Infections, HospitalWardGelNCT02435719
Alcohol Hand Gel Use in Mbale Regional Referral Hospital: a Cost Effectiveness Evaluation
An observational study of Infections, Hospital, run by Sanyu Africa Research Institute at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Hospital
- How many people
- 3,626 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include in-patients and health care providers on six (6) selected wards (Labour ward, Postnatal ward, Gynaecological ward, Acute Care unit, paediatric Ward, and general surgical wards) The sample will be selected by convenience non-probability sampling method
Who may be able to join
- Patients is admitted for at least 24 hours
- Any health care provider, including students
Who cannot join
- Patients discharged before 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Infections, Hospital
- Keywords
- HCAIs, Handgel, Hospital, Effectiveness
- Medical subject headings
- Cross Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Hospital acquired infection confirmed clinically
Hospital acquired infection will be defined as new clinically diagnosed infection developed whilst an inpatient or within 2 days of discharge (for readmitted patients).
Measured: 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.
Secondary outcomes (3)
Evidence of Hospital Acquired infection confirmed by laboratory investigations (CBC and C&S)
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Measured: At least 48 hours after admission or readmission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Hand hygiene compliance by health care providers based on the WHO's 5-moments of Hand hygiene
participants will be observed during their clinical care practice, an expected average of 30 minutes per session
Measured: during patient clinical care.participants will be observed during their clinical care practice, an expected average of 30 minutes per session
cost-effectiveness of hand gel use by micro-economic assessment
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Measured: Additional period due to confirmed hospital acquired infection.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanyu Africa Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mbale Regional Referral Hospital, University of Liverpool, Nagasaki University
- Responsible party
- Sponsor
- Investigators
- Andrew Weeks, PhD, Principal investigator, University of LiverpoolJames Ditai, MPH, Principal investigator, Sanyu Africa Research InstituteBenon Wanume, MMED (CP), Principal investigator, Mbale Regional Referral HospitalJulian Abeso, MMED (Paed), Study director, Mbale Regional Referral HospitalKyoko Inoue, MPH, Study director, Nagasaki University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435719
- Sponsor's protocol ID
- SAfRI/OBS/001
- Acronym
- WardGel
- Status last verified
- Oct 2016
- First submitted
- 20 Apr 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Saito H, Inoue K, Ditai J, Wanume B, Abeso J, Balyejussa J, Weeks A. Alcohol-based hand rub and incidence of healthcare associated infections in a rural regional referral and teaching hospital in Uganda ('WardGel' study). Antimicrob Resist Infect Control. 2017 Dec 28;6:129. doi: 10.1186/s13756-017-0287-8. eCollection 2017.
PubMed 29299303
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation of Alcohol Hand Gel Use in Mbale Regional Referral Hospital, Rural Eastern Uganda
- ClinicalTrials.gov ID
- NCT02435719
- Acronym / sponsor ID
- WardGel / SAfRI/OBS/001
- Conditions
- Infections, Hospital
- Keywords
- HCAIs, Handgel, Hospital, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,626 participants (actual)
- Lead sponsor
- Sanyu Africa Research InstituteUniversity, hospital or other
- Collaborators
- Mbale Regional Referral Hospital, University of Liverpool, Nagasaki University
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include in-patients and health care providers on six (6) selected wards (Labour ward, Postnatal ward, Gynaecological ward, Acute Care unit, paediatric Ward, and general surgical wards) The sample will be selected by convenience non-probability sampling method
Key inclusion criteria (2 listed)
- Patients is admitted for at least 24 hours
- Any health care provider, including students
Key exclusion criteria (1 listed)
- Patients discharged before 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evidence of Hospital acquired infection confirmed clinically
Time frame: 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.
Hospital acquired infection will be defined as new clinically diagnosed infection developed whilst an inpatient or within 2 days of discharge (for readmitted patients).
3 secondary outcomes
Evidence of Hospital Acquired infection confirmed by laboratory investigations (CBC and C&S)
Time frame: At least 48 hours after admission or readmission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Hand hygiene compliance by health care providers based on the WHO's 5-moments of Hand hygiene
Time frame: during patient clinical care.participants will be observed during their clinical care practice, an expected average of 30 minutes per session
cost-effectiveness of hand gel use by micro-economic assessment
Time frame: Additional period due to confirmed hospital acquired infection.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 29299303Saito H, Inoue K, Ditai J, Wanume B, Abeso J, Balyejussa J, Weeks A. Alcohol-based hand rub and incidence of healthcare associated infections in a rural regional referral and teaching hospital in Uganda ('WardGel' study). Antimicrob Resist Infect Control. 2017 Dec 28;6:129. doi: 10.1186/s13756-017-0287-8. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Weeks, PhD principal investigator
University of Liverpool
James Ditai, MPH principal investigator
Sanyu Africa Research Institute
Benon Wanume, MMED (CP) principal investigator
Mbale Regional Referral Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Hospital, run by Sanyu Africa Research Institute at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Hospital acquired infection confirmed clinically (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.