Increased telestroke call burden after the extended thrombectomy window trials.

INTRODUCTION: Clinical trials have proven the efficacy of mechanical thrombectomy in stroke patients with large-vessel occlusion presenting within 24 hours of symptom onset. Extending the thrombectomy window to 24 hours resulted in a higher number of thrombectomies being performed. However, little is known about the impact of the extended thrombectomy window on the telestroke call burden. METHODS: We used the prospectively maintained database of a telestroke network covering a large geographic area in the Southeast USA. We included patients presenting between January 2015 and December 2019. We compared the characteristics and outcomes between patients who presented before and after the publication of the extended window thrombectomy trials. RESULTS: A total of 9041 patients presented with stroke-like symptoms during the study period. Of these, 4995 presented after February 2018. There was no difference in the patient demographics in both groups. However, patients in the post extended window group had a lower National Institute of Health Stroke Scale on presentation (3 vs. 4; p < 0.001) and longer symptom-onset-to-door time (124 vs. 85 minutes; p < 0.001). The number of consults per month nearly doubled (200 vs. 103; p < 0.001) in the extended thrombectomy window era. Similarly, the number of mechanical thrombectomies performed per month increased from four to seven since extending the thrombectomy window (p < 0.001). DISCUSSION: The number of telestroke consults nearly doubled after the publication of the extended thrombectomy window trials, with an increase in the number of thrombectomies performed. These findings have important operational implications for hospitals implementing telestroke call coverage.

Beyond acute stroke: Rate of stroke transfers to a tertiary centre following the implementation of a dedicated inpatient teleneurology network.

INTRODUCTION: This study evaluated the impact of establishing an inpatient teleneurology consultation service alongside an already established telestroke network on the stroke transfers to the hub. The study also aimed to assess the financial impact of establishing this network. METHODS: Prospectively collected data on all stroke patients evaluated through our telestroke and teleneurology networks between January 2008 and March 2018 were interrogated. For all spokes (eight sites) that had both teleneurology and telestroke services, we compared the rate of transfers to the hub before and after the establishment of the teleneurology network in August 2014. The cost reduction was estimated using the Medicare 5% standard analytic files. RESULTS: A total of 4296 stroke patients were evaluated during the study period. Of these, 2493 were seen before and 1803 were seen after the implementation of the teleneurology network at the included sites. Patients in the pre-teleneurology group were older (66.4 years (SD = 14.7 years) vs. 67.8 years (SD = 15.1 years); p = 0.002). Otherwise, there were no differences in baseline characteristics. Patients in the pre-teleneurology group were more likely to be transferred to the telestroke hub (29.4% vs. 20.2%; p < 0.001). The estimated mean cost reduction for each one minus the cost of transfer was estimated to be US$4997. DISCUSSION: The implementation of an inpatient teleneurology network was associated with a significant reduction in the transfer rate of stroke patients to hospitals with a higher level of care and could lead to a significant cost reduction.

Outcomes of interfacility helicopter transportation in acute stroke care.

OBJECTIVE: To evaluate the long-term functional outcome of interhospital transfer of patients with stroke with suspected large vessel occlusion (LVO) using Helicopter Emergency Medical Services (HEMS). METHODS: Records of consecutive patients evaluated through 2 telestroke networks and transferred to thrombectomy-capable stroke centers between March 2017 and March 2018 were reviewed. Inverse probability of treatment weighting (IPTW) using the propensity score was performed to address confounding factors. Multivariate logistic regression analysis with IPTW was used to determine whether HEMS were associated with good long-term functional outcome (modified Rankin scale score ≤ 2). RESULTS: A total of 199 patients were included; median age was 67 years (interquartile range [IQR] 55-79 years), 90 (45.2%) were female, 120 (60.3%) were white, and 100 (50.3%) were transferred by HEMS. No significant differences between the 2 groups were found in mean age, sex, race, IV tissue plasminogen activator (tPA) receipt, and thrombectomy receipt. The median baseline NIH Stroke Scale score was 14 (IQR 9-18) in the helicopter group vs 11 (IQR 6-18) for patients transferred by ground (p = 0.039). The median transportation time was 60 minutes (IQR 49-70 minutes) by HEMS and 84 minutes (IQR 25-102 minutes) by ground (p < 0.001). After weighting baseline characteristics, the use of HEMS was associated with higher odds of good long-term outcome (OR 4.738, 95% CI 2.15-10.444, p < 0.001) controlling for transportation time, door-in-door-out time, and thrombectomy and tPA receipt. The magnitude of the HEMS effect was larger in thrombectomy patients who had successful recanalization (OR 1.758, 95% CI 1.178-2.512, p = 0.027). CONCLUSIONS: HEMS use was associated with better long-term functional outcome in patients with suspected LVO, independently of transportation time.

Leveraging health system telehealth and informatics infrastructure to create a continuum of services for COVID-19 screening, testing, and treatment.

OBJECTIVES: We describe our approach in using health information technology to provide a continuum of services during the coronavirus disease 2019 (COVID-19) pandemic. COVID-19 challenges and needs required health systems to rapidly redesign the delivery of care. MATERIALS AND METHODS: Our health system deployed 4 COVID-19 telehealth programs and 4 biomedical informatics innovations to screen and care for COVID-19 patients. Using programmatic and electronic health record data, we describe the implementation and initial utilization. RESULTS: Through collaboration across multidisciplinary teams and strategic planning, 4 telehealth program initiatives have been deployed in response to COVID-19: virtual urgent care screening, remote patient monitoring for COVID-19-positive patients, continuous virtual monitoring to reduce workforce risk and utilization of personal protective equipment, and the transition of outpatient care to telehealth. Biomedical informatics was integral to our institutional response in supporting clinical care through new and reconfigured technologies. Through linking the telehealth systems and the electronic health record, we have the ability to monitor and track patients through a continuum of COVID-19 services. DISCUSSION: COVID-19 has facilitated the rapid expansion and utilization of telehealth and health informatics services. We anticipate that patients and providers will view enhanced telehealth services as an essential aspect of the healthcare system. Continuation of telehealth payment models at the federal and private levels will be a key factor in whether this new uptake is sustained. CONCLUSIONS: There are substantial benefits in utilizing telehealth during the COVID-19, including the ability to rapidly scale the number of patients being screened and providing continuity of care.

Population Health Indicators Associated with a Statewide Telestroke Program.

Background: Studies show that telestroke (TS) improves rural access to care and outcome for stroke patients receiving TS services, but population health impacts of TS are not known. We examine impacts associated with South Carolina's (SC) statewide TS network on an entire state population of patients suffering acute ischemic stroke (AIS) as TS became available across SC counties. Methods: A population health study using Donabedian's conceptual model and an ecological design to describe the change observed over time in use of thrombolysis and endovascular therapy (EVT) as the SC TeleStroke Network (SCTN) diffused across SC counties. Changes in county rates of stroke mortality and discharge destination are reported. The unit of interest is the population rate for AIS patients living in a SC county. Patients' county of residence at the time of hospitalization defined county cohorts. Relative risks were estimated using logistic regression adjusted for age >75 years. Results: Overall tissue plasminogen activator (tPA) rate was 6.28%, and EVT rate was 1.10%. Patients living where SCTN was available had a 25% higher likelihood of receiving tPA (adjusted relative risk [ARR] = 1.25, 95% confidence interval [CI] = 1.15-1.36) and lower risks of mortality (ARR = 0.91; 95% CI = 0.84-0.99) or discharge to skilled nursing (ARR = 0.93; 95% CI = 0.89-0.97). Conclusions: TS diffusion affects the structure of the health system serving a county, as well as the processes of care delivered in the emergency department; these changes are associated with measurable population health improvements. Results support a population benefit of TS implementation.

Teleneurology Network to Improve Access to Neurologists for Patients in Rural Areas: A Real-World Experience.

Background: The need for neurologists has been steadily increasing over the past few years. The implementation of teleneurology networks could serve as a potential solution to this need. Methods: A retrospective review of the Medical University of South Carolina (MUSC) Teleneurology records for all consults performed between August 2014 and July 2018 was conducted. Collected data included number of consults, baseline characteristics, final diagnosis, and number of providers and hospitals over the study period. Results: A total of 4,542 Teleneurology consults were performed during the study period. The most common diagnosis was cerebrovascular disease, followed by seizure disorders. The number of consults per month increased throughout the study period from three in August 2014 to 257 in July 2018. The number of community hospitals covered has increased from 3 hospitals in August 2014 to 14 hospitals throughout the state of South Carolina in July 2018. Conclusion: Over 4 years, the MUSC teleneurology program has evolved into a robust partnership with 14 partner hospitals, and is now delivering more than 250 expert neurology consultations monthly to patients throughout the state of South Carolina.

Functional Outcomes of Intravenous Thrombolysis in Octogenarians and Nonagenarians Through Telestroke: Single-Center Experience.

Background: Patients aged ≥80 years are often underrepresented in stroke trials. Observational studies have shown that older patients have worse outcomes compared with younger patients, but outcomes in patients aged ≥80 years treated with intravenous (IV)-alteplase specifically through telestroke (TS) have not been studied. Aim: To compare clinical and safety outcomes in stroke patients aged ≥80 and 60-79 years treated with IV-alteplase via TS. Methods: The Medical University of South Carolina TS database was analyzed to identify IV-alteplase-treated patients aged 60-79 and ≥80 years between January 2015 and March 2018. Baseline demographics and TS-specific variables were compared. Clinical outcomes were assessed using the 90-day modified Rankin Scale (mRS). Safety outcomes were evaluated by comparing symptomatic intracranial hemorrhage (sICH). Multivariate logistic regression analysis was performed to determine odds ratio (OR) for good outcome (mRS 0-2) in the older age group at 90 days. Results: IV-alteplase was used in 151 patients in ≥80 years age group and 273 patients in 60-79 years age group. The older age group had more women and a higher National Institutes of Health Stroke Scale. The mean "ED-door-to-TS-consultant-login" time was shorter (21.6 min vs. 25.6 min; p = 0.048), but "TS-consultant-login-to-alteplase" time was longer (22.1 min vs. 19.3 min; p = 0.01) in the older age group. No difference was noted in eventual "door-to-needle" time. The older age group had fewer good outcomes (39.1% vs. 74%; p = 0.001) and more deaths (38% vs. 14%; p = 0.001) at 90 days. The sICH rates were similar in the two groups. The OR for good outcome in ≥80 years age group was 0.20 (95% CI: 0.12-0.34) after controlling for baseline variables. Conclusions: Stroke patients aged ≥80 years treated via TS have similar post-thrombolysis hemorrhage rates but worse clinical outcomes compared with patients aged 60-79 years.

Ischemic stroke in children and young adults with sickle cell disease in the post-STOP era.

The Stroke Prevention Trial in Sickle Cell Anemia (STOP) and Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) trials established routine transcranial Doppler ultrasound (TCD) screening, with indefinite chronic red cell transfusions (CRCT) for children with abnormal TCD as standard of care. Implementation failures and limitations to the STOP protocol may contribute to continued ischemic stroke occurrence. In the "Post-STOP" study, we sought to assess the impact of the STOP protocol on the incidence of ischemic stroke in a multicenter cohort of former STOP and/or STOP 2 trial participants. A central team abstracted data for 2851 (74%) of the 3835 children who took part in STOP and/or STOP 2. Data included TCD and neuroimaging results, treatment, laboratory data, and detailed clinical information pertaining to the stroke. Two stroke neurologists independently confirmed each stroke using pre-specified imaging and clinical criteria and came to consensus. Among the 2808 patients who were stroke-free at the start of Post-STOP with available follow-up, the incidence of first ischemic stroke was 0.24 per 100 patient-years (95% CI, 0.18, 0.31), with a mean (SD) duration of follow-up of 9.1 (3.4) [median 10.3, range (0-15.4)] years. Most (63%) strokes occurred in patients in whom the STOP protocol had not been properly implemented, either failure to screen appropriately with TCD (38%) or failure to transfuse adequately patients with abnormal TCD (25%). This study shows that substantial opportunities for ischemic stroke prevention remain by more complete implementation of the STOP Protocol.

Door in door out and transportation times in 2 telestroke networks.

BACKGROUND: Inter-hospital transfer is important in the treatment of acute stroke. We sought to assess door in to door out (DIDO) time at spoke sites, and transportation time between spoke sites and thrombectomy-capable stroke center (TSC) in 2 large, rural telestroke networks. METHODS: Records of patients treated with tissue plasminogen activator through 2 telestroke networks between March 2017 and December 2017 were reviewed. Mann-Whitney test was used to compare median times, and a generalized linear regression model was used to predict the total time of care controlling for transportation distance. RESULTS: Eighty-five patients were included with median NIH stroke scale on presentation of 13 (interquartile range [IQR] 7-17), median door to needle time 49 minutes (IQR 40-62), and median DIDO 111 minutes (IQR 92-157). Eighteen patients (21%) underwent computed tomography angiography (CTA) at spoke prior to transportation. Median DIDO was 169 minutes for patients who received CTA before transfer, compared with 107 minutes for patients who did not (p = 0.0004). Median door-to-groin time at TSC was 68 minutes for the CTA group and 85 minutes in the non-CTA group (p = 0.832). Controlling for distance, the predicted time of care from spoke door in time to groin puncture at TSC (sDTG) is 93.68 minutes longer for patients who receive CTA prior to transport (p = 0.034). CONCLUSION: In the included telestroke networks, the sDTG time is longer when CTA is conducted at spoke site prior to transportation to TSC. New strategies are urgently needed to decrease sDTG when CTA is done prior to transfer to TSC.

The Accuracy of Large Vessel Occlusion Recognition Scales in Telestroke Setting.

Introduction: A significant proportion of acute ischemic stroke (AIS) patients who are evaluated through telestroke consultation are transferred to thrombectomy-capable stroke centers (TSCs) for concern of large vessel occlusion (LVO). Patient triage selection is commonly based on the clinical suspicion of LVO, which lacks specificity and could result in unnecessary transfers. In this study, we aimed to assess the accuracy of the most commonly used LVO recognition scales in telestroke setting. Methods: AIS patients transferred to TSCs for suspicion of an LVO were included in this retrospective study. Patients were evaluated by a stroke neurologist through a telestroke consult before transfer. The National Institute of Health Stroke Scale (NIHSS) score documented by the stroke neurologist was retrieved from medical records and used to calculate five other LVO recognition scales (Rapid Arterial Occlusion Evaluation Scale [RACE], Field Assessment Stroke Triage for Emergency Destination [FAST-ED], Cincinnati Prehospital Stroke Severity Scale [CPSSS], 3-item stroke scale [3I-SS], and Prehospital Acute Stroke Severity Scale [PASS]). We calculated the sensitivity, specificity, accuracy, positive and negative predictive values, false positive rate (FPR), and false negative rate (FNR) of each score using published cutoffs and then examined all possible cutoff values for each of these scales in addition to the NIHSS. Results: A total of 439 patients were included in the final analysis. A total of 48.5% of patients had an LVO confirmed on computed tomography angiogram. RACE score had the highest accuracy (78%). Overall, the five derived LVO recognition scores have at least 10% FNR. When examining all possible cutoff values, the NIHSS (cutoff of 6) had a 3% FNR but 73% FPR (false transfer). Conclusion: The use of the NIHSS and other LVO recognition scores over telestroke may result in unnecessary transfers. Better diagnostic tools that could maximize sensitivity with acceptable specificity are urgently needed.

Door to needle time and functional outcome for mild ischemic stroke over telestroke.

INTRODUCTION: Faster intravenous alteplase (tPA) administration from time of symptom onset is associated with better functional outcome. Lack of recognition of mild ischemic stroke (MIS) might result in delay in treatment with tPA. We hypothesise that patients with MIS have a longer door to needle (DTN) time when compared to patients with severe stroke symptoms. METHODS: Data on all patients who received tPA at spoke hospitals through the Medical University of South Carolina (MUSC) telestroke network were analysed. Collected data included baseline characteristics, stroke severity on presentation measured by the National Institute of Health Stroke Scale (NIHSS), the rate of symptomatic intracerebral haemorrhage, discharge location, and discharge functional outcome measured by the modified Rankin scale. RESULTS AND DISCUSSION: Of the 454 patients treated with tPA through the MUSC telestroke network in the period from January 2013 to April 2017, 98 (22%) had MIS defined as NIHSS ≤ 5 on presentation; the remaining 356 (78%) patients were found to have severe stroke defined as NIHSS > 5 on presentation. Patients presenting with MIS were found to have a delay in receiving intravenous tPA by ∼10 min (p = 0.007) and approximately 15% of them had poor functional outcome at discharge. Patients with a MIS on presentation have significantly more prolonged DTN time. Nearly 15% of low severity strokes had poor outcome even after receiving tPA.

Long-Term Functional Outcome of Telestroke Patients Treated Under Drip-and-Stay Paradigm Compared with Patients Treated in a Comprehensive Stroke Center: A Single Center Experience.

Objective:The purpose of this study is to compare long-term functional outcome for patients who receive intravenous alteplase (tPA) at a primary stroke center (spoke) through telestroke consultations and remain at the spoke (drip-and-stay) with that for patients who receive tPA at the comprehensive stroke center (hub).Methods:Data on baseline characteristics, stroke severity on presentation, door to needle (DTN) time, the rate of symptomatic intracerebral hemorrhage (sICH) and long-term outcomes for all patients evaluated at the Medical University of South Carolina (MUSC) hub and MUSC telestroke network spoke sites between January 2016 and March 2017 were collected. Eligible patients received tPA at either the spoke or hub location during the study period. Patients who received mechanical thrombectomy were excluded from the study. Functional outcome was assessed with 90-day modified Rankin Scale (mRS). Descriptive statistics were used to compare patient demographics and clinical outcomes across the two groups.Results:Total of 426 were identified (60 hub patients and 366 drip-and-stay patients). There were no significant differences in patient age, sex, admission National Institute of Health Stroke Scale (NIHSS), sICH, or DTN times between the two groups. mRS of 0-2 at 90 days was achieved in 37 (61.7%) of the hub and in 255 (69.7%) in the drip-and-stay patients (p = 0.216). On regression analysis, there was no difference in the adjusted relative risk of having a lower mRS between drip-and-stay and hub patients (incidence rate ratio 1.14, p = 0.278, 95% confidence interval [0.9-1.43]).Conclusion:Our study shows no difference in the long-term functional outcome for patients who received tPA through telestroke consultation and remained at spoke hospitals (drip-and-stay) compared with patients who received tPA at the hub.

Rate of Symptomatic Intracerebral Hemorrhage Related to Intravenous tPA Administered Over Telestroke Within 4.5-Hour Window.

BACKGROUND: Intravenous tissue plasminogen activator (tPA) remains the cornerstone medical treatment for acute ischemic stroke. The establishment of telestroke technology has allowed patients presenting to hospitals that lack expert stroke care to be evaluated and receive tPA. The safety of tPA administered through telestroke has been evaluated only when tPA is given within the 3-h window of last known normal. The purpose of this study is to evaluate the safety of tPA when administered through telestroke within a 4.5-h window. METHODS: A retrospective analysis on the prospectively collected database for all patients who received tPA at the Medical University of South Carolina Comprehensive Stroke Center (MUSC) (hub), as well as the MUSC telestroke network partner hospitals (spokes), was performed. Collected data included demographics, baseline characteristics, time from last known well to tPA administration, and symptomatic intracerebral hemorrhage (sICH) rates. Logistic regression was used to examine the odds of a sICH in patients at spoke sites compared with the hub controlling for patient stroke severity, gender, age, and race. RESULTS: A total of 830 patients were identified. Median National Institute of Health Stroke Scale was significantly higher among patients treated at the hub (9 vs. 8, p = 0.013), and the hub treated a higher percentage of nonwhite patients (p = 0.039). sICH occurred in 27 (4.8%) in the spoke group and 10 (3.8%) in the hub group (p = 0.523). Logistic regression results found no significant difference in the odds of sICH if tPA is given in a spoke site. CONCLUSIONS: Our study shows similar rates of sICH when intravenous tPA is administered at spokes through telestroke network compared with the hub.

Door to Needle Time over Telestroke-A Comprehensive Stroke Center Experience.

BACKGROUND: The implementation of telestroke programs has allowed patients living in rural areas suffering from acute ischemic stroke to receive expert acute stroke consultation and intravenous Alteplase (tPA). The purpose of this study is to compare door to needle (DTN) time when tPA is administered at telestroke sites (spokes) through telestroke consultations compared to tPA administration at the comprehensive stroke center (hub). METHODS: Data on all patients who received intravenous tPA at the hub and spoke hospitals through a large telestroke program between May 2008 and December 2016 were collected. Baseline characteristics were compared between the two groups, and the percentage of patients meeting DTN guidelines was compared between the hub and spoke hospitals during the study period. Comparison of DTN before and after the implementation of a quality improvement project was performed. RESULTS: A total of 1,665 patients received tPA at either the spoke (n = 1,323) or the hub (n = 342) during the study period. Baseline characteristics were comparable in both treatment groups. Before the intervention, DTN time <60 min was achieved in 88% of the hub patients versus 38% of the spoke patients. This difference between the two groups decreased by 35 percentage points, controlling for year (p = 0.0018) after the interventions. CONCLUSION: Overall, DTN is longer at the spoke hospitals compared to the hub hospital. This can be improved by various interventions that target quality, training, education, and improving the comfort level of the staff at partner hospitals when treating acute stroke patients.

Medical University of South Carolina Telestroke: A Telemedicine Facilitated Network for Stroke Treatment in South Carolina-A Progress Report.

BACKGROUND: Patients in rural communities lack access to acute stroke therapies. Rapid administration of lytic therapy increases the likelihood of favorable functional outcome in acute ischemic stroke (AIS). At the Medical University of South Carolina (MUSC), we implemented a Web-based telestroke program that allows patients presenting with AIS at a rural hospital to receive expert stroke consultation within minutes. This increases their chances of receiving lytic therapy, and therefore increases the likelihood of good functional outcome. OBJECTIVES: Our study aims to provide an update on how our telestroke program had developed and the rate and safety of intravenous (IV) alteplase administration through telestroke. METHODS: Data were collected on all patients evaluated through the MUSC Telestroke program from May 2008 through April 2014. Collected data included National Institutes of Health Stroke Scale (NIHSS) on presentation, number of IV alteplase administrations, number of patients transferred to MUSC, number of mechanical thrombectomies performed on transferred patients, rate of symptomatic intracerebral hemorrhages (sICHs), and discharge location. RESULTS: A total of 7,694 consults were performed during the study period. Of them 3,795 (49.2%) patients were diagnosed with ischemic stroke, of those 1,324 (34.8%) received IV alteplase. A total of 1,282 patients were transferred to MUSC for further care. From November 2014 to April 2016, 56 patients received mechanical thrombectomy. sICH occurred in 33 patients who received alteplase, and in 5 patients receiving a combination of IV and intraarterial thrombolysis. Over the study period, the number of participating sites increased from 6 to 19 sites. The percentage of transfers to MUSC decreased from 36% to 14%. CONCLUSIONS: Our study shows that our telestroke program had evolved over time to involve more sites throughout the state of South Carolina. Post-IV alteplase sICH was low and within the expected range.

Patient awareness and perception of stroke symptoms and the use of 911.

BACKGROUND: Response to stroke symptoms and the use of 911 can vary by race/ethnicity. The quickness with which a patient responds to such symptoms has implications for the outcome and treatment. We sought to examine a sample of patients receiving a Remote Evaluation of Acute isCHemic stroke (REACH) telestroke consult in South Carolina regarding their awareness and perception of stroke symptoms related to the use of 911 and to assess possible racial/ethnic disparities. METHODS: As of September 2013, 2325 REACH telestroke consults were conducted in 13 centers throughout South Carolina. Telephone surveys assessing use of 911 were administered from March 2012-January 2013 among 197 patients receiving REACH consults. Univariate and multivariate logistic regression was performed to assess factors associated with use of 911. RESULTS: Most participants (73%) were Caucasian (27% were African-American) and male (54%). The mean age was 66 ± 14.3 years. Factors associated with use of 911 included National Institutes of Health Stroke Scale scores >4 (odds ratio [OR], 5.4; 95% confidence interval [CI], 2.63-11.25), unknown insurance which includes self-pay or not charged (OR, 2.90; 95% CI, 1.15-7.28), and perception of stroke-like symptoms as an emergency (OR, 4.58; 95% CI, 1.65-12.67). African-Americans were significantly more likely than Caucasians to call 911 (62% vs. 43%, P = .02). CONCLUSIONS: African-Americans used 911 at a significantly higher rate. Use of 911 may be related to access to transportation, lack of insurance, or proximity to the hospital although this information was not available. Interventions are needed to improve patient arrival times to telemedicine equipped emergency departments after stroke.

REACH MUSC: A Telemedicine Facilitated Network for Stroke: Initial Operational Experience.

REACH Medical University of South Carolina (MUSC) provides stroke consults via the internet in South Carolina. From May 2008 to April 2011 231 patients were treated with intravenous (IV) thrombolysis and 369 were transferred to MUSC including 42 for intra-arterial revascularization [with or without IV tissue plasminogen activator (tPA)]. Medical outcomes and hemorrhage rates, reported elsewhere, were good (Lazaridis et al., 2011). Here we report operational features of REACH MUSC which covers 15 sites with 2,482 beds and 471,875 Emergency Department (ED) visits per year. Eight Academic Faculty from MUSC worked with 165 different physicians and 325 different nurses in the conduct of 1085 consults. For the 231 who received tPA, time milestones (in minutes) were: Onset to Door: 62 (mean), 50 (median); Door to REACH Consult: 43 and 33, Consult Request to Consult Start: was 9 and 7, Consult Start to tPA Decision: 31 and 25; Decision to Infusion: 20 and 14, and total Door to Needle: 98 and 87. The comparable times for the 854 not receiving tPA were: Onset to Door: 140 and 75; Door to REACH Consult: 61 and 41; Consult Request to Consult Start: 9 and 7, Consult Start to tPA Decision: 27 and 23. While the consultants respond to consult requests in <10, there is a long delay between arrival and Consult request. Tracking of operations indicates if we target shortening Door to Call time and time from tPA decision to start of drug infusion we may be able to improve Door to Needle times to target of <60. The large number of individuals involved in the care of these patients, most of whom had no training in REACH usage, will require novel approaches to staff education in ED based operations where turnover is high. Despite these challenges, this robust system delivered tPA safely and in a high fraction of patients evaluated using the REACH MUSC system.

Recruitment of infants with sickle cell anemia to a Phase III trial: data from the BABY HUG study.

BACKGROUND: Protocol-eligible subjects may not be candidates for research participation or may decline. To determine factors that affected accrual, we evaluated enrollment in BABY HUG, a multi-center, randomized, placebo-controlled Phase III trial of hydroxyurea (HU) in infants with sickle cell anemia. METHODS: An anonymized registry of potential subjects served as the primary source of data. Study coordinators considered all infants less than age 18 months with a hemoglobin FS diagnosis on newborn screening. Data included the number of potentially eligible subjects, whether parents were approached, and reasons for participating or declining. RESULTS: Of 1106 potential participants, 28% were not approached for reasons such as prior poor adherence to clinical care. Interested families expressed willingness to contribute to medical knowledge (51%), hope of being randomized to receive hydroxyurea (51%), and desire for closer clinical care (51%) as reasons for participating. Disease severity or the perception that their child was ill had less impact on willingness to participate (16%). Parents who declined cited fear of research (19%), transportation problems (14%), and the demanding nature of the study (25%). Ultimately, 234 (21%) gave informed consent, with little variability of acceptance rates among sites. Importantly, the number of subjects enrolled correlated with the number of families that were approached. Sites that excluded patients based on clinical/psychosocial biases were not more successful in recruiting than those who approached all eligible subjects. CONCLUSION: Large, demanding clinical trials require an adequate pool of potential participants. Approaching all potentially eligible patients without predetermined biases enhances success in recruitment.