The study assesses the effectiveness of the Centers for Disease Control and Prevention’s (CDC) Framework for Preventing Clostridioides difficile infection (CDI) in Acute Care Facilities in reducing hospital-onset CDI (HO-CDI) rates. This study found no direct temporal association between the Framework’s implementation and reduced incidence rates, highlighting the complexity of attributing changes to specific interventions. Pre-existing downward trends in HO-CDI incidence at intervention sites complicate interpretation, suggesting that other factors might influence the observed declines.

The analysis revealed a complex picture. Initially, the intervention hospitals exhibited a significant reduction in HO-CDI incidence, with an annual incidence rate ratio (IRR) of 0.79 (95% CI, 0.67-0.94, P = .01) compared to control sites. However, deeper examination showed that this decline was part of a pre-existing trend, as HO-CDI rates had decreased before the study began. The level of Framework implementation correlated with sharper declines in HO-CDI incidence, with an annual IRR of 0.95 (95% CI, 0.90-0.99, P = .03), suggesting a dose-response relationship between the extent of implementation and the observed effects.

“HO-CDI incidence was already falling across intervention sites before study onset,” according to the investigators. “The disparate results between our 2 primary analyses highlight one of the strengths of time-series analysis: use of external controls or simple before-and-after comparisons may fail to account for preexisting trends that can otherwise inflate type I error rates. In this case, higher HO-CDI incidence among intervention sites might have important implications for interpreting study results.”

Throughout the study period, 2,184 HO-CDI cases were reported over 7,269,429 patient days. Intervention hospitals reported 1,403 cases over 3,513,755 patient days, while control hospitals accounted for 781 cases over 3,755,674 patient days. Before the study’s initiation, a baseline analysis of participating hospitals documented 1,751 HO-CDI cases across 2,538,874 patient days, indicating a higher IRR among intervention sites.

“The higher HO-CDI rate among participating hospitals was anticipated since the invitation to participate was contingent on having an above-median HO-CDI rate,” according to the investigators. “Regression toward the mean may have contributed to the steeper decline in HO-CDI incidence observed among intervention sites. Alternatively, sites with higher HO-CDI incidence rates may already have been enacting C difficile control measures that were not captured before study onset. In either case, it remains appropriate to consider that implementation of the Framework was not temporally associated with declining HO-CDI incidence.”

This study was July 1, 2019, between March 31, 2022. 20 hospitals within the network engaged in a study to implement the recommendations of the Framework, and 26 hospitals opted not to participate and were used as control groups. The Framework consists of 39 distinct intervention categories, which are divided into 5 key areas for the prevention of CDI:

1. isolation and contact precautions.
2. confirmation of CDI
3. environmental sanitation
4. development of infrastructure
5. engagement in antimicrobial stewardship

Limitations are related to study power and the pandemic, and like any observational study, unmeasured confounders exist. Other sites implemented HO-CDI prevention strategies and incorporating them into the analysis was challenging. Evaluating interventions could have been more straightforward if the Framework’s measures had been uniformly structured across sites, avoided increasing the study’s cost and complexity, strict implementation protocols were not dictated. Moreover, the study did not track adherence to the Framework over time, fluctuations in adherence could have influenced the trends in HO-CDI incidence.

Certain framework interventions showed reducing HO-CDI rates, emphasizing the importance of infection prevention systems. The study suggests a correlation between the thorough implementation of prevention measures and HO-CDI decline, needing further exploration into the effectiveness of comprehensive prevention strategies. Future research should focus on these approaches to enhance HO-CDI prevention efforts.

Reference

Turner NA, Krishnan J, Nelson A, et al. CDC’s Hospital-Onset Clostridioides difficile Prevention Framework in a Regional Hospital Network. JAMA Network Open. Published March 27, 2024. Accessed March 28, 2024. doi:10.1001/jamanetworkopen.2024.3846