Ralph Anna P, Read Clancy, Johnston Vanessa, de Dassel Jessica L, Bycroft Kerstin, Mitchell Alice, Bailie Ross S, Maguire Graeme P, Edwards Keith, Currie Bart J, Kirby Adrienne, Carapetis Jonathan R
Menzies School of Health Research, Darwin, NT, Australia.
Telethon Kids Institute, University of Western Australia, and Princess Margaret Hospital for Children, Perth, WA, Australia.
Trials. 2016 Jan 27;17:51. doi: 10.1186/s13063-016-1166-y.
Rheumatic heart disease (RHD), caused by acute rheumatic fever (ARF), is a major health problem in Australian Aboriginal communities. Progress in controlling RHD requires improvements in the delivery of secondary prophylaxis, which comprises regular, long-term injections of penicillin for people with ARF/RHD.
METHODS/DESIGN: This trial aims to improve uptake of secondary prophylaxis among Aboriginal people with ARF/RHD to reduce progression or worsening of RHD. This is a stepped-wedge, randomised trial in consenting communities in Australia's Northern Territory. Pairs of randomly-chosen clinics from among those consenting enter the study at 3-monthly steps. The intervention to which clinics are randomised comprises a multi-faceted systems-based package, in which clinics are supported to develop and implement strategies to improve penicillin delivery, aligned with elements of the Chronic Care Model. Continuous quality improvement processes will be used, including 3-monthly feedback to clinic staff of adherence rates of their ARF/RHD clients. The primary outcome is the proportion of people with ARF/RHD receiving ≥ 80% of scheduled penicillin injections over a minimum 12-month period. The sample size of 300 ARF/RHD clients across five community clusters will power the study to detect a 20% increase in the proportion of individuals achieving this target, from a worrying low baseline of 20%, to 40 %. Secondary outcomes pertaining to other measures of adherence will be assessed. Within the randomised trial design, a mixed-methods evaluation will be embedded to evaluate the efficiency, effectiveness, impact and relevance, sustainability, process and fidelity, and performance of the intervention. The evaluation will establish any causal link between outcomes and the intervention. The planned study duration is from 2013 to 2016.
Continuous quality improvement has a strong track record in Australia's Northern Territory, and its use has resulted in modest benefits in a pilot, non-randomised ARF/RHD study. If successful, this new intervention using the Chronic Care Model as a scaffold and evaluated using a well-developed theory-based framework, will provide a practical and transferable approach to ARF/RHD control.
Australian New Zealand Clinical Trials Registry: ACTRN12613000223730. Date registered: 25 February 2013.
由急性风湿热（ARF）引起的风湿性心脏病（RHD）是澳大利亚原住民社区的一个主要健康问题。控制RHD的进展需要改进二级预防措施的实施，二级预防措施包括为患有ARF/RHD的人定期、长期注射青霉素。
方法/设计：本试验旨在提高患有ARF/RHD的原住民对二级预防措施的接受程度，以减少RHD的进展或恶化。这是一项在澳大利亚北领地同意参与的社区中进行的阶梯式随机试验。从同意参与的诊所中随机选取的成对诊所以每三个月为一个阶段进入研究。随机分配给诊所的干预措施包括一个多方面的基于系统的方案，其中支持诊所制定和实施改善青霉素注射的策略，与慢性病护理模式的要素相一致。将使用持续质量改进流程，包括每三个月向诊所工作人员反馈其ARF/RHD患者的依从率。主要结局是在至少12个月的时间内，接受≥80%预定青霉素注射的ARF/RHD患者的比例。来自五个社区集群的300名ARF/RHD患者的样本量将使该研究有足够的效力检测达到这一目标的个体比例从令人担忧的低基线20%增加到40%的情况。将评估与其他依从性测量相关的次要结局。在随机试验设计中，将嵌入一项混合方法评估，以评估干预措施的效率、效果、影响和相关性、可持续性、过程和保真度以及性能。该评估将确定结局与干预措施之间的任何因果关系。计划的研究持续时间为2013年至2016年。
在澳大利亚北领地，持续质量改进有良好的记录，并且在一项试点的、非随机的ARF/RHD研究中使用该方法已带来了一定益处。如果成功，这种以慢性病护理模式为框架并使用完善的基于理论的框架进行评估的新干预措施，将为控制ARF/RHD提供一种实用且可推广的方法。
澳大利亚新西兰临床试验注册中心：ACTRN12613000223730。注册日期：2013年2月25日。
