Hand Hygiene Intervention Study

NCT01933087 | Completed

• 1 other identifier: MICRO1202
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Infections acquired by patients in hospitals are a major cause of illness and death worldwide, and particularly so in hospitals with very limited resources. Simple hygiene measures, including improved hand hygiene (particularly with increased use of alcohol-based hand rub) by healthcare workers (HCWs) in physical contact with patients, are thought to be amongst the most effective ways of reducing such infections. However, in most hospitals hand hygiene is practiced poorly and improving hand hygiene behavior amongst hospital staff has been found to be difficult. This study aims to evaluate the impact of a multimodal intervention to improve hand hygiene amongst health care workers in accordance with the WHO Guidelines on Hand Hygiene in Health Care. The research design is a prospective stepped wedged trial using all in-patient wards in a 1,000 bed hospital located in Northeast Thailand (Sappasitthiprasong hospital, Ubon Ratchatani). A stepped wedge design is a type of cluster randomized controlled trial which is appropriate when there are prior reasons to believe the intervention will be beneficial (as opposed to equipoise) and when it is impractical to deliver the intervention to all study units simultaneously. Both conditions hold here. The intervention will include educational visits to healthcare workers, improved reminders in the workplace, audit and feedback and social marketing with the aim of inducing behavioural and cultural change in relation to hand hygiene. The intervention will be delivered by the infection control team and the infection control ward nurses (ICWNs) who will receive additional training. The primary outcome will be directly observed hand hygiene compliance. Secondary outcomes will include incidence density of hospital-associated bloodstream and urinary tract infections with specified multiply antibiotic resistant bacteria, incidence density of hospital-associated bloodstream and urinary tract infections with non-multiply antibiotic resistant bacteria, total patient mortality rates, and ward-based consumption of alcohol hand rub and soap (a proxy for hand hygiene compliance). Results from this study will be immediately generalisable to other resource-constrained hospitals in Thailand. The research will also have much wider international significance as there have been very few methodologically sound evaluations of the impact of hand hygiene interventions in hospitals. Moreover, the findings will provide essential information for subsequent work on economic evaluations of infection control interventions to determine under what circumstances such interventions are likely to be cost-effective.

Conditions

Health Care Workers

Keywords

Hand hygiene,; Randonmised Controlled Trials,; Hospital

Outcome Measures

Primary Outcomes (1)

• Hand hygiene compliance amongst healthcare workers having direct patient contact.

  Directly observed hand hygiene compliance data will be collected during all three phases of the study by two observers. Each observer will directly observe healthcare worker compliance with the recommended five moments of hand hygiene in study wards, and a minimum of one hour's hand hygiene observation data will be collected from each ward during each week of the study. Observations will be in accordance with WHO recommendations and make use of the WHO's "5-movements" framework and the standard WHO hand hygiene compliance observation forms.

  16 months

Secondary Outcomes (1)

• Incidence of healthcare-associated bloodstream and urinary tract infections

  16 months

Other Outcomes (4)

• 28-day mortality following hospital admission

  16 months

• Ward-level consumption of alcohol hand-rub and soap per occupied bed day (an indirect measure o hand hygiene compliance)

  16 months

• Knowledge and beliefs of healthcare workers regarding hand hygiene

  16 months

Study Arms (2)

Control with no hand hygiene promotion

NO INTERVENTION

no implementation of hand hygiene promotion

Hand hygiene promotion

EXPERIMENTAL

Intervention to promote hand hygiene which is based on the WHO multimodal hand hygiene improvement strategy.

Behavioral: Hand hygiene promotion

Interventions

Hand hygiene promotion BEHAVIORAL

The intervention will adapt from the WHO Multimodal HH Improvement Strategy making use of five components: 1) system change (for example, changing systems to ensure that alcohol-based hand-rub is readily available wherever and whenever needed), 2) training and education, 3) observation and feedback, 4) reminders in the hospital, and 5) a hospital safety climate with the aim of inducing behavioural and cultural change in relation to reduce HCAI and improve HH. The intervention will be delivered to infection control ward nurses (ICWNs) of each ward at each time step by researcher and the infection control team (ICT).

Also known as: Hand hygiene intervention, WHO multimodal hand hygiene improvement strategy

Hand hygiene promotion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All HCWs, having direct patient contact, in all in-patient wards including Intensive Care Units (ICU) and non-ICUs.

You may not qualify if:

• HCWs who refuse to sign the informed consent to participate self-administered questionnaire will be excluded from the secondary outcome assessing knowledge and beliefs of HCWs.

Sponsors & Collaborators

• University of Oxford: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: December 24, 2013
• Primary Completion: May 2, 2015
• Study Completion: May 2, 2015
• Last Updated: October 20, 2020

Record last verified: 2020-10