The personal, social and economic costs for the approximately 12 to 24 million adults living with chronic obstructive pulmonary disease (COPD) are tremendous, with annual expenditures of nearly $50 billion. There is mounting epidemiological evidence that physical inactivity is significantly associated with more frequent hospitalizations and increased mortality in COPD even after adjusting for disease severity. Our recent findings based on data captured from routine clinical care further extend these observations, by showing that hospitalized COPD patients who reported engaging in any level of moderate to vigorous exercise prior to the index admission had a 34% lower risk of 30-day readmission compared to inactive patients. Moreover, the evidence is unequivocal that intensive supervised exercise training as part of pulmonary rehabilitation improves COPD outcomes. Yet the persistently low uptake of intensive rehabilitation by only 1-3% of eligible patients questionsthe acceptability and scalability of the current model. We and others have tested several physical activity intervention models in COPD with promising results. A paradigm shift is needed from a traditional rehabilitation model to a more patient-centered, scalable, and sustainable model of promoting active lifestyles to improve outcomes for COPD and its common co-morbidities. Therefore, for the UH3 phase, we propose a pragmatic randomized controlled trial in a large integrated health care system to determine the effectiveness of a patient-centered, physical activity coaching (PAC) model on the primary outcome of all- cause hospitalizations and secondary outcomes of COPD-related hospitalizations and emergency department visits, COPD exacerbations, self-reported physical activity, and cardio-metabolic markers compared to standard care in 1656 COPD patients at risk for hospitalization. The proposed research leverages many strengths of our health system and is completely consistent with the core principles of pragmatic trials, including: population-based identification of study participants an ascertainment of outcomes captured during usual care delivery using electronic medical record (EMR) systems, automated assignment of study participants to intervention or standard care, flexible and generalizable models for intervention delivery, and comparisons based on initial group assignment, regardless of intervention participation. In order to successfully undertake this trial, we plan to accomplish the following specific preparatory milestones during the UH2, one-year planning phase: 1) Obtain the necessary IRB approvals for the UH2 and UH3 activities; 2) Refine procedures for identifying study participants and ascertainment of outcomes using our EMR; 3) Adapt, field test and refine the PAC intervention protocol based on feasibility testing and input from the project steering committee; and 4) Develop intervention delivery and quality control tools in our Epic EMR system If successful, findings from this study of a novel, generalizable, and scalable patient-centered physical activity coaching model could represent a significant shift in re-defining the standard of care for patients with COPD.
The personal and societal burden of chronic obstructive pulmonary disease (COPD); a third leading cause of death and a second leading cause of disability; is tremendous. Physical inactivity is highly prevalent in COPD and is associated with worse outcomes; yet it is a highly modifiable risk factor. Findings from this study of a generalizable and scalable patient-centered physical activity coaching intervention model could represent a significant shift in re-defining the standard of care for patients with COPD. (End of abstract)