- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02435719
Alcohol Hand Gel Use in Mbale Regional Referral Hospital: a Cost Effectiveness Evaluation (WardGel)
Effectiveness Evaluation of Alcohol Hand Gel Use in Mbale Regional Referral Hospital, Rural Eastern Uganda
Ministry of Health through the National Medical Stores has supplied alcohol-based handgels to the different health facilities in Uganda for the health care providers to use during clinical care. However, constant stock-outs and or limited supplies remains the main constraint faced by the hospitals. Thus the handgels are generally used by a few of the senior health care providers.
The promotion of bedside, antiseptic handrubs largely contributes to the increase in compliance and sustained improvement of hand hygiene compliance reduces Health care acquired infections (HCAIs), but it is not yet established how cost- effective the intervention is in a a rural Ugandan hospital where funds are severely rationed and, which serves over 4 million people in over 15 districts in Uganda. An evaluation of an intervention's cost-effectiveness is a crucial factor in whether the government will be prepared to fund the intervention and sustain it.
This WardGel study thus aims to assess the cost-benefit of providing hand gel for all health care workers in Mbale Regional Referral Hospital.
Visão geral do estudo
Status
Condições
Descrição detalhada
The WardGel Study aims to assess the cost- effectiveness of providing handgel for all health care workers in selected wards of Mbale regional Referral Hospital in rural Eastern Uganda.
The WardGel study seeks to address the following specific objectives:-
- To determine the incidence of new infections following hospital admission among in-patients
- To assess the hand hygiene compliance among the health care providers (HCPs) as the usual practice and with handgel
- To determine the effectiveness of handgel in reduction of new infections after hospital admission
- To determine the additional costs associated with development of new infections after hospital stay
This study will compare infection rates before (pre-intervention phase) and after implementation of the hand gel for use by health care providers (intervention phase). The study will also assess hand-hygiene compliance amongst health workers and additional costs associated with management of new acquired infections amongst inpatients while at the hospital.
The pre-intervention phase lasting for 12 weeks will involve baseline evaluation of the current hand hygiene practices on each of the study wards, ascertaining how frequently HCPs washed their hands or used handgel.
At the end of 12 weeks, the Intervention will begin and last for 12 weeks. Alcohol-based hand gels will be introduced and provided to health care providers (HCPs) for use before and after each patient care episode.
In ward Training will be provided for all HCPs, including student trainees of clinical medicine and nursing prior to introduction of the hand gels on its use and any promotion messages for example, displaying posters in each hand washing area in the respective wards. Any other training will be arranged and conducted accordingly. 1-Litre handgel bottles will be fitted in the holders fixed to the walls on the wards, and other free bottles placed on the trolleys for using while conducting ward rounds, others on the reception area during the registration of inpatient, and treatment area while administering patients' treatment.
Also 40ml hand-sized bottles will be availed to health care providers. Additional stocks of the hand gel will be available in the staff areas and one central pharmacy area. Compliance with the intervention will be assessed by direct observation by the research assistants on each ward based on the WHO assessment tools and by volume of gel use.
In both phases, the following will be crosscutting: -
- The study shall adopt the WHO hand hygiene tools (the WHO 5-Moment Tool and hand hygiene compliance tool) to assess the hand hygiene compliance (WHO 2009).
- Prospective data will also be collected daily from all recruited inpatients on the wards prior to and during the implementation of the intervention to document the frequency of infections on admission and the rate of new acquired infections during their hospital stay.
The new infections definitions acquired after admission of the patients and applied in this WardGel study have been developed and modified from the CDC/NHSN Surveillance definitions for specific infections [CDC 2014].
- Individual patients data collected from patient interviews will be augmented by a review of their case files.
- Research assistants will interview all recruited patients and or their carers diagnosed with a new infection to assess the exact extra care costs incurred from patients' perspective. Meanwhile, hospital records shall help to establish the extra costs incurred for antibiotics, and health workers extra time. Other costs will be related hand gel supplies, training and start-up costs.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Mbale, Uganda
- Mbale Regional Referral Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients is admitted for at least 24 hours
- Any health care provider, including students
Exclusion Criteria:
- Patients discharged before 24 hours
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evidence of Hospital acquired infection confirmed clinically
Prazo: At least 48 hours after hospital admission or re-admission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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Hospital acquired infection will be defined as new clinically diagnosed infection developed whilst an inpatient or within 2 days of discharge (for readmitted patients).
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At least 48 hours after hospital admission or re-admission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evidence of Hospital Acquired infection confirmed by laboratory investigations (CBC and C&S)
Prazo: At least 48 hours after admission or readmission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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At least 48 hours after admission or readmission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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Hand hygiene compliance by health care providers based on the WHO's 5-moments of Hand hygiene
Prazo: during patient clinical care.participants will be observed during their clinical care practice, an expected average of 30 minutes per session
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participants will be observed during their clinical care practice, an expected average of 30 minutes per session
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during patient clinical care.participants will be observed during their clinical care practice, an expected average of 30 minutes per session
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cost-effectiveness of hand gel use by micro-economic assessment
Prazo: Additional period due to confirmed hospital acquired infection.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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Additional period due to confirmed hospital acquired infection.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew Weeks, PhD, University of Liverpool
- Investigador principal: James Ditai, MPH, Sanyu Africa Research Institute
- Investigador principal: Benon Wanume, MMED (CP), Mbale Regional Referral Hospital
- Diretor de estudo: Julian Abeso, MMED (Paed), Mbale Regional Referral Hospital
- Diretor de estudo: Kyoko Inoue, MPH, Nagasaki University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SAfRI/OBS/001
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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