Puchalski Ritchie Lisa M, van Lettow Monique, Makwakwa Austine, Chan Adrienne K, Hamid Jemila S, Kawonga Harry, Martiniuk Alexandra L C, Schull Michael J, van Schoor Vanessa, Zwarenstein Merrick, Barnsley Jan, Straus Sharon E
Department of Medicine, University of Toronto, Toronto, ON, Canada.
Department of Emergency Medicine, University Health Network, Toronto, ON, Canada.
Trials. 2016 Sep 7;17(1):439. doi: 10.1186/s13063-016-1563-2.
Despite availability of effective treatment, tuberculosis (TB) remains an important cause of morbidity and mortality globally, with low- and middle-income countries most affected. In many such settings, including Malawi, the high burden of disease and severe shortage of skilled healthcare workers has led to task-shifting of outpatient TB care to lay health workers (LHWs). LHWs improve access to healthcare and some outcomes, including TB completion rates, but lack of training and supervision limit their impact. The goals of this study are to improve TB care provided by LHWs in Malawi by refining, implementing, and evaluating a knowledge translation strategy designed to address a recognized gap in LHWs' TB and job-specific knowledge and, through this, to improve patient outcomes.
METHODS/DESIGN: We are employing a mixed-methods design that includes a pragmatic cluster randomized controlled trial and a process evaluation using qualitative methods. Trial participants will include all health centers providing TB care in four districts in the South East Zone of Malawi. The intervention employs educational outreach, a point-of-care reminder tool, and a peer support network. The primary outcome is proportion of treatment successes, defined as the total of TB patients cured or completing treatment, with outcomes taken from Ministry of Health treatment records. With an alpha of 0.05, power of 0.80, a baseline treatment success of 0.80, intraclass correlation coefficient of 0.1 based on our pilot study, and an estimated 100 clusters (health centers providing TB care), a minimum of 6 patients per cluster is required to detect a clinically significant 0.10 increase in the proportion of treatment successes. Our process evaluation will include interviews with LHWs and patients, and a document analysis of LHW training logs, quarterly peer trainer meetings, and mentorship meeting notes. An estimated 10-15 LHWs and 10-15 patients will be required to reach saturation in each of 2 planned interview periods, for a total of 40-60 interview participants.
This study will directly inform the efforts of knowledge users within TB care and, through extension of the approach, other areas of care provided by LHWs in Malawi and other low- and middle-income countries.
ClinicalTrials.gov NCT02533089 . Registered 20 August 2015. Protocol Date/Version 29 May 2016/Version 2.
尽管有有效的治疗方法，但结核病仍然是全球发病和死亡的重要原因，低收入和中等收入国家受影响最为严重。在包括马拉维在内的许多此类地区，疾病负担沉重且熟练医护人员严重短缺，导致门诊结核病护理工作向非专业卫生工作者（LHWs）转移。LHWs改善了医疗服务的可及性以及包括结核病治愈率在内的一些治疗效果，但缺乏培训和监督限制了他们的作用。本研究的目标是通过完善、实施和评估一项知识转化策略来改善马拉维LHWs提供的结核病护理，该策略旨在弥补LHWs在结核病及特定工作知识方面公认的差距，并借此改善患者治疗效果。
方法/设计：我们采用混合方法设计，包括一项实用的整群随机对照试验和一项使用定性方法的过程评估。试验参与者将包括马拉维东南部地区四个区所有提供结核病护理的卫生中心。干预措施包括开展教育推广、使用即时护理提醒工具以及建立同伴支持网络。主要结局是治疗成功率，定义为治愈或完成治疗的结核病患者总数，数据取自卫生部的治疗记录。设定α值为0.05，检验效能为0.80，基线治疗成功率为0.80，根据我们的预试验研究，组内相关系数为0.1，估计有100个整群（提供结核病护理的卫生中心），为了检测出治疗成功率比例临床上显著提高0.10，每个整群至少需要6名患者。我们的过程评估将包括对LHWs和患者的访谈，以及对LHWs培训日志、季度同伴培训会议和指导会议记录的文件分析。在两个计划的访谈阶段，每个阶段估计需要10 - 15名LHWs和10 - 15名患者才能达到饱和，总共需要40 - 60名访谈参与者。
本研究将直接为结核病护理领域的知识使用者提供信息，并通过推广该方法，为马拉维和其他低收入及中等收入国家LHWs提供护理的其他领域提供信息。
ClinicalTrials.gov NCT02533089。于2015年8月20日注册。方案日期/版本2016年5月29日/版本2。
