Sage Personal Hand Hygiene System
DeviceUtilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
NCT Number: NCT02252562
Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public health concerns that impact all areas of healthcare. Further work is needed to better understand these healthcare issues so that effective preventive measures can be developed.
The investigators have developed and validated an experimental model for studying the risk factors for bacterial cross contamination in the surgical operating room. The investigators have confirmed in our previous work that intraoperative bacterial transmission events occur frequently both within and between surgical cases and that these transmission events are linked to 30-day postoperative HCAIs and increased patient mortality.
In response, the investigators have implemented various strategies designed to bacterial transmission in the operating room, including anesthesia provider hand hygiene compliance. The investigators' recent work in the intensive care unit suggests that the hand hygiene system the investigators have previously studied could be further optimized.
The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene system enhanced with novel wireless technology designed to facilitate real-time group and individual performance feedback.
The investigators hypothesize that the use of this system will increase hourly hand decontamination events of anesthesia and circulating nurse providers and reduce 30-day postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay duration, and hospital re-admission rates, and mortality(secondary outcomes).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public health concerns that impact all healthcare arenas. Further work is indicated to better understand these healthcare issues in order that effective preventive measures can be developed.
The investigators have developed and validated an experimental model for studying the mechanisms, risk factors for, and implications of bacterial cross contamination in the surgical operating room. The investigators have confirmed through use of this model that intraoperative bacterial transmission events occur frequently within and between operative cases and that these transmission events are linked to 30-day postoperative HCAIs and to increased patient mortality. In response, the investigators have implemented and evaluated various strategies designed to target risk factors for intraoperative bacterial transmission events including anesthesia provider hand hygiene compliance, improved handling and design of intravascular catheters, and improved environmental decontamination of high-risk objects. While these focused strategies have been successful in reducing transmission events and the incidence of 30-day postoperative infections, the investigators' recent work in the intensive care unit suggests that the hand hygiene system the investigators studied could be further optimized. The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene system enhanced with novel wireless technology designed to facilitate real-time group and individual performance feedback, two evidence-based educational interventions, in reducing 30-day postoperative HCAIs (primary outcome) and intraoperative bacterial transmission events, hospital stay duration, and hospital re-admission rates (secondary outcomes).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Surgical inclusion procedures were selected because they captured the majority of 30-day postoperative infections in a prior multi-center study that we conducted across three major academic medical centers [3].
The investigators will [randomize by the day in order to ensure that the treatment and control arms maintain their integrity and to facilitate an environment conducive to behavior change.] The investigators anticipate that the randomization strategy will allow equal distribution of urgent and emergent patients in the treatment and control groups. Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions (see below). The investigators realize that decolonization procedures have the capacity to reduce the effect size, and as such, we have appropriately adjusted the sample size (see statistical section).
Exclusion criteria
Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
Time frame: 30-day after surgery
Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.
Time frame: Within 30 days of discharge
Readmission to the hospital within 30 days of discharge
Time frame: Within 30 Days of discharge
Patient Mortality
Time frame: 30 days after surgery
Duration of Hospital Stay
Time frame: During active OR cases
The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.
Dartmouth-Hitchcock Medical Center
Other
Reduction in 30-Day Postoperative Healthcare-Associated Infections Through Use of a Novel Hand Hygiene System
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