Stroke Team Remote Evaluation Using a DigitalObservation Camera in Arizona

The Initial Mayo Clinic Experience Trial

Bart M. Demaerschalk, MD, MSc, FRCP(C); Bentley J. Bobrow, MD; Rema Raman, PhD;Terri-Ellen J. Kiernan, MSN, FNP-BC, CC, RN, CNRN; Maria I. Aguilar, MD;

Timothy J. Ingall, MD, PhD; David W. Dodick, MD, FRCP(C); Michael P. Ward, DO;Phillip C. Richemont, MD; Karina Brazdys, RN; Tiffany C. Koch, BPsych; Madeline L. Miley, BSc;Charlene R. Hoffman Snyder, CNP, NP, RNN; Doren A. Corday, BS; Brett C. Meyer, MD; for the

STRokE DOC AZ TIME Investigators

Background and Purpose—Telemedicine techniques can be used to address the rural–metropolitan disparity in acute strokecare. The Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) trial reported more accuratedecision making for telemedicine consultations compared with telephone-only and that the California-based research networkfacilitated a high rate of thrombolysis use, improved data collection, low risk of complications, low technical complications,and favorable assessment times. The main objective of the STRokE DOC Arizona TIME (The Initial Mayo ClinicExperience) trial was to determine the feasibility of establishing, de novo, a single-hub, multirural spoke hospital telestrokeresearch network across a large geographical area in Arizona by replicating the STRokE DOC protocol.

Methods—Methods included prospective, single-hub, 2-spoke, randomized, blinded, controlled trial of a 2-way,site-independent, audiovisual telemedicine system designed for remote examination of adult patients with acute strokeversus telephone consultation to assess eligibility for treatment with intravenous thrombolysis. The primary outcomemeasure was whether the decision to give thrombolysis was correct. Secondary outcomes were rate of thrombolytic use,90-day functional outcomes, incidence of intracerebral hemorrhages, and technical observations.

Results—From December 2007 to October 2008, 54 patients were assessed, 27 of whom were randomized to each arm. MeanNational Institutes of Health Stroke Scale score at presentation was 7.3 (SD 6.2) points. No consultations were aborted;however, technical problems (74%) were prevalent in the telemedicine arm. Overall, the correct treatment decision wasestablished in 87% of the consultations. Both modalities, telephone (89% correct) and telemedicine (85% correct), performedwell. Intravenous thrombolytic treatment was used in 30% of the telemedicine and telephone consultations. Good functionaloutcomes at 90 days were not significantly different. There were no statistically significant differences in mortality (4% intelemedicine and 11% in telephone) or rates of intracerebral hemorrhage (4% in telemedicine and 0% in telephone).

Conclusions—It is feasible to extend the original STRokE DOC trial protocol to a new state and establish an operationalsingle-hub, multispoke rural hospital telestroke research network in Arizona. The trial was not designed to have sufficientpower to detect a difference between the 2 consultative modes: telemedicine and telephone-only. Whether by telemedicine ortelephone consultative modalities, there were appropriate treatment decisions, high rates of thrombolysis use, improved datacollection, low rates of intracerebral hemorrhage, and equally favorable time requirements. The learning curve was steep forthe hub and spoke personnel of the new telestroke network, as reflected by frequent technical problems. Overall, the resultssupport the effectiveness of highly organized and structured stroke telemedicine networks for extending expert stroke care intorural remote communities lacking sufficient neurological expertise. (Stroke. 2010;41:00-00.)

Key Words: stroke � telemedicine � rural hospitals � rural health � state government� randomized controlled trials

Received November 27, 2009; accepted January 12, 2010.From the Department of Neurology (B.M.D., T.-E.J.K., M.I.A., T.J.I., D.W.D., C.R.H.S.), the Division of Clinical Research Services (K.B.), and the

Division of Information Technology (D.A.C.), Mayo Clinic Arizona, Phoenix, Ariz; Arizona Department of Health Services Bureau of EmergencyMedical Services and Trauma System and Maricopa Medical Center (B.J.B.), Phoenix, Ariz; Department of Neurosciences (R.R., B.C.M.), Universityof California San Diego School of Medicine; Department of Emergency Medicine (M.P.W.), Kingman Regional Medical Center, Kingman, Ariz;Department of Emergency Medicine (P.C.R.), Yuma Regional Medical Center, Yuma, Ariz; Arizona Research Center (T.C.K.), Phoenix, Ariz; and theDepartment of Neuroscience (M.L.M.), Loyola University, Chicago, Ill.

Correspondence to Bart M. Demaerschalk, MD, MSc, FRCP(C), Professor of Neurology, Director, Cerebrovascular Diseases Center, Director, StrokeTelemedicine for Arizona Rural Residents, Division of Cerebrovascular Diseases, Division of Critical Care Neurology, Department of Neurology, MayoClinic Hospital, 5777 E Mayo Blvd, Phoenix, AZ 85054. E-mail demaerschalk.bart@mayo.edu

© 2010 American Heart Association, Inc.

Stroke is available at http://stroke.ahajournals.org DOI: 10.1161/STROKEAHA.109.574509

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Rural communities endure a shortage of stroke specialistcare.1,2 Telemedicine techniques can be implemented

within stroke networks of care to address the rural–metro-politan disparity that exists.3,4 The Stroke Team RemoteEvaluation using a Digital Observation Camera (STRokEDOC) trial5 reported both that stroke telemedicine (audio–video) consultations resulted in more accurate thrombolysiseligibility decision making compared with telephone-onlyconsultations, and that the University of California SanDiego–based research network facilitated a high rate ofthrombolysis use, improved data collection, low risk ofcomplications, low technical complications, and favorableassessment times.

The main objective of the STRokE DOC Arizona TIME(The Initial Mayo Clinic Experience) trial was to determine thefeasibility of establishing, de novo, a single-hub, multiruralspoke hospital telestroke research network in Arizona byreplicating the University of California San Diego STRokEDOC protocol. In addition, the purpose was to determine theeffectiveness of telemedicine and telephone-only consultationmodes for decision making in acute stroke in a different stateamong different hospitals and providers.

MethodsPatientsBetween December 2007 and October 2008, the dedicated STRokEDOC Arizona (AZ) TIME trial alphanumeric group pager hotlinewas activated 84 times. Seventy-nine patients were determined to bepotentially eligible, 55 patients were consented, and 54 were enrolledin the study. Those 54 patients underwent random assignment toeither telemedicine or telephone-only consultations when they pre-sented with an acute stroke syndrome at one of 2 remote sites(spokes) located 186 to 205 miles (299 to 330 kilometers), respec-tively, from an academic metropolitan Joint Commission certifiedprimary stroke center hub hospital. The trial flow (Figure) describesthe reasons patients were determined to be ineligible, the reasonswhy investigators elected not to consent, and the instances wheneither no surrogates or no certified spoke investigators were availablefor consent. The typical reasons that investigators elected not toproceed with consenting of otherwise eligible patients were ultra-early emergency medicine and vascular neurologist investigatorcollaborative perception that the patient was not eligible for intrave-nous thrombolysis (eg, time confirmed to exceed 3 hours, rapidresolution of focal neurological symptoms, stroke mimic, intracere-bral hemorrhage reported on CT, minor persistent focal neurologicaldeficits, and past history of intracerebral hemorrhage). This trial wasundertaken before publication of the American Heart AssociationScientific Statement concerning a 4.5-hour expanded time window.6

We authorized a standard of clinical practice telephone-only run-inperiod of 1-month duration before trial start date while we acquiredthe STRokE DOC camera equipment and conducted the necessaryhub and spoke training. This pretrial period allowed time for spokeemergency medicine and hub vascular neurology investigators tofamiliarize themselves with the hotline activation protocol, the trialprotocol, and each other. Trial inclusion criteria were �18 years ofage, ability for patient or surrogate to sign consent, symptoms andsigns consistent with an acute stroke syndrome, and onset �3 hours.Prisoners were excluded from enrollment. Written informed consentwas obtained at the spoke by an emergency physician investigatorand sent to the hub vascular neurology investigator by electronic faxfor final verification before randomization.

The trial was approved by each participating spoke hospitalinstitutional review board and also by the Mayo Clinic institutionalreview board, with authorization for central oversight. The trial wasregistered at ClinicalTrials.gov (No. NCT00623350).

ProceduresA description of how the early Arizona hub and spoke telestrokenetwork was established and descriptions of the technologicalfactors, information technology, security, data encryption, theSTRokE DOC camera system and technique, and prospective reli-ability have already been published.3,5,7–9

The hub stroke team was contacted directly by the STRokE DOCAZ TIME trial alphanumeric group pager system when a patient withacute stroke symptoms presented at the spoke emergency department.The designated on-call hub vascular neurologist telephoned the appli-cable spoke emergency department and spoke briefly with the spokeemergency physician to determine patient eligibility status. Thepublished STRokE DOC trial protocol5 was replicated. Eligibleconsented patients were randomized with permuted blocks that werestratified by study site to prevent group imbalances. The randomiza-tion to telemedicine or telephone-only consultation was performed inreal time using a web-based system, eliminating investigator prefer-ence bias. For patients who were randomized to telemedicine, theconsultation started with site-independent access to the telemedicinesystem. The hub consultant established audio and video contact withthe spoke site and immediately acquired a medical history from thepatient and all accompanying relatives, supplemented by verbal andwritten reports from emergency medical systems, physicians, andnursing staff. After the history acquisition, the hub consultantperformed a National Institutes of Health Stroke Scale (NIHSS)examination with the aid of healthcare provider staff at the spokesite. Other relevant elements of the examination were performed by,or reported to, the hub consultant as appropriate. Diagnostic testresults were reported to the hub consultant by the spoke emergencyphysician, either verbally or by e-fax. Head CT images were viewedby hub neurologist with digital imaging and communications inmedicine viewer. For patients who were randomized to telephone-only consultation, the hub consultant queried the spoke emergencyphysician about the history, physical examination including theNIHSS examination, the diagnostic test results, and the spokeradiologist’s report of the CT. The telephone communication withthe emergency physician was supplemented, whenever feasible, bydirect telephone communication between hub consultant and patientor surrogate. Neither the video nor the head CT images were viewedby the hub consultant with telephone-only consultations.

In both consultative modalities, the hub consultant completed aprespecified case report form. The consultant was free to repeat orrequest a repeated examination item and could speak with thepatient, relatives, witnesses, and emergency nurses. Clinical deficitand functional scale scores (including NIHSS and prestroke andpoststroke modified Rankin scale scores) were calculated by the hubconsultant with the information provided by the bedside emergencyphysician or other healthcare providers. After review of the history,the examination findings, stroke scales, and head CT interpretation,the hub consultant presented a recommendation regarding patienteligibility for intravenous thrombolysis to the spoke emergencyphysician.

The main objective of the trial was to establish the feasibility ofestablishing a single-hub, multirural spoke hospital telestroke re-search network in Arizona by replicating the STRokE DOC trialprotocol in a new state, new hub, new spokes, among telemedicine-naïve practitioners.

An additional objective was to further assess the efficacy oftelephone and telemedicine consultations for decision making. Theoutcome measure was whether the decision to give thrombolytictreatment was appropriate, as established with a rigorous multistage,masked adjudication process, the details of which have been pub-lished.9 Additional outcomes were rates of thrombolytic use, 90-dayoutcomes, rates of intracerebral hemorrhage, the completeness of thedata, and technical observations.

Equipment included Internet-enabled desktops and laptops usedby a pool of 4 American Board of Psychiatry and Neurology–certified, fellowship-trained vascular neurologists and the telemedi-cine systems at remote emergency departments. The software en-abled site-independent access to 2-way audio and high-resolutionvideo over standard Internet connections (BF Technologies).

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The previously described STRokE DOC adjudication committeeand levels 1, 2a, 2b, 3a, and 3b adjudication procedures were alsoused for the STRokE DOC AZ TIME trial.5,9

Statistical AnalysisSTRokE DOC AZ TIME trial was principally a feasibility trial. Itwas not designed to have sufficient power to detect a statisticallysignificant difference between the 2 consultative modes: telemedi-cine and telephone-only. Determination of the trial sample size of 54randomized subjects was made based on the number of participantsthe investigators estimated to be achievable in the course of the1-year trial. The Cochran-Mantel-Haenszel test, stratified by studysite, was used to compare the correct decision rate (primary studyoutcome) between treatment groups. A Fisher exact test was used forall other correct decision outcomes, rate of thrombolytic use, rate ofintracranial hemorrhage, mortality, and the 90-day modified Rankinscale score (0 to 1 versus 2 to 6). A Wilcoxon rank sum test was usedfor 90-day Barthel index and time point comparisons. All analyseswere performed using the statistical software R (version 2.9.0).

Whereas in the STRokE DOC trial,5 patients were enrolled forwhom treatment disagreements were impossible, thus artificiallyenhancing agreement in both arms, this was not the case in STRokEDOC AZ TIME (Figure).

Role of the Funding SourceThe sponsors of the trial had no role in the trial design, trialconduct, data acquisition, data analysis, data interpretation, orwriting of the report. The corresponding author had full access toall data in the study and final responsibility for the decision tosubmit for publication.

ResultsThe primary objective of this feasibility trial was satisfacto-rily achieved: an operational, single-metropolitan hub pri-mary stroke center, double-rural hospital spoke researchnetwork was established in Arizona.

Fifty-four patients presenting to a participating emergencydepartment were randomized (Figure). Overall, 39 of 54(72%) patients arrived by emergency medical systems. Therewere no demographic differences between groups. Ninety-day outcomes were available for 46 of 54 (85%) patients.Loss to 90-day follow-up was not significantly differentacross the 2 consultative methodology groups. The riskfactor, myocardial infarction (P�0.0183), was present in a

Figure. Trial flow.

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higher proportion of the telemedicine group subjects, but theproportions having other risk factors were not significantlydifferent (Table 1).

Table 2 displays subjects’ prestroke functional status andstroke severity at baseline. The mean NIHSS score was 7.3for the overall trial cohort and 12.2 for thrombolysis subset.Seventy-three percent of the trial cohort presented with strokesresulting in moderate to severe disability at baseline. BaselineCT scans were interpreted to be normal in 30%, harbor aradiological contraindication to thrombolysis in 7%, andreveal intracerebral hemorrhage in 2%.

A single subject was excluded from the evaluation timeanalysis because it was ultimately determined that the strokeonset had been several days before his hospital assessment.Table 3 reveals that the evaluation times for subjects in the 2consultative modes featured no statistically significant differ-ences. Overall, mean stroke symptom onset to emergencydepartment door arrival time was 81 minutes. Mean door-to–emergency physician evaluation time was 8.1 minutes; totelestroke hotline call, 41.4 minutes; to consent, 49.5 minutes;to neurological assessment, 79.6 minutes; to CT interpreta-tion, 89.4 minutes; and to treatment decision, 95.6 minutes.Mean telestroke hotline call–to-consent was 8.0 minutes;consent to neurological assessment, 30.1 minutes, neurolog-ical assessment start to decision, 16.1 minutes; and decisionto thrombolysis (when applicable) 19.8 minutes.

Correct treatment decisions were made in similar propor-tions of the telemedicine and telephone-only consultationgroups, as demonstrated by the primary outcome measure(level 2b adjudication) 87% overall (85% telemedicine and89% telephone-only; P�0.999), and in identical proportions,

89%, when assessed at level 1 (Table 4). Overall intravenousthrombolytic treatment was used in identical proportions(30%) of the telemedicine and telephone consultations. Therewere no differences between the groups in the proportions ofsubjects who reached good 90-day functional outcomes asassessed by the Barthel index (95 to 100) and the modifiedRankin Scale scores (dichotomized 0 to 1) or mortality.

There were no statistically significant differences in theproportion of correct treatment decisions between the 2consultative modes in the thrombolysis subgroup (Table 4),and only 1 patient sustained a symptomatic intracranialhemorrhage overall.

All level-2b thrombolysis eligibility protocol violations aredisplayed in Table 5. The most common violation in the trialpatients treated with thrombolysis was time of stroke symp-tom onset remaining unclear. The violations among trialpatients who had not received thrombolytics were variable(Table 5).

The demographics and NIHSS analysis combined showedno difference in noncompleted data between telephone-onlyand telemedicine consultation groups.

Site-independent evaluations were performed in 27 (100%)of the telemedicine consultations, using local area networkwired Internet access or broadband wireless access.

The distribution of consultations across sites, emergencyphysicians, and neurology consultants were as follows: 34(63%) consultations were conducted at one site and 20 (37%)at the second site. Twenty different spoke emergency physi-cians requested consultations: 8 (40%) of them initiated asingle consultation, 7 (35%) initiated between 2 and 4consultations, and 5 (25%) initiated �5 consultations. One

Table 1. Subject Demographics and Risk Factors

Patient Characteristics Overall (n�54) Telemedicine (n�27) Telephone (n�27) P Value

Age (years)

Mean�SD 66.3�13.5 66.4�13.6 66.1�13.6 �0.99

Female, n (%) 27 (50) 13 (48) 14 (52) �0.99

Race, n (%) 52 (96) 26 (96) 26 (96) �0.99

White 2 (4) 1 (4) 1 (4)

Black

Not Hispanic, n (%) 47 (87) 23 (85) 24 (89) �0.99

Weight (kg)

Mean�SD 84.7�19.7 88.2�18.8 80.9�20.3 0.49

Risk factors, n (%) and �% unknown�

Coronary disease 16 (30) �6%� 11 (41) �4%� 5 (19) �7%� 0.23

Myocardial infarction 10 (19) �9%� 9 (33) �7%� 1 (4) �11%� 0.02

Previous cerebrovascular accident 14 (26) �2%� 8 (30) �0%� 6 (22) �4%� 0.76

Atrial fibrillation 10 (19) �6%� 5 (19) �4%� 5 (19) �7%� �0.99

Diabetes 14 (26) �4%� 6 (23) �0%� 8 (30) �7%� 0.32

Hypertension 40 (74) �2%� 22 (82) �0%� 18 (67) �4%� 0.35

Hyperlipidemia 19 (35) �11%� 10 (37) �7%� 9 (33) �15%� 0.85

Family history stroke/transientischemic attack

6 (11) �60%� 4 (15) �67%� 2 (7) �52%� 0.22

Present alcohol use 6 (11) �41%� 2 (7) �33%� 4 (15) �48%� 0.40

Present tobacco use 14 (26) �15%� 8 (30) �(7%� 6 (22) �22%� 0.44

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remote consultant performed 31 (57%) of the consultations,the second performed 13 (24%), the third performed 9 (17%),and the fourth conducted a single (2%) consultation. At onesite, emergency medicine residents, supervised by emergencyphysician investigators, participated in 16 of 34 (47%) of theconsultations. There was no apparent relationship betweenprovider or spoke hospital experience and the occurrence ofadjudication disagreements.

Technical problems were noted in 20 of 27 (74%) oftelemedicine consultations and in 0 of 27 (0%) telephoneconsultations. None of the technical problems prevented thedetermination of a treatment decision, but some did impactthe time to treatment decision. Of the 20 observations, onewas attributable to video-only, 3 to Internet connection–only,5 were attributable to audio-only, 5 to digital imaging andcommunications in medicine–only, and 6 were attributable tomultiple or other causes.

There were no differences in diagnoses. Only 3 of 54 (6%)subjects were discharged from the emergency departmentwith a diagnosis other than stroke or transient ischemicattack.

Patients were determined ineligible for thrombolysis forseveral reasons, including, in order of descending proportions,minor deficit (36%), time since stroke onset exceeded 3 hours(29%), rapid spontaneous resolution (14%), recent ischemicstroke (7%), active genitourinary bleeding (7%), anticoagulantuse, and international normalized ratio �1.7 (7%).

DiscussionThe results of this prospective, blinded, randomized trialconfirm that the successful elements of the University ofCalifornia San Diego STRokE DOC hub and spoke telestrokenetwork were transferable and reproducible in a completelynew and separate geographic location among telemedicinenaïve healthcare institutions and personnel. The results dem-onstrate that both telemedicine and telephone, incorporatedinto a state network of emergency stroke care, are efficaciousfor making acute treatment decisions.

Telephone-only and telemedicine consultations resultedin 89% and 85% correct decisions, respectively, withoutany statistically significant difference. STRokE DOC AZtelephone-only consultations may have overperformed com-pared with STRokE DOC5 (82% correct) for the followingreasons: STRokE DOC AZ TIME trial authorized a 1-monthtelephone-only run-in experience before randomization, andthe vascular neurology consultants devoted approximately thesame time to telephone consultations as they did to telemedi-cine consultations (consent to decision time interval), 43.7minutes versus 48.6 minutes, respectively. Consultants regu-larly and liberally reacquired the history directly by telephonefrom patient, family members, and witnesses in addition torequesting repeat neurological assessments from emergencydepartment nurses and physicians. A testament to the thor-oughness of the telephone consultations was the comparablecompleteness of data collection between telephone and tele-

Table 2. Subject Stroke Severity at Baseline

Baseline Stroke Severity Overall (n�54) Telemedicine (n�27) Telephone (n�27) P Value

Prestroke mRS (complete scale) n (%)

Dichotomized (0–1) 46 (85) 23 (85) 23 (85) �0.99

0�No symptoms 42 (78) 20 (74) 22 (82)

1�No significant disability 4 (7) 3 (11) 1 (4)

2�Slight disability 5 (9) 3 (11) 2 (7)

3�Moderate disability 3 (6) 1 (4) 2 (7)

4�Moderate to severe disability 0 (0) 0 (0) 0 (0)

5�Severe disability 0 (0) 0 (0) 0 (0)

Baseline mRS (complete scale) n (%)

Dichotomized (0–1) 6 (11) 3 (11) 3 (11) �0.99

0�No symptoms 2 (4) 1 (4) 1 (5)

1�No significant disability 4 (7) 2 (7) 2 (7)

2�Slight disability 8 (15) 3 (11) 5 (19)

3�Moderate disability 11 (20) 6 (22) 5 (19)

4�Moderate to severe disability 25 (46) 13 (48) 12 (44)

5�Severe disability 4 (7) 2 (7) 2 (7)

NIHSS mean�SD (median) 7.3�6.2 (5.5) 7.1�5.7 (5) 7.6�6.7 (6) 0.82

Modified NIHSS mean�SD (median) 5.2�5.3 (3) 5.3�5.2 (3) 5.1�5.6 (3) 0.89

Baseline CT

Scan normal 16 (30%) 7 (26%) 9 (33%) 0.77

Primary intracerebral hemorrhage 1 (2%) 1 (4%) 0 (0%) �0.99

CT contraindication to rt-PA 4 (7%) 2 (7%) 2 (7%) �0.99

rt-PA subset NIHSS (mean�SD) 12.2�7.6 12.6�6.1 11.8�9.2 0.64

rt-PA subset modified NIHSS (mean�SD) 9.1�6.7 10.1�5.6 8.0�7.8 0.49

mRS indicates modified Rankin Scale; rt-PA, recombinant tissue plasminogen activator.

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medicine modalities. STRokE DOC AZ telemedicine consul-tations may have underperformed compared with the originalSTRokE DOC trial (98% correct) because of the relativetelemedicine inexperience of the hub and spoke healthcarepersonnel and the high proportion of technical observationswitnessed by the telemedicine consultations. Ultimately, thetrial was not designed to have sufficient power to detect adifference between the 2 consultation modalities, and nostatistically significant differences were observed. Funda-mentally, the results display that both telemedicine andtelephone consultations rendered satisfactory levels of correcttreatment decision making regarding thrombolysis eligibilityamong remote acute stroke patients in the context of arigorous clinical trial protocol within an established strokenetwork of care.

Historically, rural Arizona hospitals, outside metropolitanTucson and Phoenix, have thrombolysed an estimated 2% to4% of all ischemic stroke patients requiring admission.4 TheSTRokE DOC AZ trial demonstrated a substantially higherproportion of patients at the 2 remote participating hospitalsreceiving thrombolysis (30%), regardless of consultativemodality. Presumably, the supportive network that was es-tablished and the real-time emergency vascular neurologyconsultative support, by telephone or telemedicine, for emer-gency physicians facilitated the accurate diagnoses, appropri-ate decision making, and thrombolysis administration toeligible stroke patients.

Regarding the measurement of long-term morbidity andmortality outcomes, Meyer et al5 caution against comparisons

being made between different trials with different patient popu-lations or different stroke care protocols and instead recommendlarger prospective trials with more patients given thrombolytictreatment after telemedicine consultations. To that end, severalresearch initiatives are under way or planned. For example, anew prospective stroke telemedicine trial in Arizona is alreadyunder way: Stroke Telemedicine for Arizona Rural Residents(STARR) Network Trial (ClinicalTrials.gov identifierNCT00829361). The objective of the STARR Network Trial isto establish a system for the prospective collection, recording,and regular analysis of telestroke patient consultation and caredata for the purpose of quality measure assessment and improve-ment and benchmarking against other national and internationaltelestroke programs. A second example under way is theSTRokE DOC Long-Term Outcomes (ClinicalTrials.gov iden-tifier NCT00936455). Finally, a pooled analysis of the STRokEDOC and STRokE DOC AZ telemedicine stroke trials isplanned.

The rate of post-thrombolytic intracerebral hemorrhagewas low: 6% overall (13% for telemedicine and 0% fortelephone; P�NS), as low as in the original STRokE DOCtrial. It is reassuring that despite the potential risks ofestablishing a novel telestroke research network in a neigh-boring state among new consultant providers in new remotehospitals with technological complexities, major adverseoutcomes to patient care were preventable.

There were no statistically significant differences in timeincrements between the telemedicine and telephone groups,even for the consent to decision (which includes the actual

Table 3. Subject Assessment, Decision, and Treatment Times

Stroke Code Times Overall (min) Telemedicine (min) Telephone (min) P

Onset to door* 81.0�92.2 (n�53) 88.2�127.8 (n�26) 74.1�34.5 (n�27) 0.10

Onset to call* 122.5�93.8 (n�53) 130.5�130.5 (n�26) 114.8�33.3 (n�27) 0.15

Onset to EKG* 169.5�99.6 (n�53) 182.3�138.8 (n�26) 157.3�31.8 (n�27) 0.35

Onset to lab* 170.5�99.2 (n�53) 182.3�138.8 (n�26) 159.1�30.0 (n�27) 0.26

Onset to decision* 176.2�98.6 (n�53) 188.2�138.2 (n�26) 164.8�28.6 (n�27) 0.07

Onset to rt-PA 167.6�24.8 (n�16) 164.8�31.7 (n�8) 170.5�17.2 (n�8) 0.80

Door to physician evaluation 8.1�10.4 (n�54) 8.1. � 11.1 (n�27) 8.1�9.7 (n�27) 0.99

Door to call 41.4�23.1 (n�54) 42.2�23.0 (n�27) 40.7�23.7 (n�27) 0.76

Door to consent 49.5�37.1 (n�54) 52.0. � 37.2 (n�27) 47.0�37.5 (n�27) 0.57

Door to EKG 89.0�28.8 (n�54) 94.7�28.3 (n�27) 83.2�28.5 (n�27) 0.08

Door to lab 89.9�28.2 (n�54) 94.8�28.2 (n�27) 85.1�27.8 (n�27) 0.13

Door to neurological exam 79.6�28.1 (n�54) 81.3�28.0 (n�27) 77.9�28.6 (n�27) 0.35

Door to CT reading 89.4�29.2 (n�54) 91.4�31.1 (n�27) 87.3�27.7 (n�27) 0.35

Door to decision 95.6�28.3 (n�54) 100.5�28.4 (n�27) 90.7�27.9 (n�27) 0.12

Call to consent 8.0�34.3 (n�54) 9.8�34.6 (n�27) 6.3�34.5 (n�27) 0.68

Call to neurological exam 38.2�17.7 (n�54) 39.1�17.2 (n�27) 37.2�18.5 (n�27) 0.72

Call to decision 54.2�18.8 (n�54) 58.3�18.0 (n�27) 50.0�18.8 (n�27) 0.12

Consent to neurological exam 30.1�30.0 (n�54) 29.3�29.0 (n�27) 30.9�31.6 (n�27) 0.33

Consent to decision 46.1�31.8 (n�54) 48.6�30.7 (n�27) 43.7�33.4 (n�27) 0.12

Consent to rt-PA 70.4�43.2 (n�16) 71.3�50.2 (n�8) 69.5�38.3 (n�27) �0.99

Decision to rt-PA 19.8�19.6 (n�16) 23.3�26.7 (n�8) 16.3�9.0 (n�27) 0.87

rt-PA indicates recombinant tissue plasminogen activator.*One patient was excluded (outlier).

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consultation time interval). This is remarkable and stronglysuggests that the investigators invested sufficient time, re-gardless of the consultative modality, to determine the salientelements of the clinical assessment and to complete therequisite data fields in the case report forms. The actualconsultation time interval is best described as the differencebetween consent to decision and consent to neurologicalexamination (eg, 46.1 minutes minus 30.1 minutes, whichequals 16 minutes).

Technical problems were noted in 74% of the STRokEDOC AZ telemedicine consultations (compared with only19% in the original STRokE DOC trial). The reasons wereplentiful. The explanation that had the greatest impact wasthat telemedicine use conflicted with Mayo Clinic corporatesecurity. The network configuration and Mayo Clinic laptopsecurity profiles adversely affected the use of telemedicine.The problems prevented the smooth and uninterrupted use ofthe Accessvideo client and digital imaging and communica-tions in medicine. The technical issues witnessed ranged fromtrusted site configuration to performance problems. Regular

changes to the system arose from profile updates that reset theconfiguration of Accessclient and prevented the use of audioand video from spoke sites. Accessclient itself had built-inHealth Insurance Portability and Accountability Act–compli-ant security, which accounted for slowdown when coupledwith Mayo Clinic corporate security profiles. What the trialexperience eventually revealed was that the best way to runthe telemedicine system was to have it installed on a standardlaptop without being on the hub hospital domain. Thisallowed for full use of the product with limited issues on theremote side. Other explanations for high technical observa-tions included the lack of telemedicine experience among thevascular neurology consultants, limited technical training andtroubleshooting skills, lack of around-the-clock informationtechnology support, at hub and spokes, for the telestroke trial,and a definition for technical observation that included anyaudio, video, Internet, or digital imaging and communicationsin medicine issue, delay, or interruption, both major andminor.

Between the completion of STRokE DOC and STRokEDOC AZ TIME, the American Heart Association published ascientific statement reviewing evidence for the use of tele-medicine within stroke systems of care.10 The NIHSStelestroke examination, when administered by a stroke spe-cialist using high-quality video teleconferencing is recom-mended when an NIHSS bedside assessment by a strokespecialist is not immediately available for patients in theacute stroke setting, and this assessment is comparable to anNIHSS bedside assessment (class I; level of evidence A). Inaddition, the American Heart Association has published apolicy statement concerning recommendations for implemen-tation of telemedicine within stroke systems of care.11 Na-tional telemedicine initiatives, like those in stroke, are essen-tial to healthcare reform. Telemedicine is capable of

Table 4. Overall Group Results and ThrombolysisSubgroup Results

Analyses Telemedicine Telephone P Value*

Overall n�27 n�27

Correct decision

Level 2b (SDAC) (Primary) 85% 89% �0.99

Level 1 (SDAC) 89% 89% �0.99

Level 2a (MM) 93% 100% 0.49

Level 3a (MM) 93% 100% 0.49

Level 3b (SDAC) 85% 96% 0.35

Overall IV rt-PA treatment 30% (n�8) 30% (n�8) �0.99

Overall postconsultintracerebral hemorrhage

4% (n�1) 0% (n�0) �0.99

90-days Barthel index(95 to 100)

59% (n�13/22) 58% (n�14/24) 0.77

90 days mRS(Dichotomized 0–1)

46% (n�10/22) 38% (n�9/24) 0.61

Overall mortality 4% (n�1) 11% (n�3)

rt-PA subgroup n�8 n�8

Correct decision 0.57

Level 2b (SDAC) 63% 88% �0.99

Level 1 (SDAC) 89% 89% 0.47

Level 2a (MM) 75% 100% 0.47

Level 3a (MM) 75% 100% 0.57

Level 3b (SDAC) 63% 88% �0.99

Post rt-PA intracerebralhemorrhage

13% (n�1) 0% (n�0) 0.59

90-day Barthel index(95 to 100)

57% (n�4/7) 29% (n�2/7) 0.56

90-days mRS (dichotomized0 to 1)

43% (n�3/7) 14% (n�1/7) �0.99

Subgroup mortality 0% (n�0) 13% (n�1)

SDAC indicates STRokE DOC adjudicating committee; MM, medical monitor;rt-PA, recombinant tissue plasminogen activator; mRS, modified Rankin Scale.

*P values are from Fisher exact test.

Table 5. Adjudication Disagreements

Group Thrombolysis Reason for Disagreement

1 Telemedicine No Committee would have attempted to lowerblood pressure and treat

2 Telemedicine No Committee would have treated a patientstatus after TURP 20 days ago without

gross hematuria

3 Telemedicine Yes Committee would not have treatedbecause time of stroke onset remained

unclear

4 Telemedicine Yes Committee would not have treatedbecause time of onset remained unclear

5 Telephone No Committee would have treated thepatient’s mild deficit

6 Telephone Yes Committee would not have treatedbecause time of onset was not

documented and remained unclear

7 Telephone No Committee would have treated a patientwho fell because there was no evidence

of head trauma

Reasons for adjudication disagreements at the primary (level 2b) adjudica-tion level, including number of disagreements at that level.

TURP indicates transurethral resection of the prostate.

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addressing inequities in access to care, economic issues, andquality enhancement.12

In summary, the authors of this trial report that it is feasibleto extend the original University of California San DiegoSTRokE DOC trial protocol to a new state and establish anoperational single-hub, multirural spoke hospital telestrokeresearch network in Arizona. The feasibility trial was notdesigned to have sufficient power to detect a differencebetween the 2 consultative modes: telemedicine andtelephone-only. Within the newly established telestroke net-work, whether by telemedicine or telephone consultativemodalities, there were appropriate treatment decisions, highrates of thrombolysis use, improved data collection, low ratesof intracerebral hemorrhage, and equally favorable timerequirements. The learning curve was steep for the hub andspoke personnel of the new telestroke network, as reflectedby the frequent technical occurrences. Overall, the resultssupport the effectiveness of highly organized and structuredstroke telemedicine networks for extending expert stroke careinto rural remote communities lacking sufficient neurologicalexpertise.

AcknowledgmentsB.C.M. is credited with the idea and design for the original STRokEDOC trial protocol. B.M.D., B.J.B., and B.C.M. had the idea for anddesigned this study (STRokE DOC AZ TIME). They participated inthe acquisition, analysis, and interpretation of the data, drafting andrevision of the manuscript, and provided administrative, technical,and material support, and supervised the study. B.J.B. and B.M.B.obtained the funding. M.I.A., T.J.I., and D.W.D. participated in theacquisition of the data and revision of the manuscript. K.B. andT.C.K. participated in the research coordination, research adminis-tration, organization, data handling, and revision of the manuscript.T.E.J.K. and M.L.M. participated in the overall network and trialmanagement, logistics, organization, and revision of the manuscript.D.A.C. developed and maintained the trial network informationtechnology and assisted with revision of the manuscript. C.R.H.S.served as trial monitor and assisted with revision of the manuscript.R.R. participated in the design of the study, the analysis andinterpretation of data, revision of the manuscript, and statisticalanalysis. M.P.W. and P.C.R. participated in organization of therespective participation of their respective spoke hospital site emer-gency departments, data acquisition, and revision of the manuscript.All authors have seen and approved the final version ofthe manuscript.

We acknowledge our participating facilities (Kingman and YumaRegional Medical Centers) and the published list of STRokE DOCAZ TIME investigators.3 We acknowledge Laura C. Pappagallo, RN,Kelley J. Dunkowski, MBA, and Paola G. Scarberry for being thefirst Arizona telestroke project managers; Nicole L. Olmstead forserving as telestroke research monitor; Carol B. Garrison for assist-ing us with credentialing and privileging; Michael E. Brown, JD, andPage Y. Underwood, JD, for legal input; and Marvin H. Ruona forgraphic designs.

Sources of FundingThis work was supported by an Arizona Department of HealthServices research grant and a Mayo Clinic research grant. The

telemedicine application (Accessvideo) was purchased from BFTechnologies.

DisclosuresNone.

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for the STRokE DOC AZ TIME Investigatorsand Brett C. Meyer

Brazdys, Tiffany C. Koch, Madeline L. Miley, Charlene R. Hoffman Snyder, Doren A. CordayAguilar, Timothy J. Ingall, David W. Dodick, Michael P. Ward, Phillip C. Richemont, Karina

Bart M. Demaerschalk, Bentley J. Bobrow, Rema Raman, Terri-Ellen J. Kiernan, Maria I.Initial Mayo Clinic Experience Trial

Stroke Team Remote Evaluation Using a Digital Observation Camera in Arizona. The

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