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Clinical Trials/NCT02223455
NCT02223455
Completed
Not Applicable

Building an Optimal Hand Hygiene Bundle: A Mixed Methods Approach

VA Office of Research and Development10 sites in 1 country58 target enrollmentOctober 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hand Hygiene
Sponsor
VA Office of Research and Development
Enrollment
58
Locations
10
Primary Endpoint
Hand Hygiene Compliance
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2014
End Date
March 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hand Hygiene Compliance

Time Frame: 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.

Study Sites (10)

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