Prasanthi Govindarajan

All Publications

• Effect of Acute Stroke Care Regionalization on Intravenous Alteplase Use in Two Urban Counties. Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors Govindarajan, P., Shiboski, S., Grimes, B., Cook, L., Ghilarducci, D., Meng, T., Trickey, A. W. 2019: 1–14

  Abstract

  Importance: Intravenous alteplase is an effective treatment for acute ischemic stroke and is significantly underutilized. It is known that stroke centers with accreditation provide higher intravenous alteplase treatment, and therefore, policies that increase the number of certified stroke centers and the number of acute ischemic stroke patients routed to these centers may be beneficial. Objective: To determine whether increasing access to primary stroke centers (regionalization) led to an increase in intravenous alteplase use in acute ischemic stroke patients. Design: An observational, longitudinal study to examine treatment trends with log-link binomial regression modeling to compare pre-post policy implementation changes in the proportions of patients treated with intravenous alteplase in two counties. Setting: Two urban counties, Santa Clara and San Mateo, in the western region of US that regionalized acute stroke care between 2005 and 2010. Participants: Patients with primary or secondary diagnosis of stroke were identified from the statewide patient discharge database by International Classification of Diseases (ICD-9) codes. We linked ambulance and hospital data to create complete patient care records. Main outcomes and measures: Stroke treatment, defined as a documented primary procedure code for intravenous alteplase administration (ICD-9: 99.10). Results: In Santa Clara County, intravenous alteplase was administered to 35 patients (1.7%) in the pre-regionalization period and 240 patients (2.1%) in the post-regionalization period. In San Mateo County, intravenous alteplase was administered to 29 patients (1.3%) in the pre-policy period and 135 patients (3.2%) in the post-policy period. After regionalization of stroke care, intravenous alteplase increased two-fold in San Mateo County [adjusted RR 2.20, p = 0.003, 95% CI (1.31, 3.69)] but did not show any statistically significant change in Santa Clara County [adjusted RR 1.10, p = 0.55, 95% CI (0.80, 1.51)]. In the post-regionalization phase, when compared with Santa Clara County, we found that San Mateo County had greater change in paramedic stroke detection, higher number of transports to primary stroke centers and more frequent use of intravenous alteplase at stroke centers. Conclusions: Our findings suggest that greater post-regionalization improvements in San Mateo County contributed to significantly better county-level thrombolysis use than Santa Clara County.

  View details for DOI 10.1080/10903127.2019.1679303

  View details for PubMedID 31599705

• Practice Variation in the Diagnosis of Aneurysmal Subarachnoid Hemorrhage: A Survey of US and Canadian Emergency Medicine Physicians. Neurocritical care Kumar, A., Niknam, K., Lumba-Brown, A., Woodruff, M., Bledsoe, J. R., Kohn, M. A., Perry, J. J., Govindarajan, P. 2019

  Abstract

  BACKGROUND AND AIMS: Spontaneous subarachnoid hemorrhage (SAH) from a brain aneurysm, if untreated in the acute phase, leads to loss of functional independence in about 30% of patients and death in 27-44%. To evaluate for SAH, the American College of Emergency Physicians (ACEP) Clinical Policy recommends obtaining a non-contrast brain computed tomography (CT) scan followed by a lumbar puncture (LP) if the CT is negative. On the other hand, current evidence from prospectively collected data suggests that CT alone may be sufficient to rule out SAH in patients who present within 6h of symptom onset while anecdotal evidence suggests that CT angiogram (CTA) may be used to detect aneurysms, which are the probable cause of SAH. Since many different options are available to emergency physicians, we examinedtheirpractice pattern variation by observing their diagnostic approaches andtheir adherence to the ACEP Clinical Policy.METHODS: We developed, validated, and distributed a survey to emergency physicians at three practice sites: (1) Stanford Healthcare, California, (2) Intermountain Healthcare (five emergency departments), Utah, and (3) Ottawa General Hospital, Toronto. The survey questions examined physician knowledge on CT and LP's test performance and used case-based scenarios to assess diagnostic approaches, variation in practice, and adherence to guidelines. Results were presented as proportions with 95% CIs.RESULTS: Of the 216 physicians surveyed, we received 168 responses (77.8%). The responses by site were: (1) (n=38, 23.2%), (2) (n=70, 42.7%), (3) (n=56, 34.1%). To the CT and LP test performance question, most physicians indicated that CT alone detects>90% of SAH in those with a confirmed SAH [n=150 (89.3%, 95% CI 83.6-93.5]. To the case-based questions, most physicians indicated that they would perform a CTA along with a CT [n=110 (65.5%, 95% CI 57.8-72.6)], some indicated a LP along with a CT [n=57, 33.9% 95% CI 26.8-41.6)], and a few indicated both a CTA and a LP [n=16, 9.5%, 95% CI 5.5-15.0]. We also observed practice site variation in the proportion of physicians who indicated that they would use CTA: (1) (n=25, 65.8%), (2) (n=54, 77.1%), and (3) (n=28, 50.0%) (p=0.006).CONCLUSIONS: Survey responses indicate that physicians use some or all of the imaging tests, with or without LP to diagnose SAH. We observed variation in the use of CTA by site and academic setting and divergence from ACEP Clinical Policy.

  View details for PubMedID 30790225

• Practice Variation in the Management of Aneurysmal Subarachnoid Hemorrhage-A Survey of US and Canadian Emergency Medicine Physicians Kumar, A., NIknam, K., Lumba-Brown, A., Bledsoe, J., Woodruff, M., Kohn, M., Perry, J., Govindarajan, P. LIPPINCOTT WILLIAMS & WILKINS. 2019

  View details for Web of Science ID 000478733402016

• Prehospital Systolic Hypertension and Outcomes in Patients with Spontaneous Intracerebral Hemorrhage. Cureus Hatcher, S., Chen, C., Govindarajan, P. 2017; 9 (1)

  Abstract

  It is well known that hematoma volume and expansion is associated with poor outcomes in patients with spontaneous intracerebral hemorrhage (sICH). The factors associated with hematoma volume and possible expansion include the use of anticoagulant medications, autoimmune or bacterial diseases that reduce platelet production, and genetic defects of Von Willebrand factor causing inhibition or reduction of platelet aggregation. However, little is known about the role of elevated systolic blood pressure (SBP) on hematoma volume and its ultimate role on sICH when identified in the prehospital setting. Our objectives were to determine the prevalence of elevated SBP among diagnosed sICH patients transported by emergency medical services (EMS), and to explore possible associations between prehospital elevated SBP and hematoma volume.This is a hypothesis-generating study for which we used a retrospective observational design. The subjects included 243 adult patients who were seen and treated for sICH in an emergency department serving a county hospital in a large metropolitan city. Elevated SBP in the setting of sICH was defined as ≥140 mm Hg. A univariate analysis was performed to investigate associations between patient demographics, elevated SBP, and sICH characteristics with the pre-determined outcome of hematoma volume. We then performed a multivariable logistic regression model to determine if elevated prehospital SBP remained associated with hematoma volume.The number of subjects with a hospital-based diagnosis of sICH was 243. Of those, 193 (79%) were transported by an ambulance. Among those transported by ambulance, 180 (93%) had a documented prehospital SBP; out of those patients with a documented SBP, 173 (96%) showed an elevated SBP of ≥140 mm Hg, and 82 (46%) had a hematoma volume of ≥30 mL. Our univariate analysis showed that sICH patients with an elevated prehospital SBP of ≥140 mm Hg were associated with hematoma volume. The multivariable regression model showed that elevated prehospital SBP (≥140 mm Hg) was associated with larger hematoma volumes (odds ratio (OR) 3.86 95% confidence interval (CI) 1.02-4.60).Prehospital elevated SBP is associated with larger hematoma volume in patients with sICH. Future studies should confirm these findings in a larger cohort of patients.

  View details for DOI 10.7759/cureus.998

  View details for PubMedID 28280651

• A low-cost, tablet-based option for prehospital neurologic assessment: The iTREAT Study. Neurology Chapman Smith, S. N., Govindarajan, P., Padrick, M. M., Lippman, J. M., McMurry, T. L., Resler, B. L., Keenan, K., Gunnell, B. S., Mehndiratta, P., Chee, C. Y., Cahill, E. A., Dietiker, C., Cattell-Gordon, D. C., Smith, W. S., Perina, D. G., Solenski, N. J., Worrall, B. B., Southerland, A. M. 2016; 87 (1): 19-26

  Abstract

  In this 2-center study, we assessed the technical feasibility and reliability of a low cost, tablet-based mobile telestroke option for ambulance transport and hypothesized that the NIH Stroke Scale (NIHSS) could be performed with similar reliability between remote and bedside examinations.We piloted our mobile telemedicine system in 2 geographic regions, central Virginia and the San Francisco Bay Area, utilizing commercial cellular networks for videoconferencing transmission. Standardized patients portrayed scripted stroke scenarios during ambulance transport and were evaluated by independent raters comparing bedside to remote mobile telestroke assessments. We used a mixed-effects regression model to determine intraclass correlation of the NIHSS between bedside and remote examinations (95% confidence interval).We conducted 27 ambulance runs at both sites and successfully completed the NIHSS for all prehospital assessments without prohibitive technical interruption. The mean difference between bedside (face-to-face) and remote (video) NIHSS scores was 0.25 (1.00 to -0.50). Overall, correlation of the NIHSS between bedside and mobile telestroke assessments was 0.96 (0.92-0.98). In the mixed-effects regression model, there were no statistically significant differences accounting for method of evaluation or differences between sites.Utilizing a low-cost, tablet-based platform and commercial cellular networks, we can reliably perform prehospital neurologic assessments in both rural and urban settings. Further research is needed to establish the reliability and validity of prehospital mobile telestroke assessment in live patients presenting with acute neurologic symptoms.

  View details for DOI 10.1212/WNL.0000000000002799

  View details for PubMedID 27281534

• PARAMEDIC PERSPECTIVES ON BARRIERS TO PREHOSPITAL ACUTE STROKE RECOGNITION PREHOSPITAL EMERGENCY CARE Hodell, E., Hughes, S. D., Corry, M., Kivlehan, S., Resler, B., Sheon, N., Govindarajan, P. 2016; 20 (3): 415-424

  Abstract

  Emergency Medical Service (EMS) providers are tasked with rapid evaluation, stabilization, recognition, and transport of acute stroke patients. Although prehospital stroke scales were developed to assist with stroke recognition, unrecognized challenges exist in the prehospital setting that hinder accurate assessment of stroke. The goal of this qualitative study was to systematically understand the challenges and barriers faced by paramedics in recognizing stroke presentations in the field.Paramedics from 12 EMS agencies serving a mix of rural, suburban, and urban communities in the State of California participated in five focus group discussions. Group size ranged from 3-8, with a total of 28 participants. Demographics of the participants were collected and focus group recordings were transcribed verbatim. Transcripts were subjected to deductive and inductive coding, which identified recurrent and divergent themes.Strong consensus existed around constraints to prehospital stroke recognition; participants cited the diversity of stroke presentations, linguistic diversity, and exam confounded by alcohol and or drug use as barriers to initial evaluation. Also, lack of educational feedback from hospital staff and physicians and continuing medical education on stroke were reported as major deterrents to enhancing their diagnostic acumen. Across groups, participants reported attempting to foster relationships with hospital personnel to augment their educational needs, but this was easier for rural than urban providers.While challenges to stroke recognition in the field were slightly different for rural and urban EMS, participants concurred that timely, systematic feedback on individual patients and case-based training would strengthen early stroke recognition skills.

  View details for DOI 10.3109/10903127.2015.1115933

  View details for Web of Science ID 000375828300013

  View details for PubMedID 26855299

• Prehospital aspirin administration for acute coronary syndrome (ACS) in the USA: an EMS quality assessment using the NEMSIS 2011 database. Emergency medicine journal : EMJ Tataris, K. L., Mercer, M. P., Govindarajan, P. 2015

  Abstract

  National practice guidelines recommend early aspirin administration to reduce mortality in acute coronary syndrome (ACS). Although timely administration of aspirin has been shown to reduce mortality in ACS by 23%, prior regional Emergency Medical Service (EMS) data have shown inadequate prehospital administration of aspirin in patients with suspected cardiac ischaemia.Using the National EMS Information System (NEMSIS) database, we sought to determine (1) the proportion of patients with suspected cardiac ischaemia who received aspirin and (2) patient and prehospital characteristics that independently predicted administration of aspirin.Analysis of the 2011 NEMSIS database targeted patients aged ≥40 years with a paramedic primary impression of 'chest pain'. To identify patients with chest pain of suspected cardiac aetiology, we included those for whom an ECG or cardiac monitoring had been performed. Trauma-related chest pain and basic life support transports were excluded. The primary outcome was presence of aspirin administration. Patient (age, sex, race/ethnicity and insurance status) and regional characteristics where the EMS transport occurred were also obtained. Multivariate logistic regression was used to assess the independent association of patient and regional factors with aspirin administration for suspected cardiac ischaemia.Of the total 14 371 941 EMS incidents in the 2011 database, 198 231 patients met our inclusion criteria (1.3%). Of those, 45.4% received aspirin from the EMS provider. When compared with non-Hispanic white patients, several groups had greater odds of aspirin administration by EMS: non-Hispanic black patients (OR 1.49, 95% CI 1.44 to 1.55), non-Hispanic Asians (OR 1.62, 95% CI 1.21 to 2.18), Hispanics (OR 1.71, 95% CI 1.54 to 1.91) and other non-Hispanics (OR 1.27, 95% CI 1.07 to 1.51). Patients living in the Southern region of the USA (OR 0.59, 95% CI 0.57 to 0.62) and patients with governmental (federally administered such as Veteran's Health Care, but not Medicare or Medicaid) insurance (OR 0.67, 95% CI 0.57 to 0.78) had the lowest odds of receiving aspirin. Age and sex (OR 1.00, 95% CI 1.00 to 1.00) were not associated with aspirin administration.It is likely that prehospital aspirin administration for patients with suspected cardiac ischaemia remains low nationally and could be improved. Reasons for disparities among the various groups should be explored.

  View details for DOI 10.1136/emermed-2014-204299

  View details for PubMedID 25678574

• Race and sex disparities in prehospital recognition of acute stroke. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine Govindarajan, P., Friedman, B. T., Delgadillo, J. Q., Ghilarducci, D., Cook, L. J., Grimes, B., McCulloch, C. E., Johnston, S. C. 2015; 22 (3): 264–72

  Abstract

  The objective of this study was to examine prehospital provider recognition of stroke by race and sex.Diagnoses at emergency department (ED) and hospital discharge from a statewide database in California were linked to prehospital diagnoses from an electronic database from two counties in Northern California from January 2005 to December 2007 using probabilistic linkage. All patients 18 years and older, transported by ambulances (n = 309,866) within the two counties, and patients with hospital-based discharge diagnoses of stroke (n = 10,719) were included in the study. Logistic regression was used to analyze the independent association of race and sex with the correct prehospital diagnosis of stroke.There were 10,719 patients discharged with primary diagnoses of stroke. Of those, 3,787 (35%) were transported by emergency medical services providers. Overall, 32% of patients ultimately diagnosed with stroke were identified in the prehospital setting. Correct prehospital recognition of stroke was lower among Hispanic patients (odds ratio [OR] = 0.77, 95% confidence interval [CI] 0.61 to 0.96), Asians (OR = 0.66, 95% CI 0.55 to 0.80), and others (OR = 0.71, 95% CI = 0.53 to 0.94), when compared with non-Hispanic whites, and in women compared with men (OR = 0.82, 95% CI = 0.71 to 0.94). Specificity for recognizing stroke was lower in females than males (OR = 0.84, 95% CI = 0.78 to 0.90).Significant disparities exist in prehospital stroke recognition.

  View details for DOI 10.1111/acem.12595

  View details for PubMedID 25728356

• National trends in the utilization of emergency medical services for acute myocardial infarction and stroke. The western journal of emergency medicine Tataris, K., Kivlehan, S., Govindarajan, P. 2014; 15 (7): 744-748

  Abstract

  The emergency medical services (EMS) system plays a crucial role in the chain of survival for acute myocardial infarction (AMI) and stroke. While regional studies have shown underutilization of the 911 system for these time-sensitive conditions, national trends have not been studied. Our objective was to describe the national prevalence of EMS use for AMI and stroke, examine trends over a six-year period, and identify patient factors that may contribute to utilization.Using the National Hospital Ambulatory Medical Care Survey-ED (NHAMCS) dataset from 2003-2009, we looked at patients with a discharge diagnosis of AMI or stroke who arrived to the emergency department (ED) by ambulance. We used a survey-weighted χ2 test for trend and logistic regression analysis.In the study, there were 442 actual AMI patients and 220 (49.8%) presented via EMS. There were 1,324 actual stroke patients and 666 (50.3%) presented via EMS. There was no significant change in EMS usage for AMI or stroke over the six-year period. Factors independently associated with EMS use for AMI and stroke included age (OR 1.21; 95% CI 1.12-1.31), Non-Hispanic black race (OR 1.72; 95% CI 1.16-2.29), and nursing home residence (OR 11.50; 95% CI 6.19-21.36).In a nationally representative sample of ED visits from 20003-2009, there were no trends of increasing EMS use for AMI and stroke. Efforts to improve access to care could focus on patient groups that underutilize the EMS system for such conditions.

  View details for DOI 10.5811/westjem.2014.9.22851

  View details for PubMedID 25493113

• Regional Differences in Emergency Medical Services Use for Patients with Acute Stroke (Findings from the National Hospital Ambulatory Medical Care Survey Emergency Department Data File) JOURNAL OF STROKE & CEREBROVASCULAR DISEASES Govindarajan, P., Gonzales, R., Maselli, J. H., Johnston, S. C., Fahimi, J., Poisson, S., Stein, J. C. 2013; 22 (8): E257-E263

  Abstract

  Our objectives were to describe the proportion of stroke patients who arrive by ambulance nationwide and to examine regional differences and factors associated with the mode of transport to the emergency department (ED).Patients with a primary discharge diagnosis of stroke based on previously validated International Classification of Disease, 9th revision codes were abstracted from the National Hospital Ambulatory Medical Care Survey for the years 2007 to 2009. We excluded subjects<18 years of age and those with missing data. Using logistic regression, we identified independent predictors of arrival by ambulance to the ED.Overall, 566 patients met the entry criteria, representing 2,153,234 patient records nationally, based on 2010 US census data. Of these, 50.4% arrived by ambulance. After adjustment for potential confounders, age was associated with use of an ambulance. In addition, patients residing in the west and south had lower odds of arriving by ambulance for stroke when compared to northeast (South: odds ratio [OR] 0.45 and 95% confidence interval [CI] 0.26-0.76; West: OR 0.45 and 95% CI 0.25-0.84; Midwest: OR 0.56 and 95% CI 0.31-1.01). Compared to the Medicare population, privately insured and self-insured patients had lower odds of arriving by ambulance (OR for private insurance 0.48 and 95% CI 0.28-0.84; OR for self-payers 0.36 and 95% CI 0.14-0.93). Gender, race, urban or rural location of ED, and safety net status was not independently associated with ambulance use.Patients with stroke arrive by ambulance more frequently in the Northeast than in other regions of the United States. Identifying reasons for this difference may be useful in improving stroke care.

  View details for DOI 10.1016/j.jstrokecerebrovasdis.2012.02.014

  View details for Web of Science ID 000327719000001

  View details for PubMedID 22465209

• Practice variability among the EMS systems participating in Cardiac Arrest Registry to Enhance Survival (CARES) RESUSCITATION Govindarajan, P., Lin, L., Landman, A., McMullan, J. T., McNally, B. F., Crouch, A. J., Sasson, C. 2012; 83 (1): 76-80

  Abstract

  To describe the demographic, organizational and provider characteristics of the Emergency Medical Services (EMS) agencies participating in the Cardiac Arrest Registry to Enhance Survival (CARES).A web based survey instrument was developed by the CARES investigators and distributed to the EMS agencies participating in CARES in 2008. Survey questions addressed three domains related to prehospital care: (1) descriptors of the participating EMS agencies, (2) methods of clinical care and clinical protocols used by EMS agencies to deliver out-of-hospital cardiac arrest care and (3) use of resuscitation techniques by EMS agencies. Survey responses were collated and analyzed using descriptive statistics.Surveys were received from 21/25 (84%) sites. The EMS agency characteristics including the response areas served by the agencies, organizational structure, medical direction status and deployment status are described. All respondents were non-volunteer agencies with a large number of them being fire-based (43%). Significant variability among the communities was observed with respect to their medical direction status and deployment status. We also observed differences in the management of OHCA among the participating agencies which included implementation of ACLS guideline updates, presence of termination of resuscitation protocol and destination policies for OHCA subjects. Similar variations between agencies were also observed in the use of resuscitation techniques.Differences were observed between the EMS agencies participating in CARES. The clinical impact of these observed differences in agency and provider characteristics on OHCA outcomes deserves study.

  View details for DOI 10.1016/j.resuscitation.2011.06.026

  View details for Web of Science ID 000299933400028

  View details for PubMedID 21741432

• Practice Variation in the Diagnosis of Aneurysmal Subarachnoid Hemorrhage: A Survey of US and Canadian Emergency Medicine Physicians NEUROCRITICAL CARE Kumar, A., Niknam, K., Lumba-Brown, A., Woodruff, M., Bledsoe, J. R., Kohn, M. A., Perry, J. J., Goyindarajan, P. 2019; 31 (2): 321–28

  View details for DOI 10.1007/s12028-019-00679-7

  View details for Web of Science ID 000487511700014

• Feasibility of a 'Psychologically Smart' Community Pharmacy Intervention to Improve Patient Recognition and Response Time in Stroke. Malcolm, E., Spokoyny, I., Safaeinili, N., Tai, A., Govindarajan, P., Donelson, S., Door, T., Fotuhi, O., Wu, W., Cohen, G. LIPPINCOTT WILLIAMS & WILKINS. 2019

  View details for Web of Science ID 000478733400430

• Paramedic Detection of Large Vessel Occlusions Using mNIHSS: A Prospective Cohort Pilot Study. Mulkerin, W., Francisco, J., Lima, B., Spokoyny, I., Gilbert, G., Brown, I., Bernier, E., Niknam, K., Govindarajan, P. LIPPINCOTT WILLIAMS & WILKINS. 2019

  View details for Web of Science ID 000478733401029

• A Web-based Decision Tool to Estimate Subarachnoid Hemorrhage Risk in Emergency Department Patients. Cureus Manella, H., Sivasankar, S., Perry, J. J., Pfeil, S., Senyak, J., Shachter, R., Govindarajan, P. 2018; 10 (1): e2096

  Abstract

  Subarachnoid hemorrhage (SAH) from a leaking aneurysm is a neurological emergency. SAH patients often present with headache-a common chief complaint among emergency department patients. If unrecognized, 70% of the patients with re-bleeds die and one third are left with neurological deficits. Therefore, it is critical to distinguish the signs and symptoms of SAH from benign causes of headache, perform the appropriate diagnostic tests and treat in a timely manner in order to reduce the disability and mortality associated with this condition. In patients with suspected SAH, traditional diagnostic strategies in the emergency department employ non-contrast computed tomography (CT) of the brain to detect blood in the subarachnoid space followed by lumbar puncture if there is a high clinical probability of aneurysmal bleed without any evidence of blood on CT scan. While the older generation CT scanners were less sensitive to blood detection in the subarachnoid space, recent advances in CT imaging have resulted in sensitivity approaching 100% for detection of blood in the subarachnoid space specifically within six hours of symptom onset. Therefore, the benefit of lumbar puncture is controversial when performed within the first six hours of symptom onset. Despite this, lumbar puncture is still commonly performed in the emergency department, exposing patients to unnecessary procedural risks. The objective of this research study is to develop a web-based risk calculator that estimates the risk of SAH based on time to emergency department presentation after symptom onset, physical findings and imaging characteristics with the goal of reducing unnecessary lumbar punctures in the emergency department. In this technical report, we describe the prototype calculator, the mathematical basis of the model and provide a link to the web-based prototype. In the future, we will refine the prototype, make it user-friendly to physicians, staff and patients and study its benefits in the emergency department.

  View details for PubMedID 29568717

• A Web-based Decision Tool to Estimate Subarachnoid Hemorrhage Risk in Emergency Department Patients Cureus Manella, H., Sivasankar, S., Perry, J., Pfeil, S., Senyak, J., Shachter, R., Govindarajan, P. 2018; 10 (1)

  View details for DOI 10.7759/cureus.2096

• Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent CLINICAL TRIALS Whitesides, L. W., Baren, J. M., Biros, M. H., Fleischman, R. J., Govindarajan, P. R., Jones, E. B., Pancioli, A. M., Pentz, R. D., Scicluna, V. M., Wright, D. W., Dickert, N. W. 2017; 14 (2): 180-186

  Abstract

  Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions.Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience.Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views.Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.

  View details for DOI 10.1177/1740774516677276

  View details for PubMedID 28359192

• Patients' perspectives of enrollment in research without consent: the patients' experiences in emergency research-progesterone for the treatment of traumatic brain injury study*. Critical care medicine Dickert, N. W., Scicluna, V. M., Baren, J. M., Biros, M. H., Fleischman, R. J., Govindarajan, P. R., Jones, E. B., Pancioli, A. M., Wright, D. W., Pentz, R. D. 2015; 43 (3): 603–12

  Abstract

  Research in acute illness often requires an exception from informed consent. Few studies have assessed the views of patients enrolled in exception from informed consent trials. This study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury.Interactive interview study.Nested within the Progesterone for the Treatment of Traumatic Brain Injury trial, a Phase III randomized controlled trial in acute traumatic brain injury.Patients and surrogates (for patients incapable of being interviewed) enrolled in Progesterone for the Treatment of Traumatic Brain Injury under exception from informed consent at 12 sites.None.Interviews focused on respondents' acceptance of exception from informed consent enrollment in Progesterone for the Treatment of Traumatic Brain Injury, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Eighty-five individuals were interviewed. Eighty-four percent had positive attitudes toward Progesterone for the Treatment of Traumatic Brain Injury inclusion. Seventy-eight percent found their inclusion under exception from informed consent acceptable, and 72% found use of exception from informed consent in Progesterone for the Treatment of Traumatic Brain Injury acceptable in general. Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment. The most common concerns (26%) related to absence of consent. Eighty percent and 92% were accepting of placebo use and randomization, respectively. Although there were few black respondents (n = 11), they were less accepting of personal exception from informed consent enrollment than white respondents (55% vs 83%; p = 0.0494).Acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. Exception from informed consent enrollment appears generally consistent with patients' preferences.

  View details for DOI 10.1097/CCM.0000000000000747

  View details for PubMedID 25574795

• COMMUNITY CONSULTATION FOR PREHOSPITAL RESEARCH: EXPERIENCES OF STUDY COORDINATORS AND PRINCIPAL INVESTIGATORS PREHOSPITAL EMERGENCY CARE Dickert, N. W., Govindarajan, P., Harney, D., Silbergleit, R., Sugarman, J., Weinfurt, K. P., Pentz, R. D. 2014; 18 (2): 274-281

  Abstract

  To assess principal investigators' and study coordinators' views and experiences regarding community consultation in a multicenter trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings.Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included 1) perceived goals of community consultation, 2) experiences with and views of community consultation methods used, 3) interactions with IRB regarding community consultation, and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data.Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median = 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings.Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.

  View details for DOI 10.3109/10903127.2013.856503

  View details for Web of Science ID 000333098000015

  View details for PubMedID 24401134

• Emergency department visits and hospitalizations by tube-fed nursing home residents with varying degrees of cognitive impairment: a national study BMC GERIATRICS Stephens, C. E., Sackett, N., Govindarajan, P., Lee, S. J. 2014; 14

  Abstract

  Numerous studies indicate that the use of feeding tubes (FT) in persons with advanced cognitive impairment (CI) does not improve clinical outcomes or survival, and results in higher rates of hospitalization and emergency department (ED) visits. It is not clear, however, whether such risk varies by resident level of CI and whether these ED visits and hospitalizations are potentially preventable. The objective of this study was to determine the rates of ED visits, hospitalizations and potentially preventable ambulatory care sensitive (ACS) ED visits and ACS hospitalizations for long-stay NH residents with FTs at differing levels of CI.We linked Centers for Medicare and Medicaid Services inpatient & outpatient administrative claims and beneficiary eligibility data with Minimum Data Set (MDS) resident assessment data for nursing home residents with feeding tubes in a 5% random sample of Medicare beneficiaries residing in US nursing facilities in 2006 (n = 3479). Severity of CI was measured using the Cognitive Performance Scale (CPS) and categorized into 4 groups: None/Mild (CPS = 0-1, MMSE = 22-25), Moderate (CPS = 2-3, MMSE = 15-19), Severe (CPS = 4-5, MMSE = 5-7) and Very Severe (CPS = 6, MMSE = 0-4). ED visits, hospitalizations, ACS ED visits and ACS hospitalizations were ascertained from inpatient and outpatient administrative claims. We estimated the risk ratio of each outcome by CI level using over-dispersed Poisson models accounting for potential confounding factors.Twenty-nine percent of our cohort was considered "comatose" and "without any discernible consciousness", suggesting that over 20,000 NH residents in the US with feeding tubes are non-interactive. Approximately 25% of NH residents with FTs required an ED visit or hospitalization, with 44% of hospitalizations and 24% of ED visits being potentially preventable or for an ACS condition. Severity of CI had a significant effect on rates of ACS ED visits, but little effect on ACS hospitalizations.ED visits and hospitalizations are common in cognitively impaired tube-fed nursing home residents and a substantial proportion of ED visits and hospitalizations are potentially preventable due to ACS conditions.

  View details for DOI 10.1186/1471-2318-14-35

  View details for Web of Science ID 000335522300001

  View details for PubMedID 24650076

• Enrollment in research under exception from informed consent: The Patients' Experiences in Emergency Research (PEER) study RESUSCITATION Dickert, N. W., Mah, V. A., Baren, J. M., Biros, M. H., Govindarajan, P., Pancioli, A., Silbergleit, R., Wright, D. W., Pentz, R. D. 2013; 84 (10): 1416-1421

  Abstract

  Resuscitation research requires an exception from informed consent (EFIC). Despite concerns that patients may find EFIC unacceptable, the views and experiences of patients enrolled in an EFIC study are largely unknown.The Patients' Experience in Emergency Research (PEER) study was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) for pre-hospital treatment of status epilepticus. PEER included 61 EFIC enrollees or their surrogates from 5 sites. Interviews used a structured, interactive guide focusing on acceptance of EFIC enrollment in RAMPART and existing regulatory protections. Simple statistics were generated, and textual data were analyzed for common themes.24 enrolled patients and 37 surrogates were successfully interviewed. 49/60 (82%) were glad they or their family member were included in RAMPART; 54/57 (95%) felt research on emergency seizure treatment is important. 43/59 (73%) found their inclusion under EFIC acceptable; 10 (17%) found it unacceptable, and 6 (10%) were neutral. There were no statistically significant interactions between enrollment attitudes and demographic characteristics, though there were trends toward lower acceptance among interviewees who were non-white, less educated, or had prior research experience. The most common concerns related to lack of consent prior to RAMPART enrollment. Positive responses related to perceived medical benefits, recognition of the impracticality of consent, and wanting doctors to do what needs to be done in emergencies. Many participants had difficulty understanding the trial and EFIC.Most subjects had positive views of enrollment, and acceptance generally correlated with results of community consultation studies.

  View details for DOI 10.1016/j.resuscitation.2013.04.006

  View details for Web of Science ID 000327099600028

  View details for PubMedID 23603291

• Nationwide Patterns of Hospitalization after Transient Ischemic Attack JOURNAL OF STROKE & CEREBROVASCULAR DISEASES Kamel, H., Fahimi, J., Govindarajan, P., Navi, B. B. 2013; 22 (7): E142-E145

  Abstract

  Little is known about nationwide patterns of hospitalization after transient ischemic attack (TIA).In a nationally representative sample of Emergency Department (ED) visits included in the National Hospital Ambulatory Medical Care Survey (NHAMCS) from 1997 through 2008, we estimated rates of hospitalization among patients with a primary ED diagnosis of TIA (International Classification of Diseases, 9th Revision (ICD-9), code 435). We used multiple logistic regression analysis to examine the association between hospitalization and demographic characteristics, geographic region, year of the visit, time of the visit, and markers of stroke risk.On the basis of 782 cases of TIA sampled by the NHAMCS, 57% (95% confidence interval [CI], 52%-61%) of patients with TIA nationwide were hospitalized. A higher proportion of patients was hospitalized in 2003 to 2008 (62%; 95% CI, 56%-68%) than in 1997 to 2002 (52%; 95% CI, 46%-58%; P = .02). Compared with the US Northeast, patients were less likely to be hospitalized in the Midwest (odds ratio [OR], 0.5; 95% CI, .3-.9), the South (OR, 0.3; 95% CI, .2-.5), or the West (OR, 0.2; 95% CI, .1-.4). Compared with white patients, hospitalization was more likely among patients who were black (OR, 2.4; 95% CI, 1.3-4.5), Hispanic (OR, 3.8; 95% CI, 1.4-10.2), or of other races (OR, 3.5; 95% CI, 1.3-9.6). Patients with Medicaid were admitted less often than those with private insurance (OR, 0.3; 95% CI, .2-.8).Nationwide patterns of hospitalization after TIA show significant regional and demographic variation. These results may provide a useful roadmap for efforts to improve systems of care for TIA across the country.

  View details for DOI 10.1016/j.jstrokecerebrovasdis.2012.09.016

  View details for Web of Science ID 000325874200022

  View details for PubMedID 23149150

• Marked reduction in length of stay for patients with psychiatric emergencies after implementation of a comanagement model. Academic emergency medicine Polevoi, S. K., Jewel Shim, J., McCulloch, C. E., Grimes, B., Govindarajan, P. 2013; 20 (4): 338-343

  Abstract

  Patients with psychiatric emergencies often spend excessive time in an emergency department (ED) due to limited inpatient psychiatric bed capacity. The objective was to compare traditional resident consultation with a new model (comanagement) to reduce length of stay (LOS) for patients with psychiatric emergencies. The costs of this model were compared to those of standard care.This was a before-and-after study conducted in the ED of an urban academic medical center without an inpatient psychiatry unit from January 1, 2007, through December 31, 2009. Subjects were all adult patients seen by ED clinicians and determined to be a danger to self or others or gravely disabled. At baseline, psychiatry residents evaluated patients and made therapeutic recommendations after consultation with faculty. The comanagement model was fully implemented in September 2008. In this model, psychiatrists directly ordered pharmacotherapy, regularly monitored effects, and intensified efforts toward appropriate disposition. Additionally, increased attending-level involvement expedited focused evaluation and disposition of patients. An interrupted time series analysis was used to study the effects of this intervention on LOS for all psychiatric patients transferred for inpatient psychiatric care. Secondary outcomes included mean number of hours on ambulance diversion per month and the mean number of patients who left without being seen (LWBS) from the ED.A total of 1,884 patient visits were considered. Compared to the preintervention phase, median LOS for patients transferred for inpatient psychiatric care decreased by about 22% (p < 0.0005, 95% confidence interval [CI] = 15% to 28%) in the postintervention phase. Ambulance diversion hours increased by about 40 hours per month (p = 0.008, 95% CI = 11 to 69 hours) and the mean number of patients who LWBS decreased by about 26 per month (p = 0.106; 95% CI = -60 to 5.9 visits per month) in the postintervention phase.A comanagement model was associated with a marked reduction in the LOS for this patient population.

  View details for DOI 10.1111/acem.12105

  View details for PubMedID 23701340

• Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations ACADEMIC EMERGENCY MEDICINE Govindarajan, P., Dickert, N. W., Meeker, M., de Souza, N., Harney, D., Hemphill, C. J., Pentz, R. 2013; 20 (1): 98-103

  Abstract

  In 1996, the U.S. Food and Drug Administration approved regulations authorizing an exception from informed consent (EFIC) for research conducted in emergency settings when obtaining prospective informed consent is not possible due to the potential subject's critical illness or injury. The regulations require that investigators conduct community consultation (CC) efforts before initiating a study and require that institutional review boards review the results of CC prior to approving a study. However, little is known about how communities view EFIC research or the CC process.The objective was to assess the views of CC meeting attendees regarding the CC process, their understanding and views of EFIC research relating to the specific research trial under discussion, and their level of trust in physician-investigators.Following CC meetings at two study sites (San Francisco and Atlanta) for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), an active comparison, randomized trial of prehospital treatment for status epilepticus, the authors administered a pair of surveys to participants. One survey focused on CC experiences (CC survey) and trust in physician-investigators; the second assessed participants' understanding of EFIC and the RAMPART clinical trial design (EFIC survey).A total of 317 individuals participated in one of the two most popular types of CC meetings (group meetings and focus group sessions) at both sites. A total of 189 participants (59%) completed the CC survey and trust questions, and 297 (92%) completed the EFIC survey. Of those who completed the CC survey, 173 of 189 (92%) were very satisfied with the meeting, and 174 of 189 (92%) felt that they learned a lot about research at the meeting. A total of 169 of 189 participants (88%) felt that researchers heard the community's concerns, while only 106 of 189 (56%) said researchers would be willing to make changes to the study based on their concerns. Of those who completed the EFIC survey, 261 of 297 (88%) supported the study, 207 of 297 (70%) said they would agree to participate in the study, and 203 of 297 (68%) reported that they would agree to consent a loved one into the study. On a recently validated scale measuring trust in physician-investigators, participants at both sites seemed to have higher levels of trust in physician-investigators than the validation study population.Overall, members of these two communities expressed satisfaction with the CC session and had relatively high levels of support for the study and trust in physician-investigators.

  View details for DOI 10.1111/acem.12039

  View details for Web of Science ID 000313719200012

  View details for PubMedID 23570483

• Feasibility study to assess the use of the Cincinnati stroke scale by emergency medical dispatchers: a pilot study EMERGENCY MEDICINE JOURNAL Govindarajan, P., Desouza, N. T., Pierog, J., Ghilarducci, D., Johnston, S. C. 2012; 29 (10): 848-850

  Abstract

  The emergency medical dispatcher (EMD) receiving a call via 911 is the first point of contact within the acute care system and plays an important role in early stroke recognition. Published studies show that the diagnostic accuracy of stroke of EMD needs to be improved. Therefore, the National Association of Emergency Medical Dispatchers implemented a stroke diagnostic tool modelled after the Cincinnati stroke scale across 3000 cities worldwide. This is the first time a diagnostic tool that requires callers to test physical findings and report those back to the EMD has been implemented. However, the ability of EMD and 911 callers to use this in real time has not been reported. The goal of this pilot study was to determine the feasibility of an EMD applying the Cincinnati stroke scale tool during a 911 call, and to report the time required to administer the tool.

  View details for DOI 10.1136/emermed-2011-200150

  View details for Web of Science ID 000309820200017

  View details for PubMedID 21849337

• Emergency Physicians Research Common Problems in Proportion to their Frequency. The western journal of emergency medicine Wilson, M. P., Vilke, G. M., Govindarajan, P., Itagaki, M. W. 2012; 13 (4): 344-350

  Abstract

  Emergency medicine (EM) organizations such as the Society for Academic Emergency Medicine and the Institute of Medicine have called for more clinical research as a way of addressing the scarcity of research in EM. Previous investigations have examined funding and productivity in EM research, but whether EM researchers preferentially concentrate on certain patient-related topics is not known. We hypothesized that at least part of the scarcity of EM research is from the tendency of EM researchers, like researchers in other fields, to focus on rarer conditions with higher morbidity or mortality instead of on more common conditions with less acuity. This study compared the frequency of specific medical conditions presenting to emergency departments nationwide with the frequency of emergency physician research on those same conditions.This study is a structured retrospective review and comparison of 2 databases during an 11-year span. Principal diagnoses made by emergency physicians as reported by the National Hospital Ambulatory Medical Care Survey were compared to all first-author publications by emergency physicians as reported in PubMed between 1996 and 2006. Statistics included correlations and linear regression with the number of emergency department (ED) visits per diagnosis as the independent variable and the number of articles published as the dependent variable.During the study period, there was significant concordance between the frequency of presenting conditions in the emergency department and the frequency of research being performed on those conditions, with a high correlation of 0.85 (P < 0.01). More common ED diagnoses such as injury/poisoning, symptoms/ill-defined conditions, and diseases of the respiratory system accounted for 60.9% of ED principal diagnoses and 50.2% of the total research published in PubMed.Unlike researchers in other fields, emergency physicians investigate clinical problems in almost the exact proportion as those conditions are encountered in the emergency department. The scarcity of EM research does not have to do with a skewed focus toward less common patient problems.

  View details for DOI 10.5811/westjem.2011.6.6722

  View details for PubMedID 23251714

• Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers (MeDS): Prospective Cohort Study Protocol BMC NEUROLOGY Govindarajan, P., Ghilarducci, D., McCulloch, C., Pierog, J., Bloom, E., Johnston, C. 2011; 11

  Abstract

  Stroke is a major cause of death and leading cause of disability in the United States. To maximize a stroke patient's chances of receiving thrombolytic treatment for acute ischemic stroke, it is important to improve prehospital recognition of stroke. However, it is known from published reports that emergency medical dispatchers (EMDs) using Card 28 of the Medical Priority Dispatch System protocols recognize stroke poorly. Therefore, to improve EMD's recognition of stroke, the National Association of Emergency Medical Dispatchers recently designed a new diagnostic stroke tool (Cincinnati Stroke Scale -CSS) to be used with Card 28. The objective of this study is to determine whether the addition of CSS improves diagnostic accuracy of stroke triage.This prospective experimental study will be conducted during a one-year period in the 911 call center of Santa Clara County, CA. We will include callers aged ≥ 18 years with a chief complaint suggestive of stroke and second party callers (by-stander or family who are in close proximity to the patient and can administer the tool) ≥ 18 years of age. Life threatening calls will be excluded from the study. Card 28 questions will be administered to subjects who meet study criteria. After completion of Card 28, CSS tool will be administered to all calls. EMDs will record their initial assessment of a cerebro-vascular accident (stroke) after completion of Card 28 and their final assessment after completion of CSS. These assessments will be compared with the hospital discharge diagnosis (ICD-9 codes) recorded in the Office of Statewide Health Planning and Development (OSHPD) database after linking the EMD database and OSHPD database using probabilistic linkage. The primary analysis will compare the sensitivity of the two stroke protocols using logistic regression and generalizing estimating equations to account for clustering by EMDs. To detect a 15% difference in sensitivity between the two groups with 80% power, we will enroll a total of 370 subjects in this trial.A three week pilot study was performed which demonstrated the feasibility of implementation of the study protocol.

  View details for DOI 10.1186/1471-2377-11-14

  View details for Web of Science ID 000287532000001

  View details for PubMedID 21272365

• Patient-centered Integrated Networks of Emergency Care: Consensus-based Recommendations and Future Research Priorities ACADEMIC EMERGENCY MEDICINE Govindarajan, P., Larkin, G. L., Rhodes, K. V., Piazza, G., Byczkowski, T. L., Edwards, M., Baren, J. M. 2010; 17 (12): 1322-1329

  Abstract

  Patient-centered care is defined by the Institute of Medicine (IOM) as care that is responsive to individual patient needs and values and that guides the treatment decisions. This article is a result of a breakout session of the 2010 Academic Emergency Medicine (AEM) consensus conference and describes the process of developing consensus-based recommendations for providing patient-centered emergency care. The objectives of the working group were to identify and describe the critical gaps in the provision of patient-centered care, develop a consensus-based research agenda, and create a list of future research priorities. Using e-mail and in-person meetings, knowledge gaps were identified in the areas of respect for patient preferences, coordination of clinical care, and communication among health care providers. Four consensus-based recommendations were developed on the following themes: enhancing communication and patient advocacy in emergency departments (EDs), facilitating care coordination after discharge, defining metrics for patient-centered care, and placing the locus of control of medical information into patients' hands. The set of research priorities based on these recommendations was created to promote research and advance knowledge in this dimension of clinical care.

  View details for DOI 10.1111/j.1553-2712.2010.00939.x

  View details for Web of Science ID 000284848100010

  View details for PubMedID 21122014