HandwashingNCT00375037
A Multifaceted Intervention to Improve Hand Hygiene
A study testing feedback and Education in people with Handwashing and Infection, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
Trial summary
This randomized controlled trial will evaluate the effect of a multifaceted intervention including performance feedback on adherence to hand hygiene among healthcare workers. A key component of the study is to demonstrate whether improved adherence to hand hygiene leads to a reduction in rates of infection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Handwashing, Infection
- What is being tested?
- feedback and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2007to Jul 2008
- 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
None listed.
Who cannot join
- Healthcare workers
- Inclusion: any hospital staff with direct patient care who are affiliated with a single unit (includes registered nurses, nursing assistants, environmental aides, allied health professionals (occupational, physical, and respiratory therapists), and some physicians
- Patients Clinical outcomes will be measured in patients on study units.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Henderson Hospital
Hamilton, Ontario, L8V 1C3
About this study
Official title: Cluster Randomized Controlled Trial of a Multifaceted Intervention to Improve Hand Hygiene Among Healthcare Workers
This randomized controlled trial will evaluate the effect of a multifaceted intervention including performance feedback on adherence to hand hygiene among healthcare workers. A key component of the study is to demonstrate whether improved adherence to hand hygiene leads to a reduction in rates of infection.
Read the detailed description
A cluster randomized controlled trial of the intervention will be conducted where hospital units (wards) in three hospitals will be allocated to either the intervention or usual practise. We will stratify by hospital site in order to minimize confounding by hospital-level factors. The unit of allocation, intervention, and analysis will be at the level of the hospital unit. Thirty hospital units will be randomized to either the intervention or comparison arm. We will compare adherence to hand hygiene, MRSA rates, and other outcomes between the two study arms.
- Conditions
- Handwashing, Infection
- Being tested
- feedback, Education, usual care
- Keywords
- hand washing, cluster randomized trial, performance feedback, healthcare workers, Hand hygiene, hand washing adherence
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feedbackBehavioural
EducationBehavioural
usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Hand hygiene | Experimental | Hand hygiene promotion Receives: Behavioral: feedback; Behavioral: Education |
| Usual care | Active comparator | usual care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MRSA
Measured: 12 months
Adherence to hand hygiene
Measured: 12 months
Secondary outcomes (3)
Incidence of multi-resistant bacteria other than MRSA
Measured: 12 months
Catheter-related blood stream infections
Measured: 12 months
Clostridium difficile related diarrhea
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HandwashingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Mark B Loeb, MD, MSc, Principal investigator, Hamilton Health Sciences- McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375037
- Sponsor's protocol ID
- 05-277
- Status last verified
- Oct 2018
- First submitted
- 11 Sep 2006
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Trial of a Multifaceted Intervention to Improve Hand Hygiene Among Healthcare Workers
- ClinicalTrials.gov ID
- NCT00375037
- Acronym / sponsor ID
- 05-277
- Conditions
- Handwashing, Infection
- Keywords
- hand washing, cluster randomized trial, performance feedback, healthcare workers, Hand hygiene, hand washing adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Sep 2006 (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.
This randomized controlled trial will evaluate the effect of a multifaceted intervention including performance feedback on adherence to hand hygiene among healthcare workers. A key component of the study is to demonstrate whether improved adherence to hand hygiene leads to a reduction in rates of infection.
Detailed description
A cluster randomized controlled trial of the intervention will be conducted where hospital units (wards) in three hospitals will be allocated to either the intervention or usual practise. We will stratify by hospital site in order to minimize confounding by hospital-level factors. The unit of allocation, intervention, and analysis will be at the level of the hospital unit. Thirty hospital units will be randomized to either the intervention or comparison arm. We will compare adherence to hand hygiene, MRSA rates, and other outcomes between the two study arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand hygiene | Experimental | Behavioral: feedback, Behavioral: EducationHand hygiene promotion |
| Usual care | Active comparator | Other: usual careusual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Healthcare workers
- Inclusion: any hospital staff with direct patient care who are affiliated with a single unit (includes registered nurses, nursing assistants, environmental aides, allied health professionals (occupational, physical, and respiratory therapists), and some physicians
- Patients Clinical outcomes will be measured in patients on study units.
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 |
|---|---|---|
| feedback | Behavioural | Hand hygiene |
| Education | Behavioural | Hand hygiene |
| usual care | Other | Usual care |
Primary outcome
Incidence of MRSA
Time frame: 12 months
Adherence to hand hygiene
Time frame: 12 months
3 secondary outcomes
Incidence of multi-resistant bacteria other than MRSA
Time frame: 12 months
Catheter-related blood stream infections
Time frame: 12 months
Clostridium difficile related diarrhea
Time frame: 12 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 26 Oct 2018.
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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.
Mark B Loeb, MD, MSc principal investigator
Hamilton Health Sciences- McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing feedback and Education in people with Handwashing and Infection, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
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 0 inclusion and 3 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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Incidence of MRSA (time frame: 12 months). The study lists 2 primary outcomes in all. 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 26 Oct 2018.