Watchful waiting management for acute otitis media (AOM), where an antibiotic is used only if the child's symptoms worsen or do not improve over the subsequent 2-3 days, is an effective approach to ...reduce antibiotic exposure for children with AOM. However, studies to compare the effectiveness of interventions to promote watchful waiting are lacking. The objective of this study is to compare the effectiveness and implementation outcomes of two pragmatic, patient-centered interventions designed to facilitate use of watchful waiting in clinical practice.
This will be a cluster-randomized trial utilizing a hybrid implementation-effectiveness design. Thirty-three primary care or urgent care clinics will be randomized to one of two interventions: a health systems-level intervention alone or a health systems-level intervention combined with use of a shared decision-making aid. The health systems-level intervention will include engagement of a clinician champion at each clinic, changes to electronic health record antibiotic orders to facilitate delayed antibiotic prescriptions as part of a watchful waiting strategy, quarterly feedback reports detailing clinicians' use of watchful waiting individually and compared with peers, and virtual learning sessions for clinicians. The hybrid intervention will include the health systems-level intervention plus a shared decision-making aid designed to inform decision-making between parents and clinicians with best available evidence. The primary outcomes will be whether an antibiotic was ultimately taken by the child and parent satisfaction with their child's care. We will explore the differences in implementation effectiveness by patient population served, clinic type, clinical setting, and organization. The fidelity, acceptability, and perceived appropriateness of the interventions among different clinician types, patient populations, and clinical settings will be compared. We will also conduct formative qualitative interviews and surveys with clinicians and administrators, focus groups and surveys of parents of patients with AOM, and engagement of two stakeholder advisory councils to further inform the interventions.
This study will compare the effectiveness of two pragmatic interventions to promote use of watchful waiting for children with AOM to reduce antibiotic exposure and increase parent satisfaction, thus informing national antibiotic stewardship policy development.
NCT06034080.
IntroductionWomen with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, ...preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care.Methods and analysisWe are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to ‘hardwire’ preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18–44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic’s assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects.Ethics and disseminationThis study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request.Trial registration numberClinicalTrials.gov Registry (NCT04976881).
Does telehealth decrease health disparities by improving connections to care or simply result in new barriers for vulnerable populations who often lack access to technology? This study aims to better ...understand the role of telehealth and social determinants of health in improving care connections and outcomes for Community Health Center patients with diabetes.
This retrospective analysis of Electronic Health Record (EHR) data examined the relationship between telehealth utilization and glycemic control and consistency of connection to the health care team ("connectivity"). EHR data were collected from 20 Community Health Centers from July 1, 2019 through December 31, 2021. Descriptive statistics were calculated, and multivariable linear regression was used to assess the associations between telehealth use and engagement in care and glycemic control.
The adjusted analysis found positive, statistically significant associations between telehealth use and each of the 2 primary outcomes. Telehealth use was associated with 0.89 additional months of hemoglobin A1c (HbA1c) control (95% confidence interval CI, 0.73 to 1.04) and 4.49 additional months of connection to care (95% CI, 4.27 to 4.70).
The demonstrated increased engagement in primary care for telehealth users is significant and encouraging as Community Health Center populations are at greater risk of lapses in care and loss to follow up.
Telehealth can be a highly effective, patient-centered form of care for people with diabetes. Telehealth can play a critical role in keeping vulnerable patients with diabetes connected to their care team and involved in care and may be an important tool for reducing health disparities.
Federally qualified health centers (FQHCs) serve vulnerable DM patients in primary care in underserved settings. The state of DM (glycemic control, complications) may differ and utilization of ...technologies (e.g. continuous glucose monitoring CGM) may be essential. But the current state of DM and CGM is poorly characterized. Using EHR data from a national FQHC network (2015-2021) we examined baseline demographic characteristics, CGM prescriptions, and their association. We included 47,579 with DM: n=1630 with T1D 3%, n= 45,949 T2D 97%, 38% Hispanic, 34% Black (Table 1). Notably, T1D pts mean age 43 SD 16, had poor glycemic control (HbA1c 9.4 SD 2.4) with elevated DM complications severity index scores mean DSCI 2.3 SD 4.7. Overall CGM prescriptions were extremely low; 9% in T1D and only 1% in T2D. Among T1D, those who were Hispanic OR 0.39, (CI 0.23, 0.66), p < 0.001 or Black OR 0.52, (CI 0.33, 0.81), p = 0.003 were less likely to have CGM prescribed than White adults, after adjustment. Among T2D, those who were Hispanic OR 0.42, CI 0.33, 0.55, p < 0.001 or Black OR 0.68, CI 0.54, 0.85, p = 0.001 were similarly less likely to have CGM. Non-private insurance was also a significant factor. DM severity (poor control, complications) is notable in FQHCs, yet CGM is exceptionally low. These findings underscore the major translation gap in standard of care for FQHCs and the critical need to understand inequities.
Disclosure
A. Wallia: Research Support; UnitedHealth Group, Novo Nordisk, Eli Lilly and Company. D. Bright: None. A. Eggleston: None. M. J. O'brien: None. S. Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. A. L. Owen: None. E. L. Lam: None. K. Davis: None. S. Bailey: Advisory Panel; Gilead Sciences, Inc., Consultant; Lundbeck, Pfizer Inc., Research Support; Eli Lilly and Company, Merck Sharp & Dohme Corp., Gilead Sciences, Inc., Lundbeck, Pfizer Inc. S. E. Delacey: None. A. Pack: Consultant; Gilead Sciences, Inc., Research Support; Merck & Co., Inc., Pfizer Inc., Gordon and Betty Moore Foundation, RRF Foundation for Aging, Lundbeck, Eli Lilly and Company, Gilead Sciences, Inc. J. Espinoza: Consultant; Sanofi, Research Support; NIH - National Institutes of Health, FDA, Speaker's Bureau; Glooko, Inc.
Funding
Centers for Diabetes Translation Research (5P30DK020541, 472P30DK092949-11A); National Pilot and Feasibility Grant for Diabetes Research Centers; Center for Diabetes Translation Research
Objectives Hypertension affects 1 in 3 adults in the United States and disproportionately affects African Americans. Kaiser Permanente demonstrated that a “bundle” of evidence-based interventions ...significantly increased blood pressure control rates. This paper describes a multiyear process of developing the protocol for a trial of the Kaiser bundle for implementation in under-resourced urban communities experiencing cardiovascular health disparities during the planning phase of this biphasic award (UG3/UH3). Methods The protocol was developed by a collaboration of faith-based community members, representatives from community health center practice-based research networks, and academic scientists with expertise in health disparities, implementation science, community-engaged research, social care interventions, and health informatics. Scientists from the National Institutes of Health and the other grantees of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance also contributed to developing our protocol. Results The protocol is a hybrid type 3 effectiveness-implementation study using a parallel cluster randomized trial to test the impact of practice facilitation on implementation of the Kaiser bundle in community health centers compared with implementation without facilitation. A central strategy to the Kaiser bundle is to coordinate implementation via faith-based and other community organizations for recruitment and navigation of resources for health-related social risks. Conclusions The proposed research has the potential to improve identification, diagnosis, and control of blood pressure among under-resourced communities by connecting community entities and healthcare organizations in new ways. Faith-based organizations are a trusted voice in African American communities that could be instrumental for eliminating disparities.
The purpose of these studies was to characterize the rates of fatty acid oxidation in reperfused myocardium and test the influence of excess fatty acids (FA) on mechanical function in the ...extracorporeally perfused, working swine heart model. Seventeen animals were prepared. Eight were untreated (LOW FA group; serum FA averaged 0.55 +/- 0.07 mumol/ml) and nine received a constant infusion of 10% Intralipid with heparin to raise serum FA to about 1.4 +/- 0.21 mumol/ml (HIGH FA group). Coronary flow in both groups was held at aerobic levels for an equilibrium period of 40 minutes, acutely reduced regionally in the anterior descending circulation by 60% for 45 minutes, and acutely restored to aerobic levels for 60-minute reflow. Appreciable mechanical depression (-47 delta% from aerobic values; p less than 0.01) during reperfusion was noted in both groups. This was associated with modest reductions in myocardial oxygen consumption (p less than 0.05) and losses of total tissue carnitine stores (p at least less than 0.02). Reperfused myocardium showed a strong preference for and aerobic use of FA during reflow such that 14CO2 production from labeled palmitate exceeded preischemic levels (+89 delta% in LOW FA hearts; +111 delta% in HIGH FA hearts). This suggested relative preservation of restoration of certain elements in mitochondrial function during reflow. The findings argue for uncoupling between substrate metabolism and energy production, accelerated but useless energy drainage, or some impairment between energy transfer and function of contractile proteins as possible explanations for the persistent depression of mechanical function (stunning) during reperfusion.
Left ventricular work efficiency (LVWE), a measure of the efficiency of energy transfer from LV to systemic circulation, declines as heart failure (CHF) becomes more severe. We compared changes in ...the response of LVWE and inotropy to dobutamine as progressively more severe CHF was induced by tachypacing. Seventeen dogs (weights 19–24kg) were instrumented with micromanometer catheters, Ultrasonic crystals and a pacemaker and paced at 215–240bpm over 3 weeks. Ventricular volumes and pressures were digitally acquired at baseline and weekly over 3 weeks. Pressure-volume area (PVA), external work (EW), end-systolic pressure-volume relation slope (Ees) and arterial elastance (Ea) were derived from variably loaded beats after IVC occlusion. The LVWE was calculated as EW/PVA. Measurements were made with and without dobutamine (DOB) at 10μg/kg/min.
BaselineCHF 1CHF 2CHF 3EW(mmHg*ml)1308±6631050±542861±633*738±506*% † on DOB+80±34+133±71+145±89+222±188*LVVVE(%)52±842±10*36±10*33±11*% † on DOB+65±27+77±26+108±77*+115±1.2*Ees (mmHg/ml)5.1±2.93.8±1.62.9±1.6*2.5±1.0*% † on DOB+269±159+135±118*+125±31*+131±58*peak+dP/dt (mmHg/s)1680±4821312±354*1008±178*1080±325*% † on DOB+162±63105±49*108±52*+81±42*Ea/Ees ratio2.0±083.7±2.4*4.1±2.2*4.1±1.6*% ↓ on DOB–78±11–72±9–73±9–65±4**p<0.05 vs baseline
The inotropic responsiveness of the LV is significantly reduced in CHF as demonstrated by the response of Ees and +dP/dt to DOB. However, EW on DOB in CHF is not significantly different than at baseline (1924±1205 vs 2269±1051mmHg*ml). This is caused by a greater increase in LVWE on DOB in CHF Improved LVWE and Ea/Ees coupling is an important mechanism for enhanced LV pump performance in CHF and helps counterbalance the reduction of inotropic responsiveness of the LV as CHF progresses.
Two fatty acid blocking agents, oxfenicine (33 mg/kg) and 4-bromocrotonic acid (0.34 mg/kg/min for 70 min), were used to selectively adjust levels of long-chain acyl CoA and carnitine in aerobic and ...ischemic myocardium. The purpose of the study was to test whether the shift in these amphiphiles was associated with alterations of mechanical function in intact myocardium. The extracorporeally perfused swine heart preparation was used. Hearts were perfused at aerobic levels for 40 min following which flow to the anterior descending (LAD) circulation was reduced by 50% for the final 30 min of perfusion. All hearts were perfused with excess fatty acids to raise serum levels to 1.37 +/- 0.16 mumol/mol throughout the studies. Oxfenicine and 4-bromocrotonic acid affected a 20% (P less than 0.05 and P less than 0.05, respectively) further decline in 14CO2 production from labelled palmitate as compared with placebo hearts during regional ischemia. Accompanying this were downward shifts in acyl carnitine (-27 delta %, NS in aerobic tissue; -70 delta %, P less than 0.001 in ischemic tissue) and acyl CoA (-13 delta %, NS in aerobic tissue; -33 delta %, P less than 0.01 in ischemic tissue) for oxfenicine and upward shifts of acyl carnitine (+212 delta %, P less than 0.001 in aerobic tissue; -9 delta %, NS in ischemic tissue) and acyl CoA (+78 delta %, P less than 0.001 in aerobic tissue; +29 delta %, P less than 0.025 in ischemic tissue) for 4-bromocrotonic acid. These adjustments in amphiphiles were further associated with improved function (+55 delta % increase in max LV dP/dt, P less than 0.05) in oxfenicine-treated hearts and depressed function (+87 delta % increase in LVEDP, P less than 0.05) in 4-bromocrotonic acid-treated hearts. Thus, at comparable conditions of coronary flow, left ventricular pressure, and fatty acid availability and oxidation between treatments, depletion or build-up of CoA and carnitine esters as affected by selective inhibitors of fatty acid metabolism were causally linked to improved or impaired cardiac performance in intact hearts.
Carnitine, certain of its derivatives, and the amino acid metabolite, taurine, when administered independently in prior studies have been shown to improve cardiac mechanic and/or metabolism. The ...purpose of these studies is to test a new compound, propionylcarnitine taurine (PCT), which potentially combines these actions, in a therapeutic trial to preserve function in a setting of myocardial ischemia. In the main protocol, PCT was administered (0.71 mg/kg/min I.V.) to eight extracorporeally perfused, intact, working swine hearts over a 70 min perfusion trial and compared with seven similarly prepared placebo hearts. Left anterior descending (LAD) flows were held at aerobic levels (6.3 +/- 0.3 ml/min/g dry) for 40 min and then reduced acutely by 50% for 30 min. Serum fatty acids (FA) in both groups were augmented to 1.27 +/- 0.5 mumol/ml. Contractility (measured regionally from shortening rates of ultrasonic crystals placed in the LAD circulation); myocardial oxygen consumption (MVO2); and FA oxidation (measured from 14CO2 production rates from labeled palmitate infused into the LAD perfusate) were obtained serially throughout the perfusion trials. Regional contractility was significantly increased in PCT-treated hearts as compared with placebo hearts both during normal and ischemic flows. Treatment appeared to deplete free carnitine stores in both aerobic and ischemic myocardium but failed to modify acyl CoA levels. In seven additional animals PCT was shown to independently stimulate fatty acid oxidation (about 39 delta % increase) at aerobic flows. Lastly in nine separate animals (4 placebo; 5 treatment) prepared and studied identically to those of the main protocol, taurine alone (0.2 mg/kg/min infused IV for 70 min) was without influence in reproducing mechanical benefits. Thus, PCT favorably enhances regional contractility in conditions of myocardial ischemia, presumably by the positive inotropic effects of the propionylcarnitine constituent of the compound.
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