Patient safety has always been of paramount importance to health care providers. Recent governmental and lay press reports provide evidence that despite the goal for patient safety, adverse event outcomes can and do occur with alarming frequency in healthcare settings, especially hospitals. Concurrently, direct care providers, especially nurses, have continued to be downsized raising concerns about the resultant impact on patient outcomes, particularly patient safety outcomes. The role that the structures and processes of these nursing patient care delivery systems play in determining the level of patient safety is unclear. Only through a thorough examination of the relationships between structure (where and by whom care is delivered) and process (how the work gets done) and patient safety outcomes can the impact of various care delivery systems be determined and a precise prescription for their formation be identified which will result in optimum patient safety. This study seeks to examine at the patient unit level, the relationship of structure and process variables on patient safety outcomes. The primary research question will be: (1) what is the relationship between hospital structural (type, size, teaching status and technological capacity) and unit structural (size, specialty, staffing hours) variables on patient safety outcomes (central line infections, pressure ulcers, falls, hours in restraint)? Additional secondary questions of a sub-study will be to: (2) describe the processes used (culture, leadership, coordination, communication, and conflict management) on units and determine (3) is there an interrelationship among structure, process, and patient safety outcomes in these units. This longitudinal study will collect structure and outcome data at the patient unit level over a 12-month period and the sub-study will measure a single set of process variables at the patient unit level. Demographic data will be collected on the hospitals, units, and patient care staff. The larger study will utilize 98 adult patient units in 10 hospitals within an integrated healthcare system. The units will be sampled from three specialty levels: intensive care (ICU, n = 22); intermediate care (IMC, n = 30); and medical/surgical (MS, n = 46). The sub-study will use 24 of these units (ICU, n = 4; IMC, n = 3; M/S, n = 17) from 3 community hospitals within this group of ten hospitals. The 10 hospitals range in size from 59 to 681 beds with a total of 114,326 annual admissions. Data from structure and outcome variables will be collected prospectively from patient observations, patient records and from existing management databases. Process variables from the patient care staff will be prospectively obtained from questionnaires. Data will be aggregated to the unit level and analyzed. Descriptive statistics will be used. Random effects growth modeling will be used to assess the variability of the variables and hierarchical generalized linear modeling will be used to assess the relationships. The findings from this study will build on existing information and provide further direction for nurse administrators as they develop care delivery systems and interventions aim at minimizing or eliminating patient safety outcomes.
