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Implementation and Evaluations of Sepsis Watch

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: NCT03655626
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
Data & Society Research Institute
Duke Clinical Research Institute
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE November 5, 2018
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Rate of Centers for Medicare and Medicaid Services (CMS) bundle completion for patients with sepsis [ Time Frame: Within 96 hours of emergency department arrival ]
Proportion of patients with sepsis that complete Center for Medicare and Medicaid Services treatment bundle
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Mean time from ED arrival to sepsis for patients with sepsis [ Time Frame: Within 96 hours of emergency department arrival ]
    Mean time from to ED arrival to sepsis
  • Average number of patients who develop sepsis per day and month [ Time Frame: Within 96 hours of emergency department arrival ]
    Number of patients daily who meet sepsis phenotype
  • Average number of patients who develop sepsis and are not treated per day and month [ Time Frame: Within 96 hours of emergency department arrival ]
    Number of patients daily who meet sepsis phenotype who are not treated for sepsis
  • Mean ED length of stay for patients with sepsis [ Time Frame: Within 96 hours of emergency department arrival ]
    Emergency department length of stay for patients with sepsis
  • Mean Hospital length of stay for patients with sepsis [ Time Frame: Within 30 days of emergency department arrival ]
    Hospital length of stay for patients with sepsis
  • Mean Inpatient mortality for patients with sepsis [ Time Frame: Within 30 days of emergency department arrival ]
    Inpatient mortality for patients with sepsis
  • Mean ICU requirement rate for patients with sepsis [ Time Frame: Within 30 days of emergency department arrival ]
    Intensive care unit requirement rate for patients with sepsis
  • Mean time from sepsis onset to blood culture [ Time Frame: Within 96 hours of emergency department arrival ]
    Time of sepsis to blood culture order and collection for patients with sepsis
  • Mean time from sepsis onset to antibiotics [ Time Frame: Within 96 hours of emergency department arrival ]
    Time of sepsis to antibiotic order and administration for patients with sepsis
  • Mean time from sepsis onset to IV fluids [ Time Frame: Within 96 hours of emergency department arrival ]
    Time of sepsis to IV fluids order and administration for patients with sepsis
  • Mean time from sepsis onset to lactate [ Time Frame: Within 96 hours of emergency department arrival ]
    Time of sepsis to lactate collection for patients with sepsis
  • Mean time from sepsis onset to CMS bundle completion [ Time Frame: Within 96 hours of emergency department arrival ]
    Time of sepsis to CMS bundle completion for patients with sepsis
  • Rate of lactate complete for patients with sepsis [ Time Frame: Within 96 hours of emergency department arrival ]
    Proportion of lactate drawn within 3 hours and potentially re-drawn within 6 hours of sepsis for patients with sepsis
  • Number of sepsis diagnosis codes across Duke University Hospital patients per month [ Time Frame: Within 30 days of emergency department arrival ]
    Number of billing diagnosis codes for sepsis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 30, 2018)
  • Number of antibiotic orders in Duke University Hospital emergency department per month [ Time Frame: Within 96 hours of emergency department arrival ]
    Number of antibiotic orders in Duke University Hospital emergency department per month
  • Number of antibiotic days in Duke University Hospital emergency department per month [ Time Frame: Within 96 hours of emergency department arrival ]
    Number of antibiotic days
  • Number of blood culture orders in Duke University Hospital emergency department per month [ Time Frame: Within 96 hours of emergency department arrival ]
    Total blood culture orders
  • Number of lactate orders in Duke University Hospital emergency department per month [ Time Frame: Within 96 hours of emergency department arrival ]
    Total lactate orders
  • Number of IV fluid orders in Duke University Hospital emergency department per month [ Time Frame: Within 96 hours of emergency department arrival ]
    Total IV fluid orders
  • Number of vasopressor orders in Duke University Hospital emergency department per month [ Time Frame: Within 96 hours of emergency department arrival ]
    Total vasopressor orders
  • Number of vasopressor days in Duke University Hospital emergency department per month [ Time Frame: Within 96 hours of emergency department arrival ]
    Number of vasopressor days
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Implementation and Evaluations of Sepsis Watch
Official Title  ICMJE Implementation and Evaluations of Previously Developed Novel Early Warning System to Detect and Treat Sepsis
Brief Summary The purpose of this study is to study the implementation and impact of an early warning system to detect and treat sepsis in the emergency room. We are observing the implementation of a Sepsis Machine Learning Model on all Adult patients. All data (observations field notes, interview recording & transcripts, and survey responses) will be stored on HIPAA-compliant Duke servers behind the Duke firewall, and requiring password-protected user authentication to access. The risk to patients is minimal. The two risks to interviewed clinical staff we have identified involve loss of work time and anonymity.
Detailed Description

Sepsis represents a significant burden to the healthcare system. National predictions estimate 751,000 cases of severe sepsis per annum which will increase at a rate of 1.5%. Sepsis accounts for >$23 billion in aggregate hospital costs across all payers and represents nearly 4% of all hospital stays. Six percent of all deaths in the US can be attributed to sepsis. Protocol driven care bundles improve clinical outcomes but require early and accurate detection of sepsis. Unfortunately, identifying sepsis early remains elusive even for experienced clinicians leading to diagnostic uncertainty.

To improve diagnostic consensus, a task force in 2016 agreed upon a new sepsis definition. The task force also included a new risk stratification tool to improve early identification, the quick Sepsis-related Organ Failure Assessment (qSOFA) model, which was more accurate than the older Systemic Inflammatory Response Syndrome (SIRS) in predicting adverse clinical outcomes. However, due to the reliance of end organ dysfunction, the new definition has been criticized for its detection of sepsis late in the clinical course. Clinical decision support tools based on predictive analytics can provide actionable information and improve diagnostic accuracy particularly in sepsis.

Several early warning tools have been described in the published literature based upon predictive analytics and large datasets. One example is the National Early Warning Score (NEWS), which was developed to discriminate patients at risk of cardiac arrest, unplanned intensive care admission, or death. Scores such as NEWS are typically broad in scope and not designed to specifically target sepsis. They are also conceptually simple, as they use only a small number of variables and compare them to normal ranges to generate a composite score. In assigning independent scores to each variable and using only the most recent value, they both ignore complex relationships between the variables and their evolution in time.

In previous work, our group developed a framework to model multivariate time series using multitask Gaussian processes, accounting for the high uncertainty, frequent missing values, and irregular sampling rates typically associated with real clinical data can be read in our prior work. Our machine learning approach is superior to other sepsis detection models that use traditional analytics and machine learning techniques. A custom web application, Sepsis Watch, presents the risk score along with relevant patient information and prompts the user to further evaluate the patient and begin treatment, if appropriate. The Sepsis Watch system is now being implemented by clinical operations at Duke University Hospital.

Our study employs a sequential roll-out study design in the Emergency Department at Duke University Hospital. Our study will involve pods A, B, C, and the Resuscitation Bay. The operational project is not being implemented on the psychiatry wing, fast track, triage or any inpatient encounters. The operational project and thus our study period is based upon a two-phase roll out:

  • 1st phase: The predictive model notifies the rapid response team through a dashboard. Nurse notifies team of the risk for sepsis and provides treatment recommendation to primary team and primary team will place orders. Rapid response team nurse documents assessment and actions taken in electronic health record.
  • 2nd phase: Improvement and optimization of the workflow integrated in phase 1. One workflow improvement includes the development of an ordering protocol and process whereby the rapid response team can place orders for patients who are deemed appropriate for sepsis treatment. A second workflow improvement includes the development of a clinician feedback and auditing report that would be sent to front-line staff with sepsis bundle compliance performance measures.

In addition to observing patient outcome measures, we propose an additional mixed-methods study component to obtain richer information about the effects of the early warning system on clinicians' situational awareness, decision-making, and workflow. This part of our research will involve (1) gathering data from clinicians through a series of semi-structured interviews, surveys, and observations (2) analysis of this data and identification of relevant patterns and insights. Relevant clinicians include include rapid response team nurses, emergency department (ED) nurses, and ED physicians. These interviews will be conducted in three rounds over the implementation period: before the 1st arm, after the 1st arm, and after the 2nd arm. Electronic surveys will be administered at the end of the 1st arm and the 2nd arm to clinicians. The observations will take place during the 1st and 2nd arms.

The goal of the interviews, surveys, and observations will be to (1) evaluate the effect of the early warning system on the clinicians' situational awareness and decision-making, (2) understand how the early warning system fits into clinician workflow, and, (3) identify opportunities to improve the implementation of the early warning system for future scale-up.

We will be structuring interviews according to the situational awareness model which differentiates between 3 levels of situational awareness: 1) perception of relevant information, 2) comprehension of that information, and 3) anticipation of future events based on that information. Through the interviews, observations, and surveys, we also hope to learn more about clinicians' perceptions of and interactions with the early warning system, and its change on the existing Emergency Department workflow for sepsis diagnosis and management. Data analysis will be conducted with the help of trained qualitative researchers from Data & Society, a research institute in New York City that is focused on the social and cultural issues arising from data-centric technological development.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sepsis
  • Severe Sepsis
  • Septic Shock
Intervention  ICMJE Other: Sepsis Watch
The operational intervention comprises of a sepsis machine learning model, custom dashboard to present risk scores, and a rapid response team to monitor patients at-risk of sepsis and deliver sepsis treatment. Sepsis Watch was developed under operational management. The rapid response team will utilize information presented on the dashboard and follow a protocol that will enable them to support the primary teams of hospitalized patients.
Study Arms  ICMJE Experimental: Sepsis Watch on Duke University Hospital ED Adults
Patients older than 18 years old at time of presentation to Duke University Hospital emergency department.
Intervention: Other: Sepsis Watch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2019)
32003
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
32000
Actual Study Completion Date  ICMJE July 5, 2019
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Arrival to Duke University Hospital emergency department pods A, B, and C, or resuscitation bay

Exclusion Criteria:

  • Under 18 years old at time of emergency department arrival
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03655626
Other Study ID Numbers  ICMJE Pro00093721
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Data & Society Research Institute
  • Duke Clinical Research Institute
Investigators  ICMJE
Principal Investigator: Cara O'Brien, MD Duke University Health System
Study Director: Mark Sendak, MD Duke Institute for Health Innovation
PRS Account Duke University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP