Sepsis Clinical Trial
— CRESTOfficial title:
Critical Care Excellence in Sepsis and Trauma
Verified date | April 2018 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Bamberg County Hospital | Bamberg | South Carolina |
United States | Barnwell County Hospital | Barnwell | South Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Williamsburg Regional Medical Center | Kingstree | South Carolina |
United States | Regional Medical Center of Orangeburg | Orangeburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
Peake SL, Judd N. Supporting rural community-based critical care. Curr Opin Crit Care. 2007 Dec;13(6):720-4. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Smedley B, Stith A, et al. Unequal treatment: confronting racial and ethnic disparities in health care. Washington, D.C.: National Academy Press; 2003.
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. Epub 2000 Feb 1. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Measure: -Mortality Source: -Data from the medical record |
Two Years | |
Secondary | Cost Elements | 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 |
Two Years | |
Secondary | Provider Acceptance and Satisfaction | 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 |
Two Years |
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