Sepsis Clinical Trial
Official title:
Critical Care Excellence in Sepsis and Trauma
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.
The impetus for CREST derives from the observation that rural patients are unlikely to
acquire on-site access to appropriate specialist care for high stakes, high acuity,
crisis-mode conditions such as sepsis and trauma. Novel, collaborative approaches are
necessary to provide rural patients with access to appropriate specialist care for sepsis and
trauma. CREST is an innovative, technologically levering mechanism that provides the
opportunity to lessen the inferior outcomes and "rural penalty" paid by patients in rural
communities.
Rural patients are less likely to have onsite access to specialist care for sepsis and trauma
for several reasons:
- Personnel: there is a nation-wide shortage of appropriate specialty providers including
intensivists, trauma surgeons, and other critical care staff 1. Small, rural communities
lack the economies of scale to support resource intense services and if a community has
these specialties, there is often not around the clock coverage necessary for best
quality care for these conditions 1.
- Physical and material resources: Sepsis and trauma patients require immediate
availability of resources such as multidisciplinary ICU staff, large blood banks,
operating rooms, and advanced radiological facilities.
- Availability of resources such as multidisciplinary ICU staff, large blood banks,
operating rooms, and advanced radiological facilities.
- Location and distance: Patients in rural communities have inferior outcomes in sepsis
and trauma 2, 3. This is likely multifactorial and includes delays in entry to the
Emergency Medical System network, longer travel times to definitive care facilities and
delays in definitive care delivery. Inter-hospital transfer may be limited both by
severity of patient illness, acute care and ICU bed shortages in tertiary care centers.
Additionally, the scarcity of tertiary care hospital beds increases the importance of
initiating transfer for patients who will maximally benefit from tertiary care referral
4, 5.
The impact to rural patients with sepsis and trauma, due to lack of access to appropriate
specialist care, is substantial. Sepsis is one of the most common serious critical illnesses.
It kills 28-50% of patients diagnosed 6, 7 and is the 10th leading cause of death in the US
8. Furthermore, the incidence is increasing in conjunction with the aging of the US
population 9. The impact of rurality on sepsis has received modest investigation, but rural
patients likely have worse outcomes.3 In SC, patients referred from Emergency Departments
(ED's) in smaller, typically rural hospitals have a 22% increase risk of death as compared to
those referred from ED's in larger, urban hospitals (CREST preliminary analysis) suggesting
the benefits of specialist directed care available to patients at larger facilities. Equally
concerning is an apparent race-associated disparity in which African American patients
presenting to rural ED's in SC are twice as likely to be discharged from the ED with a
diagnosis of sepsis as compared to white patients. Although the rates for discharge from an
ED with a diagnosis of sepsis are low at 3.95% for whites and 8.71% for African Americans
(CREST preliminary analysis), it is concerning that any patient is discharged from an ED with
this diagnosis and the disparate rates may reflect the well-described phenomenon of unequal
treatment 10. Critically ill patients with any diagnosis benefit from intensivist-directed
care including a 30-40% reduction in mortality.11 Unfortunately, over half of US hospitals
have no intensivist coverage at all and rural hospitals are disproportionately affected by
this problem 12.
Likewise, trauma is the leading cause of death among Americans up to age 45 and the fourth
leading cause of death overall for all ages 8. Deaths from injury occur in a tri-phasic
distribution: 50% of deaths from injury occur at the scene, 30% occur in the first 1-2 hours
and 20% occur during hospitalization between 1-2 weeks after admission. Trauma care at
designated trauma centers improves survival 13. Yet, rural hospitals are rarely trauma
centers and in SC patients injured in rural communities have inferior outcomes and higher
costs 14. Significant disparities can be identified among SC's elderly and minority
populations. 14 An important barrier to facilitating quality care for SC trauma patients
relates to triage efficiency between rural hospitals and a trauma center. Outcomes for
seriously injured rural patients are negatively affected when patients are taken to
non-trauma EDs and then transferred to a trauma center 13 . Conversely, transfer of patients
with low risk of death and disability to trauma centers represents over-triage, and creates
additional stressors at already busy trauma centers accruing financial burden on the health
care system.
CREST is scientifically innovative on multiple levels. It is the first prospective,
mixed-methods evaluation of telemedicine; as well as one of the few studies in
remote/telemedicine not sponsored by industry. CREST is the first study to demonstrate
improved outcomes for sepsis using telemedicine and will augment the sparse literature on
trauma and telemedicine. CREST also serves as a demonstration project showing that access to
specialist care for rural patients with high stakes, high acuity conditions can be reliably
provided through telemedicine. CREST technology is non-proprietary and relatively low cost
and thus allows important cost-effectiveness analyses to ascertain the viability of
telemedicine in rural settings.
CREST includes two elements - an educational program for rural providers and clinical
consultation for patients with sepsis and trauma. Collaborating hospitals receive
telemedicine hardware and software, usage instruction, and 24/7 access to MUSC experts in
sepsis and trauma for patient consultation in real-time. This project uses a
quasi-experimental design, which incorporates a controlled experiment using pre-existing
patient groups as the controls. This design minimizes threats to external validity and offers
efficiency in the longitudinal aspect of the research. Main dependent measures include time
to initiation of appropriate antibiotics for septic patients and reduced transfer rates of
less-severe trauma patients as measured by average increase in the Injury Severity Score
(ISS). Data collection for the controls in the retrospective groups and the prospective
intervention group will be conducted by using structured audit forms by trained staff. The
research plan includes investigation of outcomes, including treatment decisions.
Rural hospitals are the primary targets for CREST because these institutions tend to have
fewer specialty providers and often cannot provide definitive care for patients with sepsis
and trauma. Eligible rural hospitals are strategically identified based on several criteria.
First, the hospital is located in a rural area as designated by the US Department of
Agriculture. Second, the hospital has substantial resource limitations as indicated by a
Level III or IV Medical Facility Status from the Joint Accreditation Committee for Hospital
Organizations. Third, the hospital is within MUSC's typical 120 mile catchment area.
CREST investigators are mindful of the importance of collegial and collaborative approaches
to recruiting rural hospitals and providers. To establish a framework for the working
relationships important to the success of CREST, collaborating hospitals and MUSC sign a
Memorandum of Agreement stipulating the roles and expectations. The fundamental duties for
the rural hospitals are: 1) work with MUSC research team to facilitate human subjects
approval of CREST; 2) coordinate their providers' availability with CREST's educational
program; 3) facilitate working relationships between MUSC clinical experts and appropriate
clinicians at rural hospitals and 4) allow CREST investigators access to patient records to
ascertain outcome measures. MUSC provides: 1) an educational program 2) the technical
expertise and equipment; 3) 24/7 availability for clinical evaluations; 4) training and
support of chart abstractors to acquire outcome data; and 5) the conducting of analyses and
writing of reports for CREST.
CREST allows rural spoke hospitals 24/7 access to MUSC sepsis and trauma experts who provide
formal consultation for patients with these conditions including appropriate documentation in
the medical record. Rural hospitals can utilize the telemedicine consultants on a one-time
basis for initial evaluation and recommendations or request ongoing collaborative care with
MUSC clinical experts. If a patient benefits by transfer to MUSC, this is identified and MUSC
clinicians are already familiar with the patient's clinical status, representing another
advantage of telemedicine services. Alternatively, if patients can be adequately managed at
referring spoke sites this is determined, thus improving triage efficiency for tertiary care
referrals.
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