- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02223455
Building an Optimal Hand Hygiene Bundle
Building an Optimal Hand Hygiene Bundle: A Mixed Methods Approach
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33125
- Miami VA Healthcare System, Miami, FL
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Iowa
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Iowa City, Iowa, United States, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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Maryland
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Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Massachusetts
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Michigan
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Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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Nebraska
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Omaha, Nebraska, United States, 68105-1873
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
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Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System, Portland, OR
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Texas
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San Antonio, Texas, United States, 78229
- South Texas Health Care System, San Antonio, TX
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Utah
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Salt Lake City, Utah, United States, 84148
- VA Salt Lake City Health Care System, Salt Lake City, UT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on these wards/units
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Single Hand Hygiene Sign
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.
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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.
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Active Comparator: Hand Hygiene Signs Changed Monthly
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.
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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.
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Active Comparator: Hand Hygiene Signs Changed Weekly
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand Hygiene Compliance
Time Frame: phase 1 (7-12 months) thru phase 3 (19-21 months)
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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.
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phase 1 (7-12 months) thru phase 3 (19-21 months)
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Collaborators and Investigators
Investigators
- Principal Investigator: Heather S Reisinger, PhD, Iowa City VA Health Care System, Iowa City, IA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE 12-289
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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