Impact of an Original Methodological Tool on the Identification of Corrective and Preventive Actions After Root Cause Analysis of Adverse Events in Health Care Facilities: Results of a Randomized Controlled Trial.

Objective: The aim of the study was to assess the effectiveness of a new methodological tool for the identification of corrective and preventive actions (CAPAs) after root cause analysis of health care-related adverse events.

Methods: From January to June 2010, we conducted a randomized controlled trial involving risk managers from 111 health care facilities of the Aquitaine Regional Center for Quality and Safety in Health Care (France). Fifty-six risk managers, randomly assigned to two groups (intervention and control), identified CAPAs in response to two sequentially presented adverse event scenarios. For the baseline measure, both groups used their usual adverse event management tools to identify CAPAs in each scenario. For the experimental measure, the control group continued using their usual tools, whereas the intervention group used a new tool involving a systemic approach for CAPA identification. The main outcome measure was the number of CAPAs the participants identified that matched a criterion standard established by eight experts.

Results: Baseline mean number of identified CAPAs did not differ between the two groups (P = 0.83). For the experimental measure, significantly more CAPAs (P = 0.001) were identified by the intervention group (mean [SD] = 4.6 [1.7]) than by the control group (mean [SD] = 2.8 [1.2]).

Conclusions: For the two scenarios tested, more relevant CAPAs were identified with the new tool than with usual tools. Further research is needed to assess the effectiveness of the new tool for other types of adverse events and its impact on patient safety.