Building an Optimal Hand Hygiene Bundle

VA Office of Research and Development

Status: Completed

Conditions: Compliance; Hand Hygiene; Health Care Associated Infection

Treatments: Other: Hand Hygiene Signs

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02223455

CRE 12-289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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58 participants in 3 patient groups, including a placebo group

Single Hand Hygiene Sign

Placebo Comparator group

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.

Treatment:

Other: Hand Hygiene Signs

Hand Hygiene Signs Changed Monthly

Active Comparator group

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.

Treatment:

Other: Hand Hygiene Signs

Hand Hygiene Signs Changed Weekly

Active Comparator group

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.

Treatment:

Other: Hand Hygiene Signs