Quality, Teaching and Research Unit, Hospital de Manacor, Manacor, Spain; Department of Nursing and Physiotherapy, Universitat de les Illes Balears, Palma, Spain; Care, Chronicity and Evidence in Health Research Group, Health Research Institute of the Balearic Islands, Palma, Spain.
Department of Nursing and Physiotherapy, Universitat de les Illes Balears, Palma, Spain; Care, Chronicity and Evidence in Health Research Group, Health Research Institute of the Balearic Islands, Palma, Spain.
Lancet Haematol. 2021 Sep;8(9):e637-e647. doi: 10.1016/S2352-3026(21)00206-4.
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.
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.
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).
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.
The College of Nurses of the Balearic Islands.
For the Spanish translation of the abstract see Supplementary Materials section.
全世界每年有 20 亿根外周静脉导管（PIVC）插入住院患者体内。几乎每两根 PIVC 中就有一根在静脉治疗完成前失效。我们旨在确定一种多模式干预措施的疗效和成本，以降低住院患者的 PIVC 失败率。
PREBACP 是在西班牙 7 家公立医院进行的一项集群随机对照试验。集群（医院病房）至少有 70%的固定工作人员，从开始静脉治疗时就有一根或多根 PIVC 的 18 岁及以上的患者中收集数据。使用中央、基于网络的随机软件，将集群随机分配（1:1）到多模式干预组或对照组，并按设置类型进行分层。我们对分配进行了隐藏式随机化，而不向患者或专业人员隐瞒干预措施。在干预组中实施了为期 12 个月的多模式模型干预和方案传播、卫生保健专业人员和患者教育以及绩效反馈。对照组接受常规护理。主要结局是 12 个月时的所有原因 PIVC 失效（静脉炎、外渗、阻塞或感染）。随后，根据 2021 年 7 月 25 日批准的方案修正案，我们将脱落纳入 PIVC 失效的一部分。分析采用改良意向治疗，包括所有随机分配的医院病房，这些病房都有主要结局的数据。这项试验在 ISRCTN 注册处，ISRCTN10438530 处注册。
在 2019 年 1 月 1 日至 2020 年 3 月 1 日期间，我们随机分配了 22 个符合条件的集群接受多模式干预（n=11 个集群；2196 名患者，2235 根 PIVC，131 名护士）或对照组的常规实践（n=11 个集群；2282 名患者，2330 根 PIVC，138 名护士）。在 12 个月时，干预组的 PIVC 失效比例低于对照组（37.10%[标准差 1.32]，HR 0.81[95%CI 0.72 至 0.92]vs 46.49%[2.59]，HR 1.23[1.04 至 1.39]；平均差异-9.39%[95%CI -11.22 至 -7.57]；p<0.0001）。排除脱落的预先规定的主要结局的按方案分析也表明，与对照组相比，干预组在 12 个月时显著降低了 PIVC 失效率（33.47%[标准差 2.98]，HR 0.85[95%CI 0.75 至 0.96]vs 41.06%[4.62]，HR 1.18[1.04 至 1.33]；平均差异-7.59%[95%CI -11.05 至 -4.13]；p<0.0001）。
多模式干预降低了 PIVC 失效率，从而降低了住院患者潜在的严重并发症。PREBACP 的发现使我们能够更深入地了解决策制定、知识动员和常规临床实践中的意义建构。
巴利阿里群岛护士学院。
