The study intervention consisted of four individual 90-minute weekly educational sessions. These sessions included an assessment of that person's COPD, including their current medications and what triggered exacerbations for them. Participants received a written, individualized action plan that included the steps they needed to take when their COPD flared up. They were taught how to recognize the symptoms of a flare, and they were given daily COPD management advice. They were also given prescriptions for prednisone (a steroid anti-inflammatory medication) and an antibiotic.
Case managers were available every day to answer any questions by phone. The study volunteers were instructed to call in if they had to initiate treatment based on their written plan. Researchers also called to check in on the volunteers every two months.
The one-year incidence of COPD hospitalizations was 27 percent in the intervention group and 24 percent in the usual-care group. Twenty-eight people died in the intervention group versus 10 people in the usual-care group -- a three times higher risk of death, according to the study.
Due to safety concerns, the trial was stopped early. The researchers don't know why extra education and self-management would lead to an increased risk of death, however.
"I'm not convinced that the intervention increased the risk of death. It certainly was not expected, and other studies that have looked at COPD and other diseases have found that people do well with these types of interventions," said Dr. Jonathan Whiteson, director of cardiopulmonary rehabilitation at NYU Langone Medical Center in New York City.
"If you flip a coin, the odds are 50-50 that you'll get heads. But, if you flip the coin 20 times, you might only get heads a few times. But, if you keep flipping the coin, it will eventually even out. That could be what was going on here. If they hadn't stopped the
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