct mailing of kits to patients. For both workflow types, higher performing clinics routinely utilized systems for patient reminders and follow-up after FIT/FOBT distribution. CONCLUSIONS: Primary care practices with higher CRC screening rates among newly age-eligible Medicaid enrollees had more established visit-based and population outreach workflows to support identifying patients due for screening, FIT/FOBT distribution, reminders, and follow up. Key to practices with higher CRC screening was having medical assistants discuss and review FIT/FOBT screening and instructions with patients. Findings present important workflow processes for primary care practices and may facilitate the implementation of evidence-based interventions into real-world, clinical settings.

Effect of Clinical Decision Support at Community Health Centers on the Risk of Cardiovascular Disease: A Cluster Randomized Clinical Trial.

Importance: Management of cardiovascular disease (CVD) risk in socioeconomically vulnerable patients is suboptimal; better risk factor control could improve CVD outcomes. Objective: To evaluate the impact of a clinical decision support system (CDSS) targeting CVD risk in community health centers (CHCs). Design, Setting, and Participants: This cluster randomized clinical trial included 70 CHC clinics randomized to an intervention group (42 clinics; 8 organizations) or a control group that received no intervention (28 clinics; 7 organizations) from September 20, 2018, to March 15, 2020. Randomization was by CHC organization accounting for organization size. Patients aged 40 to 75 years with (1) diabetes or atherosclerotic CVD and at least 1 uncontrolled major risk factor for CVD or (2) total reversible CVD risk of at least 10% were the population targeted by the CDSS intervention. Interventions: A point-of-care CDSS displaying real-time CVD risk factor control data and personalized, prioritized evidence-based care recommendations. Main Outcomes and Measures: One-year change in total CVD risk and reversible CVD risk (ie, the reduction in 10-year CVD risk that was considered achievable if 6 key risk factors reached evidence-based levels of control). Results: Among the 18 578 eligible patients (9490 [51.1%] women; mean [SD] age, 58.7 [8.8] years), patients seen in control clinics (n = 7419) had higher mean (SD) baseline CVD risk (16.6% [12.8%]) than patients seen in intervention clinics (n = 11 159) (15.6% [12.3%]; P < .001); baseline reversible CVD risk was similarly higher among patients seen in control clinics. The CDSS was used at 19.8% of 91 988 eligible intervention clinic encounters. No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P < .001). However, when the CDSS was used, both risk measures decreased more among patients with high baseline risk in intervention than control clinics; notably, mean reversible risk decreased by an absolute 4.4% (95% CI, -5.2% to -3.7%) among patients in intervention clinics compared with 2.7% (95% CI, -3.4% to -1.9%) among patients in control clinics (P = .001). Conclusions and Relevance: The CDSS had low use rates and failed to improve CVD risk in the overall population but appeared to have a benefit on CVD risk when it was consistently used for patients with high baseline risk treated in CHCs. Despite some limitations, these results provide preliminary evidence that this technology has the potential to improve clinical care in socioeconomically vulnerable patients with high CVD risk. Trial Registration: ClinicalTrials.gov Identifier: NCT03001713.

Exhaustive expansion: A novel technique for analyzing complex data generated by higher-order polychromatic flow cytometry experiments.

BACKGROUND: The complex data sets generated by higher-order polychromatic flow cytometry experiments are a challenge to analyze. Here we describe Exhaustive Expansion, a data analysis approach for deriving hundreds to thousands of cell phenotypes from raw data, and for interrogating these phenotypes to identify populations of biological interest given the experimental context. METHODS: We apply this approach to two studies, illustrating its broad applicability. The first examines the longitudinal changes in circulating human memory T cell populations within individual patients in response to a melanoma peptide (gp100209-2M) cancer vaccine, using 5 monoclonal antibodies (mAbs) to delineate subpopulations of viable, gp100-specific, CD8+ T cells. The second study measures the mobilization of stem cells in porcine bone marrow that may be associated with wound healing, and uses 5 different staining panels consisting of 8 mAbs each. RESULTS: In the first study, our analysis suggests that the cell surface markers CD45RA, CD27 and CD28, commonly used in historical lower order (2-4 color) flow cytometry analysis to distinguish memory from naïve and effector T cells, may not be obligate parameters in defining central memory T cells (TCM). In the second study, we identify novel phenotypes such as CD29+CD31+CD56+CXCR4+CD90+Sca1-CD44+, which may characterize progenitor cells that are significantly increased in wounded animals as compared to controls. CONCLUSIONS: Taken together, these results demonstrate that Exhaustive Expansion supports thorough interrogation of complex higher-order flow cytometry data sets and aids in the identification of potentially clinically relevant findings.