Infection ControlEarly 2RISNCT03075813
Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts: The Early 2RIS Study
A study testing Intervention Cluster in people with Infection Control and Surgical Site Infection, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection Control, Surgical Site Infection
- What is being tested?
- Intervention Cluster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
Official title: Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts
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.
Read more
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.
- Conditions
- Infection Control, Surgical Site Infection
- Being tested
- Intervention Cluster
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ClusterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Cluster | Experimental | 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. Receives: Other: Intervention Cluster |
| Control Cluster | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in rates of SSI.
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.
Measured: SSIs can be diagnosed up 30 to 90 days following the procedure, depending on the type of procedure
Secondary outcomes (9)
Proportion of SSIs determined to be potentially preventable
Among SSIs investigated, each will be provided a "preventability score" after reviewing if best practices were followed.
Measured: diagnosed up 30 to 90 days following the procedure, depending on the type of procedure
Description of and difference in number and type of signals
Signals identified using optimized SPC will be compared to signals identified using standard surveillance; Not a patient-specific outcome
Measured: 36 months (entire study period)
Difference in number of outbreaks identified
Outbreaks identified using optimized SPC will be compared to outbreaks identified using standard surveillance; Not a patient-specific outcome
Measured: 36 months (entire study period)
Difference in number of investigations of increased rates of SSI
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
Measured: 36 months (entire study period)
Total number and differences in proportion of signals that led to investigations
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
Measured: 36 months (entire study period)
Time required to investigate signals
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
Measured: 36 months (entire study period)
Timing of signals
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
Measured: 36 months (entire study period)
Time to completion of investigation
Investigators will determine the time required to complete investigations
Measured: 36 months (entire study period)
Strength and type of signals
Investigators will compare the strength and types of signals generated from each type of surveillance with subsequent adjudication and intervention.
Measured: 36 months (entire study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start6 Mar 2017
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection ControlStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Deverick Anderson, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075813
- Sponsor's protocol ID
- Pro00081013
- Acronym
- Early 2RIS
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baker AW, Ilies I, Benneyan JC, Lokhnygina Y, Foy KR, Lewis SS, Wood B, Baker E, Crane L, Crawford KL, Cromer AL, Padgette P, Roach L, Adcock L, Nehls N, Salem J, Bratzler D, Dellinger EP, Greene LR, Huang SS, Mantyh CR, Anderson DJ. Early recognition and response to increases in surgical site infections using optimised statistical process control charts-The early 2RIS trial: A multicentre stepped wedge cluster randomised controlled trial. EClinicalMedicine. 2022 Oct 17;54:101698. doi: 10.1016/j.eclinm.2022.101698. eCollection 2022 Dec.
PubMed 36277312Anderson DJ, Ilies I, Foy K, Nehls N, Benneyan JC, Lokhnygina Y, Baker AW. Early recognition and response to increases in surgical site infections using optimized statistical process control charts-the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design. Trials. 2020 Oct 28;21(1):894. doi: 10.1186/s13063-020-04802-4.
PubMed 33115527
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts
- ClinicalTrials.gov ID
- NCT03075813
- Acronym / sponsor ID
- Early 2RIS / Pro00081013
- Conditions
- Infection Control, Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Cluster | Experimental | Other: Intervention ClusterSurgical 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. |
| Control Cluster | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ClusterSurgical 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. | Other | Intervention Cluster |
Primary outcome
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.
9 secondary outcomes
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
Description of and difference in number and type of signals
Time frame: 36 months (entire study period)
Difference in number of outbreaks identified
Time frame: 36 months (entire study period)
Difference in number of investigations of increased rates of SSI
Time frame: 36 months (entire study period)
Total number and differences in proportion of signals that led to investigations
Time frame: 36 months (entire study period)
Time required to investigate signals
Time frame: 36 months (entire study period)
Timing of signals
Time frame: 36 months (entire study period)
Time to completion of investigation
Time frame: 36 months (entire study period)
Strength and type of signals
Time frame: 36 months (entire study period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Derived from this study: PubMed 36277312Baker AW, Ilies I, Benneyan JC, Lokhnygina Y, Foy KR, Lewis SS, Wood B, Baker E, Crane L, Crawford KL, Cromer AL, Padgette P, Roach L, Adcock L, Nehls N, Salem J, Bratzler D, Dellinger EP, Greene LR, Huang SS, Mantyh CR, Anderson DJ. Early recognition and response to increases in surgical site infections using optimised statistical process control charts-The early 2RIS trial: A multicentre stepped wedge cluster randomised controlled trial. EClinicalMedicine. 2022 Oct 17;54:101698. doi: 10.1016/j.eclinm.2022.101698. eCollection 2022 Dec.
- Derived from this study: PubMed 33115527Anderson DJ, Ilies I, Foy K, Nehls N, Benneyan JC, Lokhnygina Y, Baker AW. Early recognition and response to increases in surgical site infections using optimized statistical process control charts-the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design. Trials. 2020 Oct 28;21(1):894. doi: 10.1186/s13063-020-04802-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deverick Anderson, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Cluster in people with Infection Control and Surgical Site Infection, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075813, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.