Hand HygieneNCT02223455
Building an Optimal Hand Hygiene Bundle
A study testing Hand Hygiene Signs in people with Hand Hygiene and Health Care Associated Infection, run by VA Office of Research and Development at 10 sites in United States.
Trial summary
Hand hygiene is the single most effective practice in preventing the spread of hospital-acquired infections. Despite the strength of the evidence, hospital staff continue to sanitize their hands less than half of the time required by guidelines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene, Health Care Associated Infection, Compliance
- What is being tested?
- Hand Hygiene Signs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Oct 2014to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on these wards/units
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1873
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: Building an Optimal Hand Hygiene Bundle: A Mixed Methods Approach
Hand hygiene is the single most effective practice in preventing the spread of hospital-acquired infections. Despite the strength of the evidence, hospital staff continue to sanitize their hands less than half of the time required by guidelines. Effective interventions are needed to improve hand hygiene compliance rates among hospital staff, but most are of poor quality and do not examine the specific effects of individual interventions. This study will build a "bundle" of three hand hygiene interventions using a research design that allows for the effectiveness of each intervention to be measured individually and combined.
Read the detailed description
The two specific aims and associated hypotheses of CREATE Project 2 include:
- Identify combinations of hand-hygiene intervention strategies that optimize hand-hygiene compliance and that could form an evidence-based hand-hygiene bundle for Veterans Health Administration (VHA) implementation. Hypothesis 1: Combinations of interventions will increase compliance rates more than single interventions. Aim 1 will entail a 30-month cluster-randomized controlled trial that will sequentially test three individual hand-hygiene interventions - hand-hygiene point-of-use reminder signs to serve as an environmental cue to action, individual hand sanitizers, and health care worker hand cultures - to identify an optimal combination of interventions to increase hand-hygiene compliance. The trial will be conducted in 59 hospital units in 10 VA hospitals in order to test the efficacy of individual and then sequentially added interventions to determine their incremental impact on hand-hygiene compliance. The focus for this clinical trial will be on Aim 1--Single Hand Hygiene Sign changes.
- Identify institutional, organizational, ward/ICU, and individual level facilitators and barriers to implementing hand-hygiene interventions.
Hypothesis 2: Facilitators and barriers will pattern around contextual factors such as level of leadership support and organization of infection control programs.
Aim 2 will entail a qualitative process evaluation that includes site visits to purposefully selected sites, semi-structured interviews, and observations to examine barriers and facilitators to the interventions and develop contextual insight for implementing and scaling-up the intervention at additional sites as a national initiative.
- Conditions
- Hand Hygiene, Health Care Associated Infection, Compliance
- Being tested
- Hand Hygiene Signs
- Keywords
- Methicillin-resistant Staphylococcus aureus (MRSA), Infection Control (IC), Hospital-associated infections (HAI), Hand Hygiene (HH), Compliance, Health Care Workers (HCWs)
- Medical subject headings
- Cross Infection, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Hygiene SignsOther
Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.
| Study group | Role | What they receive |
|---|---|---|
| Single Hand Hygiene Sign | Placebo comparator | Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change. Receives: Other: Hand Hygiene Signs |
| Hand Hygiene Signs Changed Monthly | Active comparator | Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room. Receives: Other: Hand Hygiene Signs |
| Hand Hygiene Signs Changed Weekly | Active comparator | Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room. Receives: Other: Hand Hygiene Signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Hygiene Compliance
Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research \& Development (HSR\&D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.
Measured: phase 1 (7-12 months) thru phase 3 (19-21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study start1 Oct 2014
- Primary completion1 Aug 2016
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Heather S Reisinger, PhD, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223455
- Sponsor's protocol ID
- CRE 12-289
- Status last verified
- Sep 2019
- First submitted
- 20 Aug 2014
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As requested
Publications
Vander Weg MW, Perencevich EN, O'Shea AMJ, Jones MP, Vaughan Sarrazin MS, Franciscus CL, Goedken CC, Baracco GJ, Bradley SF, Cadena J, Forrest GN, Gupta K, Morgan DJ, Rubin MA, Thurn J, Bittner MJ, Reisinger HS. Effect of Frequency of Changing Point-of-Use Reminder Signs on Health Care Worker Hand Hygiene Adherence: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1913823. doi: 10.1001/jamanetworkopen.2019.13823.
PubMed 31642930
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building an Optimal Hand Hygiene Bundle: A Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT02223455
- Acronym / sponsor ID
- CRE 12-289
- Conditions
- Hand Hygiene, Health Care Associated Infection, Compliance
- Keywords
- Methicillin-resistant Staphylococcus aureus (MRSA), Infection Control (IC), Hospital-associated infections (HAI), Hand Hygiene (HH), Compliance, Health Care Workers (HCWs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand hygiene is the single most effective practice in preventing the spread of hospital-acquired infections. Despite the strength of the evidence, hospital staff continue to sanitize their hands less than half of the time required by guidelines. Effective interventions are needed to improve hand hygiene compliance rates among hospital staff, but most are of poor quality and do not examine the specific effects of individual interventions. This study will build a "bundle" of three hand hygiene interventions using a research design that allows for the effectiveness of each intervention to be measured individually and combined.
Detailed description
The two specific aims and associated hypotheses of CREATE Project 2 include:
- Identify combinations of hand-hygiene intervention strategies that optimize hand-hygiene compliance and that could form an evidence-based hand-hygiene bundle for Veterans Health Administration (VHA) implementation. Hypothesis 1: Combinations of interventions will increase compliance rates more than single interventions. Aim 1 will entail a 30-month cluster-randomized controlled trial that will sequentially test three individual hand-hygiene interventions - hand-hygiene point-of-use reminder signs to serve as an environmental cue to action, individual hand sanitizers, and health care worker hand cultures - to identify an optimal combination of interventions to increase hand-hygiene compliance. The trial will be conducted in 59 hospital units in 10 VA hospitals in order to test the efficacy of individual and then sequentially added interventions to determine their incremental impact on hand-hygiene compliance. The focus for this clinical trial will be on Aim 1--Single Hand Hygiene Sign changes.
- Identify institutional, organizational, ward/ICU, and individual level facilitators and barriers to implementing hand-hygiene interventions.
Hypothesis 2: Facilitators and barriers will pattern around contextual factors such as level of leadership support and organization of infection control programs.
Aim 2 will entail a qualitative process evaluation that includes site visits to purposefully selected sites, semi-structured interviews, and observations to examine barriers and facilitators to the interventions and develop contextual insight for implementing and scaling-up the intervention at additional sites as a national initiative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Hand Hygiene Sign | Placebo comparator | Other: Hand Hygiene SignsWards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change. |
| Hand Hygiene Signs Changed Monthly | Active comparator | Other: Hand Hygiene SignsIntervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room. |
| Hand Hygiene Signs Changed Weekly | Active comparator | Other: Hand Hygiene SignsIntervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on these wards/units
Key exclusion criteria (1 listed)
- None
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 SignsHand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room. | Other | Hand Hygiene Signs Changed Monthly, Hand Hygiene Signs Changed Weekly, Single Hand Hygiene Sign |
Primary outcome
Hand Hygiene Compliance
Time frame: phase 1 (7-12 months) thru phase 3 (19-21 months)
Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research \& Development (HSR\&D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31642930Vander Weg MW, Perencevich EN, O'Shea AMJ, Jones MP, Vaughan Sarrazin MS, Franciscus CL, Goedken CC, Baracco GJ, Bradley SF, Cadena J, Forrest GN, Gupta K, Morgan DJ, Rubin MA, Thurn J, Bittner MJ, Reisinger HS. Effect of Frequency of Changing Point-of-Use Reminder Signs on Health Care Worker Hand Hygiene Adherence: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1913823. doi: 10.1001/jamanetworkopen.2019.13823.
- Individual participant dataSharing planned: Yes. As requested
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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.
Heather S Reisinger, PhD principal investigator
Iowa City VA Health Care System, Iowa City, IA
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Hygiene Signs in people with Hand Hygiene and Health Care Associated Infection, run by VA Office of Research and Development at 10 sites in United States.
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 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: phase 1 (7-12 months) thru phase 3 (19-21 months)). 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 NCT02223455, 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 4 Oct 2019.