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.

Early Peanut Introduction in Primary Care: Evaluation of a Multicomponent Intervention.

OBJECTIVE: To determine whether a multicomponent intervention focused on early peanut introduction was associated with a lower peanut allergy incidence in young children. METHODS: The study cohort comprised all children born January 1, 2013 through December 31, 2018 receiving care at a large health care organization. Intervention activities occurred over 16 months and included provider educational programs, electronic health record tools, and new patient instructions. We used an interrupted time series design to assess whether peanut allergy incidence differed across 3 time periods (preintervention, interim, postintervention) among high- and low-risk children. The primary outcome was incident peanut allergy by age 24 months, defined as peanut allergy in the allergy field or active problem list plus a positive supportive test. Severe eczema and/or egg allergy presence defined high-risk. Because the study was conducted as part of routine care, it was not feasible to measure what counseling clinicians provided, or how and when parents fed their children peanut-containing foods. RESULTS: In a cohort of 22,571 children, the percent with peanut allergy by age 24 months was 17.3% (116 of 671) among high-risk and 0.8% (181 of 21,900) among low-risk children. In multivariate analyses, the adjusted peanut allergy rate per 100 person-years was not significantly different across study periods among high-risk (9.6 preintervention, 11.7 interim, and 9.9 postintervention, P = .70) or low-risk (0.5 preintervention, 0.7 interim, and 0.5 postintervention, P = .17) children. CONCLUSIONS: In a community-based setting, the incidence of peanut allergy did not decline following a multicomponent intervention focused on early peanut introduction.

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.

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.

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.

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.

Implementing Health Care Technology Research into Practice to Improve Adult Asthma Management.

BACKGROUND: Use of health technology has shown potential to improve asthma adherence and outcomes. Few studies have looked at the implementation of such research within larger asthma populations. OBJECTIVE: This report examines the process of translating results from a pragmatic trial using speech recognition (SR) in children with persistent asthma into the standard operating procedure within a large health maintenance organization. Medication adherence and outcomes in adults with asthma were examined. METHODS: The SR protocol was implemented for the total Kaiser Permanente Colorado (KPCO) patient population of 480,142, of whom 36,356 had asthma. Patients had persistent asthma, filled 1 or more inhaled corticosteroid prescriptions in the prior 6 months, and remained continuously enrolled with KPCO for 2 years. Documented exacerbations included the presence of a hospitalization, emergency department visit, or course of oral corticosteroid where asthma was the principal diagnosis. Adherence and exacerbation events were compared 1 year before and 1 year after intervention for 4,510 adults aged 19 to 64. RESULTS: Patient adherence demonstrated a small but significant improvement from 39.5% to 41.7% (P < .0001). Although not significant, data trends suggested greater improvement for patients with lower socioeconomic status. When an outlier month was removed from both the pre- and postintervention time periods, courses of oral corticosteroids decreased. Emergency department visits and hospitalizations were infrequent in both time periods and did not decrease over time. CONCLUSIONS: A low-cost SR intervention reminding patients to fill and take their daily controller asthma medication can improve treatment adherence and decrease the need for oral corticosteroids due to asthma exacerbations, but not decrease emergency department visits or hospitalizations.

Pragmatic trial of health care technologies to improve adherence to pediatric asthma treatment: a randomized clinical trial.

IMPORTANCE: Most patients with asthma take fewer than half of prescribed doses of controller medication. Interventions to improve adherence have typically been costly, impractical, and at best only minimally successful. OBJECTIVE: To test a speech recognition (SR) intervention to improve adherence to pediatric asthma controller medication. DESIGN, SETTING, AND PARTICIPANTS: The Breathe Well study was a 24-month pragmatic randomized clinical trial. The study was conducted within Kaiser Permanente Colorado, a large, group-model health maintenance organization. A total of 1187 children aged 3 to 12 years with a persistent asthma diagnosis and prescription for an inhaled corticosteroid were randomized to the computerized SR intervention or usual care condition and followed up for 24 months between October 2009 and February 2013. INTERVENTIONS: Speech recognition telephone calls to parents in the intervention condition were triggered when an inhaled corticosteroid refill was due or overdue. Calls were automatically tailored with medical and demographic information from the electronic health record and from parent answers to questions in the call regarding recent refills or a desire to receive help refilling, learn more about asthma control, or speak with an asthma nurse or pharmacy staff member. MAIN OUTCOMES AND MEASURES: Adherence to pediatric asthma controller medication, measured as the medication possession ratio over 24 months. RESULTS: In the intention-to-treat analysis, inhaled corticosteroid adherence was 25.4% higher in the intervention group than in the usual care group (24-month mean [SE] adherence, 44.5% [1.2%] vs 35.5% [1.1%], respectively; P < .001). Asthma-related urgent care events did not differ between the 2 groups. The intervention effect was consistent in subgroups stratified by age, sex, race/ethnicity, body mass index, and disease-related characteristics. CONCLUSIONS AND RELEVANCE: The intervention's significant impact on adherence demonstrates strong potential for low-cost SR adherence programs integrated with an electronic health record. The absence of change in urgent care visits may be attributable to the already low number of asthma urgent care visits within Kaiser Permanente Colorado. Application of electronic health record-leveraged SR interventions may reduce health care utilization when applied in a population with less-controlled asthma. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00958932.