NCT02223455

Building an Optimal Hand Hygiene Bundle

Completed NA Results posted Last updated 4 October 2019

What this trial tests

NA trial testing Hand Hygiene Signs in Hand Hygiene in 58 participants. Completed in 1 March 2019.

Timeline

1 October 2014

Primary endpoint
1 August 2016

1 March 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	58
Start date	1 October 2014
Primary completion	1 August 2016
Estimated completion	1 March 2019
Sites	10 locations across United States

Drugs / interventions tested

• Hand Hygiene Signs

Conditions studied

• Hand Hygiene — all drugs for Hand Hygiene →
• Health Care Associated Infection — all drugs for Health Care Associated Infection →
• Compliance — all drugs for Compliance →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Hand Hygiene or Health Care Associated Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hand Hygiene Compliance Primary · 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.

Room Entry

Group	Value	95% CI
Single Hand Hygiene Sign	-0.4	-20.5 – 23.0
Hand Hygiene Signs Changed Monthly	1.8	-21.5 – 29.7
Hand Hygiene Signs Changed Weekly	-1.3	-17.9 – 17.4

Room Exit

Group	Value	95% CI
Single Hand Hygiene Sign	-3.7	-16.4 – 10.2
Hand Hygiene Signs Changed Monthly	-5.2	-16.2 – 6.7
Hand Hygiene Signs Changed Weekly	1.8	-11.1 – 16.1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Frequency of Changing Point-of-Use Reminder Signs on Health Care Worker Hand Hygiene Adherence: A Cluster Randomized Clinical Trial.
   Vander Weg MW, Perencevich EN, O'Shea AMJ, Jones MP, et al · · 2019 · cited 7× · PMID 31642930 · DOI 10.1001/jamanetworkopen.2019.13823