Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled Trial
Background Mobile stroke units have been shown to deliver faster patient care and improve clinical outcomes. However, costs associated with staffing limit their use to densely populated cities. Using the Melbourne mobile stroke unit, we aim to evaluate the safety, timeliness, and resource efficiency...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-11-01
|
| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.124.036856 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850265612056526848 |
|---|---|
| author | Vignan Yogendrakumar Anna H. Balabanski Hannah Johns Leonid Churilov Nicola K. Parsons James Beharry Louise Weir Nawaf Yassi Henry Zhao Alex Warwick Skye Coote Francesca Langenberg Leigh Branagan Wasseem Siddiqi Andrew Bivard Bruce C. V. Campbell Geoffrey A. Donnan Stephen M. Davis |
| author_facet | Vignan Yogendrakumar Anna H. Balabanski Hannah Johns Leonid Churilov Nicola K. Parsons James Beharry Louise Weir Nawaf Yassi Henry Zhao Alex Warwick Skye Coote Francesca Langenberg Leigh Branagan Wasseem Siddiqi Andrew Bivard Bruce C. V. Campbell Geoffrey A. Donnan Stephen M. Davis |
| author_sort | Vignan Yogendrakumar |
| collection | DOAJ |
| description | Background Mobile stroke units have been shown to deliver faster patient care and improve clinical outcomes. However, costs associated with staffing limit their use to densely populated cities. Using the Melbourne mobile stroke unit, we aim to evaluate the safety, timeliness, and resource efficiency of a telemedicine model, where the neurologist assesses a patient remotely, via telemedicine, compared with an onboard neurologist model. We hypothesize that, without compromising patient safety, the telemedicine model will provide timely care and superior resource efficiency. Methods Using a prospective, randomized, blinded end‐point controlled design, 270 participants consecutively assessed on the Melbourne mobile stroke unit over ≈12 months will be assigned into 2 arms: (1) telemedicine neurologist assessment (intervention) versus (2) onboard assessment (comparator). Enrollment is based on prospectively designated randomized days of neurologist review onboard versus telemedicine. The primary outcome will be the odds that a randomly selected participant in the telemedicine arm will have a better outcome than a randomly selected participant in the onboard arm, measured using a desirability‐of‐outcome ranking, an outcome measure that includes, in order of importance: (1) safety, (2) scene‐to‐treatment‐decision time metrics, and (3) resource usage. All participants within each arm will be compared with those in the other, resulting in a “win/tie/loss” distribution for telemedicine compared with the onboard model. Conclusions The study will establish whether use of a telemedicine neurologist delivers superior resource efficiency without compromising patient care. This would enable the broader use of mobile stroke units, particularly relevant to regions with limited access to neurologists, thus improving equity in access to time‐critical, lifesaving stroke care. Registration URL: clinicaltrials.gov; Unique Identifier: NCT05991310. |
| format | Article |
| id | doaj-art-40ce316dacf14ec9b7426da63e6b4e18 |
| institution | OA Journals |
| issn | 2047-9980 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-40ce316dacf14ec9b7426da63e6b4e182025-08-20T01:54:22ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802024-11-01132110.1161/JAHA.124.036856Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled TrialVignan Yogendrakumar0Anna H. Balabanski1Hannah Johns2Leonid Churilov3Nicola K. Parsons4James Beharry5Louise Weir6Nawaf Yassi7Henry Zhao8Alex Warwick9Skye Coote10Francesca Langenberg11Leigh Branagan12Wasseem Siddiqi13Andrew Bivard14Bruce C. V. Campbell15Geoffrey A. Donnan16Stephen M. Davis17Department of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Medicine, Melbourne Medical School University of Melbourne AustraliaDepartment of Medicine, Melbourne Medical School University of Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology Christchurch Hospital Christchurch New ZealandDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaAmbulance Victoria Melbourne AustraliaAmbulance Victoria Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaDepartment of Neurology, University of Melbourne Melbourne Brain Centre at the Royal Melbourne Hospital Melbourne AustraliaBackground Mobile stroke units have been shown to deliver faster patient care and improve clinical outcomes. However, costs associated with staffing limit their use to densely populated cities. Using the Melbourne mobile stroke unit, we aim to evaluate the safety, timeliness, and resource efficiency of a telemedicine model, where the neurologist assesses a patient remotely, via telemedicine, compared with an onboard neurologist model. We hypothesize that, without compromising patient safety, the telemedicine model will provide timely care and superior resource efficiency. Methods Using a prospective, randomized, blinded end‐point controlled design, 270 participants consecutively assessed on the Melbourne mobile stroke unit over ≈12 months will be assigned into 2 arms: (1) telemedicine neurologist assessment (intervention) versus (2) onboard assessment (comparator). Enrollment is based on prospectively designated randomized days of neurologist review onboard versus telemedicine. The primary outcome will be the odds that a randomly selected participant in the telemedicine arm will have a better outcome than a randomly selected participant in the onboard arm, measured using a desirability‐of‐outcome ranking, an outcome measure that includes, in order of importance: (1) safety, (2) scene‐to‐treatment‐decision time metrics, and (3) resource usage. All participants within each arm will be compared with those in the other, resulting in a “win/tie/loss” distribution for telemedicine compared with the onboard model. Conclusions The study will establish whether use of a telemedicine neurologist delivers superior resource efficiency without compromising patient care. This would enable the broader use of mobile stroke units, particularly relevant to regions with limited access to neurologists, thus improving equity in access to time‐critical, lifesaving stroke care. Registration URL: clinicaltrials.gov; Unique Identifier: NCT05991310.https://www.ahajournals.org/doi/10.1161/JAHA.124.036856mobile stroke unitprehospitalstroketelemedicinetrial design |
| spellingShingle | Vignan Yogendrakumar Anna H. Balabanski Hannah Johns Leonid Churilov Nicola K. Parsons James Beharry Louise Weir Nawaf Yassi Henry Zhao Alex Warwick Skye Coote Francesca Langenberg Leigh Branagan Wasseem Siddiqi Andrew Bivard Bruce C. V. Campbell Geoffrey A. Donnan Stephen M. Davis Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled Trial Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease mobile stroke unit prehospital stroke telemedicine trial design |
| title | Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled Trial |
| title_full | Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled Trial |
| title_fullStr | Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled Trial |
| title_full_unstemmed | Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled Trial |
| title_short | Evaluating the Safety and Efficacy of Telemedicine Physician Assessments on a Mobile Stroke Unit: Protocol for a Prospective Open‐Label Blinded End‐Point Randomized Controlled Trial |
| title_sort | evaluating the safety and efficacy of telemedicine physician assessments on a mobile stroke unit protocol for a prospective open label blinded end point randomized controlled trial |
| topic | mobile stroke unit prehospital stroke telemedicine trial design |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.124.036856 |
| work_keys_str_mv | AT vignanyogendrakumar evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT annahbalabanski evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT hannahjohns evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT leonidchurilov evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT nicolakparsons evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT jamesbeharry evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT louiseweir evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT nawafyassi evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT henryzhao evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT alexwarwick evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT skyecoote evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT francescalangenberg evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT leighbranagan evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT wasseemsiddiqi evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT andrewbivard evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT brucecvcampbell evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT geoffreyadonnan evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial AT stephenmdavis evaluatingthesafetyandefficacyoftelemedicinephysicianassessmentsonamobilestrokeunitprotocolforaprospectiveopenlabelblindedendpointrandomizedcontrolledtrial |