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临床试验/NCT02533089
NCT02533089已完成不适用

Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi

Dignitas International1 个研究点 分布在 1 个国家目标入组 1,153 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,153
试验地点
1
主要终点
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.

研究概览

简要总结

Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In response to the combined high TB burden and severe healthcare worker shortages in these settings, outpatient TB care is among the tasks commonly shifted to LHWs.

LHWs are community members who have received some training but are not healthcare professionals. Randomised trials show LHWs improve access to basic health services and TB treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness.

The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of evidence into LHW practice. The investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •all health centers in participating districts that routinely provide TB care will be included.
  • •LHWs who have received the intervention and patients receiving care at participating health centers will be eligible to participate in interviews

排除标准

  • •health centers that do not routinely provide TB care
  • •LHWs unwilling or unable to give informed consent.
  • •TB patients less than 18 years of age unaccompanied by a parent or guardian, patients/guardians or LHWs unwilling or unable to give informed consent, patients presenting to a health center they are not routinely followed at.

研究组 & 干预措施

KT intervention

Experimental

Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.

干预措施: KT intervention (Other)

Control

No Intervention

Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool.

结局指标

主要结局

Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.

时间窗: 1 year

primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.

次要结局

  • Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)(1 year)
  • Proportion of Successes Among HIV Co-infected Cases(1 year)

研究者

发起方
Dignitas International
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa M Puchalski Ritchie

Dr.

Unity Health Toronto

研究点 (1)

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