COVID-19-Related Outcomes Among Group Home Residents with Serious Mental Illness in Massachusetts in the First Year of the Pandemic.

This study examined COVID-19 infection and hospitalizations among people with serious mental illness who resided in residential care group homes in Massachusetts during the first year of the COVID-19 pandemic. The authors analyzed data on 2261 group home residents and COVID-19 data from the Massachusetts Department of Public Health. Outcomes included positive COVID-19 tests and COVID-19 hospitalizations March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2). Associations between hazard of outcomes and resident and group home characteristics were estimated using multi-level Cox frailty models including home- and city-level frailties. Between March 2020 and March 2021, 182 (8%) residents tested positive for COVID-19, and 51 (2%) had a COVID-19 hospitalization. Compared with the Massachusetts population, group home residents had age-adjusted rate ratios of 3.0 (4.86 vs. 1.60 per 100) for COVID infection and 13.5 (1.99 vs. 0.15 per 100) for COVID hospitalizations during wave 1; during wave 2, the rate ratios were 0.5 (4.55 vs. 8.48 per 100) and 1.7 (0.69 vs. 0.40 per 100). In Cox models, residents in homes with more beds, higher staff-to-resident ratios, recent infections among staff and other residents, and in cities with high community transmission risk had greater hazard of COVID-19 infection. Policies and interventions that target group home-specific risks are needed to mitigate adverse communicable disease outcomes in this population.Clinical Trial Registration Number This study provides baseline (i.e., pre-randomization) data from a clinical trial study NCT04726371.

Lithium plus antipsychotics or anticonvulsants for bipolar disorder: Comparing clinical response and metabolic changes.

OBJECTIVE: Patients with bipolar disorder treated with lithium often require additional antipsychotics or anticonvulsants. However, the comparative effectiveness and safety of these agents as add-on to lithium has not been studied. METHODS: This secondary analysis combined two similar 24-week trials on outpatients with bipolar disorder randomized to lithium (target serum level 0.4-0.6 mEq/L). Guideline-based adjunctive antipsychotics (Li+AP) and anticonvulsants (Li+AC) could be used if clinically indicated and was assessed at every study visit. Response was measured on the Clinical Global Impression scale and we performed adjusted mixed effects linear regression analyses. Analysis of variance tests compared metabolic measures including a binary diagnosis of metabolic syndrome before and after 24 weeks of treatment. RESULTS: Among 379 outpatients (57% female, mean age 38 years, mean Clinical Global Impression 4.4), users of Li+AP (N = 50, primarily quetiapine and aripiprazole) improved to a similar degree (mean Clinical Global Impression improvement = 1.6, standard deviation = 1.5) as those using lithium-only (i.e. without adjunctive antipsychotics or anticonvulsants, N = 149, mean Clinical Global Impression improvement = 1.7, standard deviation = 1.4) (p = 0.59). Users of Li+AC (N = 107, primarily lamotrigine and valproate, mean Clinical Global Impression improvement = 1.2, standard deviation = 1.3) and users of Li+AP+AC (N = 73, mean Clinical Global Impression improvement = 1.1, standard deviation = 1.3) showed worse response compared to lithium-only users (all p < 0.01). When comparing Li+AP to Li+AC, users of Li+AP improved slightly better on general (p = 0.05) and manic symptoms (p = 0.01), but showed a worse development of glucose, triglycerides, and metabolic syndrome. CONCLUSION: Despite treatment-by-indication confounding, these findings are relevant for real-world treatment settings and emphasize the need for randomized trials on this clinically important topic.

Geographic access to federally qualified health centers before and after the affordable care act.

BACKGROUND: The Affordable Care Act (ACA) increased funding for Federally Qualified Health Centers (FQHCs). We defined FQHC service areas based on patient use and examined the characteristics of areas that gained FQHC access post-ACA. METHODS: We defined FQHC service areas using total patient counts by ZIP code from the Uniform Data System (UDS) and compared this approach with existing methods. We then compared the characteristics of ZIP codes included in Medically Underserved Areas/Populations (MUA/Ps) that gained access vs. MUA/P ZIP codes that did not gain access to FQHCs between 2011-15. RESULTS: FQHC service areas based on UDS data vs. Primary Care Service Areas or counties included a higher percentage of each FQHC's patients (86% vs. 49% and 71%) and ZIP codes with greater use of FQHCs among low-income residents (29% vs. 22% and 22%), on average. MUA/Ps that gained FQHC access 2011-2015 included more poor, uninsured, publicly insured, and foreign-born residents than underserved areas that did not gain access, but were less likely to be rural (p < .05). CONCLUSIONS: Measures of actual patient use provide a promising method of assessing FQHC service areas and access. Post-ACA funding, the FQHC program expanded access into areas that were more likely to have higher rates of poverty and uninsurance, which could help address disparities in access to care. Rural areas were less likely to gain access to FQHCs, underscoring the persistent challenges of providing care in these areas.

Payment Discrepancies and Access to Primary Care Physicians for Dual-eligible Medicare-Medicaid Beneficiaries.

BACKGROUND: Physicians often receive lower payments for dual-eligible Medicare-Medicaid beneficiaries versus nondual Medicare beneficiaries because of state reimbursement caps. The Affordable Care Act (ACA) primary care fee bump temporarily eliminated this differential in 2013-2014. OBJECTIVE: To examine how dual payment policy impacts primary care physicians' (PCP) acceptance of duals. RESEARCH DESIGN: We assessed differences in the likelihood that PCPs had dual caseloads of ≥10% or 20% in states with lower versus full dual reimbursement using linear probability models adjusted for physician and area-level traits. Using a triple-difference approach, we examined changes in dual caseloads for PCPs versus a control group of specialists in states with fee bumps versus no change during years postbump versus prebump. SUBJECTS: PCPs and specialists (cardiologists, orthopedic surgeons, general surgeons) that billed fee-for-service Medicare. MEASURES: State dual payment policies and physicians' dual caseloads as a percentage of their Medicare patients. RESULTS: In 2012, 81% of PCPs had dual caseloads of ≥10% and this was less likely among PCPs in states with lower versus full dual reimbursement (eg, difference=-4.52 percentage points; 95% confidence interval, -6.80 to -2.25). The proportion of PCPs with dual caseloads of ≥10% or 20% decreased significantly between 2012 and 2017 and the fee bump was not consistently associated with increases in dual caseloads. CONCLUSIONS: Pre-ACA, PCPs' participation in the dual program appeared to be lower in states with lower reimbursement for duals. Despite the ACA fee bump, dual caseloads declined over time, raising concerns of worsening access to care.

Adjunctive antidepressant treatment among 763 outpatients with bipolar disorder: Findings from the Bipolar CHOICE and LiTMUS trials.

BACKGROUND: Adjunctive antidepressants are frequently used for bipolar depression but their clinical efficacy has been studied in few trials and little is known about how co-occurring manic symptoms affect treatment response. METHODS: Bipolar Clinical Health Outcomes Initiative in Comparative Effectiveness (N = 482) and Lithium Treatment Moderate-Dose Use Study (N = 281) were similar comparative effectiveness trials on outpatients with bipolar disorder comparing four different randomized treatment arms with adjunctive personalized guideline-based treatment for 24 weeks. Adjunctive antidepressant treatment could be used if clinically indicated and was assessed at every study visit. Adjusted mixed effects linear regression analyses compared users of antidepressants to nonusers overall and in different subcohorts. RESULTS: Of the 763 patients, 282 (37.0%) used antidepressant drugs during the study. Antidepressant users had less improvement compared to nonusers on the Clinical Global Impression Scale for Bipolar Disorder and on measures of depression. This was particularly true among patients with co-occurring manic symptoms. Exclusion of individuals begun on antidepressants late in the study (potentially due to overall worse response) resulted in no differences between users and nonusers. We found no differences in treatment effects on mania scales. CONCLUSIONS: In this large cohort of outpatients with bipolar disorder, clinically indicated and guideline-based adjunctive antidepressant treatment was not associated with lower depressive symptoms or higher mania symptoms. The treatment-by-indication confounding due to the nonrandomized design of the trials complicates causal interpretations, but no analyses indicated better treatment effects of adjunctive antidepressants.

The Impact of Changes in Medicaid Provider Fees on Provider Participation and Enrollees' Care: a Systematic Literature Review.

BACKGROUND: Changing Medicaid fees is a common approach for states to address budget fluctuations, and many currently set Medicaid physician fees at levels lower than Medicare and private insurers. The Affordable Care Act included a temporary Medicaid fee bump for primary care providers (PCPs) in 2013-2014 that recently led to both an increase and then subsequent decrease in PCP fees in many states. OBJECTIVE: To conduct a systematic literature review on the effects of changing Medicaid fees on provider participation and enrollees' access to care and service use. METHODS: We searched PubMed/Medline and JSTOR and identified 18 studies that assessed the longitudinal impact of provider fee changes in Medicaid on the outcomes of interest. We summarized information on study design, methods, and findings. RESULTS: Seven studies examined the impact of fee changes on provider participation in Medicaid. Of these, three studies found that fee increases were associated with positive effects on providers' likelihood of accepting Medicaid patients or on their Medicaid caseloads. Five studies that examined the impact of fee changes on Medicaid enrollees' access to care found a positive association with one or more access measure, such as having a usual source of care or appointment availability. Lastly, eight of 14 studies that examined service use found positive associations between fee changes and at least one measure of use, such as changes in the probability of enrollees having any visit, the number of visits, and shifts in the site of care toward office-based care; others largely did not find significant associations. CONCLUSIONS: There is mixed evidence on the impact of changing Medicaid fees on provider participation and enrollees' service use; however, increasing fees appears to have more consistent positive effects on access to care. Whether these improvements in access translate into better health outcomes or downstream cost savings are critical questions.

Cigarette Smoking and Quitting-Related Factors Among US Adult Health Center Patients with Serious Mental Illness.

INTRODUCTION: US adults with serious mental illness (SMI), compared to those without SMI, have a higher prevalence of smoking, which contributes to a shorter life expectancy. This study compared current smoking and quitting-related characteristics of low-income US adults with and without SMI who received healthcare at federally funded health centers. METHODS: Using cross-sectional data from adults ≥ 18 years old in the nationally representative 2014 Health Center Patient Survey (n = 5592), we compared the prevalence of ever and current smoking among adults with and without SMI and calculated quit ratios as the percentage of ever smokers who have quit smoking. We examined the association between SMI and receiving advice to quit, making quit attempts, and having plans to quit in the next 30 days using multivariable logistic regression. RESULTS: A total of 1376 (23%) of participants had SMI. Ever smoking prevalence was 68% in adults with SMI and 41% in adults without SMI, and current smoking prevalence was 48% and 22%, respectively. The quit ratio was 30% and 46% among participants with and without SMI, respectively. Compared to smokers without SMI, more smokers with SMI reported receiving advice to quit in the past 12 months (aOR 2.47, 95% CI 1.20-5.07). Smokers with and without SMI did not differ significantly in their odds of having made a past-12-month quit attempt or plans to quit. CONCLUSIONS: Smokers with SMI seen in federally funded health centers were just as likely to have made a quit attempt and to have plans to quit as smokers without SMI. Despite a higher likelihood of receiving clinician advice to quit, the lower quit ratio in this population suggests that advice alone is unlikely to be sufficient. These results underscore the need for augmented strategies to promote smoking cessation and reduce the excess burden of tobacco-related disease in patients with SMI.

Access to care among Medicaid and uninsured patients in community health centers after the Affordable Care Act.

BACKGROUND: The Affordable Care Act expanded Medicaid and increased federal funding for Community Health Centers (CHCs). To examine the role of Medicaid coverage on care patterns for those with available safety net care, we assessed differences in access to care for CHC patients with continuous Medicaid coverage vs. gaps in insurance coverage in the last year. METHODS: We used data on adult respondents from the 2014 Health Center Patient Survey (N = 1720) with continuous Medicaid coverage vs. those with some period without insurance coverage in the last 12 months. We examined reported need for any medical care, mental health care, prescription drugs, dental care, and referrals for care outside of the CHC in the last 12 months, and reports of being delayed or unable to get needed care by insurance status. We used logistic regression to assess the association between insurance status and care access, adjusting for patient characteristics. RESULTS: Patients with insurance gaps and continuous Medicaid coverage reported similar levels of need for most types of care in the last 12 months, but those with insurance gaps were significantly more likely to report having difficulty obtaining medical care, prescription drugs, dental care, and completing outside referrals. Of those with incomplete referrals for care outside of the CHC, patients with insurance gaps were more likely than those with continuous Medicaid to cite cost or insurance-related reasons for not following up (70% vs. 19%, p < 0.01). CONCLUSIONS: Having continuous Medicaid coverage appeared to mitigate barriers to care for CHC patients compared to having intermittent or no insurance coverage over the last year. Policies that increase disruptions in Medicaid coverage could adversely impact access to care, even among those with available safety net care.

Racial disparities in family-provider interactions for pediatric asthma care.

OBJECTIVE: Black and Latino children experience significantly worse asthma morbidity than their white peers for multifactorial reasons. This study investigated differences in family-provider interactions for pediatric asthma, based on race/ethnicity. METHODS: This was a cross-sectional study of parent surveys of asthmatic children within the Population-Based Effectiveness in Asthma and Lung Diseases Network. Our study population comprised 647 parents with survey response data. Data on self-reported race/ethnicity of the child were collected from parents of the children with asthma. Outcomes studied were responses to the questions about family-provider interactions in the previous 12 months: (1) number of visits with asthma provider; (2) number of times provider reviewed asthma medications with patient/family; (3) review of a written asthma treatment plan with provider; and (4) preferences about making asthma decisions. RESULTS: In multivariate adjusted analyses controlling for asthma control and other co-morbidities, black children had fewer visits in the previous 12 months for asthma than white children: OR 0.63 (95% CI 0.40, 0.99). Additionally, black children were less likely to have a written asthma treatment plan given/reviewed by a provider than their white peers, OR 0.44 (95% CI 0.26, 0.75). There were no significant differences by race in preferences about asthma decision-making nor in the frequency of asthma medication review. CONCLUSION: Black children with asthma have fewer visits with their providers and are less likely to have a written asthma treatment plan than white children. Asthma providers could focus on improving these specific family-provider interactions in minority children.

Statin exposure is associated with decreased asthma-related emergency department visits and oral corticosteroid use.

RATIONALE: Statins, or HMG-CoA reductase inhibitors, may aid in the treatment of asthma through their pleiotropic antiinflammatory effects. OBJECTIVES: To examine the effect of statin therapy on asthma-related exacerbations using a large population-based cohort. METHODS: Statin users aged 31 years or greater with asthma were identified from the Population-Based Effectiveness in Asthma and Lung population, which includes data from five health plans. Statin exposure and asthma exacerbations were assessed over a 24-month observation period. Statin users with a statin medication possession ratio greater than or equal to 80% were matched to non-statin users by age, baseline asthma therapy, site of enrollment, season at baseline, and propensity score, which was calculated based on patient demographics and Deyo-Charlson conditions. Asthma exacerbations were defined as two or more oral corticosteroid dispensings, asthma-related emergency department visits, or asthma-related hospitalizations. The association between statin exposure and each of the three outcome measures was assessed using conditional logistic regression. MEASUREMENTS AND MAIN RESULTS: Of the 14,566 statin users, 8,349 statin users were matched to a nonuser. After adjusting for Deyo-Charlson conditions that remained unbalanced after matching, among statin users, statin exposure was associated with decreased odds of having asthma-related emergency department visits (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.53-0.77; P < 0.0001) and two or more oral corticosteroid dispensings (OR, 0.90; 95% CI, 0.81-0.99; P = 0.04). There were no differences in asthma-related hospitalizations (OR, 0.91; 95% CI, 0.66-1.24; P = 0.52). CONCLUSIONS: Among statin users with asthma, statin exposure was associated with decreased odds of asthma-related emergency department visits and oral corticosteroid dispensings.

Implementing automated Medicaid eligibility renewals was not associated with higher levels of program participation.

Increasing participation in Medicaid among eligible individuals is critical for improving access to care among low-income populations. The administrative burdens of enrolling and renewing eligibility are a major barrier to participation. To reduce these burdens, the Affordable Care Act required states to adopt automated renewal processes that use available databases to verify ongoing eligibility. By 2019, nearly all states adopted automated renewals, but little is known about how this policy affected Medicaid participation rates. Using the 2015-2019 American Community Survey, we found that participation rates among nondisabled, nonelderly adults and children varied widely by state, with an average of 70.8% and 90.7%, respectively. Among Medicaid-eligible adults, participation was lower among younger adults, males, unmarried individuals, childless households, and those living in non-expansion states compared with their counterparts. State adoption of automated renewals varied over time, but participation rates were not associated with adoption. This finding could reflect limitations to current automated renewal processes or barriers to participation outside of the eligibility renewal process, which will be important to address as additional states expand Medicaid and pandemic-era protections on enrollment expire.

Medical and Psychiatric Care Preceding the First Psychotic Disorder Diagnosis.

BACKGROUND: Individuals with psychotic symptoms experience substantial morbidity and have shortened life expectancies; early treatment may mitigate the worst effects. Understanding care preceding a first psychotic disorder diagnosis is critical to inform early detection and intervention. STUDY DESIGN: In this observational cohort study using comprehensive information from the Massachusetts All-Payer Claims Database, we identified the first psychotic disorder diagnosis in 2016, excluding those with historical psychotic disorder diagnoses in the prior 48 months among those continuous enrollment data. We reviewed visits, medications, and hospitalizations 2012-2016. We used logistic regression to examine characteristics associated with pre-diagnosis antipsychotic use. STUDY RESULTS: There were 2505 individuals aged 15-35 years (146 per 100 000 similarly aged individuals in the database) with a new psychotic disorder diagnosis in 2016. Most (97%) had at least one outpatient visit in the preceding 48 months; 89% had a prior mental health diagnosis unrelated to psychosis (eg, anxiety [60%], depression [60%]). Many received psychotropic medications (77%), including antipsychotic medications (46%), and 68% had a visit for injury or trauma during the preceding 48 months. Characteristics associated with filling an antipsychotic medication before the psychotic disorder diagnosis included male sex and Medicaid insurance at psychosis diagnosis. CONCLUSIONS: In this insured population of Massachusetts residents with a new psychotic disorder diagnosis, nearly all had some healthcare utilization, visits for injury or trauma were common, and nearly half filled an antipsychotic medication in the preceding 48 months. These patterns of care could represent either pre-disease signals, delays, or both in receiving a formal diagnosis.

The Impact of the Medicaid Reimbursement Bump on Influenza Vaccination Rates Among US Teens: Evidence from the National Immunization Survey-Teen 2011-2020.

BACKGROUND: Many adolescents do not receive basic preventive care such as influenza vaccinations. The Affordable Care Act (ACA) temporarily increased Medicaid reimbursements for primary care services, including vaccine administration, in 2013 to 2014. The objective of this study is to assess the impact of reimbursement increases on influenza vaccination rates among adolescents with Medicaid. METHODS: This repeated cross-sectional study used a difference-in-difference approach to compare changes in annual influenza vaccination rates for 20,884 adolescents 13 to 17 years old covered by Medicaid with adequate provider-reported data in 18 states with larger extended (>$5, 2013 to 2019) versus larger temporary (2013 to 2014 only) versus smaller reimbursement changes. We used linear probability models with individual-level random effects, adjusting for state and individual characteristics and annual time trends to assess the impact of a Medicaid vaccine administration reimbursement increase on annual influenza vaccination. RESULTS: Mean Medicaid reimbursements for vaccine administration doubled from 2011 to 2013 to 2014 (eg, from $11 to $22 for CPT 90460). States with smaller reimbursement changes had higher mean reimbursements and higher adjusted vaccination rates at baseline (2011) compared with states with larger temporary and extended reimbursement changes. The reimbursement change was not associated with increases in influenza vaccination rates. DISCUSSION: Influenza vaccination rates were low among adolescents with Medicaid throughout the study period, particularly in states with lower Medicaid reimbursement levels before the ACA. CONCLUSION: That reimbursement increases were not associated with higher vaccination rates suggests additional efforts are needed to improve influenza vaccination rates in this population.

Association of food insecurity with changes in diet quality, weight, and glycemia over two years in adults with prediabetes and type 2 diabetes on medicaid.

Little is known about longitudinal associations between food insecurity (FI) and diet, weight, and glycemia in people with prediabetes and type 2 diabetes (T2D). In a secondary analysis of Medicaid-enrolled health center patients with prediabetes or T2D in Boston, Massachusetts (N = 188), we examined associations between food security (FS) and measures of diet quality, weight, and hyperglycemia. FS (10-item USDA FS module) was ascertained at baseline, 1-year, and 2-year follow-up and categorized as persistently secure, intermittently insecure, or persistently insecure. Associations between FS category and changes in Healthy Eating Index-2020 (HEI-20), body mass index (BMI), and hemoglobin A1c (A1c) from baseline to year 2 were assessed using multivariate generalized linear models. Participants had median (p25, p75) age of 52 (42, 57); 71.8% were female and 62.8% Hispanic. Over follow-up, 32.4% were persistently food secure, 33.0% intermittently insecure, and 34.5% persistently insecure. Baseline mean (SD) HEI-20, BMI, and A1c were 55.8 (14.5), 35.9 (8.7) kg/m2, 7.1% (1.6) and did not differ by FS category. FS category was not associated with changes in HEI-20, BMI, and A1c at 2 years (all p > 0.05). Results suggest that Medicaid-enrolled adults with prediabetes or T2D, regardless of FS status, would benefit from dietary and weight management interventions.

Associations Between Annual Medicare Part D Low-Income Subsidy Loss and Prescription Drug Spending and Use.

Importance: The Medicare Part D Low Income Subsidy (LIS) program provides millions of beneficiaries with drug plan premium and cost-sharing assistance. The extent to which LIS recipients experience subsidy losses with annual redetermination cycles and the resulting associations with prescription drug affordability and use are unknown. Objective: To examine how frequently annual LIS benefits are lost among Medicare Part D beneficiaries and how this is associated with prescription drug use and out-of-pocket costs. Design, Setting, and Participants: In this cohort study of Medicare Part D beneficiaries from 2007 to 2018, annual changes in LIS recipients among those automatically deemed eligible (eg, due to dual eligibility for Medicare and Medicaid) and nondeemed beneficiaries who must apply for LIS benefits were analyzed using Medicare enrollment and Part D event data. Subsidy losses were classified in 4 groups: temporary losses (<1 year); extended losses (≥1 year); subsidy reductions (change to partial LIS); and disenrollment from Medicare Part D after subsidy loss. Temporary losses could more likely represent subsidy losses among eligible beneficiaries. Multinomial logit models were used to examine associations between beneficiary characteristics and subsidy loss; linear regression models were used to compare changes in prescription drug cost and use in the months after subsidy losses vs before. Analyses were conducted between November 2022 and November 2023. Exposure: Subsidy loss at the beginning of each year among subsidy recipients in December of the prior year. Main Outcomes and Measures: The main outcomes were out-of-pocket costs and prescription drug fills overall and for 4 classes: antidiabetes, antilipid, antidepressant, and antipsychotic drugs. Results: In 2008, 731 070 full LIS beneficiaries (17%) were not deemed automatically eligible (39% were aged <65 years; 59% were female). Nearly all beneficiaries deemed automatically eligible (≥99%) retained the subsidy annually from 2007 to 2018, compared with 78% to 84% of nondeemed beneficiaries. Among nondeemed beneficiaries, disabled individuals younger than 65 years and racial and ethnic minority groups were more likely to have temporary subsidy losses vs none. Temporary losses were associated with an average 700% increase in out-of-pocket drug costs (+$52.72/mo [95% CI, 52.52-52.92]) and 15% reductions in prescription fills (-0.58 fills/mo [95% CI, -0.59 to -0.57]) overall. Similar changes were found for antidiabetes, antilipid, antidepressant, and antipsychotic prescription drug classes. Beneficiaries who retained their subsidy had few changes. Conclusions and Relevance: The conclusions of this cohort study suggest that efforts to help eligible beneficiaries retain Medicare Part D subsidies could improve drug affordability, treatment adherence, and reduce disparities in medication access.

Using simulation modeling to inform intervention and implementation selection in a rapid stakeholder-engaged hybrid effectiveness-implementation randomized trial.

BACKGROUND: Implementation research generally assumes established evidence-based practices and prior piloting of implementation strategies, which may not be feasible during a public health emergency. We describe the use of a simulation model of the effectiveness of COVID-19 mitigation strategies to inform a stakeholder-engaged process of rapidly designing a tailored intervention and implementation strategy for individuals with serious mental illness (SMI) and intellectual/developmental disabilities (ID/DD) in group homes in a hybrid effectiveness-implementation randomized trial. METHODS: We used a validated dynamic microsimulation model of COVID-19 transmission and disease in late 2020/early 2021 to determine the most effective strategies to mitigate infections among Massachusetts group home staff and residents. Model inputs were informed by data from stakeholders, public records, and published literature. We assessed different prevention strategies, iterated over time with input from multidisciplinary stakeholders and pandemic evolution, including varying symptom screening, testing frequency, isolation, contact-time, use of personal protective equipment, and vaccination. Model outcomes included new infections in group home residents, new infections in group home staff, and resident hospital days. Sensitivity analyses were performed to account for parameter uncertainty. Results of the simulations informed a stakeholder-engaged process to select components of a tailored best practice intervention and implementation strategy. RESULTS: The largest projected decrease in infections was with initial vaccination, with minimal benefit for additional routine testing. The initial level of actual vaccination in the group homes was estimated to reduce resident infections by 72.4% and staff infections by 55.9% over the 90-day time horizon. Increasing resident and staff vaccination uptake to a target goal of 90% further decreased resident infections by 45.2% and staff infections by 51.3%. Subsequent simulated removal of masking led to a 6.5% increase in infections among residents and 3.2% among staff. The simulation model results were presented to multidisciplinary stakeholders and policymakers to inform the "Tailored Best Practice" package for the hybrid effectiveness-implementation trial. CONCLUSIONS: Vaccination and decreasing vaccine hesitancy among staff were predicted to have the greatest impact in mitigating COVID-19 risk in vulnerable populations of group home residents and staff. Simulation modeling was effective in rapidly informing the selection of the prevention and implementation strategy in a hybrid effectiveness-implementation trial. Future implementation may benefit from this approach when rapid deployment is necessary in the absence of data on tailored interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04726371.

Predictors of COVID-19 infection and hospitalization in group homes for individuals with intellectual and/or developmental disabilities.

BACKGROUND: More than seven million people with intellectual and/or developmental disabilities (ID/DD) live in the US and may face an elevated risk for COVID-19. OBJECTIVE: To identify correlates of COVID-19 and related hospitalizations among people with ID/DD in group homes in Massachusetts. METHODS: We collected data during March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2) from the Massachusetts Department of Public Health and six organizations administering 206 group homes for 1035 residents with ID/DD. The main outcomes were COVID-19 infections and related hospitalizations. We fit multilevel Cox proportional hazards models to estimate associations with observed predictors and assess contextual home- and organizational-level effects. RESULTS: Compared with Massachusetts residents, group home residents had a higher age-adjusted rate of COVID-19 in wave 1 (incidence rate ratio [IRR], 12.06; 95 % confidence interval [CI], 10.51-13.84) and wave 2 (IRR, 2.47; 95 % CI, 2.12-2.88) and a higher age-adjusted rate of COVID-19 hospitalizations in wave 1 (IRR, 17.64; 95 % CI, 12.59-24.70) and wave 2 (IRR, 4.95; 95 % CI, 3.23-7.60). COVID-19 infections and hospitalizations were more likely among residents aged 65+ and in group homes with 6+ resident beds and recent infection among staff and residents. CONCLUSIONS: Aggressive efforts to decrease resident density, staff-to-resident ratios, and staff infections through efforts such as vaccination, in addition to ongoing access to personal protective equipment and COVID-19 testing, may reduce COVID-19 and related hospitalizations in people with ID/DD living in group homes.

Adverse clinical events among medicare beneficiaries using antipsychotic drugs: linking health insurance benefits and clinical needs.

OBJECTIVE: Medicare Part D provides formulary protections for antipsychotics but does not exempt these drugs from cost-sharing. We investigated the impact of Part D coverage on antipsychotic drug spending, adherence, and clinical outcomes among beneficiaries with varying indications for use. METHODS: We conducted a historical cohort study of Medicare Advantage beneficiaries who received antipsychotic drugs, with diagnoses of schizophrenia or bipolar disorder or with no mental health diagnoses (N=10,190). Half had a coverage gap; half had no gap because of low-income subsidies. Using fixed effects regression models, we examined changes in spending and adherence as beneficiaries experienced cost-sharing increases after reaching the gap. We examined changes in hospitalizations and emergency department visits using proportional hazard models. RESULTS: Across all diagnostic groups, total monthly expenditure on antipsychotic drugs decreased with cost-sharing increases in the gap compared with those with no gap (eg, schizophrenia: -$123 95% confidence interval [-$138, -$108]), and out-of-pocket spending increased (eg, schizophrenia: $104 [$98, $110]). Adherence similarly decreased, with the largest declines among those with schizophrenia (-20.6 percentage points [-22.3, -18.9] in proportion of days covered). Among beneficiaries with schizophrenia and bipolar disorder, hospitalizations and emergency department visit rates increased with cost-sharing increases (eg, schizophrenia: hazard ratio=1.32 [1.06, 1.65] for all hospitalizations), but did not among subjects without mental health diagnoses. Clinical event rates did not change among beneficiaries with low-income subsidies without gaps. CONCLUSIONS: There is evidence of interruptions in antipsychotic use attributable to Part D cost-sharing. Adverse events increased among beneficiaries with approved indications for use, but not among beneficiaries without such indications.