Health Care WorkersHANDNCT01933087
Hand Hygiene Intervention Study
A study testing Hand hygiene promotion in people with Health Care Workers, run by University of Oxford.
Trial summary
Infections acquired by patients in hospitals are a major cause of illness and death worldwide, and particularly so in hospitals with very limited resources. Simple hygiene measures, including improved hand hygiene (particularly with increased use of alcohol-based hand rub) by healthcare workers (HCWs) in physical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Care Workers
- What is being tested?
- Hand hygiene promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 24 Dec 2013to 2 May 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All HCWs, having direct patient contact, in all in-patient wards including Intensive Care Units (ICU) and non-ICUs.
Who cannot join
- There are no exclusion criteria for the primary outcome.
- HCWs who refuse to sign the informed consent to participate self-administered questionnaire will be excluded from the secondary outcome assessing knowledge and beliefs of HCWs.
About this study
Official title: A Stepped Wedge Cluster Randomised Controlled Trial to Evaluate the Impact of a Multimodal Hand Hygiene Intervention at Sappasithiprasong Hospital, Ubon Ratchathani
Infections acquired by patients in hospitals are a major cause of illness and death worldwide, and particularly so in hospitals with very limited resources. Simple hygiene measures, including improved hand hygiene (particularly with increased use of alcohol-based hand rub) by healthcare workers (HCWs) in physical contact with patients, are thought to be amongst the most effective ways of reducing such infections. However, in most hospitals hand hygiene is practiced poorly and improving hand hygiene behavior amongst hospital staff has been found to be difficult.
This study aims to evaluate the impact of a multimodal intervention to improve hand hygiene amongst health care workers in accordance with the WHO Guidelines on Hand Hygiene in Health Care. The research design is a prospective stepped wedged trial using all in-patient wards in a 1,000 bed hospital located in Northeast Thailand (Sappasitthiprasong hospital, Ubon Ratchatani). A stepped wedge design is a type of cluster randomized controlled trial which is appropriate when there are prior reasons to believe the intervention will be beneficial (as opposed to equipoise) and when it is impractical to deliver the intervention to all study units simultaneously. Both conditions hold here. The intervention will include educational visits to healthcare workers, improved reminders in the workplace, audit and feedback and social marketing with the aim of inducing behavioural and cultural change in relation to hand hygiene. The intervention will be delivered by the infection control team and the infection control ward nurses (ICWNs) who will receive additional training. The primary outcome will be directly observed hand hygiene compliance. Secondary outcomes will include incidence density of hospital-associated bloodstream and urinary tract infections with specified multiply antibiotic resistant bacteria, incidence density of hospital-associated bloodstream and urinary tract infections with non-multiply antibiotic resistant bacteria, total patient mortality rates, and ward-based consumption of alcohol hand rub and soap (a proxy for hand hygiene compliance).
Results from this study will be immediately generalisable to other resource-constrained hospitals in Thailand. The research will also have much wider international significance as there have been very few methodologically sound evaluations of the impact of hand hygiene interventions in hospitals. Moreover, the findings will provide essential information for subsequent work on economic evaluations of infection control interventions to determine under what circumstances such interventions are likely to be cost-effective.
Read the detailed description
Healthcare-associated infections(HCAIs) are a global problem and a major source of preventable morbidity and mortality worldwide, but particularly so in low and middle income countries. A recent review estimated the pooled prevalence of HCAI in developing countries (defined as Organisation Economic Co-operation Development (OECD) low or middle income countries) to be 15.5 per 100 patients, and highlighted the need to improve infection control practices. Rates of surgical site infection have been reported to range from 12 to 39% in developing countries compared to 2 to 5% in developed countries and rates of HCAI in neonates have been found to be 12 times higher in developing countries. Mortality due to such infections in developing countries is found to greatly exceed that in developed countries.
There is, however, evidence from quasi experimental research that concerted and sometimes low-cost interventions are able to greatly reduce the hospital transmission and prevalence of multi-drug resistant organisms (MDROs), resulting in improved patient outcomes. Improved hand hygiene(HH) is widely believed to be the single most effective intervention. However a 2010 Cochrane review has highlighted the lack of methodologically sound research evaluating interventions to improve HH: only four studies met the minimum inclusion criteria and only one such study came from a lower or middle income country (a randomised trial of an educational intervention for nurses in China). Moreover, a recent review has identified a need for stronger evidence linking improved HH compliance with reductions in HCAIs (currently such evidence is based only on observational studies).
While there are comprehensive hospital infection control guidelines at the proposed study site, Sappasithiprasong hospitals, a recent observational study our team carried out at this hospital has indicated poor HH compliance, below 5% for all health-care workers(HCWs) (manuscript in preparation). Previous data collected by our team has suggested hospital infection control guidelines may not have been implemented consistently due, in part, to resource constraints[5]. More recent qualitative research we have carried out at Sappasithiprasong hospital into the causes of poor hand hygiene compliance has identified several obstacles, and highlighted in particular a lack of knowledge about appropriate hand hygiene behaviour.
Available evidence suggests that hand hygiene promotion (HHP) with a multimodal intervention will be the most effective approach to improve HCW hand hygiene compliance[6]. While formal evaluation of such an intervention using a strong study design in lower and middle income countries is lacking, such interventions are relatively inexpensive and thought likely to be cost-effective (and potentially cost-saving as a result of reduced infections rates). Again, however, formal economic evaluations outside high income countries are lacking.
This approach promoted by the WHO guidelines identifies five moments for HH (before patient contact, before aseptic procedure, after body fluid exposure, after touching a patient, after touching a patient's surroundings). These guidelines aim to encourage good HH compliance in the real world and recommend a multimodal HHP strategy making use of up to five components: 1) system change (for example, changing systems to ensure that alcohol-based hand-rub is readily available wherever and whenever needed), 2) training and education, 3) observation and feedback, 4) reminders in the hospital, and 5) a hospital safety climate.
Adapting these guidelines to local conditions is important, and will make use of our initial qualitative research. This has identified important local barriers to achieving high levels of HH compliance.
Another major issue for improving HH behaviour in hospital HCWs is sustainability. While many studies have reported immediate improvements in HH following interventions, sustaining such improvements is much more challenging and another area where research has been very limited.
In conclusion, there is a need for methodologically rigorous research to evaluate the impact of a multimodal intervention based on the WHO recommendations both in the short and longer-term considering as outcomes both HH compliance, and preventable HCAIs. The need for such research is greatest in resource-constrained settings in lower and middle income countries where the burden of disease due to healthcare associated infections is the greatest. Findings from this research can also inform economic evaluations which are needed to determine the conditions under which such interventions are cost-effective.
- Conditions
- Health Care Workers
- Being tested
- Hand hygiene promotion
- Keywords
- Hand hygiene,, Randonmised Controlled Trials,, Hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand hygiene promotionBehavioural
Also called Hand hygiene intervention, WHO multimodal hand hygiene improvement strategy
The intervention will adapt from the WHO Multimodal HH Improvement Strategy making use of five components: 1) system change (for example, changing systems to ensure that alcohol-based hand-rub is readily available wherever and whenever needed), 2) training and education, 3) observation and feedback, 4) reminders in the hospital, and 5) a hospital safety climate with the aim of inducing behavioural and cultural change in relation to reduce HCAI and improve HH. The intervention will be delivered to infection control ward nurses (ICWNs) of each ward at each time step by researcher and the infection control team (ICT).
| Study group | Role | What they receive |
|---|---|---|
| Control with no hand hygiene promotion | No intervention | no implementation of hand hygiene promotion |
| Hand hygiene promotion | Experimental | Intervention to promote hand hygiene which is based on the WHO multimodal hand hygiene improvement strategy. Receives: Behavioral: Hand hygiene promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand hygiene compliance amongst healthcare workers having direct patient contact.
Directly observed hand hygiene compliance data will be collected during all three phases of the study by two observers. Each observer will directly observe healthcare worker compliance with the recommended five moments of hand hygiene in study wards, and a minimum of one hour's hand hygiene observation data will be collected from each ward during each week of the study. Observations will be in accordance with WHO recommendations and make use of the WHO's "5-movements" framework and the standard WHO hand hygiene compliance observation forms.
Measured: 16 months
Secondary outcomes (1)
Incidence of healthcare-associated bloodstream and urinary tract infections
Data from hospital records and from the microbiology laboratory will be used together to identify hospital acquired bacteraemias and urinary tract infections. These two routine data sets will be extracted by the hospital staff at three-monthly intervals. Hospital-acquired infections will be defined by standard criteria; for example, isolation of multi-drug resistant organisms from blood or sterile (urine) site culture taken more than 48 hours after admission. This study will not perform additional microbiology tests, but will make use of results from tests taken as part of routine hospital work.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start24 Dec 2013
- Primary completion2 May 2015
- Study completion2 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care WorkersStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933087
- Sponsor's protocol ID
- MICRO1202
- Acronym
- HAND
- Status last verified
- Oct 2020
- First submitted
- 27 Aug 2013
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped Wedge Cluster Randomised Controlled Trial to Evaluate the Impact of a Multimodal Hand Hygiene Intervention at Sappasithiprasong Hospital, Ubon Ratchathani
- ClinicalTrials.gov ID
- NCT01933087
- Acronym / sponsor ID
- HAND / MICRO1202
- Conditions
- Health Care Workers
- Keywords
- Hand hygiene,, Randonmised Controlled Trials,, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 24 Dec 2013 (actual)
- Primary completion
- 2 May 2015 (actual)
- Study completion
- 2 May 2015 (actual)
- First posted
- 30 Aug 2013 (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.
Infections acquired by patients in hospitals are a major cause of illness and death worldwide, and particularly so in hospitals with very limited resources. Simple hygiene measures, including improved hand hygiene (particularly with increased use of alcohol-based hand rub) by healthcare workers (HCWs) in physical contact with patients, are thought to be amongst the most effective ways of reducing such infections. However, in most hospitals hand hygiene is practiced poorly and improving hand hygiene behavior amongst hospital staff has been found to be difficult.
This study aims to evaluate the impact of a multimodal intervention to improve hand hygiene amongst health care workers in accordance with the WHO Guidelines on Hand Hygiene in Health Care. The research design is a prospective stepped wedged trial using all in-patient wards in a 1,000 bed hospital located in Northeast Thailand (Sappasitthiprasong hospital, Ubon Ratchatani). A stepped wedge design is a type of cluster randomized controlled trial which is appropriate when there are prior reasons to believe the intervention will be beneficial (as opposed to equipoise) and when it is impractical to deliver the intervention to all study units simultaneously. Both conditions hold here. The intervention will include educational visits to healthcare workers, improved reminders in the workplace, audit and feedback and social marketing with the aim of inducing behavioural and cultural change in relation to hand hygiene. The intervention will be delivered by the infection control team and the infection control ward nurses (ICWNs) who will receive additional training. The primary outcome will be directly observed hand hygiene compliance. Secondary outcomes will include incidence density of hospital-associated bloodstream and urinary tract infections with specified multiply antibiotic resistant bacteria, incidence density of hospital-associated bloodstream and urinary tract infections with non-multiply antibiotic resistant bacteria, total patient mortality rates, and ward-based consumption of alcohol hand rub and soap (a proxy for hand hygiene compliance).
Results from this study will be immediately generalisable to other resource-constrained hospitals in Thailand. The research will also have much wider international significance as there have been very few methodologically sound evaluations of the impact of hand hygiene interventions in hospitals. Moreover, the findings will provide essential information for subsequent work on economic evaluations of infection control interventions to determine under what circumstances such interventions are likely to be cost-effective.
Detailed description
Healthcare-associated infections(HCAIs) are a global problem and a major source of preventable morbidity and mortality worldwide, but particularly so in low and middle income countries. A recent review estimated the pooled prevalence of HCAI in developing countries (defined as Organisation Economic Co-operation Development (OECD) low or middle income countries) to be 15.5 per 100 patients, and highlighted the need to improve infection control practices. Rates of surgical site infection have been reported to range from 12 to 39% in developing countries compared to 2 to 5% in developed countries and rates of HCAI in neonates have been found to be 12 times higher in developing countries. Mortality due to such infections in developing countries is found to greatly exceed that in developed countries.
There is, however, evidence from quasi experimental research that concerted and sometimes low-cost interventions are able to greatly reduce the hospital transmission and prevalence of multi-drug resistant organisms (MDROs), resulting in improved patient outcomes. Improved hand hygiene(HH) is widely believed to be the single most effective intervention. However a 2010 Cochrane review has highlighted the lack of methodologically sound research evaluating interventions to improve HH: only four studies met the minimum inclusion criteria and only one such study came from a lower or middle income country (a randomised trial of an educational intervention for nurses in China). Moreover, a recent review has identified a need for stronger evidence linking improved HH compliance with reductions in HCAIs (currently such evidence is based only on observational studies).
While there are comprehensive hospital infection control guidelines at the proposed study site, Sappasithiprasong hospitals, a recent observational study our team carried out at this hospital has indicated poor HH compliance, below 5% for all health-care workers(HCWs) (manuscript in preparation). Previous data collected by our team has suggested hospital infection control guidelines may not have been implemented consistently due, in part, to resource constraints[5]. More recent qualitative research we have carried out at Sappasithiprasong hospital into the causes of poor hand hygiene compliance has identified several obstacles, and highlighted in particular a lack of knowledge about appropriate hand hygiene behaviour.
Available evidence suggests that hand hygiene promotion (HHP) with a multimodal intervention will be the most effective approach to improve HCW hand hygiene compliance[6]. While formal evaluation of such an intervention using a strong study design in lower and middle income countries is lacking, such interventions are relatively inexpensive and thought likely to be cost-effective (and potentially cost-saving as a result of reduced infections rates). Again, however, formal economic evaluations outside high income countries are lacking.
This approach promoted by the WHO guidelines identifies five moments for HH (before patient contact, before aseptic procedure, after body fluid exposure, after touching a patient, after touching a patient's surroundings). These guidelines aim to encourage good HH compliance in the real world and recommend a multimodal HHP strategy making use of up to five components: 1) system change (for example, changing systems to ensure that alcohol-based hand-rub is readily available wherever and whenever needed), 2) training and education, 3) observation and feedback, 4) reminders in the hospital, and 5) a hospital safety climate.
Adapting these guidelines to local conditions is important, and will make use of our initial qualitative research. This has identified important local barriers to achieving high levels of HH compliance.
Another major issue for improving HH behaviour in hospital HCWs is sustainability. While many studies have reported immediate improvements in HH following interventions, sustaining such improvements is much more challenging and another area where research has been very limited.
In conclusion, there is a need for methodologically rigorous research to evaluate the impact of a multimodal intervention based on the WHO recommendations both in the short and longer-term considering as outcomes both HH compliance, and preventable HCAIs. The need for such research is greatest in resource-constrained settings in lower and middle income countries where the burden of disease due to healthcare associated infections is the greatest. Findings from this research can also inform economic evaluations which are needed to determine the conditions under which such interventions are cost-effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control with no hand hygiene promotion | No intervention | –no implementation of hand hygiene promotion |
| Hand hygiene promotion | Experimental | Behavioral: Hand hygiene promotionIntervention to promote hand hygiene which is based on the WHO multimodal hand hygiene improvement strategy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All HCWs, having direct patient contact, in all in-patient wards including Intensive Care Units (ICU) and non-ICUs.
Key exclusion criteria (2 listed)
- There are no exclusion criteria for the primary outcome.
- HCWs who refuse to sign the informed consent to participate self-administered questionnaire will be excluded from the secondary outcome assessing knowledge and beliefs of HCWs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand hygiene promotionAlso: Hand hygiene intervention, WHO multimodal hand hygiene improvement strategyThe intervention will adapt from the WHO Multimodal HH Improvement Strategy making use of five components: 1) system change (for example, changing systems to ensure that alcohol-based hand-rub is readily available wherever and whenever needed), 2) training and education, 3) observation and feedback, 4) reminders in the hospital, and 5) a hospital safety climate with the aim of inducing behavioural and cultural change in relation to reduce HCAI and improve HH. The intervention will be delivered to infection control ward nurses (ICWNs) of each ward at each time step by researcher and the infection control team (ICT). | Behavioural | Hand hygiene promotion |
Primary outcome
Hand hygiene compliance amongst healthcare workers having direct patient contact.
Time frame: 16 months
Directly observed hand hygiene compliance data will be collected during all three phases of the study by two observers. Each observer will directly observe healthcare worker compliance with the recommended five moments of hand hygiene in study wards, and a minimum of one hour's hand hygiene observation data will be collected from each ward during each week of the study. Observations will be in accordance with WHO recommendations and make use of the WHO's "5-movements" framework and the standard WHO hand hygiene compliance observation forms.
1 secondary outcome
Incidence of healthcare-associated bloodstream and urinary tract infections
Time frame: 16 months
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 20 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Health Care Workers
Active, not recruiting
Khanya Ekhaya: A Home-Based Intervention
Mental Health, Community Health Workers
Not yet recruiting
Intervention to Increase Physical Activity and Wellbeing Among Staff and Residents in Assisted Living Facilities
Worksite Health Promotion, Lifestyle Risk Reduction
Recruiting
Integrating Systems and Basic Income: Improving Outcomes for Families of Young Children
Income, Infant, Newborn
Enrolling by invitation
A Structured Method for Systematic and Integrated Occupational Safety and Health and Patient Safety Management Systems
Sick Leave, Quality Of Care
Active, not recruiting
The Effect of Kinesio Taping on Posture in Healthy Young Adults
Healthy Young Adults Who Are Health Care Workers at Haydarpaşa Numune Training and Research Hospital
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hand hygiene promotion in people with Health Care Workers, run by University of Oxford.
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 1 inclusion and 2 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Hand hygiene compliance amongst healthcare workers having direct patient contact. (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2020; AzTrials last refreshed its copy on 27 Oct 2026.