Background: Two billion peripheral intravenous catheters (PIVC) are inserted into inpatients worldwide year. Almost 1 in 2 PIVC failed for various reasons before completion of intravenous therapy. We aimed to determine the efficacy and costs of a multimodal intervention to reduce PIVC failure rates among hospitalised patients.
Methods:We conducted a cluster-randomised controlled trial at seven public hospitals in Spain. Clusters had at least 70% of permanent staff, being enrolled and randomly assigned (1:1) to the multimodal intervention or control arms. We concealed randomisation to allocation, without masking patients and professionals to the intervention arm. The protocol-prespecified primary outcomes were PIVC failure at 12 months (phlebitis, extravasation, obstruction or infections). Subsequently, we included dislodgment as part of PIVC failure, being a post-hoc modification. We registered this trial with the ISRCTN Registry, number 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 control group (n=11; 2282 patients, 2330 PIVCs, and 138 nurses). The intervention arm reduced the percentage of PIVC failure rates compared to the control group (37•10 [SD 1•32; HR = 0•81] vs 46•49 [SD 2•59; HR = 1•23]; mean difference -9•39 [95% CI -11•22 to -7•57; p<0•001]), as incurred less costs (€21•39 [SD 191•05] vs €40•89 [SD 389•55]) with a reduction of €-19•50 per PIVC (95% CI -37•20 to -1•80]; p=0.033) at 12 months. Per protocol-prespecified analysis of the primary outcome showed the intervention significantly reduced PIVC failure compared to the control group at 12 months. The median PIVC dwell time was 85 hours (IQR 55-110). Interpretation: A multimodal intervention reduced PIVC failure, potentially serious complications for hospitalised patients, improved adherence to the best available evidence and savings for the National Health System. Funding: This study is funded by The College of Nurses of the Balearic Islands under award number PI2017/0192.