Critical Care Excellence in Sepsis and Trauma (CREST)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01426711
First received: August 30, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

The care of patients with sepsis and trauma requires the delivery of appropriate definitive care in the early stages of the illness. Hospitals with limited resources, those in rural and underserved areas of South Carolina, may be unable to consistently provide optimal care to these patients. In addition, the shortage of specialists nationally makes it more difficult for these hospitals to recruit and retain the specialists needed. Patients in these areas continue to pay the rural penalty of poorer outcomes. This study provides specialists' level care through telemedicine consults to rural emergency departments in rural areas of SC to improve outcomes for these patients.

The CREST study is a project that specifically addresses the need to bring health care to rural communities in SC, as well as evaluates methods and tests technology to implement this care in rural communities. The CREST study uses telemedicine remotely from MUSC to rural community hospitals to provide rural community physicians care from specialists for trauma and sepsis, which are both high acuity, difficult to treat conditions.

CREST is a multi-site trial of telemedicine services to meet rural patients' and providers' need for expert evaluation and management of sepsis and trauma. The specific aims of CREST are:

  1. To test the hypothesis that a telemedicine program including education and clinical consultation between a tertiary care academic medical center and rural, local hospitals will significantly improve key treatment decisions and outcome measures in sepsis and trauma.
  2. To test the hypothesis that the differences in ISS and time to antibiotics for trauma and sepsis patients exposed to telemedicine intervention and those without the intervention matched on propensity scores are not due to unmeasured confounders.

CREST seeks new solutions to rural health disparities, to advance technology, create and retain jobs and address important research opportunities by combining implementation of a novel, trans disciplinary clinical program with rigorous, mixed methods scientific evaluation including clinical, process, and economic outcome measures. The impact on both science and quality healthcare outcomes is broad and CREST has far reaching implications for addressing rural health disparities for acute, life-threatening illnesses.


Condition
Sepsis
Trauma

Study Type: Observational
Official Title: Critical Care Excellence in Sepsis and Trauma

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Mortality [ Time Frame: Two Years ] [ Designated as safety issue: No ]

    Measure:

    -Mortality

    Source:

    -Data from the medical record



Secondary Outcome Measures:
  • Cost Elements [ Time Frame: Two Years ] [ Designated as safety issue: No ]

    Measure:

    • Patient charges and cost (before and after telemedicine)
    • Cost of telemedicine
    • Total charges per admission

    Sources:

    • Hospital billing records
    • Staff and consultant time estimates and invoices
    • All-payer hospital discharge data set annual staff salary data

  • Provider Acceptance and Satisfaction [ Time Frame: Two Years ] [ Designated as safety issue: No ]

    Measure:

    • Provider Experience and Ratings
    • Reports of use, frequency, type
    • Ratings of reliability, expertise, technology
    • Personal efficacy
    • Overall satisfaction

    Sources:

    • Post-project Survey
    • Actual use of the system


Estimated Enrollment: 2600
Study Start Date: September 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population is adult patients presenting to rural community hospital's emergency departments wth possible sepsis or severe sepsis and/or blunt or penetrating trauma.

Criteria

Inclusion Criteria:

Sepsis study patients are adult patients presenting to the rural hospital's EDs that meet the screening criteria for sepsis and two of four SIRS criteria.

The screening criteria for possible sepsis are:

  • known or suspected infection AND EITHER
  • systolic blood pressure < 90mmHg after fluid challenge of 30mL/kg over 30 minutes OR
  • lactate > 4mmol/L

The screening criteria for possible SIRS are:

  • abnormal core body temperature (<36.5 C or > 38 C)
  • heart rate > 90 bpm
  • respiratory insufficiency (respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg or mechanical ventilation)
  • abnormal white blood count (>12,000/cumm or < 4000/cumm)

Trauma study patients are adult patients presenting to the rural hospital's EDs with blunt or penetrating injury and one or more of the following criteria:

  • Respiratory insufficiency and/or intubation
  • Glasgow coma scale < 8 with mechanism attributed to trauma
  • Systolic blood pressure of <90mmHg
  • Paralysis
  • Penetrating injury to the head/neck/torso
  • Crush to torso/upper thighs
  • Major amputations
  • Loss of consciousness > 5 minutes
  • Maxillo-facial trauma
  • Significant subcutaneous air
  • Evidence of pelvic instability
  • Two or more long bone deformities
  • Major lacerations involving fascia
  • Ejection from vehicle
  • Pedestrian struck > 15 mph
  • Motorcycle Crash > 25 mph
  • Motor Vehicle Collision > 35 mph
  • Documented falls > 20 feet or 2 stories

Exclusion Criteria:

The exclusion criteria for septic patients are:

-Age < 18 years

The exclusion criteria for trauma patients are:

  • Age < 18 years
  • Burn injury of greater than 10% total body surface area
  • Traumatic asphyxiation
  • Lightning strike/electrical shock
  • Patients undergoing cardiopulmonary resuscitation (CPR) on arrival
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426711

Locations
United States, South Carolina
Bamberg County Hospital
Bamberg, South Carolina, United States, 29003
Barnwell County Hospital
Barnwell, South Carolina, United States, 29812
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Williamsburg Regional Medical Center
Kingstree, South Carolina, United States, 29556
Regional Medical Center of Orangeburg
Orangeburg, South Carolina, United States, 29118
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Dee W Ford, MD Medical University of South Carolina
Principal Investigator: Samir M. Fakhry, MD Medical University of South Carolina
  More Information

Publications:
National Vital Statistics System - National Center for Health Statistics - CDC. 10 Leading Causes of Death by Age Group - United States. http://www.cdc.gov/ncipc/osp/charts.htm. Accessed Dec. 1, 2008.
Smedley B, Stith A, et al. Unequal treatment: confronting racial and ethnic disparities in health care. Washington, D.C.: National Academy Press; 2003.

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01426711     History of Changes
Other Study ID Numbers: CREST-004405-02, RC1MD004405
Study First Received: August 30, 2011
Last Updated: August 30, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sepsis
Toxemia
Wounds and Injuries
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 29, 2014