Integrated Infectious Disease Capacity-Building Evaluation (IDCAP)
2014年12月1日 更新者:Marcia Weaver、University of Washington
Cost Effectiveness of Building Capacity of Mid-level Practitioners in Sub-Saharan Africa for the Care and Prevention of HIV, Tuberculosis, Malaria and Related Infectious Diseases
This evaluation aim is to investigate a cost-effective way to build capacity for the care and prevention of infectious diseases among mid-level practitioners (MLP) in sub-Saharan Africa.
Classroom based training continues to be the dominant form of training, despite evidence that suggests that on-site support (OSS) is more beneficial.
Definitive evidence that on-site support is the most effective way to deliver the required outputs and related outcomes is still lacking.
IDCAP will provide two interventions that integrate training in TB, HIV/AIDS and malaria as well as other infectious diseases, and the effects will be studied: 1) Integrated Management of Infectious Disease (IMID) training program for individual MLP, and 2) On-site support (OSS) for team of health professionals.
This study employs a mixed design with pre/post and cluster randomized trial components.
Interventions are at the level of the individual participant for IMID and at the level of the site (health facility) for OSS.
All participants attend a 3-week course, followed by two 1-week booster courses over a six month period.
After the 3-week course, a randomized arm of half the sampled facilities also received OSS every month for 9 months and bi-monthly for 6 additional months.
研究概览
地位
完全的
详细说明
There are four major components of the evaluation design as described below: 1) Site Assessment, 2) Competence and practice of individual MLP who participate in IDT, 3) Facility cost and performance indicators, and 4) Mortality survey.
The site assessment guided the curriculum development and site selection.
As shown in Figure 1, it occurred only once in Year 1.
The effect of the IMID and OSS on competence of individual MLP will be evaluated with written case scenarios or vignettes.
Data on case scenarios will be collected three times: a) before training, b) after the three-week course, and c) after the nine-month program that includes two, one-week booster courses and distance learning.
To estimate the effect of IMID, aggregate changes in test score across all 3 time points for both arms will be analyzed jointly.
To estimate the effect of OSS, differences in change in test score starting from after the three-week course to the end of the nine-month program will be compared across the 2 arms.
The effects on practice of individual trainees will be evaluated with clinical assessments by mobile team faculty during five outpatients visits and five HIV clinic visits by individual MLP.
Data on clinical assessments will be collected two times: a) before training, and b) after the nine-month program.
Facility performance indicators will be collected on a monthly basis from each site.
Sites will be randomly assigned to begin OSS in either Phase 1 or Phase 2 and the facility indicators of these two samples of sites will be compared.
The principal investigators of IDCAP are actively considering collecting data on mortality among children under five, but a final decision has not been made.
At the request of the acting chairperson of SOMREC, we are including information about this potential activity.
Mortality surveys would be conducted before and after the OSS.
研究类型
介入性
注册 (实际的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Kampala、乌干达
- Infectious Disease Institute, Makerere University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
Facilities selected for OSS:
- The health facility had to be a HC IV or comparable facility such as a small general hospital or non-governmental organization clinic
- It had to be an active ART site or accredited ART site that is scheduled to become active by April 2009
- No past or current participation in a partnership with the U.S. Department of Defense
- Has a population of potential patients who are not prisoners
- Representation from all six administrative regions of Uganda
Exclusion Criteria:
- NA
MLP selected from the participating facilities for IMID:
Two mid-level practitioners (clinical officers, nurses, or midwives) who are actively engaged in clinical infectious-disease care will be selected for enrollment in IMID
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:OSS Phase 1
Thirty-six sites will receive the On Site Support service (OSS) activities for nine to 15 months; 18 will be randomly assigned to receive the OSS in phase 1
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On-Site-Support (OSS) service training will occur monthly for a period of 9 months.
This training and supervision will support the proper utilization of newly learned clinical skills.
The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda.
After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI.
Then the engage in 12 more weeks of distance learning and a final one-week boost course.
This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
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有源比较器:OSS Phase 2
Thirty-six sites will receive the OSS activities for nine to 15 months; 18 will be randomly assigned to receive the OSS in phase 2 that will serve as a control group in phase 1 and receive OSS nine months later.
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The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda.
After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI.
Then the engage in 12 more weeks of distance learning and a final one-week boost course.
This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
On-Site-Support (OSS) service training will occur monthly for a period of 9 to 15 months.
This training and supervision will support the proper utilization of newly learned clinical skills and continuous quality improvement of processes of care.
For the control group, the OSS training will occur during phase 2, after a randomly assigned wait list control period.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Model of Integrated Capacity Building Program
大体时间:monthly over 3 years
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The principal output of this evaluation will be a proven model of an integrated capacity-building package for the care and prevention of infectious disease in Africa.
The package will include a single curriculum for MLP and a portfolio of on-site support services founded on Accordia Global Health Foundation's considerable experience in training clinicians in North America and Africa.
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monthly over 3 years
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Competence of individual clinicians
大体时间:3 observations at pre/post IMID and final
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Competence of individual clinicians will be measured by scores on 12 written case scenarios or vignettes.
Three blocks of 4 scenarios each covered different aspects of HIV/AIDS, tuberculosis, malaria, and other infectious diseases and included cases involving children, adults, and pregnant women.
Each case scenario addressed 6 principal domains: emergency or danger signs, history and physical examination, laboratory testing, diagnosis or classification of patients' medical problems; initial treatment or referral plan, and evolution of the case over time.
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3 observations at pre/post IMID and final
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Practice of individual clinicians
大体时间:Baseline and Endline (9 months)
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Clinical assessments will be conducted by mobile team faculty who will observe individual clinicians during five outpatient visits with children under five years and five HIV clinic visits.
Clinical practice will be assessed on history, physical examination, review of medical records (HIV clinic only), laboratory investigations ordered, diagnosis, treatment prescribed and patient education.
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Baseline and Endline (9 months)
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Clinical performance indicators
大体时间:Monthly beginning 5 months before OSS
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54 clinical performance indicators used by the Ministry of Health, the Uganda Malaria Surveillance Program or recommended by international organizations will be used to measure performance in general areas: 1) HIV prevention, 2) HIV care, 3) Antiretroviral therapy, 4) TB/HIV care, 5) Case management of respiratory infections, 6) Case Management of Fever, and 7) Emergency Triage and Treatment.
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Monthly beginning 5 months before OSS
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reduce Infection, Illness, and Mortality Rates
大体时间:3 years
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The population in the areas surrounding the proposed sites will benefit directly from lower infection, illness and mortality rates.
The improved ability of clinic staff to deliver quality prevention and care services will increase access to cost-effective interventions delivered according to national guidelines by 9% to 25% depending on the intervention.
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3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Marcia Weaver, PhD、University of Washington
- 首席研究员:Sarah Naikoba, BMBCh, MPH、Infectious Disease Institute, Makarere University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Weaver M, Krieger J, Castorina J, et. al.
- World Health Organization. Generalized Cost-Effeciveness Analysis: A Guide. Geneva: World Health Organization, 2003. Available online at: http://www.who.int/choice/en/ Accessed on April 14, 2008.
- The Uganda Bureau of Statistics (UBOS), Macro International Inc., and MEASURE Evaluation. 2008. Uganda Child Verbal Autopsy Study 2007. Calverton, Maryland, USA: UBOS, Macro International Inc., and MEASURE Evaluation.
- Weaver MR, Crozier I, Eleku S, Makanga G, Mpanga Sebuyira L, Nyakake J, Thompson M, Willis K. Capacity-building and clinical competence in infectious disease in Uganda: a mixed-design study with pre/post and cluster-randomized trial components. PLoS One. 2012;7(12):e51319. doi: 10.1371/journal.pone.0051319. Epub 2012 Dec 14.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年11月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2010年8月25日
首先提交符合 QC 标准的
2010年8月25日
首次发布 (估计)
2010年8月27日
研究记录更新
最后更新发布 (估计)
2014年12月3日
上次提交的符合 QC 标准的更新
2014年12月1日
最后验证
2014年12月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 42657-EG
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