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Evaluating the Potential Evaluating the Potential of of

REACH MUSC REACH MUSC as a Research Networkas a Research Network

Robert J. Adams, MS MDRobert J. Adams, MS MDProfessor of NeuroscienceProfessor of NeuroscienceUniversity Eminent ScholarUniversity Eminent Scholar

Director South Carolina Center of Economic ExcellenceDirector South Carolina Center of Economic ExcellenceDirector MUSC Stroke CenterDirector MUSC Stroke Center

SCTR/CTSA TELEMEDICINE RETREATSCTR/CTSA TELEMEDICINE RETREATNovember 19, 2010November 19, 2010

A Telemedicine Facilitated A Telemedicine Facilitated Network for Urgent Stroke Network for Urgent Stroke

Treatment in South CarolinaTreatment in South CarolinaRobert J. Adams , MS., MD. for the MUSC REACH ProgramRobert J. Adams , MS., MD. for the MUSC REACH Program

November, 2010November, 2010

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What is REACH MUSC ?What is REACH MUSC ?

RRemoteemote EEvaluation of valuation of AAcute iscute isCHCHemic strokeemic stroke

100% web based service through which 100% web based service through which MUSC specialists deliver urgent consults to MUSC specialists deliver urgent consults to rural/community emergency departments to rural/community emergency departments to improve the care of acute stroke patientsimprove the care of acute stroke patients

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Justification for TelemedicineJustification for Telemedicine

Telemedicine allows remote facilities to Telemedicine allows remote facilities to communicate with the HUB at MUSC to access communicate with the HUB at MUSC to access vascular neurologists specially trained in vascular neurologists specially trained in stroke treatment-including the use of stroke treatment-including the use of Alteplase (tPA)Alteplase (tPA)

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HUB - MUSCComprehensive Stroke Center

SpokeRemote Hospital

Stroke ExpertLocation: Anywhere

REACH Telemedicine ProtocolREACH Telemedicine Protocol

Suspected stroke Suspected stroke patient arrives the patient arrives the Spoke calls the Spoke calls the MUSC Admit MUSC Admit Transfer Center Transfer Center (ATC) to request a (ATC) to request a “REACH Stroke “REACH Stroke consult”consult”

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REACH—Spoke Side of WebpageREACH—Spoke Side of Webpage

REACH Telemedicine Protocol REACH Telemedicine Protocol

Consultant logs into the Consultant logs into the REACH secure website to REACH secure website to access and control the access and control the REACH cart (mobile unit REACH cart (mobile unit composed of a computer, composed of a computer, LCD screen, and fully LCD screen, and fully adjustable camera) to do adjustable camera) to do the exam and NIHSSthe exam and NIHSS

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REACH Telemedicine Protocol REACH Telemedicine Protocol

Consultant speaks to the patient and/or Consultant speaks to the patient and/or family, performs the NIH Stroke Scale, and family, performs the NIH Stroke Scale, and views the CT scan that the site has previously views the CT scan that the site has previously uploaded to the REACHCall website uploaded to the REACHCall website

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REACH Telemedicine Protocol REACH Telemedicine Protocol

The consultant examines the patient using The consultant examines the patient using the NIHSS with the help of spoke nursethe NIHSS with the help of spoke nurse

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REACH Telemedicine Protocol REACH Telemedicine Protocol Cont.Cont.

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Grand Strand

McLeod Florence

Waccamaw

Georgetown

Marion

Williamsburg

Coastal Carolina

Piedmont

Camden

McLeodDillon

REACH Data REACH Data May 2008 – June 2010May 2008 – June 2010

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10 Spoke Hospitals10 Spoke Hospitals1857 Hospital beds1857 Hospital beds360,000 ED visits/yr360,000 ED visits/yr

Future PlansFuture Plans

Overlay onto this clinical Overlay onto this clinical service network a service network a “distributed translational “distributed translational research grid” capable of research grid” capable of facilitating SCTR objectivesfacilitating SCTR objectives

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IntroductionIntroductionTranslational research can be time sensitive, Translational research can be time sensitive, non time sensitive, observational or treatment non time sensitive, observational or treatment studies studies

We can find no examples using a telemedicine We can find no examples using a telemedicine platform for time sensitive translational platform for time sensitive translational research research

But great potential exists to enroll subjects But great potential exists to enroll subjects acutely or follow research subjects who live acutely or follow research subjects who live some distance from the academic some distance from the academic hub hub

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What REACH OffersWhat REACH Offers REACH MUSC offers a novel way to expand translational research REACH MUSC offers a novel way to expand translational research capacity capacity

A research-ready REACH “distributed network” would add A research-ready REACH “distributed network” would add qualitatively & quantitatively to SCTR’s capacity for translational qualitatively & quantitatively to SCTR’s capacity for translational research. research.

Added value:Added value: Qualitative improvements in capacity :Qualitative improvements in capacity :

Access and recruit patients earlier in the course of their symptoms Access and recruit patients earlier in the course of their symptoms or before and shortly after they are treatedor before and shortly after they are treatedeither with standard care or research therapies.either with standard care or research therapies.

Quantitative addition to the pool of potential research candidates.Quantitative addition to the pool of potential research candidates.

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What REACH OffersWhat REACH Offers REACH MUSC offers a novel way to expand translational research REACH MUSC offers a novel way to expand translational research capacity and could be used for routine follow ups capacity and could be used for routine follow ups

Greatest contribution would be expansion of severely time Greatest contribution would be expansion of severely time limited observational or treatment studieslimited observational or treatment studies

With REACH carts in emergency rooms, the current program is With REACH carts in emergency rooms, the current program is physically well placed for urgent evaluationphysically well placed for urgent evaluation

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Methods: Methods: Assessment of ReadinessAssessment of Readiness To assess the potential & challenges, To assess the potential & challenges, accurate information needs to be accurate information needs to be obtained for each site from:obtained for each site from:1.1. Hospital leadershipHospital leadership2.2. Key staff members including ED Key staff members including ED

physicians & nurses physicians & nurses 3.3. Patients and community Patients and community

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Assessment of ReadinessAssessment of Readiness

Key domains of interestKey domains of interest

InterestInterestExperienceExperienceInfrastructureInfrastructureProtocolsProtocolsProcessesProcessesNeedsNeeds

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Methods: Assessment Scoring Methods: Assessment Scoring From staff interviews: From staff interviews: a) Does the staff appear to support the idea of a) Does the staff appear to support the idea of participating in clinicalparticipating in clinical research involving acute and time sensitive research involving acute and time sensitive protocols? protocols? b) Is staff reluctance evident?b) Is staff reluctance evident?

Community will be characterized as: Community will be characterized as: a) Enthusiastic about the idea;a) Enthusiastic about the idea;b) Cautiously interested; b) Cautiously interested; c) Without evident interest in, or trust of, c) Without evident interest in, or trust of,

participating in clinical research participating in clinical research

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Methods: Site CategoriesMethods: Site Categories

Tier 1 -- ready, willing, able & Tier 1 -- ready, willing, able & experienced, (at least one study)experienced, (at least one study)

Tier 2 -- willing, but lacking experience, Tier 2 -- willing, but lacking experience, and some key elementsand some key elements

Tier 3 -- willing but lacking nearly all the Tier 3 -- willing but lacking nearly all the key elements and without relevant key elements and without relevant experienceexperience

Tier 4---not interested or sees itself as Tier 4---not interested or sees itself as unable to participate unable to participate

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Examples of Likely ProjectsExamples of Likely ProjectsMinocycline for acute strokeMinocycline for acute stroke Medical College of Georgia grant application with MUSC as a participantMedical College of Georgia grant application with MUSC as a participant

““Sham Stroke Trial”Sham Stroke Trial” Purpose: Test readiness/ability to conduct studies with IV treatmentsPurpose: Test readiness/ability to conduct studies with IV treatments Subject: REACH stroke patient who is not a candidate for thrombolysis Subject: REACH stroke patient who is not a candidate for thrombolysis

and who is expected to be transferred to MUSC. and who is expected to be transferred to MUSC. Method: Randomized; “drug” assigned, with dose and infusion rate. Method: Randomized; “drug” assigned, with dose and infusion rate. Expected Result: Protocol execution judged when subject arrives MUSCExpected Result: Protocol execution judged when subject arrives MUSC

Early biomarkers for strokeEarly biomarkers for stroke First phase would require a few research related steps that should not slow First phase would require a few research related steps that should not slow down the clinical evaluation and treatment, including: down the clinical evaluation and treatment, including:

1) consenting1) consenting2) drawing blood into specified media2) drawing blood into specified media3) handling the specimen properly3) handling the specimen properly4) recording the data4) recording the data5) getting the sample and data to the hub5) getting the sample and data to the hub

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More Likely ProjectsMore Likely ProjectsClotting abnormalities after IV thrombolysisClotting abnormalities after IV thrombolysis After consent the pre-treatment PT/PTT and INR as well as fibrinogen could be used for After consent the pre-treatment PT/PTT and INR as well as fibrinogen could be used for

research, then labs drawn during/after the infusion. research, then labs drawn during/after the infusion. Possible funding opportunity: Genentech research foundation Possible funding opportunity: Genentech research foundation Potential case comparison of post infusion research behavior Potential case comparison of post infusion research behavior

At drip and keep sites At drip and keep sites Hub site, when drip and ship patients/subjects are enrolled Hub site, when drip and ship patients/subjects are enrolled

Non time sensitive sample collectionNon time sensitive sample collection Seek/obtain gene samples from stable patients with common/rare conditions Seek/obtain gene samples from stable patients with common/rare conditions

Real time subject monitoring using “smart systems” Real time subject monitoring using “smart systems” and linked EMRand linked EMR ““Smart systems” scan for subjects admitted to ED/hospital with desired Smart systems” scan for subjects admitted to ED/hospital with desired

conditions for research and alerts investigative teams in “real time” conditions for research and alerts investigative teams in “real time” In keeping with state effort to develop RIO or HIE and growth in hospital EMR. In keeping with state effort to develop RIO or HIE and growth in hospital EMR. Conceptual planning should be done to open this avenue of research recruitmentConceptual planning should be done to open this avenue of research recruitment Importance: Importance:

Research staff not likely to be present in partner sites when research Research staff not likely to be present in partner sites when research candidates present at local sites. candidates present at local sites. A pop-up reminder or alerting system could assist, at least for simple studies.A pop-up reminder or alerting system could assist, at least for simple studies.

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ConclusionsConclusions

A conceptual framework for evaluation, preparation, and A conceptual framework for evaluation, preparation, and testing of research capability at REACH MUSC sites has testing of research capability at REACH MUSC sites has been described. been described.

Considerable effort and resources will be needed to Considerable effort and resources will be needed to transform the REACH MUSC clinical stroke network into a transform the REACH MUSC clinical stroke network into a research network.research network.

This cannot be carried out until/unless a real interest and need from This cannot be carried out until/unless a real interest and need from the hub, or funding for a demonstration project, can be obtained. the hub, or funding for a demonstration project, can be obtained.

Prudent to make an assessment of who needs such a Prudent to make an assessment of who needs such a network, and who might use it if it was developed.network, and who might use it if it was developed.

Perhaps SCTR and the Success Center can help Perhaps SCTR and the Success Center can help Possible funding through the Genentech research foundationPossible funding through the Genentech research foundation

Need input from experts outside the MUSC Stroke Center, Need input from experts outside the MUSC Stroke Center, such as research pharmacists, ED nurses and at least one such as research pharmacists, ED nurses and at least one interested spoke site.interested spoke site.