Complication of Surgical Procedure
Conditions
Keywords
Hand hygiene, Hospital acquired infections (HAI), Healthcare acquired infections (HCAI)
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).
Interventions
DEVICESage 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.
Sponsors
Sage Products, Inc.
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Healthcare Acquired Infections | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Re-admission Rates | Within 30 days of discharge | Readmission to the hospital within 30 days of discharge |
| Mortality | Within 30 Days of discharge | Patient Mortality |
| Hospital Duration | 30 days after surgery | Duration of Hospital Stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hand Hygiene Events Per Hour Utilizing the Device | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
The randomization unit was the operating room (OR); not the patient or provider. Clinicians were educated on the purpose of the study and utilized standard practice or hand hygiene device based on the ORs. 316 clinicians utilizing the personal hand hygiene device were followed for assessment, but not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Standard Practice Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers) | 1,620 |
| Personal Hand Hygiene Device Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),
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. | 1,636 |
| Total | 3,256 |
Baseline characteristics
| Characteristic | Standard Practice | Personal Hand Hygiene Device | Total |
|---|---|---|---|
| Age, Continuous | 57.29 years STANDARD_DEVIATION 16.4 | 56.75 years STANDARD_DEVIATION 16.6 | 57.02 years STANDARD_DEVIATION 16.5 |
| Region of Enrollment United States | 1620 participants | 1636 participants | 3256 participants |
| Sex: Female, Male Female | 814 Participants | 785 Participants | 1599 Participants |
| Sex: Female, Male Male | 806 Participants | 851 Participants | 1657 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 1,620 | 7 / 1,636 |
| other Total, other adverse events | 0 / 1,620 | 0 / 1,636 |
| serious Total, serious adverse events | 0 / 1,620 | 0 / 1,636 |
Outcome results
Primary
Number of Participants With Postoperative Healthcare Acquired Infections
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: 30-day after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Practice | Number of Participants With Postoperative Healthcare Acquired Infections | 108 Participants |
| Personal Hand Hygiene Device | Number of Participants With Postoperative Healthcare Acquired Infections | 116 Participants |
95% CI: [0.82, 1.4]fixed effects univariable analysis
Secondary
Hospital Duration
Duration of Hospital Stay
Time frame: 30 days after surgery
Population: Data was not collected
Secondary
Hospital Re-admission Rates
Readmission to the hospital within 30 days of discharge
Time frame: Within 30 days of discharge
Population: Data was not collected.
Secondary
Mortality
Patient Mortality
Time frame: Within 30 Days of discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Practice | Mortality | 6 Participants |
| Personal Hand Hygiene Device | Mortality | 7 Participants |
Other Pre-specified
Hand Hygiene Events Per Hour Utilizing the Device
The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.
Time frame: During active OR cases
Population: A control arm was not tabulated as the control group did not utilize the study device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Practice | Hand Hygiene Events Per Hour Utilizing the Device | 4.3 hand decontamination event per hour | Standard Deviation 2.9 |