Building an Optimal Hand Hygiene Bundle

Not Applicable

Completed

• Conditions: Compliance; Hand Hygiene; Health Care Associated Infection
• Interventions: Other: Hand Hygiene Signs

• Registration Number: NCT02223455
• Lead Sponsor: VA Office of Research and Development

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:

1. 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.

2. 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 Timeline

• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-22
• Study Start: 2014-10-01
• Primary Completion: 2016-08-01
• Study Completion: 2019-03-01
• Results First Submitted: 2019-07-19
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-11
• Last Update Submitted: 2019-09-11
• Results First Posted: 2019-10-04
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

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Exclusion Criteria

None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Hand Hygiene Signs Changed Weekly	Hand Hygiene Signs	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.
Single Hand Hygiene Sign	Hand Hygiene Signs	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 Changed Monthly	Hand Hygiene Signs	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.

Primary Outcome Measures

Name	Time	Method
Hand Hygiene Compliance	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.

Trial Locations

Locations (10)

Miami VA Healthcare System, Miami, FL; 🇺🇸 Miami, Florida, United States

Iowa City VA Health Care System, Iowa City, IA; 🇺🇸 Iowa City, Iowa, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE; 🇺🇸 Omaha, Nebraska, United States

South Texas Health Care System, San Antonio, TX; 🇺🇸 San Antonio, Texas, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States

VA Salt Lake City Health Care System, Salt Lake City, UT; 🇺🇸 Salt Lake City, Utah, United States

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States