Establishing Evidence-Based Criteria for Directly Observed Hand Hygiene Compliance Monitoring Programs: A Prospective, Multicenter Cohort Study

Abstract

objective. Hand hygiene surveillance programs that rely on direct observations of healthcare worker activity may be limited by the Hawthorne effect. In addition, comparing compliance rates from period to period requires adequately sized samples of observations. We aimed to statistically determine whether the Hawthorne effect is stable over an observation period and statistically derive sample sizes of observations necessary to compare compliance rates. design. Prospective multicenter cohort study. setting. Five intensive care units and 6 medical/surgical wards in 3 geographically distinct acute care hospitals. methods. Trained observers monitored hand hygiene compliance during routine care in fixed 1-hour periods, using a standardized collection tool. We estimated the impact of the Hawthorne effect using empirical fluctuation processes and F tests for structural change. Standard sample-size calculation methods were used to estimate how many hand hygiene opportunities are required to accurately measure hand hygiene across various levels of baseline and target compliance. results. Exit hand hygiene compliance increased after 14 minutes of observation (from 56.2% to 60.5%; P