Global impacts of COVID-19 pandemic on sexual and reproductive health services: An international comparative study on primary care from the INTRePID Consortium.

OBJECTIVE: To understand how the COVID-19 pandemic has impacted sexual and reproductive health (SRH) visits. DESIGN: An ecological study comparing SRH services volume in different countries before and after the onset of the COVID-19 pandemic. SETTING: Seven countries from the INTernational ConsoRtium of Primary Care BIg Data Researchers (INTRePID) across four continents. POPULATION: Over 3.8 million SRH visits to primary care physicians in Australia, China, Canada, Norway, Singapore, Sweden and the USA. METHODS: Difference in average SRH monthly visits before and during the pandemic, with negative binomial regression modelling to compare predicted and observed number of visits during the pandemic for SRH visits. MAIN OUTCOME MEASURES: Monthly number of visits to primary care physicians from 2018 to 2021. RESULTS: During the pandemic, the average volume of monthly SRH visits increased in Canada (15.6%, 99% CI 8.1-23.0%) where virtual care was pronounced. China, Singapore, Sweden and the USA experienced a decline (-56.5%, 99% CI -74.5 to -38.5%; -22.7%, 99% CI -38.8 to -6.5%; -19.4%, 99% CI -28.3 to -10.6%; and -22.7%, 99% CI -38.8 to -6.5%, respectively); while Australia and Norway showed insignificant changes (6.5%, 99% CI -0.7 to -13.8% and 1.7%, 99% CI -6.4 to -9.8%). The countries that maintained (Australia, Norway) or surpassed (Canada) pre-pandemic visit rates had the greatest use of virtual care. CONCLUSIONS: In-person SRH visits to primary care decreased during the pandemic. Virtual care seemed to counterbalance that decline. Although cervical cancer screening appeared insensitive to virtual care, strategies such as incorporating self-collected samples for HPV testing may provide a solution in a future pandemic.

A Cluster Randomized Trial of Primary Care Practice Redesign to Integrate Behavioral Health for Those Who Need It Most: Patients With Multiple Chronic Conditions.

PURPOSE: Patient outcomes can improve when primary care and behavioral health providers use a collaborative system of care, but integrating these services is difficult. We tested the effectiveness of a practice intervention for improving patient outcomes by enhancing integrated behavioral health (IBH) activities. METHODS: We conducted a pragmatic, cluster randomized controlled trial. The intervention combined practice redesign, quality improvement coaching, provider and staff education, and collaborative learning. At baseline and 2 years, staff at 42 primary care practices completed the Practice Integration Profile (PIP) as a measure of IBH. Adult patients with multiple chronic medical and behavioral conditions completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29) survey. Primary outcomes were the change in 8 PROMIS-29 domain scores. Secondary outcomes included change in level of integration. RESULTS: Intervention assignment had no effect on change in outcomes reported by 2,426 patients who completed both baseline and 2-year surveys. Practices assigned to the intervention improved PIP workflow scores but not PIP total scores. Baseline PIP total score was significantly associated with patient-reported function, independent of intervention. Active practices that completed intervention workbooks (n = 13) improved patient-reported outcomes and practice integration (P ≤ .05) compared with other active practices (n = 7). CONCLUSION: Intervention assignment had no effect on change in patient outcomes; however, we did observe improved patient outcomes among practices that entered the study with greater IBH. We also observed more improvement of integration and patient outcomes among active practices that completed the intervention compared to active practices that did not. Additional research is needed to understand how implementation efforts to enhance IBH can best reach patients.

Subcutaneous Insulin Versus Traditional Intravenous Insulin Infusion in Treatment of Mild to Moderate Diabetic Ketoacidosis.

BACKGROUND: Intravenous (IV) insulin infusions are the current standard of care for treatment of diabetic ketoacidosis (DKA). Subcutaneous (SQ) insulin, however, may also be a safe and effective alternative. OBJECTIVE: The purpose of this study was to compare patient-centered outcomes related to the treatment of mild to moderate DKA using two different protocols: an SQ insulin protocol and an IV insulin infusion protocol with an initial bolus (IVB) or without a bolus (IVNB). METHODS: We retrospectively conducted a multicenter cohort study evaluating SQ vs. IV insulin for the treatment of mild to moderate DKA. The primary outcome was time to DKA resolution. Secondary outcomes included time to glucose correction, hospital length of stay (LOS), intensive care unit LOS, hypoglycemia events, readmission rates, and IV insulin use. RESULTS: Within the study time frame, 257 patients were included in the multivariate Cox proportional hazards regression analysis. There was no significant difference in the time to DKA resolution between the IVB (p = 0.603) or IVNB (p = 0.269) groups compared with the population who received SQ insulin only. Hospital LOS was significantly longer when comparing the SQ group with the IVNB group (p < 0.001), but not when comparing it with the IVB group (p = 0.259). The IV protocols had significantly more hypoglycemic events compared with the SQ protocol (IVB vs. SQ, p < 0.001; IVNB vs. SQ, p = 0.001). CONCLUSIONS: SQ insulin may be an effective alternative option for treating mild to moderate DKA with fewer hypoglycemic effects.

Patterns of care in the management of high-risk COPD in the US (2011-2019): an observational study for the CONQUEST quality improvement program.

Background: In this study, we compare management of patients with high-risk chronic obstructive pulmonary disease (COPD) in the United States to national and international guidelines and quality standards, including the COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST). Methods: Patients were identified from the DARTNet Practice Performance Registry and categorized into three high-risk cohorts in each year from 2011 to 2019: newly diagnosed (≤12 months after diagnosis), already diagnosed, and patients with potential undiagnosed COPD. Patients were considered high-risk if they had a history of exacerbations or likely exacerbations (respiratory consult with prescribed medication). Descriptive statistics for 2019 are reported, along with annual trends. Findings: In 2019, 10% (n = 16,610/167,197) of patients met high-risk criteria. Evidence of spirometry for diagnosis was low; in 2019, 81% (n = 1228/1523) of patients newly diagnosed at high-risk had no record of spirometry/peak expiratory flow in the 12 months pre- or post-diagnosis and 43% (n = 651/1523) had no record of COPD symptom review. Among those newly and already diagnosed at high-risk, 52% (n = 4830/9350) had no evidence of COPD medication. Interpretation: Findings suggest inconsistent adherence to evidence-based guidelines, and opportunities to improve identification, documentation of services, assessment, therapeutic intervention, and follow-up of patients with COPD. Funding: This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution.

How do we build a comprehensive Vein-to-Vein (V2V) database for conduct of observational studies in transfusion medicine? Demonstrated with the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric V2V database protocol.

BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is the fourth iteration of the National Heart, Lung, and Blood Institute's REDS program and includes a focus on pediatric populations. The REDS-IV-P Vein-to-Vein (V2V) database encompasses linked information from blood donors, blood components, and patients to facilitate studies in transfusion medicine. STUDY DESIGN AND METHODS: The V2V database is an Observational Medical Outcomes Partnership Common Data Model database. The study period is April 1, 2019 through December 31, 2023. Data from all donors and donations at participating blood centers, all blood components derived from the donations, and all inpatient visits and selected outpatient visits at participating hospitals are included. The database captures all information within patient data domains not restricting data to a preselected subset of medical records. RESULTS: The V2V database contains data from 7 blood centers and 22 hospitals. We project the database will have over 2 billion pieces of information from 1.3 million patients with 20.6 million healthcare encounters. The database will include data on approximately 1 million transfused units and 2.3 million donors with approximately 6.8 million donation visits. CONCLUSION: The REDS-IV-P V2V database is a comprehensive database with data from millions of blood donors, blood components, and patients. A diverse set of data from the encounters are included in the database such that emerging questions can likely be addressed. The Observational Medical Outcomes Partnership Common Data Model is an efficient, flexible, and increasingly used common data model. The final de-identified database will be publicly available.

Preference for and impact of telehealth vs in-person asthma visits among Black and Latinx adults.

BACKGROUND: Black and Latinx adults experience disproportionate asthma-related morbidity and limited specialty care access. The severe acute respiratory syndrome coronavirus 2 pandemic expanded telehealth use. OBJECTIVE: To evaluate visit type (telehealth [TH] vs in-person [IP]) preferences and the impact of visit type on asthma outcomes among Black and Latinx adults with moderate-to-severe asthma. METHODS: For this PREPARE trial ancillary study, visit type preference was surveyed by e-mail or telephone post-trial. Emergency medical record data on visit types and asthma outcomes were available for a subset (March 2020 to April 2021). Characteristics associated with visit type preferences, and relationships between visit type and asthma outcomes (control [Asthma Control Test] and asthma-related quality of life [Asthma Symptom Utility Index]), were tested using multivariable regression. RESULTS: A total of 866 participants consented to be surveyed, with 847 respondents. Among the participants with asthma care experience with both visit types, 42.0% preferred TH for regular checkups, which associated with employment (odds ratio [OR] = 1.61; 95% confidence interval [CI], 1.09-2.39; P = .02), lower asthma medication adherence (OR = 1.06; 95% CI, 1.01-1.11; P = .03), and having more historical emergency department and urgent care asthma visits (OR = 1.10 for each additional visit; 95% CI, 1.02-1.18; P = .02), after adjustment. Emergency medical record data were available for 98 participants (62 TH, 36 IP). Those with TH visits were more likely Latinx, from the Southwest, employed, using inhaled corticosteroid-only controller therapy, with lower body mass index, and lower self-reported asthma medication adherence vs those with IP visits only. Both groups had comparable Asthma Control Test (18.4 vs 18.9, P = .52) and Asthma Symptom Utility Index (0.79 vs 0.84, P = .16) scores after adjustment. CONCLUSION: TH may be similarly efficacious as and often preferred over IP among Black and Latinx adults with moderate-to-severe asthma, especially for regular checkups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02995733.

Outcomes of A Virtual Practice-Tailored Medicare Annual Wellness Visit Intervention.

INTRODUCTION: Interventions are needed to promote utilization of the Medicare Annual Wellness Visit (AWV), an underused opportunity to perform screenings and plan individualized preventive health services. METHOD: Using remote practice redesign and electronic health record (EHR) support, we implemented the Practice-Tailored AWV intervention in 2021 (during the COVID-19 pandemic) in 3 small community-based practices. The intervention combines EHR-based tools with practice redesign approaches and resources. Outcomes included completion of AWV and fulfillment of recommended preventive services. RESULTS: At baseline the 3 practices had 1,513 Medicare patients with at least 1 visit in the past 12 months. AWV utilization went from 7% at baseline to 54% 8 months postintervention implementation; advance care planning increased 10.7% (from 7.9% to 18.6%); depression screening increased 16.3% (from 51.7% to 68.0%); and alcohol misuse screening increased 17.3% (from 42.6% to 59.9%). Every individual preventive health service was received more often by patients with an AWV than those without. At the patient level, fulfillment of all eligible preventive services (of a maximum of 12 evaluated) went from 47.5% to 53.8% (P < .001). Subgroup analyses showed that patients with AWVs completed a greater percentage of their total recommended preventive health services than those without an AWV. CONCLUSION: Virtual implementation of an intervention that combined EHR-based tools with practice redesign approaches increased AWV and preventive services utilization in Medicare patients. Given the success of this intervention during the COVID-19 pandemic (when practices had many competing demands), greater consideration should be given to delivering future interventions virtually.

Comparing asthma control assessment using the Asthma Control Test and the Asthma APGAR in African American/Black and Hispanic/Latinx populations.

INTRODUCTION: The objective of this analysis was to compare the Asthma Control Test (ACT) and the Asthma APGAR asthma control assessment tools in African-Ancestry/Black (AA/B) and Hispanic/Latinx (H/L) adults with moderate to severe asthma. METHODS: This pre-planned sub-study of the PREPARE clinical trial compares the baseline ACT and Asthma APGAR scores for the PREPARE populations using correlation coefficients, generalized linear modeling and receiver operating curve (ROC) analyses. Correlations were also assessed for both control tests and the Asthma Symptom Utility Index (ASUI). RESULTS: Among the 1201 adults (603 AA/B and 598 H/L) with moderate to severe asthma, most had uncontrolled asthma by both the ACT and the Asthma APGAR. Correlation coefficients between the ACT, Asthma APGAR and ASUI were strong and did not differ significantly by race/ethnicity. The ACT consistently assessed more patients as uncontrolled compared with the Asthma APGAR. The differences in ACT and Asthma APGAR scores did not differ by age, gender, race/ethnicity, self-reported health literacy or medication adherence but did differ by education level. Both the ACT and Asthma APGAR had similar ROCs for predicting an asthma exacerbation in the next 3 months. CONCLUSIONS: Both the ACT and the Asthma APGAR can be used for asthma control assessment in AA/B and H/L populations with moderate to severe asthma, providing comparable rates of uncontrolled asthma and similar limited ability to predict exacerbations. Further work is required to better understand the basis and clinical implications of the higher rates of uncontrolled asthma identified using the ACT.

COPD Population in US Primary Care: Data From the Optimum Patient Care DARTNet Research Database and the Advancing the Patient Experience in COPD Registry.

PURPOSE: To describe demographic and clinical characteristics of chronic obstructive pulmonary disease patients managed in US primary care. METHODS: This was an observational registry study using data from the Chronic Obstructive Pulmonary Disease (COPD) Optimum Patient Care DARTNet Research Database from which the Advancing the Patient Experience COPD registry is derived. Registry patients were aged ≥35 years at diagnosis. Electronic health record data were collected from both registries, supplemented with patient-reported information/outcomes from the Advancing the Patient Experience registry from 5 primary care groups in Texas, Ohio, Colorado, New York, and North Carolina (June 2019 through November 2020). RESULTS: Of 17,192 patients included, 1,354 were also in the Advancing the Patient Experience registry. Patients were predominantly female (56%; 9,689/17,192), White (64%; 9,732/15,225), current/ex-smokers (80%; 13,784/17,192), and overweight/obese (69%; 11,628/16,849). The most commonly prescribed maintenance treatments were inhaled corticosteroid with a long-acting ß2-agonist (30%) and inhaled corticosteroid with a long-acting muscarinic antagonist (27%). Although 3% (565/17,192) of patitents were untreated, 9% (1,587/17,192) were on short-acting bronchodilator monotherapy, and 4% (756/17,192) were on inhaled corticosteroid monotherapy. Despite treatment, 38% (6,579/17,192) of patients experienced 1 or more exacerbations in the last 12 months. These findings were mirrored in the Advancing Patient Experience registry with many patients reporting high or very high impact of disease on their health (43%; 580/1,322), a breathlessness score 2 or more (45%; 588/1,315), and 1 or more exacerbation in the last 12 months (50%; 646/1,294). CONCLUSIONS: Our findings highlight the high exacerbation, symptom, and treatment burdens experienced by COPD patients managed in US primary care, and the need for more real-life effectiveness trials to support decision making at the primary care level.

Use and Impact of Type 2 Diabetes Prevention Interventions.

INTRODUCTION: RCTs have found that type 2 diabetes can be prevented among high-risk individuals by metformin medication and evidence-based lifestyle change programs. The purpose of this study is to estimate the use of interventions to prevent type 2 diabetes in real-world clinical practice settings and determine the impact on diabetes-related clinical outcomes. METHODS: The analysis performed in 2020 used 2010‒2018 electronic health record data from 69,434 patients aged ≥18 years at high risk for type 2 diabetes in 2 health systems. The use and impact of prescribed metformin, lifestyle change program, bariatric surgery, and combinations of the 3 were examined. A subanalysis was performed to examine uptake and retention among patients referred to the National Diabetes Prevention Program. RESULTS: Mean HbA1c values declined from before to after intervention for patients who were prescribed metformin (-0.067%; p<0.001) or had bariatric surgery (-0.318%; p<0.001). Among patients referred to the National Diabetes Prevention Program lifestyle change program, the type 2 diabetes postintervention incidence proportion was 14.0% for nonattendees, 12.8% for some attendance, and 7.5% for those who attended ≥4 sessions (p<0.001). Among referred patients to the National Diabetes Prevention Program lifestyle change program, uptake was low (13% for 1‒3 sessions, 15% for ≥4 sessions), especially among males and Hispanic patients. CONCLUSIONS: Findings suggest that metformin and bariatric surgery may improve HbA1c levels and that participation in the National Diabetes Prevention Program may reduce type 2 diabetes incidence. Efforts to increase the use of these interventions may have positive impacts on diabetes-related health outcomes.

Changes in primary care visits arising from the COVID-19 pandemic: an international comparative study by the International Consortium of Primary Care Big Data Researchers (INTRePID).

INTRODUCTION: Through the INTernational ConsoRtium of Primary Care BIg Data Researchers (INTRePID), we compared the pandemic impact on the volume of primary care visits and uptake of virtual care in Australia, Canada, China, Norway, Singapore, South Korea, Sweden, the UK and the USA. METHODS: Visit definitions were agreed on centrally, implemented locally across the various settings in INTRePID countries, and weekly visit counts were shared centrally for analysis. We evaluated the weekly rate of primary care physician visits during 2019 and 2020. Rate ratios (RRs) of total weekly visit volume and the proportion of weekly visits that were virtual in the pandemic period in 2020 compared with the same prepandemic period in 2019 were calculated. RESULTS: In 2019 and 2020, there were 80 889 386 primary care physician visits across INTRePID. During the pandemic, average weekly visit volume dropped in China, Singapore, South Korea, and the USA but was stable overall in Australia (RR 0.98 (95% CI 0.92 to 1.05, p=0.59)), Canada (RR 0.96 (95% CI 0.89 to 1.03, p=0.24)), Norway (RR 1.01 (95% CI 0.88 to 1.17, p=0.85)), Sweden (RR 0.91 (95% CI 0.79 to 1.06, p=0.22)) and the UK (RR 0.86 (95% CI 0.72 to 1.03, p=0.11)). In countries that had negligible virtual care prepandemic, the proportion of visits that were virtual were highest in Canada (77.0%) and Australia (41.8%). In Norway (RR 8.23 (95% CI 5.30 to 12.78, p<0.001), the UK (RR 2.36 (95% CI 2.24 to 2.50, p<0.001)) and Sweden (RR 1.33 (95% CI 1.17 to 1.50, p<0.001)) where virtual visits existed prepandemic, it increased significantly during the pandemic. CONCLUSIONS: The drop in primary care in-person visits during the pandemic was a global phenomenon across INTRePID countries. In several countries, primary care shifted to virtual visits mitigating the drop in in-person visits.

Variation in Demographic and Clinical Characteristics of Patients with COPD Receiving Care in US Primary Care: Data from the Advancing the Patient EXperience (APEX) in COPD Registry.

Introduction: Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to describe demographic and clinical characteristics of people with COPD and compare management across five primary care medical groups in the US. Methods: This is a retrospective observational registry study utilizing electronic health records stored in the Advancing the Patient Experience (APEX) COPD registry. The APEX registry contains data from five US healthcare organizations located in Texas, Ohio, Colorado, New York, and North Carolina. Data on demographic and clinical characteristics of primary care patients with COPD between December 2019 and January 2020 were extracted and compared. Results: A total of 17,192 patients with COPD were included in analysis: Texas (n = 811), Ohio (n = 8722), Colorado (n = 472), New York (n = 1149) and North Carolina (n = 6038). The majority of patients at each location were female (>54%) and overweight/obese (>60%). Inter-location variabilities were noted in terms of age, race/ethnicity, exacerbation frequency, treatment pattern, and prevalence of comorbid conditions. Patients from the Colorado site experienced the lowest number of exacerbations per year while those from the New York site reported the highest number. Hypertension was the most common co-morbidity at 4 of 5 sites with the highest prevalence in New York. Depression was the most common co-morbidity in Ohio. Treatment patterns also varied by site; Colorado had the highest proportion of patients not on any treatment. ICS/LABA was the most commonly prescribed treatment except in Ohio, where ICS/LABA/LAMA was most common. Conclusions and Relevance: Our data show heterogeneity in demographic, clinical, and treatment characteristics of patients diagnosed with COPD who are managed in primary care across different healthcare organizations in the US.

Socioeconomic status associates with worse asthma morbidity among Black and Latinx adults.

BACKGROUND: Asthma disproportionately affects African American/Black (AA/B) and Hispanic/Latinx (H/L) patients and individuals with low socioeconomic status (SES), but the relationship between SES and asthma morbidity within these racial/ethnic groups is inadequately understood. OBJECTIVE: To determine the relationship between SES and asthma morbidity among AA/B and H/L adults with moderate to severe asthma using multidomain SES frameworks and mediation analyses. METHODS: We analyzed enrollment data from the PeRson EmPowered Asthma RElief randomized trial, evaluating inhaled corticosteroid supplementation to rescue therapy. We tested for direct and indirect relationships between SES and asthma morbidity using structural equation models. For SES, we used a latent variable defined by poverty, education, and unemployment. For asthma morbidity, we used self-reported asthma exacerbations in the year before enrollment (corticosteroid bursts, emergency room/urgent care visits, or hospitalizations), and Asthma Control Test scores. We tested for mediation via health literacy, perceived stress, and self-reported discrimination. All models adjusted for age, sex, body mass index, ethnicity, and comorbidities. RESULTS: Among 990 AA/B and H/L adults, low SES (latent variable) was directly associated with hospitalizations (ß = 0.24) and worse Asthma Control Test scores (ß = 0.20). Stress partially mediated the relationship between SES and increased emergency room/urgent care visits and worse asthma control (ß = 0.03 and = 0.05, respectively). Individual SES domains were directly associated with asthma morbidity. Stress mediated indirect associations between low educational attainment and unemployment with worse asthma control (ß = 0.05 and = 0.06, respectively). CONCLUSIONS: Lower SES is directly, and indirectly through stress, associated with asthma morbidity among AA/B and H/L adults. Identification of stressors and relevant management strategies may lessen asthma-related morbidity among these populations.

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

Socioeconomic impact of COVID-19 and willingness to be vaccinated in African American/Black and Hispanic/Latinx adults.

PURPOSE: To describe the socioeconomic and healthcare-related effects of the COVID-19 pandemic, and willingness to receive a free COVID-19 vaccine, among African American/Black (AA/B) and Hispanic/Latinx (H/L) adults with asthma currently enrolled in a large trial. METHODS: The present analysis is a sub-study of the PeRson EmPowered Asthma RElief (PREPARE) study, a pragmatic study of 1201 AA/B and H/L adults with asthma. A monthly questionnaire was completed by a subset of PREPARE participants (n = 325) during May-August, 2020. The 5-item questionnaire assessed self-reported impact of COVID-19 on respondents' ability to obtain asthma medications, medical care quality, employment, income and ability to pay bills; and willingness to get a free COVID-19 vaccine. Bivariate analysis and multivariate logistic regression were performed to investigate factors associated with vaccine hesitancy. RESULTS: Of 325 survey respondents (25% AA/B, 75% H/L), the majority reported no impact of COVID-19 on medical care or ability to get asthma medications. Approximately half of employed respondents experienced a lower level of employment or job loss, and approximately half reported having difficulty paying bills during the pandemic. Thirty-five percent of respondents reported unwillingness and 31% reported being somewhat likely to receive a free COVID-19 vaccine. AA/B race/ethnicity and poorer reported physical health were associated with a higher likelihood of COVID-19 vaccine hesitancy. CONCLUSION: AA/B and H/L adults with asthma may experience changes in the quality of their asthma care and increased socioeconomic stressors as a result of the COVID-19 pandemic and may be hesitant or unwilling to receive a COVID-19 vaccine.

Integrating behavioral health & primary care for multiple chronic diseases: Clinical trial of a practice redesign toolkit.

Context: Most patients in need of behavioral health (BH) care are seen in primary care, which often has difficulty responding. Some practices integrate behavioral health care (IBH), with medical and BH providers at the same location, working as a team. However, it is difficult to achieve high levels of integration. Objective: Test the effectiveness of a practice intervention designed to increase BH integration. Study Design: Pragmatic, cluster-randomized controlled trial. Setting: 43 primary care practices with on-site BH services in 13 states. Population: 2,460 adults with multiple chronic medical and behavioral conditions. Intervention: 24-month practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Outcomes: Primary outcomes were changes in the 8 Patient-Reported Outcomes Measurement Information System (PROMIS-29) domain scores. Secondary outcomes were changes in medication adherence, self-reported healthcare utilization, time lost due to disability, cardiovascular capacity, patient centeredness, provider empathy, and several condition-specific measures. A sample of practice staff completed the Practice Integration Profile at each time point to estimate the degree of BH integration in that site. Practice-level case studies estimated the typical costs of implementing the intervention. Results: The intervention had no significant effect on any of the primary or secondary outcomes. Subgroup analyses showed no convincing patterns of effect in any populations. COVID-19 was apparently not a moderating influence of the effect of the intervention on outcomes. The intervention had a modest effect on the degree of practice integration, reaching statistical significance in the Workflow domain. The median cost of the intervention was $18,204 per practice. In post-hoc analysis, level of BH integration was associated with improved patient outcomes independent of the intervention, both at baseline and longitudinally. Conclusions: The specific intervention tested in this study was inexpensive, but had only a small impact on the degree of BH integration, and none on patient outcomes. However, practices that had more integration at baseline had better patient outcomes, independent of the intervention. Although this particular intervention was ineffective, IBH remains an attractive strategy for improving patient outcomes.

Longitudinal Association of a Medication Risk Score With Mortality Among Ambulatory Patients Acquired Through Electronic Health Record Data.

The use of electronic health records allows for the application of a novel medication risk score for the rapid identification of ambulatory patients at risk of adverse drug events. We sought to examine the longitudinal association of medication risk score with mortality. This retrospective cohort study included patients whose data were available through electronic health records from multiple health care organizations in the United States that provided data as part of a Patient Safety Organization. Patients were included if they had ≥1 visit and ≥1 medication in their record between January 1, 2011, to June 30, 2017. Cox proportional hazards regression was used to examine the association between continuous and categorized medication risk score with all-cause mortality. Among 427,103 patients, the median age was 50 years (interquartile range, 29-64 years); 61% were female; 50% were White, 11% were Black, and 38% were Hispanic; and 6873 had a death date recorded. Patients 30 to 49 years old had the highest hazard ratios (HRs), followed by the 50- to 64-year-olds and lastly those 65 years or older. Controlling for all covariates, 30- to 49-year-olds with a score of 20 to 30 (versus <10) had a 604% increase in the hazard of death (HR, 7.04; 95% confidence interval [CI], 3.86-12.85), 50- to 64-year-olds had a 254% increase (HR, 3.54; 95% CI, 2.71-4.63), and ≥65-year-olds had an 87% increase (HR, 1.87; 95% CI, 1.67-2.09). The medication risk score was independently associated with death, adjusting for multimorbidities and other conditions. Risk was found to vary by age group and score. Results suggest that pharmaceutical interventions among those with elevated scores could improve medication safety for patients taking multiple medications.