A Randomized Encouragement Trial to Increase Mail Order Pharmacy Use and Medication Adherence in Patients with Diabetes.

BACKGROUND: Mail order pharmacy (MOP) use has been linked to improved medication adherence and health outcomes among patients with diabetes. However, no large-scale intervention studies have assessed the effect of encouraging MOP use on medication adherence. OBJECTIVE: To assess an intervention to encourage MOP services to increase its use and medication adherence. DESIGN: Randomized encouragement trial. PATIENTS: 63,012 diabetes patients from three health care systems: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Hawaii (KPHI), and Harvard Pilgrim Health Care (HPHC) who were poorly adherent to at least one class of cardiometabolic medications and had not used MOP in the prior 12 months. INTERVENTION: Patients were randomized to receive either usual care (control arm) or outreach encouraging MOP use consisting of a mailed letter, secure email message, and automated telephone call outlining the potential benefits of MOP use (intervention arm). HPHC intervention patients received the letter only. MEASUREMENTS: We compared the percentages of patients that began using MOP and that became adherent to cardiometabolic medication classes during a 12-month follow-up period. We also conducted a race/ethnicity-stratified analysis. RESULTS: During follow-up, 10.6% of intervention patients began using MOP vs. 9.3% of controls (p < 0.01); the percent of cardiometabolic medication delivered via mail was 42.1% vs. 39.8% (p < 0.01). Metformin adherence improved in the intervention arm relative to control at the two KP sites (52% vs. 49%, p < 0.01). Stratified analyses suggested a significant positive effect of the intervention in White (RR: 1.12, 95% CI: 1.03, 1.22) and Asian (RR: 1.30, 95% CI: 1.17, 1.45) patients. CONCLUSION: This pragmatic trial showed that simple outreach to encourage MOP modestly increased its use and improved adherence measured by refills to a key class of diabetes medications in some settings. Given its minimal cost, clinicians and health systems should consider outreach interventions to actively promote MOP use among diabetes patients. TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT02621476.

Comorbid Diabetes and Severe Mental Illness: Outcomes in an Integrated Health Care Delivery System.

BACKGROUND: Diabetes prevalence is twice as high among people with severe mental illness (SMI) when compared to the general population. Despite high prevalence, care outcomes are not well understood. OBJECTIVE: To compare diabetes health outcomes received by people with and without comorbid SMI, and to understand demographic factors associated with poor diabetes control among those with SMI. DESIGN: Retrospective cohort study PARTICIPANTS: 269,243 adults with diabetes MAIN MEASURES: Primary outcomes included optimal glycemic control (A1c < 7) or poor diabetes control (A1c > 9) in 2014. Secondary outcomes included control of other cardiometabolic risk factors (hypertension, dyslipidemia, smoking) and recommended diabetes monitoring. KEY RESULTS: Among this cohort, people with SMI (N = 4,399), compared to those without SMI (N = 264,844), were more likely to have optimal glycemic control, adjusting for various covariates (adjusted relative risk (aRR) 1.25, 95% CI 1.21-1.28, p < .001) and less likely to have poor control (aRR 0.92, 95% CI 0.87-0.98, p = 0.012). Better blood pressure and lipid control was more prevalent among people with SMI when compared to those without SMI (aRR 1.03; 95% CI 1.02-1.05, p < .001; aRR 1.02; 95% CI 1.00-1.05, p = 0.044, respectively). No differences were observed in recommended A1c or LDL testing, but people with SMI were more likely to have blood pressure checked (aRR 1.02, 95% CI 1.02-1.03, p < .001) and less likely to receive retinopathy screening (aRR 0.80, 95% CI 0.71-0.91, p < .001) than those without SMI. Among people with diabetes and comorbid SMI, younger adults and Hispanics were more likely to have poor diabetes control. CONCLUSIONS: Adults with diabetes and comorbid SMI had better cardiometabolic control than people with diabetes who did not have SMI, despite lower rates of retinopathy screening. Among those with comorbid SMI, younger adults and Hispanics were more vulnerable to poor A1c control.

Identifying Common Predictors of Multiple Adverse Outcomes Among Elderly Adults With Type-2 Diabetes.

OBJECTIVE: As part of a multidisciplinary team managing patients with type-2 diabetes, pharmacists need a consistent approach of identifying and prioritizing patients at highest risk of adverse outcomes. Our objective was to identify which predictors of adverse outcomes among type-2 diabetes patients were significant and common across 7 outcomes and whether these predictors improved the performance of risk prediction models. Identifying such predictors would allow pharmacists and other health care providers to prioritize their patient panels. RESEARCH DESIGN AND METHODS: Our study population included 120,256 adults aged 65 years or older with type-2 diabetes from a large integrated health system. Through an observational retrospective cohort study design, we assessed which risk factors were associated with 7 adverse outcomes (hypoglycemia, hip fractures, syncope, emergency department visit or hospital admission, death, and 2 combined outcomes). We split (50:50) our study cohort into a test and training set. We used logistic regression to model outcomes in the test set and performed k-fold validation (k=5) of the combined outcome (without death) within the validation set. RESULTS: The most significant predictors across the 7 outcomes were: age, number of medicines, prior history of outcome within the past 2 years, chronic kidney disease, depression, and retinopathy. Experiencing an adverse outcome within the prior 2 years was the strongest predictor of future adverse outcomes (odds ratio range: 4.15-7.42). The best performing models across all outcomes included: prior history of outcome, physiological characteristics, comorbidities and pharmacy-specific factors (c-statistic range: 0.71-0.80). CONCLUSIONS: Pharmacists and other health care providers can use models with prior history of adverse event, number of medicines, chronic kidney disease, depression and retinopathy to prioritize interventions for elderly patients with type-2 diabetes.

Diabetes Screening among Antipsychotic-Treated Adults with Severe Mental Illness in an Integrated Delivery System: A Retrospective Cohort Study.

BACKGROUND: Severe mental illness (SMI) is associated with increased risk for type 2 diabetes, partly due to adverse metabolic effects of antipsychotic medications. In public health care settings, annual screening rates are 30%. We measured adherence to national diabetes screening guidelines for patients taking antipsychotic medications. OBJECTIVE: To estimate diabetes screening prevalence among patients with SMI within an integrated health care system, and to assess characteristics associated with lack of screening. DESIGN: Retrospective cohort study. PARTICIPANTS: Antipsychotic-treated adults with SMI. We excluded participants with known diabetes. MAIN MEASURES: Primary outcome was screening via fasting glucose test or hemoglobin A1c during a 1-year period. KEY RESULTS: In 2014, 16,754 patients with SMI diagnoses were receiving antipsychotics. Seventy-four percent of these patients' providers ordered diabetes screening tests that year, but only 55% (9247/16,754) received screening. When the observation time frame was extended to 2 years, 73% (12,250/16,754) were screened. Adjusting for sex and race/ethnicity, young adults (aged 18-29 years) were less likely to receive screening than older age groups [adjusted RR (aRR) 1.23-1.57, p < 0.0001]. Compared to whites, screening was more common for Asians (aRR 1.141, 95% CI 1.089-1.195, p < 0.0001), less common for blacks (aRR 0.946, 95% CI 0.898-0.997, p < 0.0375), and no different for Hispanics (aRR 1.030, 95% CI 0.988-1.074, p = 0.165). Smokers were less likely to be screened than non-smokers (aRR 0.93, 95% CI 0.89-0.97, p < 0.0008). Utilization of either mental health or primary care services increased the likelihood of screening. CONCLUSIONS: While almost three-fourths of adults with SMI taking antipsychotic medications received a lab order for diabetes screening, only 55% received screening within a 12-month period. Young adults and smokers were less likely to be screened, despite their disproportionate metabolic risk. Future studies should assess the barriers and facilitators with regard to diabetes screening in this vulnerable population at the patient, provider, and system levels.

The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.

BACKGROUND: Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy. METHODS: We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. RESULTS: Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age is 67 (standard deviation = 12) years. The racial ethnic make-up is 56% White, 8% Asian, 13% Black or African American, and 19% Hispanic or Latino. CONCLUSION: Innovative strategies are needed to guide improvements in healthcare delivery for patients with symptomatic diabetic peripheral neuropathy. This trial aims to assess whether real-time collection and clinical feedback of patient treatment experiences can reduce patient symptom burden. Implementation of a clinical trial closely involving clinical care required researchers to partner with clinicians. If successful, this intervention provides a critical information feedback loop that would optimize diabetic peripheral neuropathy medication titration through widely available interactive voice response technology.

Health care system-level factors associated with performance on Medicare STAR adherence metrics in a large, integrated delivery system.

BACKGROUND: The Centers for Medicare and Medicaid Services provide significant incentives to health plans that score well on Medicare STAR metrics for cardiovascular disease risk factor medication adherence. Information on modifiable health system-level predictors of adherence can help clinicians and health plans develop strategies for improving Medicare STAR scores, and potentially improve cardiovascular disease outcomes. OBJECTIVE: To examine the association of Medicare STAR adherence metrics with system-level factors. RESEARCH DESIGN: A cross-sectional study. SUBJECTS: A total of 129,040 diabetes patients aged 65 years and above in 2010 from 3 Kaiser Permanente regions. MEASURES: Adherence to antihypertensive, antihyperlipidemic, and oral antihyperglycemic medications in 2010, defined by Medicare STAR as the proportion of days covered ≥ 80%. RESULTS: After controlling for individual-level factors, the strongest predictor of achieving STAR-defined medication adherence was a mean prescribed medication days' supply of > 90 days (RR=1.61 for antihypertensives, oral antihyperglycemics, and statins; all P < 0.001). Using mail order pharmacy to fill medications > 50% of the time was independently associated with better adherence with these medications (RR = 1.07, 1.06, 1.07; P < 0.001); mail order use had an increased positive association among black and Hispanic patients. Medication copayments ≤ $10 for 30 days' supply (RR = 1.02, 1.02, 1.02; P < 0.01) and annual individual out-of-pocket maximums ≤ $2000 (RR = 1.02, 1.01, 1.02; P < 0.01) were also significantly associated with higher adherence for all 3 therapeutic groupings. CONCLUSIONS: Greater medication days' supply and mail order pharmacy use, and lower copayments and out-of-pocket maximums, are associated with better Medicare STAR adherence. Initiatives to improve adherence should focus on modifiable health system-level barriers to obtaining evidence-based medications.

Prescription medication burden in patients with newly diagnosed diabetes: a SUrveillance, PREvention, and ManagEment of Diabetes Mellitus (SUPREME-DM) study.

OBJECTIVE: To understand the burden of medication use for patients with newly diagnosed diabetes both before and after diabetes diagnosis and to identify subpopulations of patients with newly diagnosed diabetes who face a relatively high drug burden. DESIGN: Retrospective cohort study. SETTING: 11 integrated health systems in the United States. PARTICIPANTS: 196,654 insured adults 20 years of age or older newly diagnosed with type 1 or type 2 diabetes from January 2005 through December 2009. MAIN OUTCOME MEASURES: Number of unique therapeutic classes of drugs dispensed in the 12 months before and 12 months after diagnosis of diabetes in five categories: overall, antihypertensive agents, antihyperlipidemic agents, mental health agents, and antihyperglycemic agents (in the postdiagnosis period only). RESULTS: The mean number of drug classes used by newly diagnosed patients with diabetes is high before diagnosis (5.0) and increases significantly afterward (6.6). Of this increase, 81% is due to antihyperglycemic initiation and increased use of medications to control hypertension and lipid levels. Multivariate analyses showed that overall drug burden after diabetes diagnosis was higher in women, older, white, and obese patients, as well as among those with higher glycosylated hemoglobin concentrations and comorbidity levels (significant for all comparisons). The overall number of drug classes used by newly diagnosed patients with diabetes after diagnosis decreased slightly but significantly between 2005 and 2009. CONCLUSION: Patients newly diagnosed with diabetes face a substantially increased burden of medications used to control diabetes and other comorbidities. This study shows an increased focus on cardiovascular disease risk factor control after diagnosis of diabetes. However, total drug burden may be slightly decreasing over time.

Hospital Readmissions Among Patients Experiencing Homelessness: An Electronic Health Record Data Study.

BACKGROUND: Population-level tracking of hospital use patterns with integrated care organizations in patients experiencing homelessness has been difficult. A California law implemented in 2019 (Senate Bill 1152) aimed to ensure safety for this population after discharge from the hospital by requiring additional documentation for patients experiencing homelessness, which provides an opportunity to evaluate hospital use by this population. METHODS: In a large integrated health system in California, patients experiencing homelessness were identified through documentation change requirements associated with this law and compared with a matched group from the general population. RESULTS: Patients experiencing homelessness had increased rates of hospital readmission after discharge compared to the general population matched on demographics and medical comorbidity in 2019 and 2020. Any address change in the prior year for patients was associated with increased odds of emergency department readmission. Patients experiencing homelessness, both enrolled in an integrated delivery system and not, were successfully identified as having higher readmission rates compared with their housed counterparts. CONCLUSION: Documentation of housing status following Senate Bill 1152 has enabled improved study of hospital use among those with housing instability. Understanding patterns of hospital use in this vulnerable group will help practitioners identify timely points of intervention for further social and health care support.

Using Peer Support to Prevent Diabetes: Results of a Pragmatic RCT.

INTRODUCTION: High-contact structured diabetes prevention programs are effective in lowering weight and HbA1cs, yet their intensity level can create barriers to participation. Peer support programs improve clinical outcomes among adults with Type 2 diabetes, but their effectiveness in diabetes prevention is unknown. This study examined whether a low-intensity peer support program improved outcomes more than enhanced usual care in a diverse population with prediabetes. STUDY DESIGN: The intervention was tested in a pragmatic 2-arm RCT. SETTING/PARTICIPANTS: Participants were adults with prediabetes at three healthcare centers. INTERVENTION: Participants randomized to the enhanced usual care arm received educational materials. Participants in the Using Peer Support to Aid in Prevention and Treatment in Prediabetes arm were matched with a peer supporter: another patient who had made healthy lifestyle changes and was trained in autonomy-supportive action planning. Peer supporters were instructed to provide weekly telephone support to their peers on specific action steps toward behavioral goals for 6 months, then monthly support for 6 months. MAIN OUTCOME MEASURES: Changes in primary outcomes of weight and HbA1c and secondary outcomes of enrollment in formal diabetes prevention programs, self-reported diet, physical activity, health-specific social support, self-efficacy, motivation, and activation at 6 and 12 months were examined. RESULTS: Data collection occurred from October 2018 to March 2022, with analyses completed in September 2022. Among 355 randomized patients, in intention-to-treat analyses, there were no between-group differences in HbA1c or weight changes at 6 and 12 months. Using Peer Support to Aid in Prevention and Treatment in Prediabetes participants were more likely to enroll in structured programs at 6 (AOR=2.45, p=0.009) and 12 (AOR=2.21, p=0.016) months and to report eating whole grains at 6 (4.49, p=0.026) and 12 (4.22, p=0.034) months. They reported greater improvements in perceived social support for diabetes prevention behaviors at 6 (6.39, p<0.001) and 12 (5.48, p<0.001) months, with no differences in other measures. CONCLUSIONS: A stand-alone, low-intensity peer support program improved social support and participation in formal diabetes prevention programs but not weight or HbA1c. It will be important to examine whether peer support could effectively complement higher-intensity, structured diabetes prevention programs. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov, NCT03689530. Full protocol available at https://clinicaltrials.gov/ct2/show/NCT03689530.

Identifying Predictors of Homelessness Among Adults in a Large Integrated Health System in Northern California.

Introduction Homelessness contributes to worsening health and increased health care costs. There is little published research that leverages rich electronic health record (EHR) data to predict future homelessness risk and inform interventions to address it. The authors' objective was to develop a model for predicting future homelessness using individual EHR and geographic data covariates. Methods This retrospective cohort study included 2,543,504 adult members (≥ 18 years old) from Kaiser Permanente Northern California and evaluated which covariates predicted a composite outcome of homelessness status (hospital discharge documentation of a homeless patient, medical diagnosis of homelessness, approved medical financial assistance application for homelessness, and/or "homeless/shelter" in address name). The predictors were measured in 2018-2019 and included prior diagnoses and demographic and geographic data. The outcome was measured in 2020. The cohort was split (70:30) into a derivation and validation set, and logistic regression was used to model the outcome. Results Homelessness prevalence was 0.35% in the overall sample. The final logistic regression model included 26 prior diagnoses, demographic, and geographic-level predictors. The regression model using the validation set had moderate sensitivity (80.4%) and specificity (83.2%) for predicting future cases of homelessness and achieved excellent classification properties (area under the curve of 0.891 [95% confidence interval = 0.884-0.897]). Discussion This prediction model can be used as an initial triage step to enhance screening and referral tools for identifying and addressing homelessness, which can improve health and reduce health care costs. Conclusions EHR data can be used to predict chance of homelessness at a population health level.

Expanding the Geographic Boundaries of Melioidosis in Queensland, Australia.

Melioidosis is an infectious disease caused by the bacterium Burkholderia pseudomallei. Although this environmental organism is endemic in certain regions of Australia, it is not considered endemic in Southern Queensland, where the last case was reported 21 years ago. We report a climate change-associated outbreak of melioidosis occurring during two La Niña events in a region previously considered nonendemic for B. pseudomallei. During a 15-month period, 14 cases of locally acquired melioidosis were identified. Twelve patients were adults (> 50 years), with diabetes mellitus the most common risk factor in 6 of 12 patients (50%). Eleven patients (79%) had direct exposure to floodwaters or the flooded environment. This study suggests an association between climate change and an increased incidence of melioidosis. In addition, this is the first report of environmental sampling and whole-genome analysis to prove endemicity and local acquisition in this region.

Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial.

BACKGROUND: Blood pressure, lipid, and glycemic control are essential for reducing cardiovascular disease (CVD) risk. Many health care systems have successfully shifted aspects of chronic disease management, including population-based outreach programs designed to address CVD risk factor control, to non-physicians. The purpose of this study is to evaluate provision of new information to non-physician outreach teams on need for treatment intensification in patients with increased CVD risk. METHODS: Cluster randomized trial (July 1-December 31, 2008) in Kaiser Permanente Northern California registry of members with diabetes mellitus, prior CVD diagnoses and/or chronic kidney disease who were high-priority for treatment intensification: blood pressure ≥ 140 mmHg systolic, LDL-cholesterol ≥ 130 mg/dl, or hemoglobin A1c ≥ 9%; adherent to current medications; no recent treatment intensification). Randomization units were medical center-based outreach teams (4 intervention; 4 control). For intervention teams, priority flags for intensification were added monthly to the registry database with recommended next pharmacotherapeutic steps for each eligible patient. Control teams used the same database without this information. Outcomes included 3-month rates of treatment intensification and risk factor levels during follow-up. RESULTS: Baseline risk factor control rates were high (82-90%). In eligible patients, the intervention was associated with significantly greater 3-month intensification rates for blood pressure (34.1 vs. 30.6%) and LDL-cholesterol (28.0 vs 22.7%), but not A1c. No effects on risk factors were observed at 3 months or 12 months follow-up. Intervention teams initiated outreach for only 45-47% of high-priority patients, but also for 27-30% of lower-priority patients. Teams reported difficulties adapting prior outreach strategies to incorporate the new information. CONCLUSIONS: Information enhancement did not improve risk factor control compared to existing outreach strategies at control centers. Familiarity with prior, relatively successful strategies likely reduced uptake of the innovation and its potential for success at intervention centers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00517686.

Address Changes Are Associated With Unmet Glycemic Targets: Opportunities to Improve Processes and Outcomes of Care Among People With Type 2 Diabetes.

Introduction The objective of this study was to identify and operationalize measures of potential housing insecurity within existing electronic health record data and to quantify the association between address changes and diabetes management goals among patients with type 2 diabetes. Methods We conducted a retrospective cohort study to measure potential housing insecurity in electronic health record data by quantifying the number of address changes in 2018. We considered at least one address change as a potential marker for housing insecurity. We used multivariable modified Poisson regressions to analyze the association between address change and clinical, utilization and preventive care outcomes while adjusting for patient and health system factors. Results We identified 274,123 adults with type 2 diabetes who were members of Kaiser Permanente Northern California in 2018 and 6% (N = 17,317) had at least one address change during 2018. In multivariate analyses, we found that one or more address changes was associated with greater chance of hemoglobin A1C < 9 (ARR: 1.12, 95% CI: 1.09, 1.15), lower chance of hemoglobin A1C < 8 (ARR: 0.95, 95% CI; 0.94, 0.96), lower chance of controlled blood pressure (ARR: 0.99, 95% CI: 0.98-0.99), greater chance of emergency department visits (ARR: 1.25, 95% CI: 1.23, 1.27), and lower chance of having a flu shot (ARR: 0.94, 95% CI: 0.93, 0.95) when compared to no address change. Discussion Changes in address are associated with worse diabetes management outcomes. Conclusion Identifying patients with potential housing insecurity and providing resources aimed at continuity of care and stable health care access could improve diabetes management for vulnerable populations.

The comparative effectiveness of mail order pharmacy use vs. local pharmacy use on LDL-C control in new statin users.

BACKGROUND: Mail order pharmacies are commonly used to deliver CVD risk factor medications. Previous studies have shown that mail order pharmacy use is associated with greater medication adherence; however, no studies have examined whether mail order pharmacy use is related to improved CVD risk factor outcomes. OBJECTIVE: To examine the comparative effectiveness of mail order pharmacy vs. local pharmacy use on LDL-C control in new statin users. DESIGN: Observational cohort study. PATIENTS: 100,298 adult Kaiser Permanente Northern California (KPNC) members who were new users of statins between January 1, 2005 and December 31, 2007. MEASUREMENTS: The main outcome measure was LDL-C control in the 3-15 month period after statin therapy was initiated. RESULTS: After adjustment for patient, clinical, and census-block characteristics, and for potential unmeasured differences between mail order and local KPNC pharmacy users with instrumental variables analysis, 85.0% of patients who used the mail order pharmacy to deliver their statin at any time achieved target LDL-C levels compared with 74.2% of patients who only used the local KPNC pharmacy to dispense the statin (p < 0.001). Greater adjusted rates of LDL-C control in mail order pharmacy users were seen across all gender and race/ethnicity subgroups. CONCLUSIONS: Mail order pharmacy use was positively associated with LDL-C control in new statin users. Future research should continue to explore the relationship between mail order pharmacy use and outcomes, and address how to appropriately target mail order services to patients most likely to benefit without compromising patient choice, care, and safety.

Smoking cessation treatment for individuals with comorbid diabetes and serious mental illness in an integrated health care delivery system.

INTRODUCTION: Smoking is a significant modifiable risk factor for mortality for persons with serious mental illness (SMI), who have a life expectancy 15-20 years shorter than the general population. Individuals with SMI and comorbid diabetes who are smokers face an even higher risk of cardiovascular complications and early death. Yet despite high rates of smoking among people with SMI, tobacco cessation interventions have not been broadly offered to this population. METHODS: We conducted a retrospective cohort study using electronic health records from 2014 in a large integrated care delivery system to examine whether use of smoking cessation pharmacotherapy among smokers with type 2 diabetes varies by serious mental illness (SMI) diagnosis. We analyzed smoking cessation medication prescription fills among adult smokers with diabetes, comparing those with SMI (N = 634) and without SMI (N = 18,021). Risk ratios were adjusted for age, gender, race, urban area type, and medical facility. RESULTS: Of the SMI group, 19.09% filled at least one smoking cessation prescription compared to 9.73% of the non-SMI group (adjusted risk ratio 1.80 [95% CI 1.52-2.13]; p < .001). For the SMI group, primary care providers wrote 80.24% of prescriptions, while psychiatrists wrote 8.81% of prescriptions. CONCLUSIONS: These findings offer an example of a delivery system with higher uptake of smoking cessation pharmacotherapy among people with SMI than without SMI, and highlight the opportunity to provide more smoking cessation interventions in mental health care settings.

Association of Cardiovascular Outcomes and Mortality With Sustained Long-Acting Insulin Only vs Long-Acting Plus Short-Acting Insulin Treatment.

Importance: Cardiovascular events and mortality are the principal causes of excess mortality and health care costs for people with type 2 diabetes. No large studies have specifically compared long-acting insulin alone with long-acting plus short-acting insulin with regard to cardiovascular outcomes. Objective: To compare cardiovascular events and mortality in adults with type 2 diabetes receiving long-acting insulin who do or do not add short-acting insulin. Design, Setting, and Participants: This retrospective cohort study emulated a randomized experiment in which adults with type 2 diabetes who experienced a qualifying glycated hemoglobin A1c (HbA1c) level of 6.8% to 8.5% with long-acting insulin were randomized to continuing treatment with long-acting insulin (LA group) or adding short-acting insulin within 1 year of the qualifying HbA1c level (LA plus SA group). Retrospective data in 4 integrated health care delivery systems from the Health Care Systems Research Network from January 1, 2005, to December 31, 2013, were used. Analysis used inverse probability weighting estimation with Super Learner for propensity score estimation. Analyses took place from April 1, 2018, to June 30, 2019. Exposures: Long-acting insulin alone or with added short-acting insulin within 1 year from the qualifying HbA1c level. Main Outcomes and Measures: Mortality, cardiovascular mortality, acute myocardial infarction, stroke, and hospitalization for heart failure. Results: Among 57 278 individuals (39 279 with data on cardiovascular mortality) with a mean (SD) age of 60.6 (11.5) years, 53.6% men, 43.5% non-Hispanic White individuals, and 4 years of follow-up (median follow-up of 11 [interquartile range, 5-20] calendar quarters), the LA plus SA group was associated with increased all-cause mortality compared with the LA group (hazard ratio, 1.27; 95% CI, 1.05-1.49) and a decreased risk of acute myocardial infarction (hazard ratio, 0.89; 95% CI, 0.81-0.97). Treatment with long-acting plus short-acting insulin was not associated with increased risks of congestive heart failure, stroke, or cardiovascular mortality. Conclusions and Relevance: Findings of this retrospective cohort study suggested an increased risk of all-cause mortality and a decreased risk of acute myocardial infarction for the LA plus SA group compared with the LA group. Given the lack of an increase in major cardiovascular events or cardiovascular mortality, the increased all-cause mortality with long-acting plus short-acting insulin may be explained by noncardiovascular events or unmeasured confounding.

Racial and Ethnic Disparities in Diabetes Care Quality among Women of Reproductive Age in an Integrated Delivery System.

BACKGROUND: Diabetes is increasingly prevalent among women of reproductive age, yet little is known about quality of diabetes care for this population at increased risk of diabetes complications and poor maternal and infant health outcomes. Previous studies have identified racial/ethnic disparities in diabetes care, but patterns among women of reproductive age have not been examined. METHODS: This retrospective cohort study analyzed 2016 data from Kaiser Permanente Northern California, a large integrated delivery system. Outcomes were quality of diabetes care measures-glycemic testing, glycemic control, and medication adherence-among women ages 18 to 44 with type 1 or type 2 diabetes (N = 9,923). Poisson regression was used to estimate the association between patient race/ethnicity and each outcome, adjusting for other patient characteristics and health care use. RESULTS: In this cohort, 83% of participants had type 2 diabetes; 31% and 36% of women with type 2 and type 1 diabetes, respectively, had poor glycemic control (hemoglobin A1c of ≥9%), and approximately one-third of women with type 2 diabetes exhibited nonadherence to diabetes medications. Compared with non-Hispanic White women with type 2 diabetes, non-Hispanic Black women (adjusted risk ratio, 1.2; 95% confidence interval, 1.1-1.3) and Hispanic women (adjusted risk ratio, 1.2; 95% confidence interval, 1.1-1.3) were more likely to have poor control. Findings among women with type 1 diabetes were similar. CONCLUSIONS: Our findings indicate opportunities to decrease disparities and improve quality of diabetes care for reproductive-aged women. Elucidating the contributing factors to poor glycemic control and medication adherence in this population, particularly among Black, Hispanic, and Asian women, should be a high research and practice priority.

Comparison of Mortality and Major Cardiovascular Events Among Adults With Type 2 Diabetes Using Human vs Analogue Insulins.

Importance: The comparative cardiovascular safety of analogue and human insulins in adults with type 2 diabetes who initiate insulin therapy in usual care settings has not been carefully evaluated using machine learning and other rigorous analytic methods. Objective: To examine the association of analogue vs human insulin use with mortality and major cardiovascular events. Design, Setting, and Participants: This retrospective cohort study included 127 600 adults aged 21 to 89 years with type 2 diabetes at 4 health care delivery systems who initiated insulin therapy from January 1, 2000, through December 31, 2013. Machine learning and rigorous inference methods with time-varying exposures were used to evaluate associations of continuous exposure to analogue vs human insulins with mortality and major cardiovascular events. Data were analyzed from September 1, 2017, through June 30, 2018. Exposures: On the index date (first insulin dispensing), participants were classified as using analogue insulin with or without human insulin or human insulin only. Main Outcomes and Measures: Overall mortality, mortality due to cardiovascular disease (CVD), myocardial infarction (MI), stroke or cerebrovascular accident (CVA), and hospitalization for congestive heart failure (CHF) were evaluated. Marginal structural modeling (MSM) with inverse probability weighting was used to compare event-free survival in separate per-protocol analyses. Adjusted and unadjusted hazard ratios and cumulative risk differences were based on logistic MSM parameterizations for counterfactual hazards. Propensity scores were estimated using a data-adaptive approach (machine learning) based on 3 nested covariate adjustment sets. Sensitivity analyses were conducted to address potential residual confounding from unmeasured differences in risk factors across delivery systems. Results: The 127 600 participants (mean [SD] age, 59.4 [12.6] years; 68 588 men [53.8%]; mean [SD] body mass index, 32.3 [7.1]) had a median follow-up of 4 quarters (interquartile range, 3-9 quarters) and experienced 5464 deaths overall (4.3%), 1729 MIs (1.4%), 1301 CVAs (1.0%), and 3082 CHF hospitalizations (2.4%). There were no differences in adjusted hazard ratios for continuous analogue vs human insulin exposure during 10 quarters for overall mortality (1.15; 95% CI, 0.97-1.34), CVD mortality (1.26; 95% CI, 0.86-1.66), MI (1.11; 95% CI, 0.77-1.45), CVA (1.30; 95% CI, 0.81-1.78), or CHF hospitalization (0.93; 95% CI, 0.75-1.11). Conclusions and Relevance: Insulin-naive adults with type 2 diabetes who initiate and continue treatment with human vs analogue insulins had similar observed rates of major cardiovascular events, CVD mortality, and overall mortality.

Reflections on a project to prevent suicide and self-harm among prisoners identified as high risk in two prisons in Northern England.

BACKGROUND: This article critically explores the implementation and evaluation of a project designed, delivered and evaluated by frontline staff to improve prison responses to prisoner suicide and self-harm. We begin by evidencing the need for the project and detail its content, delivery and attempts at evaluation. We draw on the reflections of the three practitioners most closely involved in its development, delivery and review in order to explore lessons learned for future staff-led projects including those aimed at tackling prison suicide and self-harm. RESULTS: Findings from staff reflections suggest that the development, implementation and evaluation of the project were influenced by a combination of issues around: project focus, communication and professional relationships, the institutional environment, funding and time, roll-out and evaluation, and the need for a 'champion' role. CONCLUSIONS: There is limited evidence that the project left a modest positive legacy in terms of impact. A more substantial legacy of the project is provided in terms of actionable learning points for future projects of this nature.

Using Neighborhood-Level Census Data to Predict Diabetes Progression in Patients with Laboratory-Defined Prediabetes.

CONTEXT: Research on predictors of clinical outcomes usually focuses on the impact of individual patient factors, despite known relationships between neighborhood environment and health. OBJECTIVE: To determine whether US census information on where a patient resides is associated with diabetes development among patients with prediabetes. DESIGN: Retrospective cohort study of all 157,752 patients aged 18 years or older from Kaiser Permanente Northern California with laboratory-defined prediabetes (fasting plasma glucose, 100 mg/dL-125 mg/dL, and/or glycated hemoglobin, 5.7%-6.4%). We assessed whether census data on education, income, and percentage of households receiving benefits through the US Department of Agriculture's Supplemental Nutrition Assistance Program (SNAP) was associated with diabetes development using logistic regression controlling for age, sex, race/ethnicity, blood glucose levels, and body mass index. MAIN OUTCOME MEASURE: Progression to diabetes within 36 months. RESULTS: Patients were more likely to progress to diabetes if they lived in an area where less than 16% of adults had obtained a bachelor's degree or higher (odds ratio [OR] =1.22, 95% confidence interval [CI] = 1.09-1.36), where median annual income was below $79,999 (OR = 1.16 95% CI = 1.03-1.31), or where SNAP benefits were received by 10% or more of households (OR = 1.24, 95% CI = 1.1-1.4). CONCLUSION: Area-level socioeconomic and food assistance data predict the development of diabetes, even after adjusting for traditional individual demographic and clinical factors. Clinical interventions should take these factors into account, and health care systems should consider addressing social needs and community resources as a path to improving health outcomes.