Impact of improved diagnostic tools, practices,training and communication on acute fever case management and antibiotic prescriptions for children and adolescents presenting at outpatient facilities in the Community Clinics of ICMR-NICED, India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,760
- 试验地点
- 1
- 主要终点
- 2.Measure and compare rates of antibiotic prescriptions for acute febrile illness in the clinic
研究概览
简要总结
A ‘just-in-case’ antibiotics prescription practice is one of the causes of both antimicrobial resistance (AMR) and inadequate management of acute febrile illnesses, both resulting in increased morbidity and mortality. At the same time, many patients who would require antibiotic treatment do not get it. An adaptation in current practice needs to occur to improve case management in LMICs. Success will mean making significant steps toward achieving the dual goal of tackling AMR and providing universal health coverage (UHC). Here the PICO question addressed is:
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In children and adolescents presenting to outpatient clinics / peripheral health centres in LMICs with acute febrile illness / Respiratory Tract Infection (Population),
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by combining available diagnostic tests plus algorithms plus clinic process flow plus training and communication for care-givers and users (Intervention)
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over current practice (Control)
can we improve patients management of acute febrile illnesses and better target the use of antibiotics / reduce unnecessary antibiotic prescriptions as appropriate and feasible (Outcome)?
The main objective is to compare the impact of a package of interventions (diagnostic tests plus algorithms plus clinic process flow plus training and communication for care-givers and users) on clinical outcomes and antibiotic prescriptions, with standard-of-care practices, in children and adolescents presenting with acute febrile illnesses (defined as fever with no focus or Respiratory Tract Infection lasting for no more than 7 days), at outpatient clinics in India. The intended outcomes are:
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Measurement and comparison of proportion of outpatient cases of acute febrile illness with favorable outcome (defined as being alive and asymptomatic) and,
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Measurement and comparison of rates of antibiotic prescription fro acute febrile illness in the clinics as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •A.Patients with fever with no focus / RTI: a.Children (6 months to <14years) and adolescents (14 years to less than 18 years old) of both sexes.
- •b.Presenting with an acute febrile illness defined as temperature of >37.5°C (oral) or history of fever within the last 7 days with no focus or suspected RTI.
- •c.Parent/guardian providing written informed consent for their children aged less than 18 years of age.
- •d.Obtain assent for adolescent between 12 and less than 18 years old e.Willing to provide blood (as well as urine, NP or throat swab if required) samples and adhere to study procedures explained in the consent forms following the protocol.
- •Available and willing to return for follow-up visit at the health facility.
- •B.Training and communication (for those randomised to intervention arm): a.Parent/guardian providing informed consent to participate in the training and communication component of the study.
- •The same informed consent form will cover both populations adult caregivers and adolescents b.Clinic staff who have provided written informed consent to participate in the training and communication as per randomisation protocol.
排除标准
- •Participants are excluded using the following exclusion criteria: oChildren and adolescents from 6 months to less than 18 years old presenting with chronic febrile illness (fever lasting more than 7 days).
- •oPatients with acute febrile illness outside the allowed age range.
- •oSeverely ill patients requiring hospital admission or referral as assessed by the study clinicians.
- •oAnyone refusing consent to the study or not available for follow-up (adults, the children of parents/guardians, or adolescents who refuse or are missed when asking for consent).
结局指标
主要结局
2.Measure and compare rates of antibiotic prescriptions for acute febrile illness in the clinic
时间窗: After 12 months of recruitment
1.Measure and compare proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic).
时间窗: After 12 months of recruitment
次要结局
- 1.Adherence to new algorithm by health care workers.(2.Adherence to prescription by patients/caregivers.)