Objective: To evaluate the impact of implementing continuous quality improvement (CQI) methods on patient's experiences and satisfaction in Tanzania. Design: Cluster-randomized trial, which randomly allocated district-level hospitals into treatment group and control group, was conducted. Setting: Sixteen district-level hospitals in Kilimanjaro and Manyara regions of Tanzania. Participants: Outpatient exit surveys targeting totally 3292 individuals, 1688 in the treatment and 1604 in the control

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... roup, from 3 time-points between September 2011 and September 2012. Intervention: Implementation of the 5S (Sort, Set, Shine, Standardize, Sustain) approach as a CQI method at outpatient departments over 12 months. Main outcome measures: Cleanliness, waiting time, patient's experience, patient's satisfaction. Results:: The 5S increased cleanliness in the outpatient department, patients' subjective waiting time and overall satisfaction. However, negligible effects were confirmed for patient's experiences on hospital staff behaviours. Conclusions: The 5S as a CQI method is effective in enhancing hospital environment and service delivery; that are subjectively assessed by outpatients even during the short intervention period. Nevertheless, continuous efforts will be needed to connect CQI practices with the further improvement in the delivery of quality health care.