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BackgroundSuboptimal medication adherence is a significant problem for patients with serious mental illness. Measuring medication adherence through subjective and objective measures can be challenging, time-consuming, and inaccurate. ObjectiveThe primary purpose of this feasibility and acceptability study was to evaluate the impact of a digital medicine system (DMS) among Veterans (patients) with serious mental illness as compared with treatment as usual (TAU) on medication adherence. MethodsThis open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semistructured interviews with patients and providers were used to examine the feasibility and acceptability of using the DMS. ResultsWe enrolled 46 patients across 2 Veterans Health Administration sites: 21 (46%) in DMS and 25 (54%) in TAU. There was no difference in the proportion of days covered by medication refill over 3 and 6 months (0.82, SD 0.24 and 0.75, SD 0.26 in DMS vs 0.86, SD 0.19 and 0.82, SD 0.21 in TAU, respectively). The DMS arm had 0.85 (SD 0.20) proportion of days covered during the period they were engaged with the DMS (mean 144, SD 100 days). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient findings described the positive impact of the DMS on medication adherence, challenges with the DMS patch connectivity and skin irritation, and challenges with the DMS app that affected overall use. Providers described an overall interest in using a DMS as an objective measure to support medication adherence in their patients. However, providers described challenges with the DMS dashboard and integrating DMS data into their workflow, which decreased the usability of the DMS for providers. ConclusionsThere was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS. Trial RegistrationClinicalTrials.gov NCT03881449; https://clinicaltrials.gov/ct2/show/NCT03881449

Background: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings. Objectives: Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials. Methods: These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina. Conclusions: We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens. Trial registration: Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.

Background: Despite strong evidence and Class I recommendations to support the use of guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF), use of these medications remain suboptimal. There is a great need to understand 1) what barriers to implementation of these therapies exist and 2) effective ways to support implementation of these therapies., Methods: Using the Consolidated Framework for Implementation Research framework, we conducted a broad array of interviews with stakeholders in the care of patients with HFrEF across 26 health systems to determine the barriers to GDMT implementation that health systems face, and to identify any factors that facilitated GDMT implementation and titration. We conducted interviews across a variety of health system phenotypes, including academic, private, fee-for-service, and bundled payment health systems to understand whether barriers and facilitators to GDMT implementation existed across system types., Results: Barriers to GDMT implementation appeared to be consistent across phenotypes and included a lack of time, difficulty in maintaining GDMT across the inpatient to outpatient transition and, among non-HF specialists, a lack of knowledge of guidelines. However, differences emerged when stakeholders described whether tools (facilitators) were available to overcome these barriers to help facilitate GDMT implementation, particularly when comparing institutions with fee-for-service vs bundled payment models. Health systems using bundled payment models were more likely than fee-for-service systems to report that they had support staff such as care managers and pharmacist technicians to improve GDMT use, institutional support for improving GDMT implementation, and champions for GDMT. In contrast, systems using a fee-for-service model rarely reported that these tools were available., Conclusion: In this analysis of stakeholder-reported barriers and facilitators to GDMT implementation and titration, we find health systems face similar barriers to GDMT implementation. However, we note that systems using bundled payment models are more likely to report the availability of tools to help overcome these barriers. Future work is needed to understand whether similar facilitators would be effective in fee-for-service systems, or whether alternative facilitators might be more appropriate., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Importance: Individuals with type 2 diabetes (T2D) have high rates of mortality following myocardial infarction (MI). Hospitalization is an opportunity to initiate or continue evidence-based treatment to reduce risk in individuals with T2D and acute coronary syndrome (ACS)., Objective: To determine patterns of evidence-based medication use during the period of transition from admission to discharge after hospitalization for MI or coronary revascularization among individuals with T2D and ACS., Design, Setting, and Participants: This retrospective cohort study used data from the Centers for Medicare & Medicaid Services (CMS) for January 1, 2018, to June 30, 2020. Medicare beneficiaries older than 18 years with T2D with a qualifying hospitalization were included. Individuals were followed before admission (90 days prior), at discharge (≤90 days), and after discharge (91-180 days after) from a hospitalization for MI or coronary revascularization. Data analysis was performed in June 2023., Exposures: Demographic data (race, sex, rural vs urban location of care, and comorbidities) were abstracted from CMS data using Master Beneficiary and Summary Files and International Statistical Classification of Diseases, Tenth Revision codes., Main Outcome and Measures: Medicare Part D prescription fill records were examined for the following agents: (1) angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or angiotensin receptor-neprilysin inhibitors (ARNIs); (2) β-blockers; (3) platelet adenosine diphosphate receptor inhibitors (P2Y12Is); (4) statins or proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is); and (5) glucagon-like peptide 1 receptor agonists (GLP-1RAs) or sodium glucose cotransporter 2 inhibitors (SGLT2Is). Logistic regression analysis was used to examine the association between covariates and lack of prescription fills in the postdischarge period., Results: A total of 188 651 eligible Medicare beneficiaries with T2D and hospitalization for MI or coronary revascularization were identified. Their median age was 73.0 (IQR, 67.0-79.0) years, and more than half (111 982 [59.4%]) were men; 18 383 (9.7%) were Black and 153 461 (81.3%) were White. Not filling a cardiovascular medication after hospitalization was associated with not filling that medication at the time of discharge (adjusted risk ratio, 0.27 [95% CI, 0.27-0.28] for ACEIs, ARBs, or ARNIs; 0.24 [0.24-0.25] for β-blockers; 0.20 [0.19-0.20] for P2Y12Is; 0.31 [0.31-0.32] for statins or PCSK9Is; and 0.27 [0.26-0.28] for SGLT2Is or GLP-1RAs)., Conclusions and Relevance: In this cohort study of Medicare beneficiaries with T2D, longer-term medication use following hospitalization for MI was associated with medication use at the time of discharge. These findings highlight the critical importance of this period to optimize preventive care for these high-risk individuals. Further implementation science research is needed to develop strategies to improve use of these evidence-based medications.

Out-of-hospital cardiac arrest (OHCA) occurs in nearly 350,000 people each year in the United States (US). Despite advances in pre and in-hospital care, OHCA survival remains low and is highly variable across systems and regions. The critical barrier to improving cardiac arrest outcomes is not a lack of knowledge about effective interventions, but rather the widespread lack of systems of care to deliver interventions known to be successful. The RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial is a 7-year pragmatic, cluster-randomized trial of 62 counties (57 clusters) in North Carolina using an established registry and is testing whether implementation of a customized set of strategically targeted community-based interventions improves survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. The multifaceted intervention comprises rapid cardiac arrest recognition and systematic bystander CPR instructions by 9-1-1 telecommunicators, comprehensive community CPR training and enhanced early automated external defibrillator (AED) use prior to emergency medical systems (EMS) arrival. Approximately 20,000 patients are expected to be enrolled in the RACE CARS Trial over 4 years of the assessment period. The primary endpoint is survival to hospital discharge with good neurologic outcome defined as a cerebral performance category (CPC) of 1 or 2. Secondary outcomes include the rate of bystander CPR, defibrillation prior to arrival of EMS, and quality of life. We aim to identify successful community- and systems-based strategies to improve outcomes of OHCA using a cluster randomized-controlled trial design that aims to provide a high level of evidence for future application., (Copyright © 2024. Published by Elsevier Inc.)

Background/objective: Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression., Methods: We evaluated the effect of a pharmacist-led intervention focused on supporting healthy behaviors, medication management, and self-monitoring on decline in estimated glomerular filtration rate (eGFR) for 36 months compared with an educational control., Results: We randomized 138 individuals to the intervention group and 143 to control. At baseline, mean (SD) eGFR was 80.7 (21.7) mL/min/1.73m 2 , 56% of participants had chronic kidney disease and a history of uncontrolled hypertension with a baseline SBP of 134.3 mm Hg. The mean (SD) decline in eGFR by cystatin C from baseline to 36 months was 5.0 (19.6) and 5.9 (18.6) mL/min/1.73m 2 for the control and intervention groups, respectively, with no significant between-group difference ( P =0.75)., Conclusions: We did not observe a significant difference in clinical outcomes by study arm. However, we showed that individuals with DKD will engage in a pharmacist-led intervention. The potential explanations for a lack of change in DKD risk factors can be attributed to 5 broad issues, challenges: (1) associated with enrolling patients with low eGFR and poor BP control; (2) implementing the intervention; (3) limited duration during which to observe any clinical benefit from the intervention; (4) potential co-intervention or contamination; and (5) low statistical power., Competing Interests: This study was supported by funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1R01DK93938.). H.B. reports research grants from the PhRMA Foundation, Proteus Digital Health, Otsuka, Novo Nordisk, Sanofi, and Improved Patient Outcomes, as well as consulting from Sanofi, Novartis, Otsuka, Abbott, Preventric Diagnostics, and the Medicines Company. U.D.P. was supported by R01DK093938, R34DK102166, and P30DK096493 before joining Gilead Sciences in 2016. C.A.D. was partially supported by UL1TR002553, the NIH Clinical and Translational Science Award at Duke. J.P. was partially supported by P30AG02871615, the NIA Claude D. Pepper Older Americans Independence Center Award at Duke. H.B. was partially supported by U24-HL137907 and U24-DK065176. A.A.L. reports receiving funds from Otsuka and PhRMA Foundation, and is supported by VA HSR&D grant #18-234. M.J.C. reports funding from the National Institutes of Health (1R01NR019594-01), the Veterans Affairs Quality Enhancement Research Initiative (VA QUE 20-012), and the Veterans Affairs Office of Rural Health. The other authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Despite recent advances in the use of guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF), achievement of target GDMT use and up-titration to goal dosages continue to be modest. In recent years, a number of interventional approaches to improve the usage of GDMT have been published, but many are limited by single-center experiences with small sample sizes. However, strategies including the use of multidisciplinary teams, dedicated GDMT titration algorithms and clinician audits with feedback have shown promise. There remains a critical need for large, rigorous trials to assess the utility of differing interventions to improve the use and titration of GDMT in HFrEF. Here, we review existing literature in GDMT implementation for those with HFrEF and discuss future directions and considerations in the field., Competing Interests: Disclosures JH and VR are funded by a T32 grant T32HL069749. MO and ML have no disclosures. RJM received research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Eli Lilly, Medtronic, Medable, Merck, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. HBB reports research funding through his institution from BeBetter Therapeutics, Boehringer Ingelheim, Esperion, Improved Patient Outcomes, Merck, NHLBI, Novo Nordisk, Otsuka, Sanofi, VA. Elton John Foundation, Hilton foundation, Pfizer, provides consulting services for Abbott, Imatar, Novartis, Sanofi, Vidya, Walmart, Webmed, and was previously on the board of directors of Preventric Diagnostics. NJP reports research support from Amgen, Boehringer Ingelheim, Eggland's Best, Eli Lilly, Novartis, Novo Nordisk, and Verily Life Sciences, has served as a consultant or on an advisory panel for Bayer, Boehringer Ingelheim, CRISPR Therapeutics, Eli Lilly, Esperion, AstraZeneca, Merck, Novartis, and Novo Nordisk, is an Executive Committee member for trials sponsored by Novo Nordisk and Amgen on DSMBs for trials sponsored by Janssen and Novartis. This research was supported by Boehringer Ingelheim, (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aim of the Study: Survival to hospital discharge from out-of-hospital cardiac arrest (OHCA) after receiving treatment from emergency medical services (EMS) is less than 10% in the United States. Community-focused interventions improve survival rates, but there is limited information on how to gain support for new interventions or program activities within these populations. Using data from the RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial, we aimed to identify the factors influencing emergency response agencies' support in implementing an OHCA intervention., Methods: North Carolina counties were stratified into high-performing or low-performing counties based on the county's cardiac arrest volume, percent of bystander-cardiopulmonary resuscitation (CPR) performed, patient survival to hospital discharge, cerebral performance in patients after cardiac arrest, and perceived engagement in the RACE-CARS project. We randomly selected 4 high-performing and 3 low-performing counties and conducted semi-structured qualitative interviews with emergency response stakeholders in each county., Results: From 10/2021 to 02/2022, we completed 29 interviews across the 7 counties (EMS ( n  = 9), telecommunications ( n  = 7), fire/first responders ( n  = 7), and hospital representatives ( n  = 6)). We identified three themes salient to community support for OHCA intervention: (1) initiating support at emergency response agencies; (2) obtaining support from emergency response agency staff (senior leadership and emergency response teams); and (3) and maintaining support. For each theme, we described similarities and differences by high- and low-performing county., Conclusions: We identified techniques for supporting effective engagement of emergency response agencies in community-based interventions for OHCA improving survival rates. This work may inform future programs and initiatives around implementation of community-based interventions for OHCA., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘This work is supported by the National Heart, Lung, and Blood Institute (NHLBI) [grant number 5UH3HL146935-03] and the Durham Center of Innovation to Accelerate Discovery and Practice Transformation at the Durham VA Health Care System (to AAL, HAK, HBB) [grant number CIN 13-410]. Also, Hayden Bosworth reports research funding through his institution from BeBetter Therapeutics, Boehringer Ingelheim, Esperion, Improved Patient Outcomes, Merck, NHLBI, Novo Nordisk, Otsuka, Sanofi, Veterans Administration, Elton John Foundation, Hilton foundation, and Pfizer. He also provides consulting services for Esperion, Imatar, Novartis, Sanofi, Vidya, Walmart, and Webmed. He was also on the board of directors of Preventric Diagnostics. Christopher Granger receives consulting fees for the following companies: Abbvie, Abiomed, Alnylam Pharmaceuticals, Anthos, Bayer Corporation, Boehringer Ingelheim, Boston Scientific Corporation, Bristol Myers Squibb, Cardionomics, CeleCor Therapeutics, Janssen Pharmaceutical, Merck, Novo Nordisk, Novartis, Pfizer, Philips, REATA, NephroSynergy. He also has salary funded by Duke grants sponsored by: Alnylam Pharmaceuticals, Boehinger Ingelheim, Bristol Myers Squibb, US Food and Drug Administration, Janssen Pharmaceuticals, NHLBI, Novartis, Pfizer, and Philips. He has Equity in Tenac.io.’., (© 2024 The Authors.)

Study Objective: To investigate whether poor sleep quality is associated with pre-term birth (PTB) risk, overall and independent of sleep apnea and habitual snoring., Methods: We used longitudinal data from the Washington University Prematurity Research Cohort to investigate the association between poor sleep quality (defined as a Pittsburgh Sleep Quality Index > 5) and PTB, overall and independent of sleep apnea and snoring (defined by the Berlin questionnaire and prior sleep clinic attendance). Associations were investigated for sleep quality early and throughout pregnancy. Stratified analyses were performed by factors previously shown to modify associations between sleep and PTB (race, pre-pregnancy obesity)., Results: Of the 976 eligible participants, 50.1% experienced poor sleep quality early in pregnancy (<20 completed weeks) and 14.2% delivered pre-term ( n  = 50 without and 89 with poor sleep quality). In multivariable-adjusted analyses, poor sleep quality early in pregnancy was associated with increased PTB risk (hazard ratio [HR] = 1.48, 95% confidence interval [CI] = 1.02-2.14). This association persisted after further adjustment for sleep apnea and snoring (HR = 1.50, 95% CI = 1.02-2.20) and in analyses stratified by race. It varied, however, by pre-pregnancy obesity. Among individuals without obesity, no association was observed between poor sleep and PTB (HR = 1.08, 95% CI = 0.65-1.79), whereas among those with obesity, a positive association was observed (HR = 2.94, 95% CI = 1.52-5.69, p -interaction = .05). This association was limited to individuals with obesity who experienced poor sleep both earlier and later in pregnancy (HR = 3.94, 95% CI = 1.56-9.99)., Conclusion: Our findings suggest that improving sleep quality early in pregnancy may be important for PTB prevention, particularly among individuals with obesity., (© The Author(s) 2023. Published by Oxford University Press on behalf of Sleep Research Society.)

Background: Adherence barriers to asthma biologics may not be uniform across administration settings for patients with moderate-to-severe asthma., Objective: To examine differences in asthma biologic adherence and associated factors, as well as association with a 1-year all-cause emergency department (ED) visit, across administration settings., Methods: A retrospective study of biologic naïve moderate-to-severe asthma patients with initial biologic therapy between January 1, 2016, and April 30, 2020, in the Optum Clinformatics Data Mart was performed. Three administration settings were identified: Clinic-only (outpatient office/infusion center), Home (self-administration), and Hybrid setting (mixture of clinic and self-administration). Asthma biologic adherence was the proportion of observed over expected biologic dose administrations received within 6 months from initial therapy. Factors associated with adherence were identified by administration setting, using Poisson regression analyses. A relationship between a 1-year all-cause ED visit and adherence was assessed for each administration setting using Cox regression analyses., Results: The study cohort was 3932 patients. Biologics adherence was 0.75 [0.5, 1] in Clinic setting, the most common administration setting, and 0.83 [0.5, 1] in both Home and Hybrid settings. Specialist access was consistently associated with better biologic adherence, whereas Black race, Hispanic ethnicity, lower education, Medicare only insurance, and higher patient out-of-pocket cost were associated with worse biologic adherence in some settings. In the Hybrid setting, hazard for a 1-year all-cause ED visit decreased with biologic adherence., Conclusions: Asthma biologic adherence varied by administration setting. Efforts to improve asthma biologic adherence should consider promoting self-administration when beneficial, improving prior specialist access, and targeting patients with higher risk of suboptimal adherence particularly Black and Hispanic patients., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: We previously conducted a concept elicitation study on the impact of S taphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient's perspective and found significant impacts on HRQoL, particularly in the physical and functional domains. Using this information and following guidance on the development of patient-reported outcome (PRO) measures, we determined which combination of measures and items (ie, specific questions) would be most appropriate in a survey assessing HRQoL in bloodstream infections., Methods: We selected a variety of measures/items from the Patient-Reported Outcomes Measurement Information System (PROMIS) representing different domains. We purposefully sampled patients ~6-12 weeks post-SAB/GNB and conducted 2 rounds of cognitive interviews to refine the survey by exploring patients' understanding of items and answer selection as well as relevance for capturing HRQoL., Results: We interviewed 17 SAB/GNB patients. Based on the first round of cognitive interviews (n = 10), we revised the survey. After round 2 of cognitive interviewing (n = 7), we finalized the survey to include 10 different PROMIS short forms/measures of the most salient HRQoL domains and 2 adapted questions (41 items total) that were found to adequately capture HRQoL., Conclusions: We developed a survey from well-established PRO measures that captures what matters most to SAB/GNB patients as they recover. This survey, uniquely tailored to bloodstream infections, can be used to assess these meaningful, important HRQoL outcomes in clinical trials and in patient care. Engaging patients is crucial to developing treatments for bloodstream infections., (© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Rationale & Objective: Little is known about how socioeconomic status (SES) relates to the prioritization of medical care spending over personal expenditures in individuals with multiple comorbid conditions, and whether this relationship differs between Blacks and non-Blacks. We aimed to explore the relationship between SES, race, and medical spending among individuals with multiple comorbid conditions., Study Design: Cross-sectional evaluation of baseline data from a randomized controlled trial., Setting & Participants: The STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study is a completed randomized controlled trial of Duke University primary care patients with diabetes, hypertension, and chronic kidney disease. Participants underwent survey assessments inclusive of measures of socio-demographics and medication adherence., Predictors: Race (Black or non-Black) and socioeconomic status (income, education, and employment)., Outcomes: The primary outcomes were based on 4 questions related to spending, asking about reduced spending on basic/leisure needs or using savings to pay for medical care. Participants were also asked if they skipped medications to make them last longer., Analytical Approach: Multivariable logistic regression stratified by race and adjusted for age, sex, and household chaos was used to determine the independent effects of SES components on spending., Results: Of 263 STOP-DKD participants, 144 (55%) were Black. Compared with non-Blacks, Black participants had lower incomes with similar levels of education and employment but were more likely to reduce spending on basic needs (29.2% vs 13.5%), leisure activities (35.4% vs 20.2%), and to skip medications (31.3% vs 15.1%), all P  < 0.05. After multivariable adjustment, Black race was associated with increased odds of reduced basic spending (OR, 2.29; 95% CI, 1.14-4.60), reduced leisure spending (OR, 1.94; 95% CI, 1.05-3.58), and skipping medications (OR, 2.12; 95% CI, 1.12-4.04)., Limitations: This study was conducted at a single site in Durham, North Carolina, and nearly exclusively included insured patients. Further, the impact of the number of comorbid conditions, medication costs, or copayments was not assessed., Conclusions: In primary care patients with multiple chronic diseases, Black patients are more likely to reduce spending on basic needs and leisure activities to afford their medical care than non-Black patients of equivalent SES., Clinicaltrialsgov Identifier: NCT01829256., (© 2021 The Authors.)

Background: Although Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) cause substantial morbidity, little is known regarding patient perceptions' of their impact on quality of life (QOL). Guidance for assessing QOL and disease-specific measures are lacking. We conducted a descriptive qualitative study to gain an in-depth understanding of patients' experiences with SAB/GNB and concept elicitation phase to inform a patient-reported QOL outcome measure., Methods: We conducted prospective one-time, in-depth, semi-structured, individual, qualitative telephone interviews 6- 8 weeks following bloodstream infection with either SAB or GNB. Patients were enrolled in an institutional registry (tertiary academic medical center) for SAB or GNB. Interviews were audio-recorded, transcribed, and coded. Directed content analysis identified a priori and emergent themes. Theme matrix techniques were used to facilitate analysis and presentation., Results: Interviews were completed with 30 patients with SAB and 31 patients with GNB. Most patients were at or near the end of intravenous antibiotic treatment when interviewed. We identified 3 primary high-level concepts: impact on QOL domains, time as a critical index, and sources of variability across patients. Across both types of bloodstream infection, the QOL domains most impacted were physical and functional, which was particularly evident among patients with SAB., Conclusions: SAB/GNB impact QOL among survivors. In particular, SAB had major impacts on multiple QOL domains. A combination of existing, generic measures that are purposefully selected and disease-specific items, if necessary, could best capture these impacts. Engaging patients as stakeholders and obtaining their feedback is crucial to conducting patient-centered clinical trials and providing patient-centered care., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline., Objective: The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline., Research Design: Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control., Measures: The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm., Results: Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02)., Conclusion: A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.

Stakeholder-informed strategies addressing cardiovascular disease (CVD) burden among people living with HIV (PWH) are needed within healthcare settings. This study provides an assessment of how human-centered design (HCD) guided the adaptation of a nurse-led intervention to reduce CVD risk among PWH. Using a HCD approach, research staff guided two multidisciplinary "design teams" in Ohio and North Carolina, with each having five HCD meetings. We conducted acceptability and feasibility testing. Six core recommendations were produced by two design teams of key stakeholders and further developed after the acceptability and feasibility testing to produce a final list of 14 actionable areas of adaptation. Acceptability and feasibility testing revealed areas for adaptation, e.g. patient preferences for communication and the benefit of additional staff to support patient follow-up. In conclusion, along with acceptability and feasibility testing, HCD led to the production of 14 key recommendations to enhance the effectiveness and scalability of an integrated HIV/CVD intervention., Competing Interests: Declaration of competing interest The author has no conflict of interest to declare., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Persons living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD). In spite of this, uptake of evidence-based clinical interventions for ASCVD risk reduction in the HIV clinic setting is sub-optimal. METHODS: EXTRA-CVD is a 12-month randomized clinical effectiveness trial that will assess the efficacy of a multi-component nurse-led intervention in reducing ASCVD risk among PLHIV. Three hundred high ASCVD risk PLHIV across three sites will be randomized 1:1 to usual care with generic prevention education or the study intervention. The study intervention will consist of four evidence-based components: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic health records support tools. The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the intervention. Tertiary outcomes will include change in the proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure <130 mm Hg and non-HDL cholesterol < National Lipid Association targets). CONCLUSIONS: The EXTRA-CVD trial will provide evidence appraising the potential impact of nurse-led interventions in reducing ASCVD risk among PLHIV, an essential extension of the HIV care continuum beyond HIV viral suppression., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Telemedicine can facilitate population health management by extending the reach of providers to efficiently care for high-risk, high-utilization populations. However, for telemedicine to be maximally useful, data collected using telemedicine technologies must be reliable and readily available to healthcare providers. To address current gaps in integration of patient-generated health data into the electronic health record (EHR), we examined 2 patient-facing platforms, Epic MyChart and Apple HealthKit, both of which facilitated the uploading of blood glucose data into the EHR as part of a diabetes telemedicine intervention. All patients were offered use of the MyChart platform; we subsequently invited a purposive sample of patients who used the MyChart platform effectively (n = 5) to also use the Apple HealthKit platform. Patients reported both platforms helped with diabetes self-management, and providers appreciated the convenience of the processes for obtaining patient data. Providers stated that the EHR data presentation format for Apple HealthKit was challenging to interpret; however, they also valued the greater perceived accuracy the Apple HealthKit data. Our findings indicate that patient-facing platforms can feasibly facilitate transmission of patient-generated health data into the EHR and support telemedicine-based care., (© The Author(s) 2019. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support., Objective: This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States., Methods: Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ≥140 mm Hg and/or diastolic blood pressure [DBP] ≥90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention., Results: Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls., Conclusion: We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact., Trial Registration: ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU)., (©Allison A Lewinski, Uptal D Patel, Clarissa J Diamantidis, Megan Oakes, Khaula Baloch, Matthew J Crowley, Jonathan Wilson, Jane Pendergast, Holly Biola, L Ebony Boulware, Hayden B Bosworth. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 09.04.2019.)

Objectives: Our primary objective was to estimate the proportion of patients with culture-proven urinary tract infection (UTI) and recurrent UTI after midurethral sling (MUS), as well as to evaluate their risk factors. Our secondary objective was to characterize the difference in the proportion of patients with recurrent UTI before and after MUS., Methods: We conducted a retrospective study of patients who underwent MUS from 2009 to 2012 within a large health maintenance organization and subsequently had documentation of at least 1 positive urine culture (>100 K CFU/mL) within 1 year. Validated procedural and diagnostic codes were used to identify patients undergoing MUS and the diagnosis of UTI, respectively., Results: Of the 7461 MUS performed, 883 (12%) patients had at least 1 culture-proven UTI and 258 (3.5%) patients met the definition of recurrent UTI postoperatively. Of those 883 patients, 89 (10%) patients met the definition of recurrent UTI before, and 258 (29%) patients after, MUS. McNemar χ test revealed that patients were more likely to have recurrent UTI after MUS compared with before (P < 0.0001). In multivariate logistic regression, Caucasian (odds ratio [OR], 1.60, 95% confidence interval [95% CI], 1.12-2.29; P = 0.01) and African-American (OR, 3.42; 95% CI, 1.42-8.29; P = 0.01) ethnicity, older age (OR, 1.02; 95% CI, 1.00-1.04; P = 0.03), and a history of recurrent UTI (OR 3.79, 95% CI 1.88-7.93, P = 0.0003) were risk factors for postoperative recurrent UTI., Conclusions: In this population, preoperative recurrent UTI was the only modifiable risk factor associated with an increased risk of postoperative recurrent UTI.