NCT03445676

Brief Summary

Although little is known about compliance with the World Health Organization (WHO) 5 Moments of hand hygiene, the few existing studies report a high number of opportunities and compliance ranging from just 22 to 60%. Previous studies have reported an increased density of opportunities, perceived insufficient time and glove use as factors associated with non-compliance. A healthcare worker performing multiple tasks in one encounter may spend up to half the time in the room doing hand hygiene. Strategies to reduce the time required for hand hygiene may in turn promote increased compliance and may ultimately be most effective in limiting microbial transmission. In this study, the investigators examine whether cleansing gloves at each hand hygiene opportunity at the point of care and reusing the same gloves is as effective as standard practice and the current recommendation (remove gloves, perform hand hygiene, and don new gloves).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

February 6, 2018

Last Update Submit

May 5, 2020

Conditions

Hand Hygiene

Keywords

Hand HygieneWHO 5-moments

Outcome Measures

Primary Outcomes (1)

  • Total bacteria colony forming units

    Total bacterial colony forming units cultured from gloved hands will be compared between the intervention and usual care group and between the intervention and ideal standard using a comparison of proportions.

    Through study completion,about 1 year

Secondary Outcomes (1)

  • Presence of pathogenic organisms

    Through study completion,about 1 year

Study Arms (3)

Usual Care

NO INTERVENTION

Study personnel silently observe and record what the healthcare worker does at each hand hygiene opportunity without direction to the healthcare worker

ABHR directly on gloves

EXPERIMENTAL

Healthcare worker will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity

Behavioral: ABHR directly on gloves

Ideal Standard

PLACEBO COMPARATOR

Healthcare worker will be directed by study personnel to remove gloves, perform hand hygiene and replace gloves at each hand hygiene opportunity

Behavioral: ABHR directly on gloves

Interventions

ABHR directly on glovesBEHAVIORAL

HCW will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity

ABHR directly on glovesIdeal Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare worker who directly interacts with patients on Contact Precautions

You may not qualify if:

  • Adults \<18 years of age
  • Care for patients with known C. difficile infection
  • No hand hygiene opportunities while at the point of care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Thom KA, Rock C, Robinson GL, Reisinger HRS, Baloh J, Chasco E, Liang Y, Li S, Diekema DJ, Herwaldt LA, Johnson JK, Harris AD, Perencevich EN. Alcohol-based decontamination of gloved hands: A randomized controlled trial. Infect Control Hosp Epidemiol. 2024 Apr;45(4):467-473. doi: 10.1017/ice.2023.243. Epub 2023 Nov 23.

    PMID: 37994538DERIVED

Study Officials

  • Kerri Thom, MD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 26, 2018

Study Start

March 15, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)