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.).

"Where You Feel Like a Family Instead of Co-workers": a Mixed Methods Study on Care Teams and Burnout.

BACKGROUND: Physicians and nurses face high levels of burnout. The role of care teams may be protective against burnout and provide a potential target for future interventions. OBJECTIVE: To explore levels of burnout among physicians and nurses and differences in burnout between physicians and nurses, to understand physician and nurse perspectives of their healthcare teams, and to explore the association of the role of care teams and burnout. DESIGN: A mixed methods study in two school of medicine affiliated teaching hospitals in an urban medical center in Baltimore, Maryland. PARTICIPANTS: Participants included 724 physicians and 971 nurses providing direct clinical care to patients. MAIN MEASURES AND APPROACH: Measures included survey participant characteristics, a single-item burnout measure, and survey questions on care teams and provision of clinical care. Thematic analysis was used to analyze qualitative survey responses from physicians and nurses. KEY RESULTS: Forty-three percent of physicians and nurses screened positive for burnout. Physicians reported more isolation at work than nurses (p<0.001), and nurses reported their care teams worked efficiently together more than physicians did (p<0.001). Team efficiency was associated with decreased likelihood of burnout (p<0.01), and isolation at work was associated with increased likelihood of burnout (p<0.001). Free-text responses revealed themes related to care teams, including emphasis on team functioning, team membership, and care coordination and follow-up. Respondents provided recommendations about optimizing care teams including creating consistent care teams, expanding interdisciplinary team members, and increasing clinical support staffing. CONCLUSIONS: More team efficiency and less isolation at work were associated with decreased likelihood of burnout. Free-text responses emphasized viewpoints on care teams, suggesting that better understanding care teams may provide insight into physician and nurse burnout.

Attitudes Toward COVID-19 Vaccination Among Pregnant Persons in Urban Hospital-Affiliated Practices: Exploring Themes in Vaccine Hesitancy.

OBJECTIVE: To explore beliefs and attitudes toward the COVID-19 vaccine among vaccinated and unvaccinated pregnant persons in order to identify reasons for both vaccine hesitancy and vaccine uptake. METHODS: From June-August 2021, we conducted a qualitative study consisting of semi-structured interviews with pregnant persons (n = 30). Participants were recruited from university-owned obstetric practices during prenatal and ultrasound appointments. Interviews were audio recorded and transcribed; transcripts were coded and analyzed to identify themes and subthemes. RESULTS: Of the participants, one-third (n = 10) had received the COVID-19 vaccine, while two-thirds (n = 20) were unvaccinated. Primary themes for unvaccinated participants were concern about the paucity of research on the vaccine in pregnancy and potential impact of the vaccine on both fetal development and maternal health. For vaccinated participants, main themes included potential maternal and fetal protection from COVID-19 and anticipated health complications from contracting COVID-19 as their motivations to get vaccinated. While most participants cited healthcare providers as the most trusted source of vaccine information, a majority reported that the internet was their primary source of vaccine information. Many participants wanted to learn more about the COVID-19 vaccine from their obstetric providers, and notably, most vaccinated participants reported the importance of their obstetrician in their vaccine decision-making process. CONCLUSIONS: COVID-19 vaccine hesitancy is prevalent among pregnant persons, with concerns for vaccine safety for their fetus, as well as for themselves, being common. Obstetric providers must therefore be prepared to address common concerns with patients during prenatal appointments, taking the time to actively recommend vaccination.

Family management of asthma in Head Start preschool children.

BACKGROUND: Urban minority preschool children are disproportionately affected by asthma with increased asthma morbidity and mortality. It is important to understand how families manage asthma in preschool children to improve asthma control. OBJECTIVE: To evaluate family asthma management and asthma outcomes among a low-income urban minority population of Head Start preschool children. METHODS: The family asthma management system scale (FAMSS) evaluates how families manage a child's asthma. A total of 388 caregivers completed the FAMSS at baseline. Asthma outcomes were evaluated at baseline and prospectively at 6 months, including asthma control (based on the Test for Respiratory and Asthma Control in Kids), courses of oral corticosteroids (OCSs) required, and caregiver health-related quality of life (Pediatric Asthma Caregiver's Quality of Life Questionnaire [PACQLQ]). Multiple regression models evaluated the relationship between the FAMSS total score, FAMSS subscales, and asthma outcomes. RESULTS: Higher FAMSS total scores were associated with fewer courses of OCSs required (b = -0.23, P < .01) and higher PACQLQ scores (b = 0.07, P < .05). At baseline, higher integration subscale scores (b = -0.19, P < .05) were associated with fewer courses of OCSs required, and higher family response scores were associates with higher PACQLQ scores (b = 0.06, P < .05). Nevertheless, higher collaboration scores were associated with lower PACQLQ at baseline (b = -0.06, P < .05) and 6 months (b = -0.07, P < .05). CONCLUSION: Among this population of low-income minority preschool children, understanding how a family manages their child's asthma may help identify gaps for education to possibly improve caregiver asthma-related quality of life and reduce courses of OCSs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01519453 (https://clinicaltrials.gov/ct2/show/NCT01519453); protocol available from meakin1@jhmi.edu.

Perspectives on Maternal Vaccination from Obstetrical Clinicians: A Qualitative Multi-site Study.

OBJECTIVES: Despite the seriousness of influenza and pertussis, availability of safe and effective vaccines against them, and long-standing maternal vaccination recommendations, US maternal influenza and Tdap vaccination rates have been low. To increase vaccination rates in obstetric offices, it is important to understand clinician perspectives and office processes. We conducted in-depth interviews with nurses and providers on these topics. METHODS: Interviewees worked in obstetric offices in one-of-four participating health systems in NY and CA. We audio-recorded and transcribed 20-30-min interviews. We used predetermined categories to code interviews with Dedoose, then iteratively refined codes and identified themes. RESULTS: We conducted 20 interviews between 4/2020 and 9/2020: 13 providers (physician or nurse midwife) (5 NY, 8 CA); 7 office nurses (6 NY, 1 CA). In almost all offices, patient refusal of influenza vaccine was considered the major vaccination barrier; Tdap was often deferred by patients until post-delivery. Nurse-only visits for either vaccine were rare. Vaccination outside the office was uncommon; few offices systematically documented vaccines given elsewhere in a retrievable manner. Participants emphasized patient education as key to prenatal care, but the number of topics left little time for immunizations. Few interviewees could identify an office "immunization champion," knew their office vaccination rates, or had participated in vaccination quality improvement. Several interviewees indicated that they or another provider were good at persuading hesitant patients, but their method had not been shared with other clinicians. CONCLUSIONS FOR PRACTICE: Multiple practical barriers and maternal vaccine hesitancy limit maternal vaccination. Quality improvement strategies are needed.

Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes.

OBJECTIVE: Because higher parental psychosocial stress is associated with worsened asthma outcomes in children, we sought to determine if a parent-focused stress management intervention would improve outcomes among their at-risk African American children. METHODS: We enrolled self-identified African American parent-child dyads (children aged 4-12 years old with persistent asthma, no co-morbidities, on Medicaid) in a prospective, single-blind, randomized clinical trial with follow-up at 3, 6, and 12 months. All children received care based on the guidelines of the National Institutes of Health. Developed with extensive local stakeholder engagement, the intervention consisted of four individual sessions with a community wellness coach (delivered over 3 months) supplemented with weekly text messaging and twice monthly group sessions (both delivered for 6 months). The main outcome was asthma symptom-free days in the prior 14 days by repeated measures at 3 and 6 months follow-up. RESULTS: We randomized 217 parent-child dyads and followed 196 (90.3%) for 12 months. Coaches completed 338/428 (79%) of all individual sessions. Symptom-free days increased significantly from baseline in both groups at 3, 6, and 12 months, but there were no significant differences between groups over the first 6 months. At 12 months, the intervention group sustained a significantly greater increase in symptom-free days from baseline [adjusted difference = 0.92 days, 95% confidence interval (0.04, 1.8)]. CONCLUSION: The intervention did not achieve its primary outcome. The efficacy of providing psychosocial stress management training to parents of at-risk African American children with persistent asthma in order to improve the children's outcomes may be limited. CLINICALTRIALS.GOV: NCT02374138.

Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.

OBJECTIVE: To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination. STUDY DESIGN: Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine. RESULTS: In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages. CONCLUSIONS: Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03294473 and NCT03246100.

A quality improvement collaborative to increase human papillomavirus vaccination rates in local health department clinics.

Human papillomavirus (HPV) vaccination rates are well below the Healthy People 2020 goal of 80%. Vaccinating in settings other than primary care, such as local health departments (LHDs), may help achieve higher HPV immunization rates. We tested the effect of a quality improvement (QI) collaborative to reduce missed opportunities (MOs) for HPV vaccine in LHDs. Between 2016 and 2019, we conducted four consecutive cohorts of a virtual QI collaborative at 24 LHDs across multiple states. Participants were trained on topics including how to provide an effective recommendation for HPV vaccine, strategies to reduce MOs, and motivational interviewing. Throughout the 6-month project implementation, LHDs tested strategies to reduce MOs through Plan-Do-Study-Act cycles, performed chart reviews to identify and characterize MOs, and received feedback reports to assess progress on MOs. HPV vaccination rates were assessed pre- and post-intervention. LHDs reduced MOs for HPV vaccine in all four cohorts with aggregated data showing a 25.3 percentage point reduction in MOs. Modified Poisson regression analysis found a 44% reduction in the relative risk of missing the opportunity for an HPV vaccine at a visit (RR = 0.56, 0.46-0.68, p < .001). This project shows that strategies effective in reducing MO for HPV vaccine in primary care settings are also effective in LHD settings. Training LHD staff on these strategies may help the U.S. approach national goals for HPV vaccine coverage.

Association between neighborhood socioeconomic status, tobacco store density and smoking status in pregnant women in an urban area.

Smoking during pregnancy can lead to serious health consequences. Given such health risks, an understanding of factors that influence maternal smoking behaviors during pregnancy is critical. The objective of this study is to assess the relationship between tobacco store density, neighborhood socioeconomic status, and neighborhood rates of maternal smoking during pregnancy. Fifty-five community areas in Baltimore City were summarized using data from the Neighborhood Health Profiles. Associations between tobacco store density and smoking while pregnant in a community were determined using Moran's I and spatial regression analyses to account for autocorrelation. The fully adjusted model took into account the following community-level socioeconomic variables as covariates: neighborhood median income, percentage of those living in poverty, percentage of uninsured, and percentage of persons with at least a college degree. In regards to the findings, the percentage of women by community area who identified as actively smoking while pregnant was 10.4% ± 5.8%. The tobacco store density was 21.0 ± 12.7 per 10,000 persons (range 0.0-49.1 tobacco store density per 10,000 persons). In the adjusted model, an increase in density of 1 tobacco store per 10,000 persons was associated with a 10% increase in women who reported smoking during pregnancy (ß = 0.10, p = 0.04). In conclusion, tobacco store density and neighborhood socioeconomic factors were associated with prevalence of maternal smoking while pregnant. These findings support the need to further assess and develop interventions to reduce the impact of tobacco store density on smoking behaviors and health risks in communities.

Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study.

BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).

It takes a village - asthma networks utilized by parents when managing childhood asthma medications.

Objective: We are yet to understand how widely parents seek asthma medication management information for their children, how they are used for health information, how parents engage with them and their influence on parent's decision-making. This study aimed to gauge the current level of asthma knowledge and skills of parents of children with asthma and gain insight into who and what influences their child's asthma medication management decisions. Method: Social network theory was used to map parents' asthma networks and identify the level of influence of each individual/resource nominated. Parents of children with asthma (aged 4-18 years) were interviewed, completed an asthma network map, questionnaires and an inhaler technique assessment. Results: Twenty-six parents participated and had significant gaps in asthma knowledge and inhaler technique skills. The asthma networks of participants ranged from two to ten individuals/resources, with an average number of five. The most commonly nominated individual/resource was general practitioners followed by family members and the internet. Professional connections represented 44% of individuals/resources in networks, personal connections 42% and impersonal connections 14%. When parents were asked about how influential individuals/resources were, professional connections represented 53% of parents influences, personal connections 36% and impersonal connections 11%. Conclusion: This study highlights the priority and co-influence of non-medical sources of information/support on parent's behaviors and decision-making with regards to their child's asthma medicine taking. In further understanding the complexities surrounding these connections and relationships, HCPs are better positioned to assist parents in addressing their needs and better supporting them in the management of their child's asthma.

Evaluating the implementation of a multicomponent asthma education program for Head Start staff.

OBJECTIVE: Asthma disproportionately affects minority groups, low income populations, and young children under 5. Head Start (HS) programs predominantly serve this high-risk population, yet staff are not trained on asthma management. The objective of this study was to assess a 5-year, multicomponent HS staff asthma education program in Baltimore City HS programs. METHODS: All HS programs were offered annual staff asthma education by a medical research team that included didactic lectures and hands-on training. Attendees received continuing education credits. HS staff were anonymously surveyed on asthma knowledge and skills and asthma medication management practices in Year 1 (preimplementation) and Year 5. RESULTS: There was an estimated response rate of 94% for Year 1 and 82% for Year 5. Compared to staff in Year 1, Year 5 staff were significantly more likely to report they had very good knowledge and skills related to asthma [odds ratio (OR) 1.63; p < 0.05] and were engaged in asthma care activities (OR 2.02; p < 0.05). Self-reported presence of asthma action plans for all children with asthma was 82% at Year 1 and increased to 89% in Year 5 (p = 0.064). CONCLUSIONS: Year 5 HS staff reported higher self-assessed knowledge and skills, self-reports of asthma medication management practices, and self-reports of asthma activities compared to Year 1 staff. HS serves high-risk children with asthma, and a multicomponent program can adequately prepare staff to manage asthma in the child care setting. Our results indicate the feasibility of providing efficacious health skill education into child care provider training to reduce asthma knowledge gaps.

Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children.

BACKGROUND: Studies have noted variations in the cost-effectiveness of school-located influenza vaccination (SLIV), but little is known about how SLIV's cost-effectiveness may vary by targeted age group (e.g., elementary or secondary school students), or vaccine consent process (paper-based or web-based). Further, SLIV's cost-effectiveness may be impacted by its spillover effect on practice-based vaccination; prior studies have not addressed this issue. METHODS: We performed a cost-effectiveness analysis on two SLIV programs in upstate New York in 2015-2016: (a) elementary school SLIV using a stepped wedge design with schools as clusters (24 suburban and 18 urban schools) and (b) secondary school SLIV using a cluster randomized trial (16 suburban and 4 urban schools). The cost-per-additionally-vaccinated child (i.e., incremental cost-effectiveness ratio (ICER)) was estimated by dividing the incremental SLIV intervention cost by the incremental effectiveness (i.e., the additional number of vaccinated students in intervention schools compared to control schools). We performed deterministic analyses, one-way sensitivity analyses, and probabilistic analyses. RESULTS: The overall effectiveness measure (proportion of children vaccinated) was 5.7 and 5.5 percentage points higher, respectively, in intervention elementary (52.8%) and secondary schools (48.2%) than grade-matched control schools. SLIV programs vaccinated a small proportion of children in intervention elementary (5.2%) and secondary schools (2.5%). In elementary and secondary schools, the ICER excluding vaccine purchase was $85.71 and $86.51 per-additionally-vaccinated-child, respectively. When additionally accounting for observed spillover impact on practice-based vaccination, the ICER decreased to $80.53 in elementary schools -- decreasing substantially in secondary schools. (to $53.40). These estimates were higher than the published practice-based vaccination cost (median = $25.50, mean = $45.48). Also, these estimates were higher than our 2009-2011 urban SLIV program mean costs ($65) due to additional costs for use of a new web-based consent system ($12.97 per-additionally-vaccinated-child) and higher project coordination costs in 2015-2016. One-way sensitivity analyses showed that ICER estimates were most sensitive to the SLIV effectiveness. CONCLUSIONS: SLIV raises vaccination rates and may increase practice-based vaccination in primary care practices. While these SLIV programs are effective, to be as cost-effective as practice-based vaccination our SLIV programs would need to vaccinate more students and/or lower the costs for consent systems and project coordination. TRIAL REGISTRATION: ClinicalTrials.gov NCT02227186 (August 25, 2014), updated NCT03137667 (May 2, 2017).

Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.

Importance: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life. Objective: To evaluate whether a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers can improve outcomes. Design, Setting, and Participants: Single-site randomized clinical trial conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016. Interventions: The intervention (n = 120) involved a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by nurses with special training on supporting patients with COPD using standardized tools. Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care. Main Outcomes and Measures: The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful). Results: Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; 61.7% women), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 62.3 (18.8) in the intervention group and 63.6 (17.4) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 1.40 (95% CI, 1.01-1.79) in the intervention group vs 0.72 (95% CI, 0.45-0.97) in the usual care group (difference, 0.68 [95% CI, 0.22-1.15]; P = .004). The mean change in participants' SGRQ total score at 6 months was 2.81 in the intervention group and -2.69 in the usual care group (adjusted difference, 5.18 [95% CI, -2.15 to 12.51]; P = .11). During the study period, there were 15 deaths (intervention: 8; usual care: 7) and 339 hospitalizations (intervention: 202; usual care: 137). Conclusions and Relevance: In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly greater COPD-related hospitalizations and emergency department visits, without improvement in quality of life. Further research is needed to determine reasons for this unanticipated finding. Trial Registration: ClinicalTrials.gov Identifier: NCT02036294.

In-Home Secondhand Smoke Exposure Among Urban Children With Asthma: Contrasting Households With and Without Residential Smokers.

CONTEXT: Secondhand smoke exposure (SHSe) affects up to half of all children in the United States. Many studies have identified factors associated with in-home SHSe, but few have contrasted these factors between households with and without residential smokers. In the latter case, exposure occurs from only external sources that enter the home, such as visitors or environmental incursion. OBJECTIVE: Among children with SHSe at home, to examine demographic and psychosocial differences between households with and without residential smokers. DESIGN: Baseline analysis of an observational cohort. SETTING: Baltimore City, Maryland. PARTICIPANTS: A total of 157 children with asthma, aged 5 to 12 years. MEASURES: At-home airborne nicotine, caregiver-reported depression, asthma-related quality of life, functional social support, and demographics. Univariable comparisons were performed between SHS-exposed households with and without residential smokers. Multivariable logistic regression models were fit to examine associations between measured factors and absence of residential smokers. RESULTS: Children (78.3%) had at-home SHSe. Of these, 40.7% lived in households without residential smokers. Compared with households with residential smokers, these caregivers endorsed stronger beliefs in SHS harms and also worse functional social support and asthma-related stress, despite no differences in asthma morbidity. In adjusted models, SHS-exposed children with caregivers in the lowest tertile of functional social support (adjusted odds ratio, 3.50; 95% confidence interval, 1.12-10.99), asthma-related quality of life (2.90; 1.06-7.95), and those living alone (5.28; 1.26-22.15) had at least twice higher odds of having exclusively external SHSe than the highest tertile (P trends < .05). CONCLUSIONS: In-home SHS exposure remains alarmingly high in urban environments. However, a substantial proportion of this exposure appears to be occurring only from external sources that enter the home. Caregivers in these homes had higher desire but lower agency to avoid SHSe, driven by lack of functional support and physical isolation. Public policies targeting these factors may help remediate exposure in this especially vulnerable population.

Inhaler technique mastery and maintenance in healthcare professionals trained on different devices.

OBJECTIVE: Healthcare professionals (HCPs) are required to assess and train patients in the correct use of inhalers but are often unable to demonstrate correct technique themselves. We sought to assess the level of training required for HCPs to master and maintain device mastery when using two different dry powder inhalers (DPIs). METHODS: We conducted a randomized, un-blinded, crossover study in undergraduate HCPs who undertook a six-step training procedure (intuitive use, patient information leaflet, instructional video, individual tuition from expert, then two repeats of individual tuition) for the use of Turbuhaler® (an established device) and Spiromax® (a newer device, reportedly easier to use). Device mastery (absence of errors) was evaluated by expert assessors at each training step. Maintenance of mastery was assessed 4 ± 1 week (visit 2) and 8 ± 2 weeks (visit 3) after initial training (visit 1). RESULTS: Of 516 eligible participants, 113 (22%) demonstrated device mastery prior to training on Spiromax® compared with 20 (4%) on Turbuhaler® (p < 0.001). The median number of training steps required to achieve mastery was 2 (interquartile range [IQR] 2-4) for Spiromax® and 3 (IQR 2-4) for Turbuhaler® (p < 0.001). A higher number of participants maintained mastery with Spiromax® compared with Turbuhaler®, at visits 2 and 3 (64% vs 41% and 79% vs 65%, respectively; p < 0.001). CONCLUSIONS: There are significant differences in the nature and extent of training required to achieve and maintain mastery for Spiromax® and Turbuhaler® devices. The implications on clinical practice, device education delivery, and patient outcomes require further evaluation.

Neighbourhood characteristics and health outcomes: evaluating the association between socioeconomic status, tobacco store density and health outcomes in Baltimore City.

INTRODUCTION: Several studies suggest that the health of an individual is influenced by the socioeconomic status (SES) of the community in which he or she lives. This analysis seeks to understand the relationship between SES, tobacco store density and health outcomes at the neighbourhood level in a large urban community. METHODS: Data from the 55 neighbourhoods of Baltimore City were reviewed and parametric tests compared demographics and health outcomes for low-income and high-income neighbourhoods, defined by the 50th percentile in median household income. Summary statistics are expressed as median. Tobacco store density was evaluated as both an outcome and a predictor. Association between tobacco store densities and health outcomes was determined using Moran's I and spatial regression analyses to account for autocorrelation. RESULTS: Compared with higher-income neighbourhoods, lower-income neighbourhoods had higher tobacco store densities (30.5 vs 16.5 stores per 10 000 persons, P=0.01), lower life expectancy (68.5 vs 74.9 years, P<0.001) and higher age-adjusted mortality (130.8 vs 102.1 deaths per 10 000 persons, P<0.001), even when controlling for other store densities, median household income, race, education status and age of residents. CONCLUSION: In Baltimore City, median household income is inversely associated with tobacco store density, indicating poorer neighbourhoods in Baltimore City have greater accessibility to tobacco. Additionally, tobacco store density was linked to lower life expectancy, which underscores the necessity for interventions to reduce tobacco store densities.

Effect of a Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Hospitalized Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.

Importance: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life. Objective: To evaluate a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers. Design, Setting, and Participants: This single-site randomized clinical trial was conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016. Interventions: The intervention (n = 120) was a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by COPD nurses (nurses with special training on supporting patients with COPD using standardized tools). Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care. Main Outcomes and Measures: The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful). Results: Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; females, 61.7%), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 63.1 (19.9) in the intervention group and 62.6 (19.3) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 0.72 (95% CI, 0.45-0.97) in the intervention group vs 1.40 (95% CI, 1.01-1.79) in the usual care group (difference, 0.68 [95% CI, 0.22 to 1.15]; P = .004). The mean change in participants' SGRQ total score at 6 months was -1.53 in the intervention and +5.44 in the usual care group (adjusted difference, -6.69 [95% CI, -12.97 to -0.40]; P = .04). During the study period, there were 15 deaths (intervention: 7; usual care: 8) and 337 hospitalizations (intervention: 135; usual care: 202). Conclusions and Relevance: In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly fewer COPD-related hospitalizations and emergency department visits and better health-related quality of life at 6 months after discharge. Further research is needed to evaluate this intervention in other settings. Trial Registration: ClinicalTrials.gov Identifier: NCT02036294.

An Official American Thoracic Society Research Statement: Implementation Science in Pulmonary, Critical Care, and Sleep Medicine.

BACKGROUND: Many advances in health care fail to reach patients. Implementation science is the study of novel approaches to mitigate this evidence-to-practice gap. METHODS: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement on implementation science in pulmonary, critical care, and sleep medicine. The committee used an iterative consensus process to define implementation science and review the use of conceptual frameworks to guide implementation science for the pulmonary, critical care, and sleep community and to explore how professional medical societies such as the ATS can promote implementation science. RESULTS: The committee defined implementation science as the study of the mechanisms by which effective health care interventions are either adopted or not adopted in clinical and community settings. The committee also distinguished implementation science from the act of implementation. Ideally, implementation science should include early and continuous stakeholder involvement and the use of conceptual frameworks (i.e., models to systematize the conduct of studies and standardize the communication of findings). Multiple conceptual frameworks are available, and we suggest the selection of one or more frameworks on the basis of the specific research question and setting. Professional medical societies such as the ATS can have an important role in promoting implementation science. Recommendations for professional societies to consider include: unifying implementation science activities through a single organizational structure, linking front-line clinicians with implementation scientists, seeking collaborations to prioritize and conduct implementation science studies, supporting implementation science projects through funding opportunities, working with research funding bodies to set the research agenda in the field, collaborating with external bodies responsible for health care delivery, disseminating results of implementation science through scientific journals and conferences, and teaching the next generation about implementation science through courses and other media. CONCLUSIONS: Implementation science plays an increasingly important role in health care. Through support of implementation science, the ATS and other professional medical societies can work with other stakeholders to lead this effort.

Using stakeholder engagement to develop a patient-centered pediatric asthma intervention.

Stakeholder engagement has the potential to develop research interventions that are responsive to patient and provider preferences. This approach contrasts with traditional models of clinical research in which researchers determine the study's design. This article describes the effect of stakeholder engagement on the design of a randomized trial of an intervention designed to improve child asthma outcomes by reducing parental stress. The study team developed and implemented a stakeholder engagement process that provided iterative feedback regarding the study design, patient-centered outcomes, and intervention. Stakeholder engagement incorporated the perspectives of parents of children with asthma; local providers of community-based medical, legal, and social services; and national experts in asthma research methodology and implementation. Through a year-long process of multidimensional stakeholder engagement, the research team successfully refined and implemented a patient-centered study protocol. Key stakeholder contributions included selection of patient-centered outcome measures, refinement of intervention content and format, and language framing the study in a culturally appropriate manner. Stakeholder engagement was a useful framework for developing an intervention that was acceptable and relevant to our target population. This approach might have unique benefits in underserved populations, leading to sustainable improvement in health outcomes and reduced disparities.