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| Name | Class |
|---|---|
| Sage Products, Inc. | INDUSTRY |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard practice | No Intervention | Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers) | |
| Personal hand hygiene device | Experimental | Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system [(SAGE Products Inc., Cary, Il),](streamdown:incomplete-link) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sage Personal Hand Hygiene System | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30-day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Re-admission Rates | Readmission to the hospital within 30 days of discharge | Within 30 days of discharge |
| Mortality | Patient Mortality |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During active OR cases |
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:
Pediatric patients
Lack of an intravenous catheter
Pregnant
A surgical procedure outside of the classes listed above
Adjustments on the day of surgery given the following considerations:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen O Heard, MD | UMass Memorial Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19352154 | Background | 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. | |
| 18719437 | Background | 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. |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Practice | Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers) |
| FG001 | 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.](streamdown:incomplete-link) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline characteristics are the patients who were seen in the operating rooms. Clinicians were not enrolled in the study and baseline data was not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Practice | Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers) |
| BG001 | 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.](streamdown:incomplete-link) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 30-day after surgery |
|
30 days postoperative
Adverse events related to the study outcome measures (Health-care-associated infections) were collected for patients only. AE's were not collected for clinicians.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Practice | Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew D. Koff, MD Staff Physician, Anesthesiology | Dartmouth-Hitchcock Medical Center | (603) 650-5922 | Matthew.D.Koff@hitchcock.org |
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| Within 30 Days of discharge |
| Hospital Duration | Duration of Hospital Stay | 30 days after surgery |
| Dartmouth-Hitchcock Medical Center |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| 27267310 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Hospital Re-admission Rates | Readmission to the hospital within 30 days of discharge | Data was not collected. | Posted | Within 30 days of discharge |
|
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| Secondary | Mortality | Patient Mortality | Posted | Count of Participants | Participants | Within 30 Days of discharge |
|
|
|
| Secondary | Hospital Duration | Duration of Hospital Stay | Data was not collected | Posted | 30 days after surgery |
|
|
| 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. | A control arm was not tabulated as the control group did not utilize the study device. | Posted | Mean | Standard Deviation | hand decontamination event per hour | During active OR cases |
|
|
|
| 6 |
| 1,620 |
| 0 |
| 1,620 |
| 0 |
| 1,620 |
| EG001 | 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.](streamdown:incomplete-link) | 7 | 1,636 | 0 | 1,636 | 0 | 1,636 |
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