C35-19 Trends in COPD Clinical Trials Evaluating Post-hospitalization Care Before and After the Hospital Readmissions Reduction Program

Abstract Rationale Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung airflow limitation and affects more than 16 million U.S. adults. COPD exacerbations are a leading cause of hospitalizations in the U.S., and rehospitalizations contribute substantially to healthcare costs. To address this, the Centers for Medicare and Medicaid Services implemented the Hospital Readmissions Reduction Program (HRRP), which began publicly reporting hospital-level 30-day risk-standardized readmission rates in 2009 and imposing financial penalties starting in fiscal year 2013. Although the HRRP incentivized hospitals to reduce readmissions, it remains unclear whether this policy also influenced research priorities. This study examined trends in COPD clinical trials evaluating interventions to improve post-hospitalization outcomes before and after HRRP implementation. Methods We conducted a systematic search of ClinicalTrials.gov to identify U.S.-based interventional studies evaluating post-hospitalization care for adult patients with COPD. Two periods were defined: pre-HRRP (January 1, 2000-December 31, 2012) and post-HRRP (January 1, 2013-present), corresponding to the periods before and after implementation of financial penalties under the HRRP. Searches combined COPD-related terms (COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Obstructive Lung Disease, Respiratory Insufficiency) with post-discharge or transitional care terms (readmission, care transition, patient navigation). Eligible studies evaluated interventions to improve post-hospitalization outcomes or reduce readmissions. Interventions were categorized as pharmacologic, device-based, pulmonary rehabilitation, care coordination, education, telehealth, or system/policy level). Results The search resulted in 18 interventional trials in the pre-HRRP period and 38 studies in the post-HRRP period that targeted post-hospital COPD outcomes. Categories increased between 0 to 11 studies pre vs post HRRP, with no categories decreasing over that time. The most common intervention categories were pharmacologic (n = 9) and care coordination (n = 6) pre-HRRP, and device-based (n = 11), care coordination (n = 11), and telehealth (n = 9) post-HRRP. All intervention categories demonstrated growth in the post-HRRP period, with the greatest increases observed in device-based, care coordination, and telehealth intervention categories. Table 1 summarizes the number of COPD trials by intervention type across pre- and post- HRRP periods. Conclusions The increase in interventional COPD studies addressing post-hospitalization care following HRRP implementation suggests that national health policy may shape research direction and innovation. The post-HRRP period was characterized by an increase in both number and type of studies. Future research should examine which interventions have been implemented into clinical practice and their effectiveness in reducing readmissions and improving post-hospital outcomes. This abstract is funded by: NIH