Effect of a quality improvement program on weaning from mechanical ventilation: a cluster randomized trial. PURPOSE: To evaluate the efficacy of a quality improvement (QI) program for protocol-directed weaning from mechanical ventilation. METHODS: This was a prospective, cluster randomized controlled trial. The study consisted of a baseline phase and a QI phase. Fourteen intensive care units (ICUs) in Beijing, China, were randomized into the QI group and non-QI group. The QI group received a QI program to improve the compliance with protocol-directed weaning during the QI phase. RESULTS: A total of 444 patients were enrolled in the non-QI group (193 for the baseline, 251 for the QI phase) and 440 in the QI group (199 for the baseline, 241 for the QI phase). During the QI phase in the QI group, compared with the non-QI group, total duration of mechanical ventilation decreased from 7.0 to 3.0 days (p = 0.003), the time before the first weaning attempt decreased from 3.63 to 1.96 days (p = 0.003), length of ICU stay decreased from 10.0 to 6.0 days (p = 0.004), length of hospital stay decreased from 23.0 to 19.0 days (p < 0.001). These differences were also significant in the QI group when the QI phase was compared with the baseline phase. In addition, there was a significant reduction in the percentage of mechanical ventilation exceeding 21 days (p = 0.001) when the baseline phase was compared with the QI phase in the QI group. CONCLUSIONS: The QI program involving protocol-directed weaning is associated with beneficial clinical outcomes in mechanically ventilated patients.