Overview

This was a randomized, prospective study conducted at Dartmouth-Hitchcock Medical Center in New Hampshire and UMass Memorial Medical Center in Massachusetts. Approval was obtained at each study site from the respective institutional review boards for the protection of human subjects with a waiver for informed consent.

Study Recruitment Process

Operating room enrollment occurred from September 30, 2013, to June 17, 2014, at Dartmouth-Hitchcock Medical Center and from January 8, 2014, to August 21, 2014, at UMass Memorial Medical Center. Five to 10 operating rooms were enrolled Monday-Friday for each of 20 working days per month at each site. A computer program was utilized to generate a list of operating rooms randomly selected for observation and associated with their randomized assignment to treatment or control (study days were randomly assigned to treatment or control observations, and rooms were randomly selected for observation according to that treatment assignment from a computer generated list). Randomization assignments included usual intraoperative hand hygiene (standard wall-mounted devices and anesthesia machine and/or anesthesia cart–based dispensers) or a personalized, body-worn hand hygiene system (Sage Products; Online Supplementary Appendix 1) in addition to usual hand hygiene. In the intervention group, providers outside of the surgical field (certified-registered nurse anesthetists, resident and attending physician anesthesiologists, circulating nurses, and break providers or observers) were assigned a personalized body-worn dispenser that delivered an alcohol-based hand rub (64% ethanol, 1.03 g dispensed per depression, and 29 doses per cartridge). Three refills (1.25 oz/refill) were placed on the anesthesia cart before case start. Additional refills were available. In the control group, routine wall-mounted, cart-based, or machine-based devices were assessed to ensure that they were in proper condition and available for use. Providers were instructed to use the devices to wash their hands at every available opportunity.Reference Koff, Loftus and Burchman ⁶ Wall-mounted devices in both the treatment and control groups were electronically monitored (separately from the healthcare provider) when operational in order to assess overall frequency of use of conventional devices. Research assistants tracked and recorded changes in provider assignments. In some instances (see below) changes in provider assignments resulted in exclusion (Fig. 1).

FIGURE 1

Patient enrollment and exclusions in randomized clinical trial of a novel hand hygiene system.

Tracking Hand Hygiene Performance

Continuous wireless monitoring linked HDEs to device/provider identification numbers (IDs) during device exposure. Only events occurring in the patient care arena (operating room environment) were recorded. At least 20 seconds between decontamination events were required for an HDE to count towards the total HDE. This time lapse was chosen to prevent “gaming” of the system. This information was also utilized to generate daily performance feedback displayed on electronic monitors (Online Supplementary Appendix 2). Individual and group level performance was compared with a benchmark of 4–8 HDEs per hour, a goal set by work evaluating a similar device.Reference Koff, Loftus and Burchman ^{6 ,} Reference Koff, Corwin, Beach, Surgenor and Loftus ⁷ Overall group and individual performance (HDE) along with top performers were communicated via work-addressed email delivered after every 2 completed shifts (providers were given individual feedback regarding performance averaged over 2 device exposures, or work days) and then at quarterly intervals (individual and group performance feedback provided at this time) during the study period (Online Supplementary Appendix 2).

Device Management

Devices were distributed in the morning and collected and decontaminated (disinfectant wipes) at the end of each day. Every provider had an assigned device with a unique ID that was linked to all data, and this device was collected and reassigned to the same provider when enrolled at a later date. Devices were tracked to prevent contamination of control rooms with treatment devices.

Linking Hand Hygiene Performance to Patient Outcomes

Each patient in each operating room was assigned a unique barcode (case-log ID) that was linked to the provider hand hygiene IDs (hand hygiene database) and to all patient, procedural, and provider demographic information and outcomes (infection, hospital duration, and readmission) listed below in a separate database. All enrolled patients were followed up prospectively for 30 days as described below.

Inclusion Criteria

Operating rooms considered eligible for enrollment included at least 2 consecutive surgical cases for patients undergoing elective, urgent, or emergent orthopedic, plastic, neurosurgical, cardiothoracic, urologic, general abdominal, gynecologic, vascular, or ear/nose/throat procedures. Procedures could require general anesthesia or monitored anesthesia care with or without regional anesthetic approaches (epidural catheters and/or peripheral nerve blocks). Use of a peripheral and/or central intravenous catheter was required.

Exclusion Criteria

Pediatric or pregnant patients, lack of an intravascular catheter, or a surgical procedure outside of the classes listed above were considered reasons for exclusion. In addition, operating rooms where one or more primary providers (anesthesia attending if a solo anesthesia provider, anesthesia resident or certified-registered nurse anesthetist otherwise) were assigned to provide care in operating rooms with and without the hand hygiene system, adjacent operating rooms for example, were excluded from enrollment and another was randomly selected as described above. Operating rooms that involved primary providers with previously documented refusal or with an allergy/intolerance to alcohol were also excluded from enrollment. If a primary provider developed an allergy/intolerance during the study period, subsequent operating rooms involving those providers were excluded from enrollment. In operating rooms where one or more providers outside of the primary provider had a history of or developed a complication as above, the operating room and associated patients would still be enrolled, the intervention deployed, and the patients followed up prospectively. Excluded cases and the rationale for exclusion were tracked and recorded (Fig. 1).

Prospective HAI Assessment

Patient electronic medical records were screened by a research nurse at each site for the presence or absence of an elevated white blood cell count, fever, anti-infective order, office visit documenting signs of infection, and/or the acquisition of bacterial cultures for 30 days following the surgical procedure. A patient positive for one or more of these initial criteria underwent an extensive medical chart review by the principal investigator at each institution (masked to the treatment assignment) in order to determine whether the patient met criteria for the diagnosis of a HAI according to National Healthcare Safety Network definitions.Reference Edwards, Peterson and Mu ¹¹

Prospective Assessment of 30-Day Postoperative Hospital Duration and Readmission Rates

The length of hospital stay (days) was recorded and entered into a database (Access; Microsoft), linked to the randomization assignment and unique barcode. All readmissions (as documented in the electronic medical record) were identified and systematically recorded.

Demographic Information

Basic patient, procedure, and provider demographic information was collected for all patients including age, sex, American Society of Anesthesiology health classification status, comorbidities (cardiovascular, neurologic, pulmonary, renal, endocrine, infectious disease, hematologic, rheumatologic, gastrointestinal, other), urgency, >2 comorbidities, general abdominal surgery, dirty or infected site, duration 2 hours or longer, anesthesia duration, surgical duration, Study on the Efficacy of Nosocomial Infection ControlReference Haley, Quade, Freeman and Bennett ¹² score (an index predicting the probability of postoperative HAI development for a given patient), case order (eg, first case, second case, third case), procedure (orthopedic or cardiovascular), anesthesia type (general, monitored anesthesia care), more than 1 visit, patient origin (same day, hospital ward, the intensive care unit, or other), patient decolonization procedures (chlorhexidine bath or nasal mupirocin ointment), prophylactic antibiotic(s), and providers involved in care (attending and resident physicians, certified-registered nurse anesthetists, circulating nurses, other).

Data Handling

Basic information (eg, operating room, date of surgery, age, sex) was compiled on source documents and linked by unique barcodes to all demographic and outcome data in a database. The unique patient barcodes were linked by device/provider IDs to hand hygiene performance data in a separate database. Finally, patient identifiers such as medical record numbers and date of surgery were compiled in a separate binder and linked to demographic/outcome and hand hygiene databases via patient barcode and device IDs.

Data Analysis