Multimodal Intervention for Preventing Peripheral Intravenous Catheter Failure in Adults (PREBACP Study): A Multicentre, Cluster-Randomised Controlled Trial in Spain

Abstract

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 inpatients. Methods: We conducted a cluster-randomised controlled trial at seven public hospitals in Spain. Clusters were randomly assigned (1:1) to the multimodal intervention or control arms, stratified by setting type and hospital. We concealed randomisation to allocation, without masking patients and professionals to the intervention arm. The primary outcomes were all-cause PIVC failure (due to phlebitis, extravasation, or obstruction) or infections before completion of scheduled intravenous therapy, at 12 months. All analyses were by intention-to-treat. 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 PIVC failure rates compared to the control group (37·10 [SD 1·32] vs 46·49 [SD 2·59]; mean difference -9·39 [95% CI -11·22 to -7·57; p<0·001], as well as 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. The status of the dressing (OR 0·509; 95% CI 0·446 to 0·580), whether a transparent dressing was used (OR 0·594; 95% CI 0·467 to 0·754) and optimal PIVC flushing (0·544; 95% CI 0·469 to 0·632) were protective against PIVC failure. Interpretation: A multimodal intervention reduced PIVC failure, potentially infectious complications for inpatients, improved adherence to the best available evidence and savings for the National Health System. Clinical Trial Registration Details: ISRCTN Registry, number ISRCTN10438530. Funding Information: This study is funded by The College of Nurses of the Balearic Islands under award number PI2017/0192. Declaration of Interests: No conflict of interest has been declared by the authors. Ethics Approval Statement: We obtained written informed consent from all patients or their legal representatives. The ethics and research committees of all participant hospitals and the Balearic Islands Ethic research Committee (IB3492/17PI) approved this study.