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Building an Optimal Hand Hygiene Bundle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02223455
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Hand Hygiene
Health Care Associated Infection
Compliance
Intervention Other: Hand Hygiene Signs
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Hand Hygiene Sign Hand Hygiene Signs Changed Monthly Hand Hygiene Signs Changed Weekly
Hide Arm/Group Description

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.

Hand Hygiene Signs: 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.

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.

Hand Hygiene Signs: 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.

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.

Hand Hygiene Signs: 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.

Period Title: Overall Study
Number of participants Number of units (inpatient wards/units) Number of participants Number of units (inpatient wards/units) Number of participants Number of units (inpatient wards/units)
Started NA [1] 19 NA [1] 19 NA [1] 20
Completed NA [1] 19 NA [1] 19 NA [1] 20
Not Completed NA 0 NA 0 NA 0
[1]
Participant level data not collected.
Arm/Group Title Single Hand Hygiene Sign Hand Hygiene Signs Changed Monthly Hand Hygiene Signs Changed Weekly Total
Hide Arm/Group Description

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.

Hand Hygiene Signs: 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.

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.

Hand Hygiene Signs: 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.

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.

Hand Hygiene Signs: 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.

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0
Hide Baseline Analysis Population Description
This study is a cluster randomized control trial. Outcomes are measured by unit/ward not individual participant.
Age, Continuous   [1] 
Number Analyzed 0 participants 0 participants 0 participants 0 participants
[1]
Measure Description: We did not collect age at a participant level. Data are aggregated at the unit level.
Sex: Female, Male   [1] 
Number Analyzed 0 participants 0 participants 0 participants 0 participants
Female
Male
[1]
Measure Description: We did not collect sex at a participant level. Data are aggregated at the unit level
Region of Enrollment  
Unit of measure:  Ward/unit
United States Number Analyzed 0 participants 0 participants 0 participants 0 participants
1.Primary Outcome
Title Hand Hygiene Compliance
Hide Description 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.
Time Frame phase 1 (7-12 months) thru phase 3 (19-21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Entry and exit HH compliance were calculated for units in each treatment group. Crude (unadjusted) change in HH compliance from baseline to follow-up was assessed for each intervention group using Fisher’s exact test.
Arm/Group Title Single Hand Hygiene Sign Hand Hygiene Signs Changed Monthly Hand Hygiene Signs Changed Weekly
Hide Arm/Group Description:

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.

Hand Hygiene Compliance Signs: 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.

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 Compliance Signs: 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.

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.

Hand Hygiene Compliance Signs: 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.

Overall Number of Participants Analyzed NA NA NA
Overall Number of Units Analyzed
Type of Units Analyzed: Inpatient wards/units
19 19 20
Mean (95% Confidence Interval)
Unit of Measure: percentage of change in HH compliance
Room Entry
-0.4
(-20.5 to 23.0)
1.8
(-21.5 to 29.7)
-1.3
(-17.9 to 17.4)
Room Exit
-3.7
(-16.4 to 10.2)
-5.2
(-16.2 to 6.7)
1.8
(-11.1 to 16.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events were not collected because of the nature of the trial - no individual level data collected.
 
Arm/Group Title Single Hand Hygiene Sign Hand Hygiene Signs Changed Monthly Hand Hygiene Signs Changed Weekly
Hide Arm/Group Description

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.

Hand Hygiene Signs: 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.

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.

Hand Hygiene Signs: 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.

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.

Hand Hygiene Signs: 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.

All-Cause Mortality
Single Hand Hygiene Sign Hand Hygiene Signs Changed Monthly Hand Hygiene Signs Changed Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Serious Adverse Events
Single Hand Hygiene Sign Hand Hygiene Signs Changed Monthly Hand Hygiene Signs Changed Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Hand Hygiene Sign Hand Hygiene Signs Changed Monthly Hand Hygiene Signs Changed Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heather Reisinger
Organization: CADRE - Iowa City VAHCS
Phone: 319-338-0581 ext 7715
EMail: heather.reisinger@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02223455    
Other Study ID Numbers: CRE 12-289
First Submitted: August 20, 2014
First Posted: August 22, 2014
Results First Submitted: July 19, 2019
Results First Posted: October 4, 2019
Last Update Posted: October 4, 2019