Development and validation of a short clinical risk management implementation (Short CRiMI) questionnaire

Clinical Risk Management (CRM) is an important instrument to continuously improve safety of health care delivery. In Germany, hospitals are required by law to implement CRM and incidence reporting systems. Since 2010, nation-wide surveys have been conducted periodically to evaluate implementation of CRM in hospitals. The instrument used in these surveys is constantly being updated to reflect previous experiences, as well as to adapt to ongoing trends and developments in CRM practices. The survey instrument used in 2022 consisted of up to 200 items and took up to an hour to complete. In this study, we aimed to develop a short instrument to measure the level of CRM implementation in hospitals, evaluate its psychometric properties, and to offer benchmarking data for health care facilities of different sizes. We used data collected in 2022 as part of KHaSiMiR study, employing a cross-sectional self-reported online survey. The hospital administrations were invited to designate one CRM manager to participate in the study. Out of 1,411 general hospitals invited, 401 responses were collected (response rate of 28%). After removing the cases with excessive missings, we imputed remaining missing values using multiple imputation, and split the resulting sample (n=362) in two halves (i.e., exploratory and testing subsamples). A principal component analysis was applied on the first subsample. We validated the resulting model using confirmatory factor analysis in the testing subsample. We evaluated internal consistency, and tested external validity of the established instrument using correlation analysis with two single-item measures: subjective evaluation of CRM implementation compared to similar organizations and compared to own ideal level. The principal component analysis included 45 items from the full instrument. The analysis resulted in a three-factor model with 26 items. In the confirmatory factor analysis, the model demonstrated acceptable fit with the data according to the commonly used fit indices: Chi²/df=1.36, CFI=0.941, TLI=0.930, RMSEA=0.045 (90% CI=0.032-0.056), SRMR=0.049. Cronbach's alpha of all three factors was good (>0.70). All three factors had statistically significant positive correlations with each other (0.359-0.497) and with the two single items (0.282-0.532). None of the correlations were high enough (>0.7) to indicate multicollinearity. The proposed short clinical risk management implementation (Short CRiMI) questionnaire is psychometrically valid and can be used to rapidly evaluate CRM implementation in hospitals. Further research can provide evidence of its external validity and association with quality and safety outcomes. Benchmarking data can be used to compare the results with the data from the most recent Germany-wide survey.