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Building an Optimal Hand Hygiene Bundle

Primary Purpose

Hand Hygiene, Health Care Associated Infection, Compliance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand Hygiene Signs
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand Hygiene focused on measuring Methicillin-resistant Staphylococcus aureus (MRSA), Infection Control (IC), Hospital-associated infections (HAI), Hand Hygiene (HH), Compliance, Health Care Workers (HCWs)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on these wards/units

Exclusion Criteria:

None

Sites / Locations

  • Miami VA Healthcare System, Miami, FL
  • Iowa City VA Health Care System, Iowa City, IA
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Minneapolis VA Health Care System, Minneapolis, MN
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
  • VA Portland Health Care System, Portland, OR
  • South Texas Health Care System, San Antonio, TX
  • VA Salt Lake City Health Care System, Salt Lake City, UT

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Single Hand Hygiene Sign

Hand Hygiene Signs Changed Monthly

Hand Hygiene Signs Changed Weekly

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 20, 2014
Last Updated
September 11, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02223455
Brief Title
Building an Optimal Hand Hygiene Bundle
Official Title
Building an Optimal Hand Hygiene Bundle: A Mixed Methods Approach
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
August 1, 2016 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Hand Hygiene Sign
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Hand Hygiene Signs Changed Monthly
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hand Hygiene Signs Changed Weekly
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hand Hygiene Signs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hand Hygiene Compliance
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on these wards/units Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather S Reisinger, PhD
Organizational Affiliation
Iowa City VA Health Care System, Iowa City, IA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105-1873
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
As requested
IPD Sharing Time Frame
August 2020 for 7 years
IPD Sharing Access Criteria
IRB and VA Research and Development approval of protocol for sharing
Citations:
PubMed Identifier
31642930
Citation
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.
Results Reference
derived

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Building an Optimal Hand Hygiene Bundle

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