Stroke Team Remote Evaluation Using a Digital Observation Camera

Stroke Clinical Trial

— STRokE DOC  

Official title:

A Prospective Study to Evaluate the Efficacy of a Remote Digital Observation Camera Protocol in the Evaluation and Thrombolytic Treatment of Acute Stroke Patients in the Remote Hospital Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283868
• Other study ID #: P50NS44148MEYER
• Secondary ID: P50NS044148
• Status: Completed
• Phase: N/A
• First received: January 26, 2006
• Last updated: June 2, 2015
• Start date: January 2004
• Est. completion date: August 2007

Study information

• Verified date: September 2009
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site.

Description:

The Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) system is a digital video camera system that can transfer video and audio images from the clinic or emergency room to a distant (remote) place where a stroke specialist can review the images in real time (as they happen). This system uses site independent software to access the camera system from multiple locations. The study will determine if video consultation is superior to telephone consultation for remote evaluation or treatment of stroke patients, and the usefulness of this system in evaluating patients with suspected stroke symptoms. However, this method is being used in other fields of medicine for assistance in medical evaluations.

Participants will be randomly assigned to receive evaluation by either the video camera system or by telephone alone. For those assigned to the video camera system, the system will be activated and will record and transmit video and audio images to a stroke specialist located at a remote location. He/she may ask the participants questions relating to medical illnesses and current symptoms, and may also review laboratory tests and x-ray images using a computer, if available. The stroke specialist will also perform general physical and neurological examinations, which will take place by video camera with the assistance of a bedside physician who will perform the actual examinations.

For those participants assigned to the telephone-only consultation, the video system will not be activated, but the same procedure as above will be followed except the stroke specialist will not be able to see the participants or examine them using the video camera system. Participation in the study will last for the entire time the participants are in the hospital. Participants will be contacted by telephone by a study nurse 3 months post-stroke for a 10-minute interview regarding their current health. The total duration for individual participation is 3 months.

The study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Symptoms consistent with acute stroke (ischemic or hemorrhagic)

• Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours)

Exclusion Criteria:

• Unlikely to complete study through 90-day follow-up

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
United States	Pioneers Memorial Hospital	Brawley	California
United States	El Centro Regional Medical Center	El Centro	California
United States	University of California San Diego	San Diego	California
United States	Twin Cities Community Hospital	San Luis Obispo	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Audebert HJ, Kukla C, Clarmann von Claranau S, Kühn J, Vatankhah B, Schenkel J, Ickenstein GW, Haberl RL, Horn M; TEMPiS Group. Telemedicine for safe and extended use of thrombolysis in stroke: the Telemedic Pilot Project for Integrative Stroke Care (TEMPiS) in Bavaria. Stroke. 2005 Feb;36(2):287-91. Epub 2004 Dec 29. — View Citation

Crome O, Bähr M. Editorial comment--Remote evaluation of acute ischemic stroke: a reliable tool to extend tissue plasminogen activator use to community and rural stroke patients? Stroke. 2003 Oct;34(10):e191-2. Epub 2003 Sep 18. — View Citation

LaMonte MP, Bahouth MN, Hu P, Pathan MY, Yarbrough KL, Gunawardane R, Crarey P, Page W. Telemedicine for acute stroke: triumphs and pitfalls. Stroke. 2003 Mar;34(3):725-8. Epub 2003 Jan 30. — View Citation

Meyer BC, Lyden PD, Al-Khoury L, Cheng Y, Raman R, Fellman R, Beer J, Rao R, Zivin JA. Prospective reliability of the STRokE DOC wireless/site independent telemedicine system. Neurology. 2005 Mar 22;64(6):1058-60. — View Citation

Patterson V. Teleneurology. J Telemed Telecare. 2005;11(2):55-9. Review. — View Citation

Schwamm LH, Rosenthal ES, Hirshberg A, Schaefer PW, Little EA, Kvedar JC, Petkovska I, Koroshetz WJ, Levine SR. Virtual TeleStroke support for the emergency department evaluation of acute stroke. Acad Emerg Med. 2004 Nov;11(11):1193-7. — View Citation

Wang S, Gross H, Lee SB, Pardue C, Waller J, Nichols FT 3rd, Adams RJ, Hess DC. Remote evaluation of acute ischemic stroke in rural community hospitals in Georgia. Stroke. 2004 Jul;35(7):1763-8. Epub 2004 May 27. — View Citation

Wiborg A, Widder B; Telemedicine in Stroke in Swabia Project. Teleneurology to improve stroke care in rural areas: The Telemedicine in Stroke in Swabia (TESS) Project. Stroke. 2003 Dec;34(12):2951-6. Epub 2003 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriateness of Decision to Treat or Not Treat With Thrombolytics	This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset.; Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was "appropriate" to give or not give rt-PA.	potentially within 3 hours of symptom onset	No
Secondary	Percentage of Participants With Intracerebral Hemorrhage (ICH)	Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage.	36 hours	Yes
Secondary	Percentage of Total Thrombolytic Administrations	This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other.	potentially within 3 hours of symptom onset	No
Secondary	Time to Treatment Decision for Administration of Thrombolytics	time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.	potentially within 3 hours of symptom onset	No
Secondary	Percentage of Evaluations With Technical Observations	Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial.	Time of consultation	No