Hand Hygiene and Hospital Acquired Infections

NCT ID: NCT02252562

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-08-31

Brief Summary

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).

Detailed Description

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).

Conditions

Complication of Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard practice

Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Personal hand hygiene device

Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),

Group Type: EXPERIMENTAL

Sage Personal Hand Hygiene System

Intervention Type: DEVICE

Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.

Interventions

Sage Personal Hand Hygiene System

Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Operating room environments involving adult patients undergoing general anesthesia, according to usual practice, for elective or urgent and emergent orthopedic, plastic, neurosurgical, cardiothoracic, urological, general abdominal, gynecological, vascular, or ear/nose/and throat surgical procedures

2. Requirement of a peripheral and/or central intravenous catheter

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

1. Pediatric patients

2. Lack of an intravenous catheter

3. Pregnant

4. A surgical procedure outside of the classes listed above

5. Adjustments on the day of surgery given the following considerations:

• Provider allergy/intolerance to 64% alcohol: In the case where the primary anesthesia provider conveys a prior allergy to 64% alcohol and/or a history of significant contact dermatitis, the operating room will be excluded from enrollment. If a primary anesthesia provider develops an allergy and/or contact dermatitis during the study period, this will be documented, and operating rooms assigned to the primary anesthesia provider for future cases will be excluded. The expectation will be that all key providers working in operating rooms randomized to the intervention will participate in utilization of the device. If an operating room is randomized and a provider subsequently refuses to participate for any reason, the operating room will be excluded from the primary analysis but included in an intention-to-treat analysis. An additional operating room will be randomized for each such occurrence.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sage Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Matthew Koff

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen O Heard, MD

Role: STUDY_CHAIR

UMass Memorial Health

Locations

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

References

Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.

Reference Type: BACKGROUND

PMID: 19352154 (View on PubMed)

Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855.

Reference Type: BACKGROUND

PMID: 18719437 (View on PubMed)

Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7.

Reference Type: RESULT

PMID: 27267310 (View on PubMed)

Other Identifiers

D13081

Identifier Type: -

Identifier Source: org_study_id