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Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.

ABSTRACT: Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ED with uncontrolled asthma that compares: [1] an ED-focused intervention to improve the quality of care on discharge to home, [2] the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and [3] enhanced usual care. All children receive spacers for the metered dose inhaler and teaching about its use. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale and Satisfaction with Participation in Social Roles at 6months are the primary outcomes in children and in caregivers, respectively. Other patient-reported outcomes and indicators of healthcare utilization are assessed as secondary outcomes. Innovative features of the CHICAGO Plan include early and continuous engagement of children, caregivers, the Chicago Department of Public Health, and other stakeholders to inform the design and implementation of the study and a shared research infrastructure to coordinate study activities. The objective of this report is to describe the development of the CHICAGO Plan, including the methods and rationale for engaging stakeholders, the shared research infrastructure, and other features of the pragmatic clinical trial design.

SUBMITTER: Krishnan JA

PROVIDER: S-EPMC5496921 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.

Krishnan Jerry A JA Martin Molly A MA Lohff Cortland C Mosnaim Giselle S GS Margellos-Anast Helen H DeLisa Julie A JA McMahon Kate K Erwin Kim K Zun Leslie S LS Berbaum Michael L ML McDermott Michael M Bracken Nina E NE Kumar Rajesh R Margaret Paik S S Nyenhuis Sharmilee M SM Ignoffo Stacy S Press Valerie G VG Pittsenbarger Zachary E ZE Thompson Trevonne M TM

Contemporary clinical trials 20170331

Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ...[more]

PMID: 28366780

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Project description:Understanding triggers is important for managing asthma particularly for patients who seek emergency department (ED) care for exacerbations. The objectives of this analysis were to delineate self-reported triggers in ED patients and to assess associations between triggers and asthma knowledge, severity, and quality of life.At the time of an ED visit, 296 patients were asked what were their usual asthma triggers based on a checklist of 25 potential items, and what they thought specifically precipitated their current ED visit. Using standardized scales, patients also were asked about asthma knowledge, severity, and quality of life.The mean age was 44 years and 72% were women. Patients cited a mean of 12 triggers; most patients had diverse triggers spanning respiratory infections, environmental irritants, emotions, allergens, weather, and exercise. Patients with more triggers were more likely to be women (odds ratio (OR) = 2.0, confidence interval (CI) = 1.3, 3.2, p = .002), obese (OR = 1.7, CI = 1.1, 2.5, p = .01), and to not have a smoking history (OR = 1.9, CI = 1.3, 2.9, p = .001). There were no associations between number of triggers and current age, age at diagnosis, education, socioeconomic status, or race/ethnicity. Patients who cited more triggers had more frequent flares (OR = 1.1, CI = 1.1, 1.2, p < .0001), worse quality of life scores (OR 1.6, CI = 1.1, 2.4, p = .02), and were more likely to have been previously hospitalized for asthma (OR = 1.9, CI = 1.3, 2.9, p = .003) and to have previously required oral corticosteroids (OR = 2.9, CI = 1.6, 5.1, p = .003). There was little clustering of specific triggers according to the variables we considered except for more frequent animal allergy in patients diagnosed at a younger age (OR = 2.8, CI = 1.7, 4.5, p < .0001) and worse quality of life in patients citing emotional stress as a trigger (OR = 2.5, CI = 1.5, 4.0, p = .0002). Patients attributed their current ED visit to multiple precipitants, particularly respiratory infections and weather, and these were concordant with what they reported were known triggers.Patients presenting to the ED for asthma reported multiple triggers spanning diverse classes of precipitants and having more triggers was associated with worse clinical status. ED patients should be instructed that although it may not be possible to eliminate all triggers, mitigating even some triggers can be helpful.

Project description:ObjectiveTo determine whether an emergency department (ED) education and empowerment intervention coupled with early risk assessment can help improve blood pressure (BP) in a high-risk population.MethodsA hypertension emergency department intervention aimed at decreasing disparities (AHEAD2) is a 3-arm, single-site randomized pilot trial for feasibility in an urban academic ED. A total of 150 predominantly ethnic minorities with no primary care provider and severely elevated blood pressure (BP) (?160/100 mm Hg) were enrolled over 10 months. Participants were randomized into 1 of 3 study arms: (1) enhanced usual care (EUC), (2) ED-initiated screening, brief intervention, and referral for treatment (ED-SBIRT), or (3) ED- SBIRT plus a 48-72 hours post-acute care hypertension transition clinic (ED-SBIRT+PACHT-c). Primary outcomes were change in systolic and diastolic BP (SBP and DBP) from baseline to 9 months. Secondary outcomes were BP control (BP <140/90 mm Hg), changes in hypertension knowledge, medication adherence, and limited bedside echocardiogram (LBE) findings.ResultsSBP reduction from baseline to month 9 was -26.8 (95% confidence interval [CI]: -32.8, -20.7) mm Hg for ED-SBIRT, -23.4 (95% CI: -29.5, -17.3) mm Hg for ED-SBIRT+PACHT-c, and -18.9 (95% CI: -24.9, -12.9) mm Hg for EUC. DBP decreased by -12.5 (95% CI: -16.1, -9.0) mm Hg for ED-SBIRT, -11.3 (95% CI: -14.8, -7.7) mm Hg for ED-SBIRT+PACHT-c, and -8.4 (95% CI: -11.9, -4.9) mm Hg for EUC. A multicomponent intervention compared with EUC resulted in SBP decrease of -7.9 mm Hg (95% CI: -16.4, 0.6). At 9 months, hypertension was controlled for 29.3% (95% CI: 20.3, 38.3) of intervention and 23.5% (95% CI: 11.9, 35.2) of EUC participants. All groups saw improvements in hypertension knowledge, medication adherence, and LBEs, with greater improvements in intervention groups.ConclusionsThe study findings suggest that a multicomponent intervention comprising of ED education and empowerment coupled with early risk assessment may help improve BP in a high-risk population.

Project description:ObjectivesThe emergency department (ED) represents a place and moment of opportunity to provide interventions to improve long-term asthma outcomes, but feasibility, effectiveness and mechanisms of impact are poorly understood. We aimed to review the existing literature on interventions that are delivered in the ED for adults and adolescents, targeting asthma outcomes beyond the ED, and to code the interventions according to theory used, and to understand the barriers and facilitators to their implementation.MethodsWe systematically searched seven electronic databases and research registers, and manually searched reference lists of included studies and relevant reviews. Both quantitative and qualitative studies that reported on interventions delivered in the ED which aimed to improve asthma outcomes beyond management of the acute exacerbation, for adolescents or adults were included. Methodological quality was assessed using the Mixed Methods Appraisal Tool and informed study interpretation. Theory was coded using the Theoretical Domains Framework. Findings were summarised by narrative synthesis.Results12 articles were included, representing 10 unique interventions, including educational and medication-based changes (6 randomised controlled trials and 4 non-randomised studies). Six trials reported statistically significant improvements in one or more outcome measures relating to long-term asthma control, including unscheduled healthcare, asthma control, asthma knowledge or quality of life. We identified limited use of theory in the intervention designs with only one intervention explicitly underpinned by theory. There was little reporting on facilitators or barriers, although brief interventions appeared more feasible.ConclusionThe results of this review suggest that ED-based asthma interventions may be capable of improving long-term outcomes. However, there was significant variation in the range of interventions, reported outcomes and duration of follow-up. Future interventions would benefit from using behaviour change theory, such as constructs from the Theoretical Domains Framework.Prospero registration numberCRD 42020223058.

Project description:Leukostasis is a life-threatening complication of acute hyperleukocytic leukemia, and is associated with substantial mortality. Management of leukostasis requires time-sensitive diagnostics and therapeutics, and leukapheresis remains a mainstay of treatment in select patients. Leukapheresis requires coordination of multi-disciplinary resources, which can prove challenging in the emergency department setting, and delays in treatment due to the complexity and coordination required are common. The objective of this study was to assess the effect of utilization of an emergency department-ICU and a multidisciplinary care pathway on outcomes of critically ill leukostasis patients presenting to the emergency department.DesignRetrospective cohort study.SettingSingle large academic medical center in the United States.PatientsAdult emergency department patients with signs and symptoms of leukostasis requiring emergent leukapheresis from 2012-2019.InterventionsImplementation of a hybrid emergency department-ICU setting (emergency critical care center) and a multidisciplinary care pathway with members from Emergency Medicine, Hematology, Blood Bank, and Clinical Pathology.Measurements and main resultsA total of 70 patients were identified and included for analysis: 14 preemergency critical care center; 32 postemergency critical care center, premultidisciplinary care pathway; and 24 postemergency critical care center, postmultidisciplinary care pathway. A statistically significant reduction in the time from emergency department presentation to initiation of leukapheresis was observed from preemergency critical care center to postemergency critical care center, premultidisciplinary care pathway and postemergency critical care center, postmultidisciplinary care pathway (11.5 vs 7.9 vs 7.7 hr; p = 0.004). Statistically significant reductions in in-hospital mortality were observed from preemergency critical care center to postemergency critical care center, premultidisciplinary care pathway and postemergency critical care center, postmultidisciplinary care pathway (64.3% vs 21.9% vs 25.0%; p = 0.01). A trend toward decreased inpatient ICU utilization was observed, although was not statistically significant (35.7% vs 12.5% vs 25.0%; p = 0.14.).Conclusions and relevanceImplementation of a multidisciplinary care pathway via use of an emergency department-ICU for critically ill patients with leukostasis was associated with statistically significant reductions in time to leukapheresis and in-hospital mortality. These findings suggest an emergency department-ICU model may allow for maximal resource and care coordination at the point of contact with critically ill patients and improved clinical outcomes.

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Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.

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Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.

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