Critical Care Excellence in Sepsis and Trauma

NCT01426711 | Completed DMC

• 2 other identifiers: CREST-004405-02RC1MD004405
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

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. 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. 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.

Conditions

Sepsis; Trauma

Outcome Measures

Primary Outcomes (1)

• Mortality

  Measure: -Mortality Source: -Data from the medical record

  Two Years

Secondary Outcomes (2)

• Cost Elements

  Two Years

• Provider Acceptance and Satisfaction

  Two Years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (5)

Bamberg County Hospital

Bamberg, South Carolina, 29003, United States

Location

Barnwell County Hospital

Barnwell, South Carolina, 29812, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Williamsburg Regional Medical Center

Kingstree, South Carolina, 29556, United States

Location

Regional Medical Center of Orangeburg

Orangeburg, South Carolina, 29118, United States

Location

Related Publications (14)

• Peake SL, Judd N. Supporting rural community-based critical care. Curr Opin Crit Care. 2007 Dec;13(6):720-4. doi: 10.1097/MCC.0b013e3282f1bb21.

  PMID: 17975397 BACKGROUND

• Selassie AW, McCarthy ML, Ferguson PL, Tian J, Langlois JA. Risk of posthospitalization mortality among persons with traumatic brain injury, South Carolina 1999-2001. J Head Trauma Rehabil. 2005 May-Jun;20(3):257-69. doi: 10.1097/00001199-200505000-00008.

  PMID: 15908825 BACKGROUND

• ARISE; ANZICS APD Management Committee. The outcome of patients with sepsis and septic shock presenting to emergency departments in Australia and New Zealand. Crit Care Resusc. 2007 Mar;9(1):8-18.

  PMID: 17352661 BACKGROUND

• Seferian EG, Afessa B, Gajic O, Keegan MT, Hubmayr RD; Mayo Epidemiology and Translational Research in Intensive Care. Comparison of community and referral intensive care unit patients in a tertiary medical center: evidence for referral bias in the critically ill. Crit Care Med. 2008 Oct;36(10):2779-86. doi: 10.1097/ccm.0b013e318186ab1b.

  PMID: 18828201 BACKGROUND

• Surgenor SD, Corwin HL, Clerico T. Survival of patients transferred to tertiary intensive care from rural community hospitals. Crit Care. 2001;5(2):100-4. doi: 10.1186/cc993. Epub 2000 Feb 1.

  PMID: 11299068 BACKGROUND

• Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 Mar 8;344(10):699-709. doi: 10.1056/NEJM200103083441001.

  PMID: 11236773 BACKGROUND

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

• 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.

  BACKGROUND

• Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

  PMID: 11445675 BACKGROUND

• Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care; Smedley BD, Stith AY, Nelson AR, editors. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK220358/

  PMID: 25032386 BACKGROUND

• Pronovost PJ, Angus DC, Dorman T, Robinson KA, Dremsizov TT, Young TL. Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA. 2002 Nov 6;288(17):2151-62. doi: 10.1001/jama.288.17.2151.

  PMID: 12413375 BACKGROUND

• Angus DC, Shorr AF, White A, Dremsizov TT, Schmitz RJ, Kelley MA; Committee on Manpower for Pulmonary and Critical Care Societies (COMPACCS). Critical care delivery in the United States: distribution of services and compliance with Leapfrog recommendations. Crit Care Med. 2006 Apr;34(4):1016-24. doi: 10.1097/01.CCM.0000206105.05626.15.

  PMID: 16505703 BACKGROUND

• MacKenzie EJ, Rivara FP, Jurkovich GJ, Nathens AB, Frey KP, Egleston BL, Salkever DS, Scharfstein DO. A national evaluation of the effect of trauma-center care on mortality. N Engl J Med. 2006 Jan 26;354(4):366-78. doi: 10.1056/NEJMsa052049.

  PMID: 16436768 BACKGROUND

• Selassie AW, Pickelsimer EE, Frazier L Jr, Ferguson PL. The effect of insurance status, race, and gender on ED disposition of persons with traumatic brain injury. Am J Emerg Med. 2004 Oct;22(6):465-73. doi: 10.1016/j.ajem.2004.07.024.

  PMID: 15520941 BACKGROUND

MeSH Terms

Conditions

Sepsis; Wounds and Injuries

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dee W Ford, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Samir M. Fakhry, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: August 31, 2011
• Study Start: September 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (5)