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临床试验/NCT01634802
NCT01634802Unknown不适用

Evaluation of Use of Clinical Decision Support System for Early Detection of Immunological Treatment Failure Among HIV Patients in Resource Constrained Settings

Kenya Medical Research Institute1 个研究点 分布在 1 个国家目标入组 1,460 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,460
试验地点
1
主要终点
The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines.

研究概览

简要总结

The purpose of this study is to determine whether the use of a Computerized Decision Support System (CDSS) in form of alerts to clinicians enhances early detection of immunological treatment failure in HIV patients.

详细描述

We hypothesize that there is no difference in the time to detecting immunological treatment failure among HIV patients in resource poor settings whether the clinicians use an Electronic Medical Record (EMR) system with a Computerized Decision Support (CDSS) or an EMR without a CDSS. In this study, 20 clinics were assigned to the intervention (EMR+CDSS) arm and non-intervention arm (EMR only) and will be followed up for 12 months to assess whether there are any differences in time taken to detect immunological treatment failure based on CD4 cell count.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All HIV patients enrolled in participating clinics

排除标准

  • 未提供

结局指标

主要结局

The main end-point of the study will be the proportion of patients on treatment who have experienced treatment failure and appropriate clinical action taken according to the guidelines.

时间窗: 12 months

次要结局

  • Other outcome measures will be the proportion of CD4 cell counts done on time and proportion of pre-ART patient eligible for treatment that are initiated within 30 days of eligibility. The median time taken to clinical action will be measured.(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Oluoch

Mr.

Centers for Disease Control and Prevention

研究点 (1)

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