Participation in an intensive post-discharge program for patients with chronic obstructive pulmonary disease (COPD) was associated with an increase in the mean number of acute care visits during the following 6 months, according to research published October 8 in the Journal of the American Medical Association. The new analysis reverses the study’s original findings that the journal had previously published.
Last year, researchers from Johns Hopkins School of Medicine, Baltimore, Maryland, reported the results of the BREATHE study, a randomized clinical trial that evaluated a 3-month education and support program for COPD patients who were discharged from the hospital. Those study results indicated that the program led to fewer subsequent emergency department visits and hospitalizations.
On Tuesday, the journal retracted that article and republished a new analysis of the trial’s data. The retraction came after the study authors reported that a coding error had flipped the usual-care and intervention groups in a file used to prepare the analytic datasets for statistical analysis. The authors reported an additional error in the handling of missing quality-of-life data points. The original analysis showed that the intervention improved patient quality of life, but after the correction, no statistically significant difference with the usual-care group was found.
The corrected finding of increased acute care use for patients in the BREATHE program is “paradoxical,” coauthors Hanan J. Aboumatar, MD, MPH, and Robert A. Wise, MD, both of the Johns Hopkins School of Medicine, write in the retraction notice.
“Why this interventional program potentially harmed people is not really clear,” said David Au, MD, a professor of pulmonary, critical care, and sleep medicine at the University of Washington, in Seattle, though he also said readmissions were not necessarily a bad thing for patients. Au was not involved with the study but coauthored an accompanying editorial. “All of the things they did seemed pretty darn reasonable, yet had this effect,” he said.
Patients who participated in the BREATHE program intervention received support in managing their disease with their caregivers from a nurse who had specialized training in supporting patients with COPD. The nurse visited patients during their initial hospital stay and for 3 months continued meeting with them via home visit or telephone. The nurse helped patients and their caregivers to prepare for discharge and to understand the care plan. The nurse offered individualized support, including help with taking medications correctly and with following an action plan in case of exacerbations, and facilitated access to community programs and treatment services.
“This was the full-court press,” said Peter Lindenauer, MD, director of the Institute for Healthcare Delivery and Population Science at the University of Massachusetts Medical School–Baystate, an editorial coauthor who was not involved with the study. The study’s control group of patients received the usual care for patients discharged from the Johns Hopkins hospital where the study was conducted: 30 days of support from a general transition coach who encouraged adherence to the discharge plan and facilitated connecting patients to outpatient care. Offering such baseline support is not something all hospitals do, Lindenauer said. The BREATHE program, although “robust,” is something health systems could have made a serious commitment to adopt, he said.
Aboumatar is not aware of another health system that has implemented the BREATHE intervention as tested in the trial, she told Medscape Medical News in an email. Many health systems do have programs for reducing the need for acute care for patients with COPD. Such programs include patient education and self-management support, case management services, remote monitoring, and close follow-up. The Johns Hopkins Health System and some others were planning to implement and further evaluate the BREATHE program through a pragmatic multisite trial, Aboumatar wrote, but that plan changed after the analytic error was discovered.
Few COPD readmission reduction programs are tested in randomized trials; Lindenauer called the area an “evidence-free zone.” Because COPD is among the conditions included in the Centers for Medicare & Medicaid Services’ program that penalizes hospitals for 30-day readmission rates that they deem excessive, the results of the BREATHE trial are important regardless of outcome, Au said.
The study’s main outcomes were mean number of acute care events, both hospitalizations and emergency department visits, and change in the St. George’s Respiratory Questionnaire (SGRQ) quality-of-life metric at 6 months after discharge from the initial hospital visit. For participants who received the BREATHE intervention, the mean number of COPD-related acute care events was 1.40; for the usual-care group, the mean number was 0.72. The difference in mean change in SGRQ score after 6 months was not statistically significant.
“The increase in COPD-related acute care use in the intervention compared with usual care group found in this study was in the opposite direction from what had been hypothesized,” Aboumatar, Wise, and their coauthors write in the republished article. “This inconsistency necessarily raises a question about the validity of the study findings and means that study interpretation needs to be cautious and provisional.”
Drawing on post hoc subgroup analyses, Aboumatar explained that patients in the BREATHE program who were more active in managing their own health may have become more vigilant in detecting early signs of exacerbations and sought medical attention within 24 hours, as their care plans directed, in acute care settings if they couldn’t receive such care another way. Increased communication with clinicians about their symptoms might have led to increased emergency department referrals if patients could not be accommodated because of busy clinic schedules. “Our study findings suggest the need for having systems in place that ensure expedited medical attention for patients with COPD when they have interim concerns between their scheduled clinical encounters,” she added.
The trial’s limitations include that it was conducted at a single site, the article’s authors note, and that the population included low-income and less-educated patients who may have faced greater challenges accessing urgent medical care other than in the emergency department. The study included 240 patients who were randomly assigned evenly to each group.
The original study results raised some enthusiasm that there was finally an intervention that could reduce COPD readmissions, Seppo Rinne, MD, PhD, an assistant professor of medicine at Boston University School of Medicine in Massachusetts, told Medscape Medical News. Rinne was a reviewer of the article and coauthored the editorial. Many previous studies of interventions have failed to find much that works, and he described a “clinical nihilism” that comes with rarely being able to do something to improve COPD patients’ lives.
The updated BREATHE results are now more in line with previous studies that show that intensive interventions with many touch points that offer opportunities to use healthcare services do not reduce hospital readmissions, Rinne said. “We are still in a world with limited evidence on how to reduce COPD readmissions.”
The Patient-Centered Outcomes Research Institute provided funding for the study. Wise reported receiving grants and personal fees from AstraZeneca/Medimmune, Boehringer Ingelheim, and GlaxoSmithKline; personal fees from AbbVie, Contrafect, Novartis, Pulmonx, Roche, Spiration, Sunovion, Merck, Circassia, Kiniksa, Pneuma, Propeller Health, Syneos, Verona, Bonti, Denali, and Aradigm; and grants from Pearl Therapeutics and Sanofi. Lindenauer reported receiving salary support from the Yale Center for Outcomes Research and Evaluation under a contract from the Centers for Medicare & Medicaid Service to develop and maintain hospital outcome measures for chronic obstructive pulmonary disease. Au reported receiving grants from the Department of Veterans Affairs, the National Heart, Lung, and Blood Institute, and the American Lung Association and personal fees from the American Thoracic Society, the American Board of Internal Medicine, and Novartis. The remaining authors have disclosed no relevant financial relationships.
JAMA. Pubolished online October 8, 2019. Abstract