Association Between Diabetes Severity and Risks of COVID-19 Infection and Outcomes.

BACKGROUND: Little is known about whether diabetes increases the risk of COVID-19 infection and whether measures of diabetes severity are related to COVID-19 outcomes. OBJECTIVE: Investigate diabetes severity measures as potential risk factors for COVID-19 infection and COVID-19 outcomes. DESIGN, PARTICIPANTS, MEASURES: In integrated healthcare systems in Colorado, Oregon, and Washington, we identified a cohort of adults on February 29, 2020 (n = 1,086,918) and conducted follow-up through February 28, 2021. Electronic health data and death certificates were used to identify markers of diabetes severity, covariates, and outcomes. Outcomes were COVID-19 infection (positive nucleic acid antigen test, COVID-19 hospitalization, or COVID-19 death) and severe COVID-19 (invasive mechanical ventilation or COVID-19 death). Individuals with diabetes (n = 142,340) and categories of diabetes severity measures were compared with a referent group with no diabetes (n = 944,578), adjusting for demographic variables, neighborhood deprivation index, body mass index, and comorbidities. RESULTS: Of 30,935 patients with COVID-19 infection, 996 met the criteria for severe COVID-19. Type 1 (odds ratio [OR] 1.41, 95% CI 1.27-1.57) and type 2 diabetes (OR 1.27, 95% CI 1.23-1.31) were associated with increased risk of COVID-19 infection. Insulin treatment was associated with greater COVID-19 infection risk (OR 1.43, 95% CI 1.34-1.52) than treatment with non-insulin drugs (OR 1.26, 95% 1.20-1.33) or no treatment (OR 1.24; 1.18-1.29). The relationship between glycemic control and COVID-19 infection risk was dose-dependent: from an OR of 1.21 (95% CI 1.15-1.26) for hemoglobin A1c (HbA1c) < 7% to an OR of 1.62 (95% CI 1.51-1.75) for HbA1c ≥ 9%. Risk factors for severe COVID-19 were type 1 diabetes (OR 2.87; 95% CI 1.99-4.15), type 2 diabetes (OR 1.80; 95% CI 1.55-2.09), insulin treatment (OR 2.65; 95% CI 2.13-3.28), and HbA1c ≥ 9% (OR 2.61; 95% CI 1.94-3.52). CONCLUSIONS: Diabetes and greater diabetes severity were associated with increased risks of COVID-19 infection and worse COVID-19 outcomes.

External Validation of the eRADAR Risk Score for Detecting Undiagnosed Dementia in Two Real-World Healthcare Systems.

BACKGROUND: Fifty percent of people living with dementia are undiagnosed. The electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) was developed to identify older adults at risk of having undiagnosed dementia using routinely collected clinical data. OBJECTIVE: To externally validate eRADAR in two real-world healthcare systems, including examining performance over time and by race/ethnicity. DESIGN: Retrospective cohort study PARTICIPANTS: 129,315 members of Kaiser Permanente Washington (KPWA), an integrated health system providing insurance coverage and medical care, and 13,444 primary care patients at University of California San Francisco Health (UCSF), an academic medical system, aged 65 years or older without prior EHR documentation of dementia diagnosis or medication. MAIN MEASURES: Performance of eRADAR scores, calculated annually from EHR data (including vital signs, diagnoses, medications, and utilization in the prior 2 years), for predicting EHR documentation of incident dementia diagnosis within 12 months. KEY RESULTS: A total of 7631 dementia diagnoses were observed at KPWA (11.1 per 1000 person-years) and 216 at UCSF (4.6 per 1000 person-years). The area under the curve was 0.84 (95% confidence interval: 0.84-0.85) at KPWA and 0.79 (0.76-0.82) at UCSF. Using the 90th percentile as the cut point for identifying high-risk patients, sensitivity was 54% (53-56%) at KPWA and 44% (38-51%) at UCSF. Performance was similar over time, including across the transition from International Classification of Diseases, version 9 (ICD-9) to ICD-10 codes, and across racial/ethnic groups (though small samples limited precision in some groups). CONCLUSIONS: eRADAR showed strong external validity for detecting undiagnosed dementia in two health systems with different patient populations and differential availability of external healthcare data for risk calculations. In this study, eRADAR demonstrated generalizability from a research sample to real-world clinical populations, transportability across health systems, robustness to temporal changes in healthcare, and similar performance across larger racial/ethnic groups.

A Centralized Program with Stepped Support Increases Adherence to Colorectal Cancer Screening Over 9 Years: a Randomized Trial.

BACKGROUND: Screening over many years is required to optimize colorectal cancer (CRC) outcomes. OBJECTIVE: To evaluate the effect of a CRC screening intervention on adherence to CRC screening over 9 years. DESIGN: Randomized trial. SETTING: Integrated health care system in Washington state. PARTICIPANTS: Between August 2008 and November 2009, 4653 adults in a Washington state integrated health care system aged 50-74 due for CRC screening were randomized to usual care (UC; N =1163) or UC plus study interventions (interventions: N = 3490). INTERVENTIONS: Years 1 and 2: (arm 1) UC or this plus study interventions; (arm 2) mailed fecal tests or information on scheduling colonoscopy; (arm 3) mailings plus brief telephone assistance; or (arm 4) mailings and assistance plus nurse navigation. In year 3, stepped-intensity participants (arms 2, 3, and 4 combined) still eligible for screening were randomized to either stopped or continued interventions in years 3 and 5-9. MAIN MEASURES: Time in adherence to CRC testing over 9 years (covered time, primary outcome), and percent with no CRC testing in participants assigned to any intervention compared to UC only. Poisson regression models estimated incidence rate ratios for covered time, adjusting for patient characteristics and accounting for variable follow-up time. KEY RESULTS: Compared to UC, intervention participants had 21% more covered time over 9 years (57.5% vs. 69.1%; adjusted incidence rate ratio 1.21, 95% confidence interval 1.16-1.25, P<0.001). Fecal testing accounted for almost all additional covered time among intervention patients. Compared to UC, intervention participants were also more likely to have completed at least one CRC screening test over 9 years or until censorship (88.6% vs. 80.6%, P<0.001). CONCLUSIONS: An outreach program that included mailed fecal tests and phone follow-up led to increased adherence to CRC testing and fewer age-eligible individuals without any CRC testing over 9 years. TRIAL REGISTRATION: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up (SOS), NCT00697047, clinicaltrials.gov/ct2/show/NCT00697047.

Renin-Angiotensin-Aldosterone System Inhibitors and COVID-19 Infection or Hospitalization: A Cohort Study.

BACKGROUND: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) may increase the risk of coronavirus disease 2019 (COVID-19) infection or affect disease severity. Prior studies have not examined risks by medication dose. METHODS: This retrospective cohort study included people aged ≥18 years enrolled in a US integrated healthcare system for at least 4 months as of 2/29/2020. Current ACEI and ARB use was identified from pharmacy data, and the estimated daily dose was calculated and standardized across medications. COVID-19 infections and hospitalizations were identified through 6/14/2020 from laboratory and hospitalization data. We used logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs), adjusting for race/ethnicity, obesity, and other covariates. RESULTS: Among 322,044 individuals, 826 developed COVID-19 infection. Among people using ACEI/ARBs, 204/56,105 developed COVID-19 (3.6 per 1,000 individuals) compared with 622/265,939 without ACEI/ARB use (2.3 per 1,000), yielding an adjusted OR of 0.91 (95% CI 0.74-1.12). For use of <1 defined daily dose (DDD) vs. nonuse, the adjusted OR for infection was 0.92 (95% CI 0.66-1.28); for 1 to <2 DDDs, 0.89 (95% CI 0.66-1.19); and for ≥2 DDDs, 0.92 (95% CI 0.72-1.18). The OR was similar for ACEIs and ARBs and in subgroups by age and sex. 26% of people with COVID-19 infection were hospitalized; the adjusted OR for hospitalization in relation to ACEI/ARB use was 0.98 (95% CI 0.63-1.54), and there was no association with dose. CONCLUSIONS: These findings support current recommendations that individuals on these medications continue their use.

Renin-angiotensin-aldosterone system inhibitors and COVID-19 infection or hospitalization: a cohort study.

There are plausible mechanisms by which angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) may increase the risk of COVID-19 infection or affect disease severity. To examine the association between these medications and COVID-19 infection or hospitalization, we conducted a retrospective cohort study within a US integrated healthcare system. Among people aged ≥18 years enrolled in the health plan for at least 4 months as of 2/29/2020, current ACEI and ARB use was identified from pharmacy data, and the estimated daily dose was calculated and standardized across medications. COVID-19 infections were identified through 6/14/2020 from laboratory and hospitalization data. We used logistic regression to estimate adjusted odds ratios (ORs) and 95% confidence intervals. Among 322,044 individuals, 720 developed COVID-19 infection. Among people using ACEI/ARBs, 183/56,105 developed COVID-19 (3.3 per 1000 individuals) compared with 537/265,939 without ACEI/ARB use (2.0 per 1000), yielding an adjusted OR of 0.94 (95% CI 0.75-1.16). For use of < 1 defined daily dose vs. nonuse, the adjusted OR for infection was 0.89 (95% CI 0.62-1.26); for 1 to < 2 defined daily doses, 0.97 (95% CI 0.71-1.31); and for ≥2 defined daily doses, 0.94 (95% CI 0.72-1.23). The OR was similar for ACEIs and ARBs and in subgroups by age and sex. 29% of people with COVID-19 infection were hospitalized; the adjusted OR for hospitalization in relation to ACEI/ARB use was 0.92 (95% CI 0.54-1.57), and there was no association with dose. These findings support current recommendations that individuals on these medications continue their use.

Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial.

Importance: Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups. Objective: To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates. Design, Setting, and Participants: This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled. Interventions: Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion). Main Outcomes and Measures: The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures. Results: A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03). Conclusions and Relevance: Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups. Trial Registration: ClinicalTrials.gov identifier: NCT00697047.

Primary care physician resource use changes associated with feedback reports.

OBJECTIVES: To measure changes in primary care physician (PCP) ordering rates for 4 global resource use measures before and after dissemination of physician feedback reports that provided peer-comparison resource use rates. We also explored whether physician practice characteristics (panel size, clinic size, and years of experience) were associated with resource use changes. STUDY DESIGN: Pre-post implementation study measuring physician resource use in an integrated healthcare system (2011-2014). METHODS: Kaiser Permanente Washington PCPs (N = 210) were provided annual feedback reports showing their personal ordering rates compared with those of their peers. Monthly physician ordering was measured from November 2011 to September 2014 (including prereport and postreport periods). We examined 4 physician ordering rates (specialty referrals, high-end imaging, laboratory tests, and 30-day prescriptions) per 1000 patients, adjusted for patient age, gender, and clinical complexity. RESULTS: After accounting for physician practice characteristics, monthly PCP ordering rates for high-end imaging significantly decreased by 0.8 images per 1000 patients (P <.01). In contrast, orders for laboratory tests and 30-day prescriptions significantly increased by 15.0 tests and 84.7 prescriptions per 1000 patients (both P <.01). We observed greater changes following feedback in physicians with fewer years of experience (≤10 years), who had 4.2 fewer specialty referrals (P = .01) and 101.3 more 30-day prescriptions (P <.01) compared with those with more experience (>20 years). CONCLUSIONS: Physician feedback reports may be associated with changes in physician resource use, and physicians with fewer years of experience may be more responsive to feedback reports. Better understanding of factors associated with changes in resource use is necessary for future targeted development of physician interventions.

A centralized mailed program with stepped increases of support increases time in compliance with colorectal cancer screening guidelines over 5 years: A randomized trial.

BACKGROUND: Screening over many years is required to optimize reductions in colorectal cancer (CRC) mortality. However, no prior trials have compared strategies for obtaining long-term adherence. METHODS: Systems of Support to Increase Colorectal Cancer Screening and Follow-Up was implemented in an integrated health care organization in Washington State. Between 2008 and 2009, 4675 individuals aged 50 to 74 years were randomized to receive the usual care (UC), which included clinic-based strategies to increase CRC screening (arm 1), or, in years 1 and 2, mailings with a call-in number for colonoscopy and mailed fecal tests (arm 2), mailings plus brief telephone assistance (arm 3), or mailings and assistance plus nurse navigation (arm 4). Active-intervention subjects (those in arms 2, 3, and 4 combined) who were still eligible for CRC screening were randomized to mailings being stopped or continued in years 3 and 5. The time in compliance with CRC screening over 5 years was compared for persons assigned to any intervention and persons assigned to UC. Screening tests contributed time on the basis of national guidelines for screening intervals (fecal tests annually, sigmoidoscopy every 5 years, and colonoscopy every 10 years). RESULTS: All participants contributed data, but they were censored at disenrollment, death, the age of 76 years, or a diagnosis of CRC. Compared with UC participants, intervention participants had 31% more adjusted covered time over 5 years (incidence rate ratio, 1.31; 95% confidence interval, 1.25-1.37; covered time, 47.5% vs 62.1%). Fecal testing accounted for almost all additional covered time. CONCLUSIONS: In a health care organization with clinic-based activities to increase CRC screening, a centralized program led to increased CRC screening adherence over 5 years. Longer term data on screening adherence and its impact on CRC outcomes are needed. Cancer 2017;123:4472-80. © 2017 American Cancer Society.

A Quality Improvement Initiative to Increase Colorectal Cancer (CRC) Screening: Collaboration between a Primary Care Clinic and Research Team.

BACKGROUND: Multiple randomized controlled trials have demonstrated that mailed fecal testing programs are effective in increasing colorectal cancer screening participation. However, few healthcare organization in the US have Implemented such programs. METHODS: Stakeholders from one clinic in an integrated healthcare system in Washington State initiated collaboration with researchers with expertise in CRC screening, aiming to increase screening rates at their clinic. Age-eligible individuals who were overdue for CRC screening and had previously completed a fecal test were randomized to receive mailed fecal immunochemical test kits (FIT) at the start of the project (Early) or 6 months later (Late). Outcomes included comparing FIT completion at 6 months by randomization group, and overall CRC screening rates at 12 months. We also assessed implementation facilitators and challenges. RESULTS: Overall 2,421 FIT tests were mailed at a cost of $10,739. At 6 months, FIT completion was significantly higher among the Early compared to the Late group (62% vs.47%, p <0.001). By 12 months, after both groups had received mailings, 71% in each group had completed a FIT. The clinic's overall CRC screening rate was 75.1% at baseline and 78.0% 12 months later. Key constructs associated with successful program implementation included strong stakeholder involvement, use of evidence-based strategies, simplicity, and low cost. Challenges included lack of a plan for maintaining the program. DISCUSSION: Collaboration between clinic stakeholders and researchers led to a successful project that rapidly increased CRC screening rates. However, institutional normalization of the program would be required to maintain it.

Psychological distress after a positive fecal occult blood test result among members of an integrated healthcare delivery system.

BACKGROUND: Colorectal cancer screening (CRCS) reduces morbidity and mortality; however, the positive benefits might be partially offset by long-term distress following positive screening results. We examined relationships among colorectal cancer-specific worry and situational anxiety after positive fecal occult blood tests [FOBT (+)] compared with receipt of negative results. METHODS: Of note, 2,260 eligible members of Group Health, an integrated healthcare delivery system, completed baseline surveys and received FOBT screening kits, with 1,467 members returning the kits. We matched FOBT (+) patients (n = 55) 1:2 on age and sex with FOBT (-) respondents (n = 110). Both groups completed follow-up surveys at 7 to 14 days and 4 months after screening. We assessed situational anxiety (State-Trait Anxiety Inventory, STAI), colorectal cancer worry frequency, and mood disturbance. RESULTS: Mean age was 59 years, and majority were women (62%) and White (89%). After adjusting for age, sex, and baseline worry, at 7 to 14 days after screening, the FOBT (+) group was 3.82 [95% confidence interval (CI), 1.09-13.43] times more likely to report colorectal cancer-related mood disturbances and significantly higher mean STAI scores than the FOBT (-) group (mean = 38.8 vs. 30.9; P = 0.007). At 4-month posttest, mood disturbances and situational anxiety seemed to drop to baseline levels for FOBT (+). No colon cancer worry frequency was observed. CONCLUSIONS: FOBT (+) results are associated with short-term situational anxiety and colorectal cancer-specific mood disturbances. IMPACT: Distress from FOBT (+) results declined to near-baseline levels by 4 months. Additional studies are needed to clarify the relationship between long-term distress and follow-up colonoscopy.

Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial.

OBJECTIVE: The aim of this study is to compare the uptake of three mailed high-sensitivity fecal occult blood tests (FOBTs). METHODS: We conducted a parallel 3-arm randomized controlled trial in an integrated healthcare delivery system in Washington State. From January 2010 through February 2011, automated data were used to identify potentially eligible patients aged 50-74 due for colorectal cancer screening. Participants were mailed one of three FOBT kits (1-sample OC-Auto® fecal immunochemical test [FIT], 2-sample InSure® FIT, or 3-sample guaiac Hemoccult SENSA®), instructions, and a postage-paid return envelope. We performed a modified intent-to-treat analysis with return of any FOBT within 6 months of randomization as the primary outcome. RESULTS: Of the 9922 people invited, 2873 returned surveys, 2263 were randomized, and 2234 were analyzed. FOBTs were returned by 1431 participants. At 6 months post-randomization, the proportions screened by any FOBT were 0.69 (95% confidence interval [CI] 0.66-0.72) for the OC-Auto arm, 0.64 (95% CI: 0.61-0.68) for the InSure arm, and 0.61 (95% CI: 0.58-0.65) for the Hemoccult SENSA arm (P<0.001 for any difference). Pairwise comparisons showed significant differences between the OC-Auto group and each of the other groups after correction for multiple comparisons. CONCLUSION: Uptake of mailed FOBT kits varies by kit type.

Nonparticipation in a population-based trial to increase colorectal cancer screening.

BACKGROUND: Many trials have tested different strategies to increase colorectal cancer (CRC) screening. Few describe whether participants are representative of the population from which they are recruited. PURPOSE: To determine risk factors related to nonparticipation among patients enrolled in an integrated health plan and not up to date for CRC testing, in a trial to increase screening rates. METHODS: Between July 2008 and October 2009, a total of 15,000 adults aged 50-74 years from 21 clinics in Washington State who were due for CRC screening were contacted. Nonparticipants were defined as English-speaking patients who did not engage in the call or refused participation while still potentially eligible. Log-binomial regression models were used to estimate the relative risk of nonparticipation. Analyses were completed between October 2010 and June 2011. RESULTS: Patients who were nonwhite, had less education, used tobacco, had less continuity of care, and had lower rates of preventive care and cancer screening were more likely to be nonparticipants. Patients reporting never having received any type of CRC testing or screening were also more likely not to participate (62% of nonparticipants vs 46% of participants; adjusted RR=1.58, 95% CI=1.47, 1.70). Reasons for refusal included costs, risks of procedures, and not wanting their medical records reviewed. CONCLUSIONS: Patients eligible for but not participating in the trial were more likely to be from minority socioeconomic and racial groups and had behaviors that can negatively affect cancer outcomes. Additional efforts are needed to recruit patients who need CRC screening the most. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov NCT 00697047.