Recognizing and Tackling Inhaler Technique Decay in Asthma and Chronic Obstructive Pulmonary Disesase (COPD) Clinical Practice.

A poor inhaler technique continues to represent a substantial barrier to effective asthma and chronic obstructive pulmonary disease management. It can result in perceived lack of treatment effectiveness even with apparent adherence to a prescribed regimen of inhaled maintenance therapies, potentially resulting in an unnecessary change or escalation of treatment. Many patients are not trained to inhaler mastery in real-world practice; furthermore, even where mastery is initially achieved, an ongoing assessment and education are seldom maintained. In this review, we present an overview of the evidence for deterioration of the inhaler technique over time after training, investigate the factors that contribute to this deterioration, and explore innovative approaches to addressing the problem. We also propose steps forward drawn from the literature and our clinical insights.

Adapting adaptive design methods to accelerate adoption of a digital asthma management intervention.

Investigators conducting translational research in real-world settings may experience changes that create challenges to the successful completion of the trial as well as post-trial adoption and implementation. Adaptive designs support translational research by systematically adapting content and methods to meet the needs of target populations, settings and contexts. This manuscript describes an adaptive implementation research model that provides strategies for changing content, delivery processes, and research methods to correct course when anticipated and unanticipated circumstances occur during a pragmatic trial. The Breathewell Program included two large pragmatic trials of the effectiveness of a digital communication technology intervention to improve symptom management and medication adherence in asthma care. The first trial targeted parents of children with asthma; the second targeted adults with asthma. Adaptations were made iteratively to adjust to dynamic conditions within the healthcare setting, informed by prospectively collected stakeholder input, and were categorized retrospectively by the authors as proactive or reactive. Study outcomes demonstrated improved treatment adherence and clinical efficiency. Kaiser Permanente Colorado, the setting for both studies, adopted the speech recognition intervention into routine care, however, both interventions required numerous adaptations, including changes to target population, intervention content, and internal workflows. Proactive and reactive adaptations assured that both trials were successfully completed. Adaptive research designs will continue to provide an important pathway to move healthcare delivery research into practice while conducting ongoing effectiveness evaluation.

Health care research often moves slowly and consequently important results may take a long time to reach the patients they are intended to help. Implementation studies conducted in routine clinical practice are intended to accelerate the process of delivering new discoveries into settings where they can be more quickly put to use. However, conducting research in real-world settings can be challenging if changes occur in those settings during the course of the study. Therefore, an adaptive implementation approach that allows researchers to make changes during the course of a study can facilitate study completion and improve likelihood of intervention adoption into routine care. This report demonstrates the use of an adaptive implementation model in two large studies of asthma in children and adults. In both studies, communication technology including computerized phone calls, texts, and email helped improve treatment consistency and efficiency.

Effect of an Asthma Exacerbation on Medication Adherence.

BACKGROUND: Few studies have looked at the effect of an asthma exacerbation on asthma medication adherence. OBJECTIVE: To measure asthma medication adherence in the 12 months after an asthma exacerbation and the influence of care type (specialist vs primary care provider) as well as social economic status on adherence. METHODS: We measured portion of days covered (PDC) during the 12 months before and after an exacerbation in a cohort of patients with asthma who were aged 18 years and older. Subanalyses looked at PDC in those who had more than one exacerbation after the sentinel exacerbation, by type of care received (primary care, allergist or pulmonologist, or no care) during both periods and by socioeconomic status (SES), defined as the lower quartile of annual income for the group. RESULTS: In a cohort of 1,697 patients, PDC improved significantly (from 0.44 to 0.53; P < .001) after an asthma exacerbation. Improvement in PDC was even greater (from 0.45 to 0.57; P < .001) if they had more than one exacerbation after the sentinel exacerbation. Being seen by a specialist after the exacerbation but not before it, resulted in the greatest improvement in PDC (0.17 mean change). Patients not seen by a specialist either before the exacerbation or after had a mean change of just 0.07. Those with a lower SES had an overall lower PDC before the exacerbation (0.37 vs 0.43) but saw a similar improvement in the PDC compared with those in a higher SES (0.09 vs 0.10). CONCLUSIONS: An asthma exacerbation is associated with a significant and sustained effect on medication adherence.

Teleallergy: Where Have We Been and Where Are We Going?

Telemedicine uptake in allergy/immunology was slow before the coronavirus disease 2019 pandemic, but has accelerated since. This review examines where telemedicine has been in allergy/immunology and where it is headed in the future. Focus is placed on patient, physician, and health care professional satisfaction with telemedicine, capacity to expand access to allergy/immunology care, cost considerations, the regulatory environment, and future applications of telemedicine including adherence monitoring, wearable biosensors, artificial intelligence, and machine learning addressed.

COVID-19 on the Navajo Nation: experiences of Diné families of children with asthma.

OBJECTIVE: The first case of COVID-19 on the Navajo Nation (NN) was found on March 17, 2020. Even with strong public health efforts, NN saw the highest per capita infection rate in the US during May of 2020 with 2450/100,000. To determine the impact of COVID-19 on families of children with asthma on the NN, families participating in the NHLBI funded Community Asthma Program were contacted to see if they would share their experiences. METHODS: Sixty-six of 193 families (34%) were interviewed.Results: The average age of the child with asthma was 13.5 (SD = 3.9) and 33% were female. Most Diné children with asthma in our study did not contract COVID-19. However, the pandemic had a significant impact on them and their families. Many family members contracted COVID-19, some children lost family members, and half of interviewed parents reported a decline in their child's mental health. Twenty-five percent of families sought the help of a traditional healer. Many accessed medical care through telehealth and most were able to obtain asthma medications when needed.Conclusions: Despite significant challenges, our research indicated resilience among Navajo families.

Assessment of Real-World Escalation to Biologics in US Patients With Asthma.

BACKGROUND: Previous studies indicate that suboptimal medication adherence may contribute to uncontrolled asthma. Global Initiative for Asthma (GINA) guidelines recommend treatment escalation to biologics for patients with uncontrolled asthma despite adherence to high-dose maintenance medication and who have eosinophilic/allergic biomarkers or require maintenance oral corticosteroids. OBJECTIVE: This study aimed to describe the clinical status of patients with asthma escalated to biologic therapy. METHODS: This retrospective claims database analysis enrolled US patients with asthma who were escalated to biologics between January 2016 and June 2020. Exacerbations, control status, GINA step, and maintenance medication adherence during the 12 months before biologic therapy initiation were analyzed. Asthma control was assessed using both the European Respiratory Society/American Thoracic Society (ERS/ATS) and Stempel criteria. Adherence was defined as the proportion of days covered (PDC) by maintenance medication claims. RESULTS: Of 1786 patients escalated to biologics, 506 were included for analysis. During the 12 months before escalation, 346 patients had confirmed exacerbations. Uncontrolled asthma status was estimated in 55% and 70% of patients (ERS/ATS and Stempel criteria, respectively). GINA step was inferred for 395 patients: 154 were at step 2, 11 at step 3, 104 at step 4, and 126 at step 5. Of 403 patients with maintenance medication claims, 63% had suboptimal maintenance medication adherence (PDC <80%). CONCLUSION: In this study, most patients initiating biologic therapy had mild-to-moderate asthma or suboptimal maintenance medication adherence, possibly indicating inappropriate escalation. Incorporating objective medication adherence monitoring into existing guidelines may reduce inappropriate escalation to biologics.

Transition to Virtual Asthma Care During the COVID-19 Pandemic: An Observational Study.

BACKGROUND: The COVID-19 pandemic increased reliance on virtual care for patients with persistent asthma. OBJECTIVE: This retrospective cohort study assessed changes from in-person to virtual care during the pandemic. In patients with persistent asthma, compared with the same period before the pandemic. METHODS: Kaiser Permanente Colorado members aged 18 to 99 years with persistent asthma were evaluated during two periods (March to October 2019 and March to October 2020). Comparison of asthma exacerbations (hospitalizations, emergency department visits, and courses of oral prednisone) and asthma medication metrics were evaluated between the two periods and by type of care received during the pandemic (no care, virtual care only, in-person care only, or a mix of virtual and in-person care). Population characteristics by type of care received during the pandemic were also evaluated. RESULTS: Among 7,805 adults with persistent asthma, those who used more virtual care or sought no care during the pandemic were younger and had fewer comorbidities, mental health diagnoses, or financial barriers. Exacerbations decreased (0.264 to 0.214; P <.001) as did courses of prednisone (0.213 to 0.169). Asthma medication adherence (0.53 to 0.54; P <.001) and the asthma medication ratio, a quality-of-care metric (0.755 to 0.762; P = .019), increased slightly. Patients receiving a mix of in-person and virtual care had the highest rate of exacerbations (0.83) and a lower asthma medication ratio (0.74) despite having the highest adherence (.57). CONCLUSIONS: Despite an increase in virtual care, asthma exacerbations decreased except among individuals who received both in-person and virtual care, likely because they had more severe disease.

Predicting Young Adult Tobacco, Drug and Alcohol Use Among Participants in the CAMP Trial.

The development of substance abuse in youth with asthma have seldom been examined with longitudinal research. The prospective and well-characterized CAMP cohort provides outcome data on youth with asthma over 13 years. This manuscript seeks to determine the contributions of asthma features and child behavioral/emotional functioning to subsequent tobacco, alcohol, and drug use in early adulthood. Childhood smoking exposures as well as parent report and youth report of substance use were prospectively assessed concurrently with assessments of asthma symptoms, study medication, and lung development. Logistic regression models evaluated predictors of adolescent and young adult tobacco, alcohol, and drug use. Use of tobacco products was reported by 33% of youth with mild/moderate asthma. Tobacco use was significantly associated with self-reported externalizing behaviors. Early life passive smoke exposure, especially in utero exposure, makes a significant contribution to tobacco use (OR1.58). Greater risk for tobacco use is conveyed by self-reported externalizing behaviors, which are consistently robust predictors of any future use of tobacco products, alcohol and drugs. These findings provide evidence for health care providers to use routine behavioral screening in youth with asthma.

The Impact of Adherence and Health Literacy on Difficult-to-Control Asthma.

Medication nonadherence and health literacy are key factors that influence the management of difficult-to-control asthma. Adherence, or the extent to which a patient follows a treatment plan, extends beyond asthma medication use and includes an appropriate inhaler technique. Assessment of adherence is critical before making a diagnosis of severe asthma and stepping up asthma therapy but is challenging in the clinical context. Health literacy, or the degree to which individuals can obtain, process, and understand health information and services needed to make health care decisions, is additionally important for asthma management and has been shown to impact medication adherence. Initiatives aiming to improve difficult-to-control asthma should address medication adherence and health literacy. Universal health literacy precautions are recommended while communicating with patients, in addition to the creation of low health literacy asthma action plans. To improve adherence, a comprehensive assessment of adherence should be conducted. Additional evidence-based interventions aiming to improve adherence focus on appropriate inhaler use, improved access to medications, the use of digital platforms, school-based asthma interventions, and the implementation of culturally tailored interventions. Data are limited regarding the use of these initiatives in patients with severe or difficult-to-control asthma.

Defining Optimal Medication Adherence for Persistent Asthma and COPD.

Adherence to prescribed medications for chronic respiratory disease is considered a keystone for successful management. There is little consensus, though, on how to measure adherence, what is optimal adherence, or the goals of appropriate medication utilization. These criteria may differ when studying medication utilization at the patient or population level. The role of consistent medication use in chronic respiratory disease is associated with better outcomes. Shared decision-making is one strategy to achieve appropriate levels of adherence that requires negotiation, compromise by both patient and provider. It also recognizes that both success and failure to achieve goals of adherence are shared. As such, we discuss the current understanding of adherence measures in respiratory disease and identify the need for more nuanced approaches to evaluate adherence to reach acceptable patient outcomes.

The Asthma Toolkit Bootcamp to Improve Rural Primary Care for Pediatric Asthma.

BACKGROUND: Children with asthma living in rural areas receive most of their care from primary care providers who have variable knowledge of evidence-based guideline management. OBJECTIVE: To test the capacity of the Asthma Toolkit Bootcamp program to improve primary care provider guidelines adherence and reduce health care utilization in rural children with asthma. METHODS: The Asthma Toolkit Bootcamp program provided intensive training in National Heart, Lung, and Blood Institute guidelines-based asthma care, evaluated within a RE-AIM implementation science framework. All primary care practices serving pediatric patients in rural La Plata County, Colorado, received (1) online instruction, (2) full-day training, and (3) follow-up, in-practice training 1 month later. Training focused on spirometry use, severity and control assessment, medication management, asthma action plan utilization, and adoption of a standardized visit protocol. RESULTS: RE-AIM evaluation determined successful enrollment of practices in La Plata County (Reach) and provider uptake of evidence-based practices including spirometry (Adoption). Pediatric asthma patients receiving spirometry increased from 22% pretraining to 86% posttraining; severity assessment from 47% to 88%; and action plans from 40% to 86%. Significant improvements in health care utilization were observed among trained practices including a 10% decrease in emergency department visits, 35% decrease in hospital admissions, and 29% decrease in oral corticosteroid prescriptions (Effectiveness). Comparison practices showed no significant reductions in health care utilization. Participating providers reported that having the training in their own community, intense practice, a team-based approach, and cost-free materials including the spirometer and patient education materials were particularly helpful. CONCLUSIONS: The Asthma Toolkit Bootcamp improved pediatric asthma care given by rural providers and reduced health care utilization among their patients.

Impact of a diagnostic therapeutic educational pathway program for asthma management in preschool children.

BACKGROUND: Preschool children with clinically-diagnosed asthma have a higher rate of emergency department visits and consume more resources for management than older children. However, no clinical trials have yet been performed measuring the impact of a combined diagnostic, therapeutic and educational pathway regimen for evaluation of wheezing control in children aged less than 6 years. The purpose of the present study was to assess the impact of a pediatric program developed in Italy, the Diagnostic Therapeutic Educational Pathway (DTEP), for asthma management in children less than 6 years old attending an asthma referral center. METHODS: This is a retrospective population-based cohort study performed in children with asthma aged 0-5 years, attending at "Io e l'Asma center", Brescia, Italy between September 2007 and December 2014. The incidence rates (IRs) of hospitalization, emergency room visits, use of outpatient services and drug usage for dyspnea, wheezing, or respiratory symptoms were evaluated for time periods prior to and after DTEP intervention. RESULTS: A total of 741 patients, aged 0-5 years completed the DTEP, including 391 and 350 children aged 0-2 and 3-5 years, respectively. The percentage of children aged 0-2 and 3-5 years showing improved control of wheezing symptoms during the 1st to 3rd visit interval as a result of the DTEP intervention increased from 39.5 to 60.9% and from 25.5 to 75.5%, respectively. During these periods, the IRs showed a significant decrease for all outcomes, from-8.6% to - 80.4%. Although specific IRs for drug prescriptions declined, particularly for LABA plus corticosteroids, antibiotics, and systemic corticosteroids, they increased for SABA, inhaled corticosteroid and leukotriene receptor antagonist usage. CONCLUSIONS: The results suggest that a real-world assessment of the integrated DTEP program for preschool children provides evidence for improved wheezing control and reduction of adverse therapeutic related outcomes.

Can digital communication technology reduce health system personnel time? An evaluation of personnel requirements and costs in a randomized controlled trial.

Use of digital communication technologies (DCT) shows promise for enhancing outcomes and efficiencies in asthma care management. However, little is known about the impact of DCT interventions on healthcare personnel requirements and costs, thus making it difficult for providers and health systems to understand the value of these interventions. This study evaluated the differences in healthcare personnel requirements and costs between usual asthma care (UC) and a DCT intervention (Breathewell) aimed at maintaining guidelines-based asthma care while reducing health care staffing requirements. We used data from a pragmatic, randomized controlled trial conducted in a large integrated health system involving 14,978 patients diagnosed with asthma. To evaluate differences in staffing requirements and cost between Breathewell and UC needed to deliver guideline-based care we used electronic health record (EHR) events, provider time tracking surveys, and invoicing. Differences in cost were reported at the patient and health system level. The Breathewell intervention significantly reduced personnel requirements with a larger percentage of participants requiring no personnel time (45% vs. 5%, p < .001) and smaller percentage of participants requiring follow-up outreach (44% vs. 68%, p < .001). Extrapolated to the total health system, cost for the Breathewell intervention was $16,278 less than usual care. The intervention became cost savings at a sample size of at least 957 patients diagnosed with asthma. At the population level, using DCT to compliment current asthma care practice presents an opportunity to reduce healthcare personnel requirements while maintaining population-based asthma control measures.

Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.

Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy.Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine.Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines.Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; "sequential").Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.

Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial.

BACKGROUND: Few interventions have targeted low-income adults with moderate to severe asthma despite their high mortality. OBJECTIVE: To assess whether a patient advocate (PA) intervention improves asthma outcomes over usual care (UC). METHODS: This 2-armed randomized clinical trial recruited adults with moderate to severe asthma from primary care and asthma-specialty practices serving low-income neighborhoods. Patients were randomized to 6 months of a PA intervention or UC. PAs were recent college graduates anticipating health care careers, who coached, modeled, and assisted participants with preparations for asthma-related medical visits, attended visits, and confirmed participants' understanding of provider recommendations. Participants were followed for at least a year for patient-centered asthma outcomes: asthma control (primary outcome), quality of life, prednisone requirements, emergency department visits, and hospitalizations. RESULTS: There were 312 participants. Their mean age was 51 years (range, 19-93 years), 69% were women, 66% African American, 8% Hispanic/Latino, 62% reported hospitalization for asthma in the year before randomization, 21% had diabetes, and 61% had a body mass index of 30 or more. Asthma control improved over 12 months, more in the intervention group (-0.45 [95% CI, -0.67 to -0.21]) than in the UC group (-0.26 [95% CI, -0.53 to -0.01]), and was sustained at 24 months but with no statistical difference between groups. The 6-month rate of emergency department visits decreased in the intervention (-0.90 [95% CI, -1.56 to -0.42]) and UC (-0.42 [95% CI, -0.72 to -0.06]) groups over 12 months. The cost of the PA program was $1521 per patient. Only 64% of those assigned had a PA visit. CONCLUSIONS: A PA may be a promising intervention to improve and sustain outcomes in this high-risk population if expanded to address factors that make keeping appointments difficult.

Planning for Implementation Success Using RE-AIM and CFIR Frameworks: A Qualitative Study.

Background: RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and CFIR (Consolidated Framework for Implementation Research) dissemination and implementation frameworks define theory-based domains associated with the adoption, implementation and maintenance of evidence-based interventions. Used together, the two frameworks identify metrics for evaluating implementation success, i.e., high reach and effectiveness resulting in sustained practice change (RE-AIM), and modifiable factors that explain and enhance implementation outcomes (CFIR). We applied both frameworks to study the implementation planning process for a technology-delivered asthma care intervention called Breathewell within an integrated care organization. The goal of the Breathewell intervention is to increase the efficiency of delivering resource-intensive asthma care services. Methods: We reviewed historical documents (i.e., meeting agendas; minutes) from 14 months of planning to evaluate alignment of implementation team priorities with RE-AIM domains. Key content was extracted and analyzed on topics, frequency and amount of discussion within each RE-AIM domain. Implementation team members were interviewed using questions adapted from the CFIR Interview Guide Tool to focus their reflection on the process and contextual factors considered during pre-implementation planning. Documents and transcripts were initially coded using RE-AIM domain definitions, and recoded using CFIR constructs, with intent to help explain how team decisions and actions can contribute to adoption, implementation and maintenance outcomes. Results: Qualitative analysis of team documents and interviews demonstrated strong alignment with the RE-AIM domains: Reach, Effectiveness, and Implementation; and with the CFIR constructs: formal inclusion of provider and staff stakeholders in implementation planning, compatibility of the intervention with workflows and systems, and alignment of the intervention with organizational culture. Focus on these factors likely contributed to RE-AIM outcomes of high implementation fidelity. However, team members expressed low confidence that Breathewell would be adopted and maintained post-trial. A potential explanation was weak alignment with several CFIR constructs, including tension for change, relative priority, and leadership engagement that contribute to organizational receptivity and motivation to sustain change. Conclusions: While RE-AIM provides a practical framework for planning and evaluating practice change interventions to assure their external validity, CFIR explains why implementation succeeded or failed, and when used proactively, identifies relevant modifiable factors that can promote or undermine adoption, implementation, and maintenance.

Adults With Asthma Experience No Increase in Asthma-related Exacerbations When Digital Communication Technology Tools Are Employed to Offset Provider Workload: A Pragmatic Randomized Trial.

BACKGROUND: Challenges to health care efficiency are increasingly addressed with the help of digital communication technology tools (DCTs). OBJECTIVE: The objective of this study was to test whether DCT, compared with Usual Care, can reduce health care clinician burden without increasing asthma-related exacerbations among patients with asthma in a large integrated health care system. RESEARCH DESIGN: The (Breathewell) program was a pragmatic, randomized trial at (Kaiser Permanente Colorado), where asthma nurses screen patients for poor symptom control when beta2-agonist refill requests came within 60 days of previous fill or in the absence of a controller medication fill within 4 months (beta2-agonist overfill). A total of 14,978 adults with asthma were randomized to Usual Care or 1 of 2 DCT intervention groups (Text/Phone call or Email). SUBJECTS: Participants included adults 18 and older with an asthma diagnosis at the time of randomization and no history of chronic obstructive pulmonary disease. MEASURES: Primary outcome measures included asthma-related health care resource utilization (eg, asthma nurse contacts), medication use, and exacerbations. RESULTS: A total of 1933 patients had 4337 events which met beta2-agonist overfill criteria. Of the 2874 events in the intervention arm, 1188 (41%) were resolved by DCT contact and did not require additional clinician contact. Asthma medication use and exacerbations over 12 months did not differ among the 3 groups. CONCLUSIONS: DCT tools can successfully contact adult asthma patients to screen for symptoms and facilitate intervention. The absence of differences in medication fills and health care utilization indicates that the strategic replacement of nursing interventions by digital outreach did not reduce treatment adherence or compromise health care outcomes.