Hand Hygiene Intervention Study (HAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01933087
Recruitment Status : Unknown
Verified April 2016 by University of Oxford.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : April 28, 2016
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Health Care Workers Behavioral: Hand hygiene promotion Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Stepped Wedge Cluster Randomised Controlled Trial to Evaluate the Impact of a Multimodal Hand Hygiene Intervention at Sappasithiprasong Hospital, Ubon Ratchathani
Study Start Date : October 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control with no hand hygiene promotion
no implementation of hand hygiene promotion
Experimental: Hand hygiene promotion
Intervention to promote hand hygiene which is based on the WHO multimodal hand hygiene improvement strategy.
Behavioral: Hand hygiene promotion
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).
Other Names:
  • Hand hygiene intervention
  • WHO multimodal hand hygiene improvement strategy

Primary Outcome Measures :
  1. Hand hygiene compliance amongst healthcare workers having direct patient contact. [ Time Frame: 16 months ]
    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.

Secondary Outcome Measures :
  1. Incidence of healthcare-associated bloodstream and urinary tract infections [ Time Frame: 16 months ]
    Data from hospital records and from the microbiology laboratory will be used together to identify hospital acquired bacteraemias and urinary tract infections. These two routine data sets will be extracted by the hospital staff at three-monthly intervals. Hospital-acquired infections will be defined by standard criteria; for example, isolation of multi-drug resistant organisms from blood or sterile (urine) site culture taken more than 48 hours after admission. This study will not perform additional microbiology tests, but will make use of results from tests taken as part of routine hospital work.

Other Outcome Measures:
  1. 28-day mortality following hospital admission [ Time Frame: 16 months ]
    28 day mortality data will be collected following completion of phase 3 of the study by linking hospital records of hospital discharges with the national register of deaths.

  2. Ward-level consumption of alcohol hand-rub and soap per occupied bed day (an indirect measure o hand hygiene compliance) [ Time Frame: 16 months ]
    Ward-level consumption data of alcohol hand-rub and soap will be collected at weekly intervals from all study wards throughout the entire study period by the infection control ward nurses. These data will be entered on standard forms which will be returned to the infection control team and entered onto the study database.

  3. Knowledge and beliefs of healthcare workers regarding hand hygiene [ Time Frame: 16 months ]
    For the hospital wards selecting an educational programme as one of the multimodal interventions, the infection control team will administer a short questionnaire to determine staff knowledge, beliefs and attitudes one month before and one month after the intervention in each ward to all staff having direct patient contact including doctors, medical students, nurses, and workers in all participating wards.

  4. Resource used or costs related to the hand hygiene promotion. [ Time Frame: 16 months ]
    Costs of intervention will be assessed using standard forms developed by health economists to record time spent on developing and delivering the intervention, and time spent by other staff attending training. These forms will be completed by the ICT and a sample of the ICWNs. Cost changes in terms of staff time for performing hand hygiene will be estimated from the primary outcome data, and cost changes resulting from changes in number of infections will be estimated from secondary outcome data sources.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • There are no exclusion criteria for the primary outcome.
  • 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.

Responsible Party: University of Oxford Identifier: NCT01933087     History of Changes
Other Study ID Numbers: MICRO1202
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Oxford:
Hand hygiene,
Randonmised Controlled Trials,