Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts: The Early 2RIS Study (Early 2RIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075813
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Duke University

Brief Summary:

The purpose of this quality improvement study is to measure the effectiveness of surveillance using optimized statistical process control (SPC) methods and feedback on rates of surgical site infection (SSI) compared to traditional surveillance and feedback.

The primary objective is to determine if hospital clusters randomized to receive feedback from optimized SPC surveillance methods collectively have lower rates of SSI compared to hospital clusters randomized to receiving feedback from traditional surveillance methods. Secondary objectives are 1) to estimate and compare the number of signals identified using optimized SPC methods and traditional surveillance methods; 2) to estimate and compare the time and effort required to investigate signals generated using optimized SPC methods and traditional surveillance methods; and 3) to estimate the number and proportion of false-positive signals identified using optimized SPC methods and traditional surveillance methods.

The Early 2RIS study will be a prospective, multicenter cluster randomized controlled trial using stepped wedge design. The active component of the quality improvement study will be performed in 29 DICON hospitals over three years, from March 2017 through February 2020. Clusters randomized to intervention will receive feedback on increasing rates of SSI identified through optimized SPC methods. This intervention is expected to decrease the subsequent rate of SSIs by closing the feedback loop on SSI outcomes.

Participating study hospitals will all be members of DICON, a network of 43 community hospitals in North Carolina, South Carolina, Georgia, Florida, and Virginia that provides community hospitals access to consultative services from infection prevention experts, data analyses and benchmarking, and educational materials designed by faculty from Duke. This study is considered part of routine quality improvement measures and a part of previously established agreements between DICON and the community hospitals. Data flow and communication are outlined in detail in approved protocols determined to be exempt research by the DUHS IRB. Briefly, existing clinical data are extracted from participating hospitals' electronic medical record into discrete files according to DICON specifications. Then a de-identification process removes direct patient identifiers into a limited dataset.

The majority of data collection will occur through methods already developed and utilized by study hospitals. In brief, each hospital routinely submits limited datasets to the DICON Surgical Surveillance Database, including the following variables: hospital, type of procedure, patient identifier, date of procedure, age, sex, surgeon identifier, start/stop times, ASA score, wound class, risk index, SSI (Yes/No), date of infection, type of SSI, location at diagnosis and organism. No identifiable patient or surgeon data are transmitted to the DICON Surgical Database. Data definitions and data collection methods are standardized across DICON hospitals. Following signal adjudication, additional data will be collected in a REDCap database to document actions and rationale.


Condition or disease Intervention/treatment Phase
Infection Control Surgical Site Infection Other: Intervention Cluster Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

Arm Intervention/treatment
Experimental: Intervention Cluster

Surgical surveillance data submitted to the DICON Surgical Database will undergo immediate analysis by optimized SPC methods. If a signal is generated, study personnel in DICON will be notified to adjudicate the signal and determine if further action is required.

Optimized SPC methods include the application of two SPC charts. The investigator determined that when either chart identifies a signal, the study will have approximately 90% sensitivity and 65% specificity to identify important increases in rates of SSI.

Other: Intervention Cluster
Surgical surveillance date will be analyzed by optimized SPC methods. if signal is generated, study personnel in DICON will be notified to adjudicate the signal and determine if further action is needed.

No Intervention: Control Cluster
Local personnel in clusters randomized to traditional surveillance and feedback will receive bar graph reports and data interpretation per routine DICON surveillance. These reports will be provided every 6 months.



Primary Outcome Measures :
  1. Differences in rates of SSI. [ Time Frame: SSIs can be diagnosed up 30 to 90 days following the procedure, depending on the type of procedure ]

    SSI rate will be calculated as number of SSI/100 procedures per month

    SSIs will be defined using standard NHSN definitions

    DICON personnel train local infection preventionists about how to use and interpret SSI definitions. Thus, standard definitions and methods are used at all study hospitals.

    Cluster-level risk adjustment will be performed using median surgical volume and median NHSN Risk Index (an operation- and patient-specific risk score that predicts SSI) per cluster.



Secondary Outcome Measures :
  1. Proportion of SSIs determined to be potentially preventable [ Time Frame: diagnosed up 30 to 90 days following the procedure, depending on the type of procedure ]
    Among SSIs investigated, each will be provided a "preventability score" after reviewing if best practices were followed.

  2. Description of and difference in number and type of signals [ Time Frame: 36 months (entire study period) ]
    Signals identified using optimized SPC will be compared to signals identified using standard surveillance; Not a patient-specific outcome

  3. Difference in number of outbreaks identified [ Time Frame: 36 months (entire study period) ]
    Outbreaks identified using optimized SPC will be compared to outbreaks identified using standard surveillance; Not a patient-specific outcome

  4. Difference in number of investigations of increased rates of SSI [ Time Frame: 36 months (entire study period) ]
    Signals may or may not lead to subsequent investigation. Investigators will compare the number of investigations performed following the use of optimized SPC to the number of investigations performed following the use of standard surveillance; signals identified using standard surveillance; Not a patient-specific outcome

  5. Total number and differences in proportion of signals that led to investigations [ Time Frame: 36 months (entire study period) ]
    Signals may or may not lead to subsequent investigation. Investigators will compare the number of investigations performed following the use of optimized SPC to the number of investigations performed following the use of standard surveillance; signals identified using standard surveillance; Not a patient-specific outcome

  6. Time required to investigate signals [ Time Frame: 36 months (entire study period) ]
    Investigators will monitor the time required to investigate signals and compare the time required following the use of optimized SPC methods to the time required following the use of standard surveillance; not a patient-specific outcome

  7. Timing of signals [ Time Frame: 36 months (entire study period) ]
    Investigators will determine how promptly the different surveillance strategies identify signals and compare average/median time to signal between the two study arms; not a patient-specific outcome

  8. Time to completion of investigation [ Time Frame: 36 months (entire study period) ]
    Investigators will determine the time required to complete investigations

  9. Strength and type of signals [ Time Frame: 36 months (entire study period) ]
    Investigators will compare the strength and types of signals generated from each type of surveillance with subsequent adjudication and intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who undergo one of 13 targeted procedures in 29 DICON study hospitals will be eligible for inclusion. The 13 targeted procedures include coronary artery bypass graft, cardiac valve replacement, colon surgery, herniorrhapy, knee arthroplasty, hip arthroplasty, Cesarean section, abdominal hysterectomy, vaginal hysterectomy, spinal fusion, laminectomy, carotid endarterectomy, and peripheral venous bypass. These procedures were selected because they are frequently performed in community hospitals and/or are associated with particularly adverse outcomes if complicated by SSI. Eligible procedures will be categorized by procedure type at each hospital using ICD9 codes published by the NHSN, per routine DICON activities. Six clusters were constructed from these procedures to ensure that surgeons who perform similar types of procedures were grouped together to limit potential bias. These clusters are labeled as Spine, GI, OB/GYN, Ortho, Vascular, and Cardiac. These clusters are the units for randomization and analysis.

Exclusion Criteria:

  • DICON hospitals that did not submit a letter of support for participating in the study will be excluded. Patients not undergoing one of these 13 procedure types at the 29 study hospitals will be excluded from the analysis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075813


Locations
Layout table for location information
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Layout table for investigator information
Principal Investigator: Deverick Anderson, MD Duke University Health System
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03075813    
Other Study ID Numbers: Pro00081013
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes