Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of an Electronic Health Record-embedded Severe Sepsis Early Warning Alert

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: NCT02376842
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
N. Lance Downing, MD, Stanford University

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date November 17, 2015
Study Start Date  ICMJE November 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
Percentage of patients with an antibiotic order within 3 hours of the alert [ Time Frame: 3 hours ]
Time from when the alert fires until appropriate antibiotics are ordered will be measured via the electronic health record and a sample of cases will be verified by manual chart review.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of an Electronic Health Record-embedded Severe Sepsis Early Warning Alert
Official Title  ICMJE Single-blind Randomized Trial of a Commercially Sold Electronic Health Record Based Severe Sepsis Early Warning Best Practice Alert.
Brief Summary The investigators hypothesize that implementing an electronic health record-based early warning system for severe infections (severe sepsis) will decrease the time to antibiotic order. The study will consist of an algorithm which will monitor lab values, vital signs, and nursing documentation for signs of severe sepsis. When these criteria are met, an alert will be delivered via the electronic health record to a nurse and doctor and simultaneously an alert via pager to another nurse. The investigators plan to randomize which patients will generate these alerts and analyze the data after collecting information for approximately 6 months which will be sufficient to detect a 10% difference in the two patient groups.
Detailed Description

Sepsis is the leading cause of mortality at Stanford Hospital and ranks only 54th out of 119 hospitals according to UHC data with approximately 60 episodes of documented sepsis per quarter. Based on some preliminary data, there is concern that sepsis is both being recognized late and not treated in a timely enough fashion. In fact, there are evidence and expert guidelines that suggestion-delaying antibiotics in a patient with septic shock can increase mortality by 6.7% per hour (1C recommendation in severe sepsis by the Surviving Sepsis Campaign authors). As part of a hospital wide initiative to improve our treatment of sepsis and ultimately reduce sepsis-related mortality, an EHR-based clinical decision support (aka BPA) will be implemented. This BPA will be an algorithm that will alert practitioners and trigger clinical workflow after criteria are met. Criteria include lab values, vital signs and nursing flow sheet descriptions of perfusion (Table 1). The algorithm will alert when, in a 24 hour period, three criteria from the manifestation group, one criteria from the suspected infection group and one criteria from the organ dysfunction group. Note that one variable (eg creatinine > 2) can fulfill criteria in more than one group. Figure 1 contains details of proposed EHR workflow. After criteria are met, whomever is next in the chart with RN or MD user-type, will receive an interruptive alert via the EHR; simultaneously a page will automatically be sent by the EHR to a crisis nurse who will assess the patient and notify the primary MD and RN.

Electronic early warning systems and predictive analytic tools lack rigorous evaluation and standardization. There are literature demonstrating unintended consequences and even harms from the implementation of electronic health records and clinical decision support tools. As such, this is a situation of clinical equipoise in which it is unclear whether this quality improvement initiative will benefit patient care or not. To evaluate this question, the severe sepsis BPA will be initiated in a randomized fashion with each patient randomly assigned to either potentially generate this alert as described above or to generate this alert silently such that only quality improvement staff will be aware that criteria have been met via the EHR.

This is a randomized, single-blind prospective quality improvement study. Patients will be randomized by encounter to have the BPA visible or invisible during hospital admission. If visible, the alert will display to the primary nurse and physician and send a page to a crisis nurse when BPA criteria are met. If invisible, the alert will be triggered but will be invisible to the care team (only visible to quality improvement staff via the EHR)

  • Inclusion criteria

    o Admitted to Stanford Hospital (inpatient or observation status) to any medical or surgical service for at least 24 hours during the period of the study

  • Exclusion criteria

    o Admitted to an intensive-care level service (MICU, SICU, CVICU, CCU)

  • While ideally we will make this available to ICU patients, the alert is likely to be far less specific in ICU patients and less clinically useful given the high level of care (eg 1:1 nursing and hourly vital signs).

    o Patient code status is DNR/C (comfort care only)

  • These patients would not be appropriate to treat with antibiotics and aggressive care generally give the comfort care goals of care.

    o Emergency Department patients (may be included in the near future)

  • Primary endpoints

    o Percentage of patients receiving antibiotics within three hours

  • Secondary endpoints

    • Percentage of patients with hypotension or lactate >= 4 who received at least 30 ml/kg fluid
    • Rate of 3 hour sepsis bundle completion (serum lactate, blood cultures, antibiotics)
    • Length of hospital stay
    • Cost of hospital stay per day and overall cost
    • Mortality at hospital discharge
  • Sample size and duration

    • Based on prior studies, we predict a 10-15% difference in one or more primary endpoints (see Sawyer et. Al, Crit Care Med. 2011 March, 39:469)
    • We therefore anticipate enrolling 1500 patients, an estimated 150 of whom will have true sepsis, over approximately six months, to achieve 80% power.
  • Analysis will compare endpoints among all patients in the treatment and control groups
  • Early stopping will be decided by an oversight committee which will review data at 3 months. If there is statistically significant different of more than 10% between groups, the study will be terminated early and in discussion with hospital quality and safety committee, use whichever strategy is superior for all patients in the hospital.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Condition  ICMJE Severe Sepsis
Intervention  ICMJE
  • Behavioral: Severe sepsis early warning best practice alert
  • Behavioral: Standard care
Study Arms  ICMJE
  • Active Comparator: Severe sepsis early warning best practice alert
    Patients in this arm will actively generate the alert.
    Intervention: Behavioral: Severe sepsis early warning best practice alert
  • Placebo Comparator: Standard care
    This arm will be the current standard of care and will not generate the alert.
    Intervention: Behavioral: Standard care
Publications *

*   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: November 16, 2015)
1149
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2015)
1500
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Admitted to Stanford Hospital (inpatient or observation status) to any medical or surgical service for at least 24 hours during the period of the study

Exclusion Criteria:

  • Admitted to an intensive-care level service (MICU, SICU, CVICU, CCU)
  • Patient code status is DNR/C (comfort care only)
  • Patients less than 18 years of age at time of admission.
  • Emergency Department patients (may be included in the near future)
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 NCT02376842
Other Study ID Numbers  ICMJE 3675309
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party N. Lance Downing, MD, Stanford University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stanford University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date November 2015

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