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Prevention of post-splenectomy sepsis in patients with asplenia - a study protocol of a controlled trial.
BMC Infectious Diseases ( IF 3.7 ) Pub Date : 2020-01-14 , DOI: 10.1186/s12879-019-4752-2
Marianne Bayrhuber 1 , Natascha Anka 1 , Johannes Camp 2 , Manuela Glattacker 1 , Erik Farin 1 , Siegbert Rieg 2
Affiliation  

BACKGROUND Patients with asplenia have a significantly increased lifelong risk of severe invasive infections, particular post-splenectomy sepsis (PSS). Clear preventive measures have been described in the literature, but previous studies found poor implementation of prevention recommendations. Aim of the study is to improve the adherence to guideline-based preventive measures and thereby reduce the incidence of PSS by a novel telephone-delivered intervention that involves both patients and their physicians. METHODS A prospective controlled, two-armed historical control group design is used to evaluate the new intervention compared to usual care. The intervention for patients includes both educational aspects and, building on the Health Action Process Approach (HAPA), intervention components that promote motivation and planning of preventive measures. For physicians the intervention is primarily information-based. The primary outcome, the adherence to preventative measures, is indicated by a study-specific 'Preventing PSS-score' (PrePSS-score), which is assessed at baseline and at 6-months follow-up. Secondary outcomes include, amongst others, patient self-efficacy and action-planning, asplenia-specific health literacy, general self-management and asplenia-specific self-management. In a process-evaluating part of the study interview-data on patients' and physicians' evaluation of the intervention will be gathered. DISCUSSION This trial will provide evidence about the effectiveness of the novel prevention intervention for asplenic patients. If demonstrated beneficial, the intervention manual will be made publicly available to enable implementation in practice. The experience gained within this trial may also be valuable for prevention strategies in patients with other diseases. TRIAL REGISTRATION German Clinical Trials Register (DRKS): DRKS00015238; Trial registration date 07. December 2018.

中文翻译:

预防无脾患者脾切除术后脓毒症-一项对照试验的研究方案。

背景技术患有弱视的患者具有严重侵袭性感染,特别是脾切除术后败血症(PSS)的终生风险显着增加。文献中已经描述了明确的预防措施,但是先前的研究发现预防建议的实施不力。该研究的目的是提高对基于指南的预防措施的依从性,从而通过涉及患者及其医生的新型电话传递干预措施来降低PSS的发生率。方法采用前瞻性对照,两臂历史对照组的设计来评估与常规护理相比的新干预措施。对患者的干预措施既包括教育方面的内容,又基于健康行动过程方法(HAPA),干预措施,可促进预防措施的动机和计划。对于医生而言,干预主要是基于信息的。主要结果是坚持预防措施,这是通过针对研究的“预防PSS评分”(PrePSS评分)进行的,该评估在基线和6个月的随访中进行评估。次要结果包括,除其他外,患者的自我效能和行动计划,针对非典的健康素养,一般自我管理和针对非典的自我管理。在研究的过程评估部分,将收集有关患者和医师对干预措施评估的数据。讨论本试验将提供有关新型预防干预措施对无症状患者的有效性的证据。如果证明是有益的,干预手册将公开提供,以使之能够在实践中实施。在该试验中获得的经验对于其他疾病患者的预防策略也可能有价值。试验注册德国临床试验注册(DRKS):DRKS00015238;试用注册日期为2018年12月7日。
更新日期:2020-01-15
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