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.

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.

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.