emergency care research - feinberg school of medicine€¦ · professional or student) conducting...

Emergency Care

Research Strengths

Challenges

Networked Collaboration

Realistic Opportunities for the future

D. Mark Courtney

Department of Emergency Medicine

Northwestern University

Chicago

Why this talk?

• Discuss opportunities and challenges of

conducting research in the emergency

setting.

• Identify opportunities for collaboration

within Northwestern Medicine

Perina et al. Annals of EM 2010

Emergency Research: at a

tipping point

The 2008 Emergency Care Research Networks (ECRN) Conference:

design, summary of findings, and an update.

Unique characteristics of emergency care research: scope,

populations, and infrastructure.

Facilitating emergency care research networks: integration into the

Clinical Translational and Science Award (CTSA) infrastructure.

Structure and Function of Emergency Care Research Networks:

Strengths, Weaknesses, and Challenges

Evaluating Emergency Care Research Networks: What Are the Right

Metrics?

AEM October 2009

What is Emergency Medicine?

what domains? topics?

sepsis

shock

PE/DVT

stroke

seizure

psychiatry

wounds

trauma

fractures

sprains

AMI

EP

asthma

COPD

pneumonia

pain

(d) “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge....

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains...

-Data through intervention or interaction with the individual, or -Identifiable private information.”

What is Research:

Code of Federal Regulations. TITLE 45 PUBLIC WELFARE DHHS

PART 46

What is Emergency Research?

What is unique about our approach?

sepsis

shock

PE/DVT

stroke

seizure

psychiatry

wounds

trauma

fractures

sprains

AMI

EP

asthma

COPD

pneumonia

pain

What is unique about Emergency

Research?

undifferentiated symptoms

stabilize

diagnose

treat

What makes Emergency Research

unique are the same things that

make Emergency medicine unique

What else is unique about

Emergency Medicine Research?

What else is unique about

Emergency Medicine Research?

Health Care Delivery Research:

diagnostic test assessment

resource utilization

cost effectiveness

Health Care Delivery Research:

access to care

psychiatric

substance abuse

Patient flow-ED operations

Education Research:

Simulation

Procedural competency

Accreditation

Curriculum

Organ system –

Disease specific

Education

Health care delivery

Definition of Emergency Care

Research:

“the systematic examination of patient

care that is expected to be continuously

available to diverse populations

presenting with undifferentiated

symptoms of acute illness, or acutely

decompensated chronic illness and

whose outcomes depend on timely

diagnosis and treatment”

Courtney DM et al. AEM 2009

Why networked Research?

32 year old female

pleuritic chest pain

brief

some shortness of breath

What next……..

Where do you turn for information?

Heit JA et al. Arch Int Med 2000

What about OCPs?

Heit JA et al. Arch Int Med 2000

Why didn’t Estrogen/OCPs

show up as a risk factor for PE?

Lack of true relationship

Inadequate power

Pulmonary Embolism

Research Consortium

Courtney et al Annals of EM 2010

Who is at risk for PE?

Reasons to not test

Reasons to test

Courtney et al Annals of EM 2010

Courtney et al Annals of EM 2010

Two step approach to interpreting

scientific literature

• Internal Validity

• External Validity (generalizability)

Courtney et al Annals of EM 2010

Increase power

Increase external validity (generalizability)

Why Networked ECR?

Uncommon disease or

small effect size? • Who does not need a CT in pediatric

trauma

• C-spine injury in pediatric trauma

• Cerebral injury from IVF in pediatric DKA

• Pediatric status eplilepticus

• Dexamethasone in mod-sev bronchiolitis

• Hypothermia in pediatric cardiac arrest

Prediction rule: peds head

trauma

Kuppermann N et al. Lancet 2009

600 children

20 different centers

double blind RCT

NO change in admission, resp status 4

hours later, or later outcomes

Corneli HM et al NEJM 2007

Overview of Current ECR

networks:

Population-Public Health

Pulmonary Embolism Research Consortium

ProCESS: Sepsis

NETT - Neuro

EmergencyID Net - Infectious Disease

EMNet - Pulmonary and Public Health

PECARN - Pediatric

Disease-Organ system

Pulmonary Embolism Research Consortium

ProCESS: Sepsis

NETT - Neuro

EmergencyID Net - Infectious Disease

EMNet - Pulmonary and Public Health

PECARN - Pediatric

Disease or organ

system specific

networks

• Neurological Emergencies Treatment Trials

(NETT)

• Large simple trials

• Goal: reduce burden of very acute

injuries/illnesses brain, spinal cord, and

peripheral nervous system.

• Funded by NINDS

• Time dependent interventions at the EMS or ED

level

• Phase 3 clinical trials only

• Hub and Spoke Network

• Separate awards for:

CCC

SDMC

Hubs

NINDS funding only for infrastructure

• Specific study funding must be secured

• NETT is an “open” network

• ALIAS - High-Dose Albumin Therapy for

Neuroprotection in Acute Ischemic

Stroke

• RAMPART - Rapid Anticonvulsant

Medication Prior to Arrival Trial

• ProTECT - Progesterone for Traumatic

Brain Injury: Experimental Clinical

Treatment

• POINT - Platelet-Oriented Inhibition in

New TIA Trial

NETT: leading the way in Consent

issues

• Exception to informed consent for ECR

• Optimize methods that respect human subjects

• Dedicate network resources to facilitate local

efforts

• Help develop centralized IRB review

Protocolized Care for Early Septic Shock

(ProCESS)

GROUPS:

1. Early Goal Directed Therapy (EGDT) - CVP monitoring and

(Scv02).

2. Protocolized Standard Care (PSC)- Monitor blood pressure and

blood oxygen level with routine equipment. Central lines only

when standard IVs are unable to give the proper amount of fluids

and medicines.

3. Active Comparator-Usual Care - standard treatment and without

any influence from the study team. A member of the study team

will simply observe and record what happens. Procedure: Usual

Care (UC)

Courtney et al. AEM 2009

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Courtney et al. AEM 2009

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Courtney et al. AEM 2009

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Courtney et al. AEM 2009

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Pulmonary Critical Care

Cardiology

Neurology

ID

? Transplant

?GI

Opportunities

NUEM Completed Clinical Research Project Funding Collaborators Status N enrolled

in NUEM ED

D-dimer and Pretest Probability

for PE

NIH -

NHLBI

Hematology, 9 other US

EDs

Data Collection, Analysis, &

Publication - Complete

1797 (at NU)

A Phase II/III, Multicenter,

Randomized, Double-blind,

Placebo-Controlled Study to

Evaluate the Efficacy and Safety

of Relaxin in Subjects With Acute

Heart Failure

Industry Cardiology Data Collection & Analysis –

Complete; Publication -

Ongoing

8

Chicago Community-Acquired

Pneumonia Consortium

CDC Pulmonary & Critical

Care (Wunderink); 5

other US EDs

Data Collection - Complete;

Analysis & Publication -

Ongoing

971 (at NU)

Rule Out Myocardial Ischemia/

Infarction Using CT (ROMICAT)

NIH -

NHLBI

Cardiology (Mikati) Data Collection – Complete;

Analysis & Publication -

Ongoing

21

Expired CO2/O2 Analysis to

Diagnose Pulmonary Embolism

Industry 3 US other EDs Data Collection – Complete;

Analysis & Publication -

Ongoing

172

Randomized Trial of Tenecteplase

to Treat Severe Submassive

Pulmonary Embolism

Industry Pulmonary & Critical

Care, 7 other US EDs

Data Collection – Complete;

Analysis & Publication -

Ongoing

7

Assessment of Early Renal Injury

in Acute Heart Failure Syndrome:

A Prospective, Observational,

Biomarker Study

Industry Cardiology Data Collection – Complete;

Analysis & Publication -

Ongoing

7

Hypoperfusion in Acute Heart

Failure Syndromes

Industry Data Collection – Complete;

Analysis & Publication -

Ongoing

50

NUEM Current Clinical Research Project Funding Collaborators Status N enrolled

in NUEM ED

Consumer Understanding of

Opioid Pain Relievers

EMF -

Purdue

Pharma

IPHAM Data Collection - Ongoing 265 Enrolled,

201(Complet

e w/ Follow-

Up)

Neuromuscular Mechanisms

Underlying Chronic Pain in

Whiplash

KL2

(NUCATS)

PT and Human

Movement Sciences

(Elliott)

Data Collection – Ongoing

65 Enrolled

Identification of Patient

Phenotypes Associated with

Elevated Aldosterone Levels

KL2

(NUCATS)

Cardiology (Shah) Data Collection – Ongoing 43 Enrolled

Procalcitonin MOnitoring SEPsis

Study (MOSES)

Industry Pulmonary & Critical

Care, 7 other US EDs

Data Collection – Ongoing 28 Enrolled

Pre-test Probability and

Diagnostic Testing for Deep

Venous Thrombosis in the

Emergency Department

Pilot Data Collection – Ongoing 213 Enrolled

NUEM Pending Clinical Research Project Funding Collaborators Status

Rapid Administration of Carnitine in sEpsis NIH - NIGMS Pulmonary & Critical Care, 4

Other Academic Centers

Pending

Start-Up

Effects of Early Versus Delayed Antibiotic

Treatment for Febrile Neutropenia

NIH Hemotology-Oncology, Infectious

Disease, Preventative Medicine

Submitted

(R21)

Measuring Out-of-Hospital Cardiac Arrest at NMH

(MOHCA-NMH)

Women’s Board of

NMH

Submitted

Inter-Unit Handoffs: Direct Observations of Handoff

Communication between Emergency Physicians

and Hospitalists

Women’s Board of

NMH

Hospital Medicine, Western

Michigan University

Submitted

A TBI Patient Registry to Examine Variations in

Diagnosis, Treatment, and Outcomes

NIH - NINDS Internal Medicine, IPHAM, RIC,

Neurology, Trauma

(Kho/Heineman)

Submitted

(U01)

Neuromuscular Mechanisms Underlying Poor

Recovery from Whiplash Injuries

NIH PTHMS (Elliott) Submitted

(R01)

Acute heart failure patients with high Copeptin

levels treated with Tolvaptan targets Increased

AVP Activation for Treatment Efficacy (ACTIVATE)

Industry Cardiology, Pulmonary & Critical

Care

Submitted

Retrievable Inferior Vena Cava Filters with Acute

Pulmonary Embolism

NHLBI One of 20 sites. CCC = MSU.

DCC = GWU

Submitted

(R01)

NUEM Health Services Research Project Funding Collaborato

rs

Status

Emilie Powell Fellowship T32 (Institutional NRSA

Fellowship)

IPHAM Complete

Danielle McCarthy T32 (Institutional NRSA

Fellowship)

IPHAM Complete

Critical Areas for Improvement in Care

Delivery of ED Severe Sepsis

Resuscitation

F32 (Individual NRSA Post

Doctoral Fellowship)

IPHAM Complete

Improving ED Quality and Safety by

Enhancing Operations and Quality

Management

AHRQ (K08 - Mentored

Clinical Scientist Career

Development Award)

IPHAM Ongoing – Year 3 of 5

Scott Dresden Fellowship T32 (Institutional NRSA

Fellowship)

IPHAM Ongoing - Year 2 of 2

Chris Richards Fellowship T32 (Institutional NRSA

Fellowship)

IPHAM Ongoing - Year 1 of 2

Discussion