Multimodal intervention for preventing peripheral intravenous catheter failure in adults (PREBACP): a multicentre, cluster-randomised, controlled trial

Abstract

[eng] Background 2 billion peripheral intravenous catheters (PIVC) are inserted into inpatients worldwide each year. Almost one in two PIVCs fail before completion of intravenous therapy. We aimed to determine the efficacy and costs of a multimodal intervention to reduce PIVC failure among hospitalised patients. Methods PREBACP was a cluster-randomised, controlled trial done at seven public hospitals in Spain. Clusters (hospital wards) had at least 70% permanent staff and data were collected from patients aged 18 years and older with one or more PIVCs at the start of intravenous therapy. Clusters were randomly assigned (1:1) to the multimodal intervention or control group using a centralised, web-based randomisation software, and stratified by type of setting. We concealed randomisation to allocation, without masking patients or professionals to the intervention. An intervention using a multimodal model and dissemination of protocols, education for health-care professionals and patients, and feedback on performance was implemented for 12 months in the intervention group. The control group received usual care. The primary outcome was all-cause PIVC failure at 12 months (phlebitis, extravasation, obstruction, or infections). Subsequently, through an amendment to the protocol approved on July 25, 2021, we included dislodgement as part of PIVC failure. Analysis was by modified intention to treat, which included all randomly assigned hospital wards for whom data on the primary endpoint were available. This trial is registered with the ISRCTN Registry, ISRCTN10438530. Findings Between Jan 1, 2019, and March 1, 2020, we randomly assigned 22 eligible clusters to receive the multimodal intervention (n=11 clusters; 2196 patients, 2235 PIVCs, and 131 nurses) or usual practice in the control group (n=11 clusters; 2282 patients, 2330 PIVCs, and 138 nurses). At 12 months, the proportion of PIVC failures was lower in the intervention group than in the control group (37·10% [SD 1·32], HR 0·81 [95% CI 0·72 to 0·92] vs 46·49% [2·59], HR 1·23 [1·04 to 1·39]; mean difference −9·39% [95% CI −11·22 to −7·57]; p<0·0001). Per-protocol-prespecified analysis of the primary outcome excluding dislodgement also showed the intervention significantly reduced PIVC failure compared with the control group at 12 months (33·47% [SD 2·98], HR 0·85 [95% CI 0·75 to 0·96] vs 41·06% [4·62], HR 1·18 [1·04 to 1·33]; mean difference −7·59% [95% CI −11·05 to −4·13]; p<0·0001). Interpretation A multimodal intervention reduced PIVC failure, thereby reducing potentially serious complications for hospitalised patients. The findings of PREBACP enabled a deeper understanding of decision making, knowledge mobilisation, and sense making in routine clinical practice.