- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Mbale, Uganda
- Mbale Regional referral Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients is admitted for at least 24 hours
- Any health care provider, including students
Exclusion Criteria:
- Patients discharged before 24 hours
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Evidence of Hospital acquired infection confirmed clinically
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Evidence of Hospital Acquired infection confirmed by laboratory investigations (CBC and C&S)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Andrew Weeks, PhD, University of Liverpool
- Investigatore principale: James Ditai, MPH, Sanyu Africa Research Institute
- Investigatore principale: Benon Wanume, MMED (CP), Mbale Regional referral Hospital
- Direttore dello studio: Julian Abeso, MMED (Paed), Mbale Regional referral Hospital
- Direttore dello studio: Kyoko Inoue, MPH, Nagasaki University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SAfRI/OBS/001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Infections, Hospital
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Weill Medical College of Cornell UniversityCompletatoPazienti medici moderatamente malati presso il Cornell Campus del New York-Presbyterian HospitalStati Uniti