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The rapid pace of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; COVID-19) pandemic presents challenges to the real-time collection of population-scale data to inform near-term public health needs as well as future investigations. We established the COronavirus Pandemic Epidemiology (COPE) consortium to address this unprecedented crisis on behalf of the epidemiology research community. As a central component of this initiative, we have developed a COVID Symptom Study (previously known as the COVID Symptom Tracker) mobile application as a common data collection tool for epidemiologic cohort studies with active study participants. This mobile application collects information on risk factors, daily symptoms, and outcomes through a user-friendly interface that minimizes participant burden. Combined with our efforts within the general population, data collected from nearly 3 million participants in the United States and United Kingdom are being used to address critical needs in the emergency response, including identifying potential hot spots of disease and clinically actionable risk factors. The linkage of symptom data collected in the app with information and biospecimens already collected in epidemiology cohorts will position us to address key questions related to diet, lifestyle, environmental, and socioeconomic factors on susceptibility to COVID-19, clinical outcomes related to infection, and long-term physical, mental health, and financial sequalae. We call upon additional epidemiology cohorts to join this collective effort to strengthen our impact on the current health crisis and generate a new model for a collaborative and nimble research infrastructure that will lead to more rapid translation of our work for the betterment of public health.

Background & aimsNoninvasive tests used in colorectal cancer screening, such as the fecal immunochemical test (FIT), are more acceptable but detect neoplasias with lower levels of sensitivity than colonoscopy. We investigated whether lowering the cut-off concentration of hemoglobin for designation as an abnormal FIT result increased the detection of advanced neoplasia in a mailed outreach program.MethodsWe performed a prospective study of 17,017 uninsured patients, age 50 to 64 years, who were not current with screening and enrolled in a safety-net system in Texas. We reduced the cut-off value for an abnormal FIT result from 20 or more to 10 or more μg hemoglobin/g feces a priori. All patients with abnormal FIT results were offered no-cost diagnostic colonoscopy. We compared proportions of patients with abnormal FIT results and neoplasia yield for standard vs lower cut-off values, as well as absolute hemoglobin concentration distribution among 5838 persons who completed the FIT. Our primary aim was to determine the effects of implementing a lower hemoglobin concentration cut-off value on colonoscopy demand and yield, specifically colorectal cancer (CRC) and advanced neoplasia detection, compared with the standard, higher, hemoglobin concentration cut-off value.ResultsThe proportions of patients with abnormal FIT results were 12.3% at the 10 or more μg hemoglobin/g feces and 6.6% at the standard 20 or more μg hemoglobin/g feces cut-off value (P = .0013). Detection rates for the lower vs the standard threshold were 10.2% vs 12.7% for advanced neoplasia (P = .12) and 0.9% vs 1.2% for CRC (P = .718). The positive predictive values were 18.9% for the lower threshold vs 24.4% for the standard threshold for advanced neoplasia (P = .053), and 1.7% vs 2.4% for CRC (P = .659). The number needed to screen to detect 1 case with advanced neoplasia was 45 at the lower threshold compared with 58 at the standard threshold; the number needed to scope to detect 1 case with advanced neoplasia increased from 4 to 5. Most patients with CRC (72.7%) or advanced adenoma (67.3%) had hemoglobin concentrations of 20 or more μg/g feces. In the group with 10 to 19 μg hemoglobin/g feces, there were 3 patients with CRC (3 of 11; 27.3%) and 36 with advanced adenoma (36 of 110; 32.7%) who would not have been detected at the standard positive threshold (advanced neoplasia Pcomparison < .001). The proportion of patients found to have no neoplasia after an abnormal FIT result (false positives) was not significantly higher with the lower cut-off value (44.4%) than the standard cut-off value (39.1%) (P = .1103).ConclusionsIn a prospective study of 17,017 uninsured patients, we found that reducing the abnormal FIT result cut-off value (to ≥10 μg hemoglobin/g feces) might increase detection of advanced neoplasia, but doubled the proportion of patients requiring a diagnostic colonoscopy. If colonoscopy capacity permits, health systems that use quantitative FITs should consider lowering the abnormal cut-off value to optimize CRC detection and prevention. (ClinicalTrials.gov no: NCT01946282.).

PURPOSE Practice facilitation is an evidence-informed implementation strategy to support quality improvement (QI) and aid practices in aligning with best evidence. Few studies, particularly of this size and scope, identify strategies that contribute to facilitator effectiveness. METHODS We conducted a sequential mixed methods study, analyzing data from EvidenceNOW, a large-scale QI initiative. Seven regional cooperatives employed 162 facilitators to work with 1,630 small or medium-sized primary care practices. Main analyses were based on facilitators who worked with at least 4 practices. Facilitators were defined as more effective if at least 75% of their practices improved on at least 1 outcome measure-aspirin use, blood pressure control, smoking cessation counseling (ABS), or practice change capacity, measured using Change Process Capability Questionnaire-from baseline to follow-up. Facilitators were defined as less effective if less than 50% of their practices improved on these outcomes. Using an immersion crystallization and comparative approach, we analyzed observational and interview data to identify strategies associated with more effective facilitators. RESULTS Practices working with more effective facilitators had a 3.6% greater change in the mean percentage of patients meeting the composite ABS measure compared with practices working with less effective facilitators (P CONCLUSIONS Facilitation strategies that differentiate more and less effective facilitators have implications for enhancing facilitator development and training, and can assist all facilitators to more effectively support practice changes. Key words: practice facilitation; quality improvement; large-scale initiative; capacity building; implementation facilitation; organizational change; organizational innovation, INTRODUCTION Practice facilitators are trained individuals who build medical practices' capacity to make meaningful operational changes aligned with current evidence. (1,2) Facilitators provide education, motivation, accountability, and guidance on organizational [...]

BackgroundFinancial incentives may improve health behaviors. We tested the impact of offering financial incentives for mailed fecal immunochemical test (FIT) completion annually for 3 years.MethodsPatients, ages 50 to 64 years, not up-to-date with screening were randomized to receive either a mailed FIT outreach (n = 6,565), outreach plus $5 (n = 1,000), or $10 (n = 1,000) incentive for completion. Patients who completed the test were reinvited using the same incentive the following year, for 3 years. In year 4, patients who returned the kit in all preceding 3 years were reinvited without incentives. Primary outcome was FIT completion among patients offered any incentive versus outreach alone each year. Secondary outcomes were FIT completion for groups offered $5 versus outreach alone, $10 versus outreach alone, and $5 versus $10.ResultsYear 1 FIT completion was 36.9% with incentives versus 36.2% outreach alone (P = 0.59) and was not statistically different for $10 (34.6%; P = 0.31) or $5 (39.2%; P = 0.070) versus outreach alone. Year 2 completion was 61.6% with incentives versus 60.8% outreach alone (P = 0.75) and not statistically different for $10 or $5 versus outreach alone. Year 3 completion was 79.4% with incentives versus 74.8% outreach alone (P = 0.080), and was higher for $10 (82.4%) versus outreach alone (P = 0.033), but not for $5 versus outreach alone. Completion was similar across conditions in year 4 (no incentives).ConclusionsOffering small incentives did not increase FIT completion relative to standard outreach.ImpactThis was the first longitudinal study testing the impact of repeated financial incentives, and their withdrawal, on FIT completion.

BackgroundFor colorectal cancer (CRC) screening to improve survival, patients with an abnormal fecal immunochemical test (FIT) must follow-up with a diagnostic colonoscopy. Adherence to follow-up is low and patient-level barriers for suboptimal adherence have yet to be explored.ObjectiveTo characterize barriers for non-completion of diagnostic colonoscopy after an abnormal FIT reported by under- and uninsured patients receiving care in a safety-net health system.DesignA longitudinal, cohort study of CRC screening outreach to 8565 patients using mailed FIT kits. Patients with abnormal FIT results received telephonic navigation to arrange for a no-cost diagnostic colonoscopy.PatientsAdults aged 50-64 years receiving care at a North Texas safety-net health system.ApproachDescriptive analyses characterized the patient sample and reasons for lack of follow-up after abnormal FIT over the 3-year outreach program. Thematic qualitative analyses characterized reasons for lack of follow-up with a colonoscopy after the abnormal FIT.Key resultsOf 689 patients with an abnormal FIT, 45% (n = 314) did not complete a follow-up colonoscopy. Among the 314 non-completers, 184 patients reported reasons for not completing a follow-up colonoscopy included health insurance-related challenges (38%), comorbid conditions (37%), social barriers such as transportation difficulties and lack of social support (29%), concerns about FIT/colonoscopy process (12%), competing life priorities (12%), adverse effects of bowel preparation (3%), and poor health literacy (3%). Among the 314 non-completers, 131 patients did not report a barrier, as 51% reported that that had completed a previous colonoscopy in the past 10 years, 10% refused with no reason, and 10% were never reached by phone.ConclusionsFuture studies aimed at improving FIT screening and subsequent colonoscopy rates need to address the unique needs of patients for effective and sustainable screening programs.Trial registrationNCT01946282.

PURPOSE We undertook a study to identify conditions and operational changes linked to improvements in smoking and blood pressure (BP) outcomes in primary care. METHODS We purposively sampled and interviewed practice staff (eg, office managers, clinicians) from a subset of 104 practices participating in EvidenceNOW--a multisite cardiovascular disease prevention initiative. We calculated Clinical Quality Measure improvements, with targets of 10-point or greater absolute improvements in the proportion of patients with smoking screening and, if relevant, counseling and in the proportion of hypertensive patients with adequately controlled BP. We analyzed interview data to identify operational changes, transforming these into numeric data. We used Configurational Comparative Methods to assess the joint effects of multiple factors on outcomes. RESULTS In clinician-owned practices, implementing a workflow to routinely screen, counsel, and connect patients to smoking cessation resources, or implementing a documentation change or a referral to a resource alone led to an improvement of at least 10 points in the smoking outcome with a moderate level of facilitation support. These patterns did not manifest in health- or hospital system-owned practices or in Federally Qualified Health Centers, however. The BP outcome improved by at least 10 points among solo practices after medical assistants were trained to take an accurate BP. Among larger, clinician-owned practices, BP outcomes improved when practices implemented a second BP measurement when the first was elevated, and when staff learned where to document this information in the electronic health record. With 50 hours or more of facilitation, BP outcomes improved among larger and health- and hospital system-owned practices that implemented these operational changes. CONCLUSIONS There was no magic bullet for improving smoking or BP outcomes. Multiple combinations of operational changes led to improvements, but only in specific contexts of practice size and ownership, or dose of external facilitation. Key words: quality improvement; configurational comparative methods; mixed methods; cardiovascular prevention; smoking cessation; blood pressure management; organizational change; primary care; practice-based research, INTRODUCTION Cardiovascular disease (CVD) is the leading cause of death in the United States, with stroke or heart disease contributing to 1 out of every 3 deaths. (1) Primary risk [...]

Context. Over 70% of cancer survivors live with additional comorbidities requiring coordinated care across primary care and oncology. Interventions to improve survivorship care planning have shown mixed results and few studies are focused on improving care coordination, specifically in the context of real-world practice. Objective: To examine effect of a care coordination intervention (Project CONNECT) for underserved breast and colorectal cancer survivors on change in patient-reported outcomes. Study Design and Analysis: Using a pre-post quasi-experimental design, eligible patients were administered a telephone survey pre-intervention and 6- and 12-months post-intervention to measure patient-reported care coordination. Summary statistics described patient characteristics and Generalized Estimating Equation assessed population-average changes in care coordination adjusted for patient characteristics. Setting: An integrated, safety-net health system with community-oriented primary care clinics and specialty tertiary care in Dallas, TX providing care to under- and uninsured patients. Population: 285 patients diagnosed with breast or colorectal cancer (stages I-III) with at least one other chronic condition (diabetes, hypertension, heart disease, chronic kidney disease, or chronic obstructive pulmonary disease). Intervention: Project CONNECT included an EMR-based registry to identify eligible cancer survivors, a nurse coordinator embedded in oncology connecting patients to primary care, and a coach to support nurse coordinator in integrating oncology and primary care. Outcome Measure: Adapted Picker Patient Experience of Care (coordination subscale) measure scores on a 1-3 scale, with a higher score representing worse perceived care coordination. Results: 70% of patients had breast cancer and 30% had colorectal cancer. Average age of eligible patients was 55 years (SD: 15.1). Our sample was predominantly women (79%) and over half were Hispanic ethnicity. After adjusting for patient characteristics, patient-reported care coordination improved significantly after intervention ([beta] = -0.062 [0.014 - -0.108]). Conclusions: Project CONNECT improved patient perception of care coordination, suggesting that a registry identifying complex cancer survivors and a dedicated nurse coordinator bridging primary care and oncology is a promising approach to improve care delivery outcomes for cancer survivors with chronic conditions in safety-net health settings., Presenters Quiera Booker, BS, MPH, PhD candidate, Simon Lee, PhD, MPH, Bijal Balasubramanian, PhD, MBBS, Navid [...]

ObjectivesOffering financial incentives to promote or "nudge" participation in cancer screening programs, particularly among vulnerable populations who traditionally have lower rates of screening, has been suggested as a strategy to enhance screening uptake. However, effectiveness of such practices has not been established. Our aim was to determine whether offering small financial incentives would increase colorectal cancer (CRC) screening completion in a low-income, uninsured population.MethodsWe conducted a randomized, comparative effectiveness trial among primary care patients, aged 50-64 years, not up-to-date with CRC screening served by a large, safety net health system in Fort Worth, Texas. Patients were randomly assigned to mailed fecal immunochemical test (FIT) outreach (n=6,565), outreach plus a $5 incentive (n=1,000), or outreach plus a $10 incentive (n=1,000). Outreach included reminder phone calls and navigation to promote diagnostic colonoscopy completion for patients with abnormal FIT. Primary outcome was FIT completion within 1 year, assessed using an intent-to-screen analysis.ResultsFIT completion was 36.9% with vs. 36.2% without any financial incentive (P=0.60) and was also not statistically different for the $10 incentive (34.6%, P=0.32 vs. no incentive) or $5 incentive (39.2%, P=0.07 vs. no incentive) groups. Results did not differ substantially when stratified by age, sex, race/ethnicity, or neighborhood poverty rate. Median time to FIT return also did not differ across groups.ConclusionsFinancial incentives, in the amount of $5 or $10 offered in exchange for responding to mailed invitation to complete FIT, do not impact CRC screening completion.

Patient-centered health risk assessments (HRAs) that screen for unhealthy behaviors, prioritize concerns, and provide feedback may improve counseling, goal setting, and health. To evaluate the effectiveness of routinely administering a patient-centered HRA, My Own Health Report, for diet, exercise, smoking, alcohol, drug use, stress, depression, anxiety, and sleep, 18 primary care practices were randomized to ask patients to complete My Own Health Report (MOHR) before an office visit (intervention) or continue usual care (control). Intervention practice patients were more likely than control practice patients to be asked about each of eight risks (range of differences 5.3-15.8 %, p

Abstract Background There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. Methods This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment – addresses 10 domains of health behaviors and psychosocial issues – and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. Discussion The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. Trial registration Clinicaltrials.gov: NCT01825746

Purpose: To understand the impact of pre-existing conditions on healthcare utilization among under- and uninsured patients in the transition from cancer treatment to post-treatment survivorship. Methods: Using electronic health record data, we constructed a cohort of patients seen in an integrated county health system between 1/1/2010 and 12/31/2016. Six hundred thirty-one adult patients diagnosed with non-metastatic breast or colorectal cancer during this period (cases) were matched 1:1 on sex and Charlson comorbidity index to non-cancer patients who had at least two chronic conditions and with at least one visit to the health system during the study period (controls). Conditional fixed effects Poisson regression models compared number of primary care and emergency department (ED) visits and completed [vs. no show or missed] appointments between cancer and non-cancer patients. Results: Cancer patients had significantly lower number of visits compared with non-cancer patients (N = 46,965 vs. 85,038). Cancer patients were less likely to have primary care (IRR = 0.25; 95% CI: 0.24, 0.27) and ED visits (IRR = 0.57; 95% CI: 0.50, 0.64) but more likely to complete a scheduled appointment (AOR = 4.83; 95% CI: 4.32, 5.39) compared with non-cancer patients. Cancer patients seen in primary care at a higher rate were more likely to visit the ED (IRR = 2.06; 95% CI: 1.52, 2.80) than those seen in primary care at a lower rate. Conclusion: Health systems need to find innovative, effective solutions to increase primary care utilization among cancer patients with chronic care conditions to ensure optimal management of both chronic conditions and cancer. Implications for Cancer Survivors: Maintaining regular connections with primary care providers during active cancer treatment should be promoted. [ABSTRACT FROM AUTHOR]