NCT02376842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

October 3, 2014

Last Update Submit

November 16, 2015

Conditions

Severe Sepsis

Keywords

severe sepsis infection

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with an antibiotic order within 3 hours of the alert

    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.

    3 hours

Study Arms (2)

Severe sepsis early warning best practice alert

ACTIVE COMPARATOR

Patients in this arm will actively generate the alert.

Behavioral: Severe sepsis early warning best practice alert

Standard care

PLACEBO COMPARATOR

This arm will be the current standard of care and will not generate the alert.

Behavioral: Standard care

Interventions

Severe sepsis early warning best practice alertBEHAVIORAL
Severe sepsis early warning best practice alert
Standard careBEHAVIORAL
Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

Related Publications (3)

  • Westphal GA, Koenig A, Caldeira Filho M, Feijo J, de Oliveira LT, Nunes F, Fujiwara K, Martins SF, Roman Goncalves AR. Reduced mortality after the implementation of a protocol for the early detection of severe sepsis. J Crit Care. 2011 Feb;26(1):76-81. doi: 10.1016/j.jcrc.2010.08.001. Epub 2010 Oct 30.

    PMID: 21036531BACKGROUND

  • Nelson JL, Smith BL, Jared JD, Younger JG. Prospective trial of real-time electronic surveillance to expedite early care of severe sepsis. Ann Emerg Med. 2011 May;57(5):500-4. doi: 10.1016/j.annemergmed.2010.12.008. Epub 2011 Jan 12.

    PMID: 21227543BACKGROUND

  • Brandt BN, Gartner AB, Moncure M, Cannon CM, Carlton E, Cleek C, Wittkopp C, Simpson SQ. Identifying severe sepsis via electronic surveillance. Am J Med Qual. 2015 Nov-Dec;30(6):559-65. doi: 10.1177/1062860614541291. Epub 2014 Jun 26.

    PMID: 24970280RESULT

MeSH Terms

Conditions

Sepsis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 3, 2014

First Posted

March 3, 2015

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(1)