IMPROVE Stroke Care- Developing and Optimizing Regional Systems of Stroke Care

NCT04242784 | Completed

• 1 other identifier: Pro00076593
• Study Type: observational
• Target: 21,646
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this program is to develop a regional integrated stroke system that identifies, classifies, and treats patients with acute ischemic stroke more rapidly and effectively with reperfusion therapy.

Conditions

Acute Stroke; Intracranial Hemorrhages; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (3)

• Change in Time from door to drug as measured by medical record

  The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of the administration of the drug (TPA)

  From baseline (Q1, 2017), to Quarter 4 (2020)

• Change in Time from Door to Tici 2c/3 flow measured by medical record

  The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of Tici 2c/c flow noted in the vessel

  From baseline (Q1, 2017), to Quarter 4 (2020)

• Change in Time from Door to Administration of Reversal Agent as measured by medical record

  The time frame starting from the earliest time that the patient is documented as arriving to the hospital to the beginning time of the administration of the drug (reversal agent)

  From baseline (Q1, 2017), to Quarter 4 (2020)

Secondary Outcomes (2)

• Change in Number of Deaths from Stroke as measure by medical record

  From baseline (Q1, 2017) to Quarter 4 (2020)

• Change in Functional Long Term Outcomes as measured by Modified Rankin Scale

  From baseline , 3 months

Study Arms (3)

Spoke Hospital

Patients that undergo the Code Stroke process at Spoke Hospitals

Hub Hospital

Patients that undergo the Code Stroke process at Hub Hospitals

Transfer

Patients that undergo the Code Stroke process at a Spoke Hospital and transfer to the Hub Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who undergo the Acute Code Stroke Process, who demonstrate symptoms of a possible acute stroke, and are presenting to a Spoke or Hub within the Southeastern US at the 9 Hub Hospitals and Spokes associated with those Hubs participating in the project.

You may qualify if:

• Adult patients \> 18 years of age who undergo the local acute code stroke process

You may not qualify if:

• In house patients with stroke are not included in this data set.

Sponsors & Collaborators

• Duke University: lead
• Medtronic: collaborator
• Daiichi Sankyo: collaborator
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (9)

Mission Health

Asheville, North Carolina, 28801, United States

Location

Atrium Health's Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Atrium Health Cabarrus

Concord, North Carolina, 28025, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Novant Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Prisma Health

Columbia, South Carolina, 29203, United States

Location

Related Publications (17)

• Fonarow GC, Smith EE, Saver JL, Reeves MJ, Hernandez AF, Peterson ED, Sacco RL, Schwamm LH. Improving door-to-needle times in acute ischemic stroke: the design and rationale for the American Heart Association/American Stroke Association's Target: Stroke initiative. Stroke. 2011 Oct;42(10):2983-9. doi: 10.1161/STROKEAHA.111.621342. Epub 2011 Sep 1.

  PMID: 21885841 RESULT

• Fonarow GC, Zhao X, Smith EE, Saver JL, Reeves MJ, Bhatt DL, Xian Y, Hernandez AF, Peterson ED, Schwamm LH. Door-to-needle times for tissue plasminogen activator administration and clinical outcomes in acute ischemic stroke before and after a quality improvement initiative. JAMA. 2014 Apr 23-30;311(16):1632-40. doi: 10.1001/jama.2014.3203.

  PMID: 24756513 RESULT

• Xian Y, Xu H, Lytle B, Blevins J, Peterson ED, Hernandez AF, Smith EE, Saver JL, Messe SR, Paulsen M, Suter RE, Reeves MJ, Jauch EC, Schwamm LH, Fonarow GC. Use of Strategies to Improve Door-to-Needle Times With Tissue-Type Plasminogen Activator in Acute Ischemic Stroke in Clinical Practice: Findings from Target: Stroke. Circ Cardiovasc Qual Outcomes. 2017 Jan;10(1):e003227. doi: 10.1161/CIRCOUTCOMES.116.003227.

  PMID: 28096207 RESULT

• Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17.

  PMID: 25517348 RESULT

• Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.

  PMID: 25671798 RESULT

• Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.

  PMID: 25882376 RESULT

• Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.

  PMID: 25671797 RESULT

• Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

  PMID: 25882510 RESULT

• Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; American Heart Association Stroke Council. 2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Oct;46(10):3020-35. doi: 10.1161/STR.0000000000000074. Epub 2015 Jun 29.

  PMID: 26123479 RESULT

• Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.

  PMID: 23370205 RESULT

• Mellor RM, Bailey S, Sheppard J, Carr P, Quinn T, Boyal A, Sandler D, Sims DG, Mant J, Greenfield S, McManus RJ. Decisions and delays within stroke patients' route to the hospital: a qualitative study. Ann Emerg Med. 2015 Mar;65(3):279-287.e3. doi: 10.1016/j.annemergmed.2014.10.018. Epub 2014 Nov 15.

  PMID: 25455907 RESULT

• Shin CN, An K, Sim J. Facilitators of and barriers to emergency medical service use by acute ischemic stroke patients: A retrospective survey. Int J Nurs Sci. 2016 Dec 26;4(1):52-57. doi: 10.1016/j.ijnss.2016.12.008. eCollection 2017 Jan 10.

  PMID: 31406718 RESULT

• Ekundayo OJ, Saver JL, Fonarow GC, Schwamm LH, Xian Y, Zhao X, Hernandez AF, Peterson ED, Cheng EM. Patterns of emergency medical services use and its association with timely stroke treatment: findings from Get With the Guidelines-Stroke. Circ Cardiovasc Qual Outcomes. 2013 May 1;6(3):262-9. doi: 10.1161/CIRCOUTCOMES.113.000089. Epub 2013 Apr 29.

  PMID: 23633218 RESULT

• Schwamm LH, Audebert HJ, Amarenco P, Chumbler NR, Frankel MR, George MG, Gorelick PB, Horton KB, Kaste M, Lackland DT, Levine SR, Meyer BC, Meyers PM, Patterson V, Stranne SK, White CJ; American Heart Association Stroke Council; Council on Epidemiology and Prevention; Interdisciplinary Council on Peripheral Vascular Disease; Council on Cardiovascular Radiology and Intervention. Recommendations for the implementation of telemedicine within stroke systems of care: a policy statement from the American Heart Association. Stroke. 2009 Jul;40(7):2635-60. doi: 10.1161/STROKEAHA.109.192361. Epub 2009 May 7. No abstract available.

  PMID: 19423851 RESULT

• Wechsler LR, Demaerschalk BM, Schwamm LH, Adeoye OM, Audebert HJ, Fanale CV, Hess DC, Majersik JJ, Nystrom KV, Reeves MJ, Rosamond WD, Switzer JA; American Heart Association Stroke Council; Council on Epidemiology and Prevention; Council on Quality of Care and Outcomes Research. Telemedicine Quality and Outcomes in Stroke: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Jan;48(1):e3-e25. doi: 10.1161/STR.0000000000000114. Epub 2016 Nov 3.

  PMID: 27811332 RESULT

• Schulman S. Clinical practice. Care of patients receiving long-term anticoagulant therapy. N Engl J Med. 2003 Aug 14;349(7):675-83. doi: 10.1056/NEJMcp025373. No abstract available.

  PMID: 12917305 RESULT

• Aycock RD, Westafer LM, Boxen JL, Majlesi N, Schoenfeld EM, Bannuru RR. Acute Kidney Injury After Computed Tomography: A Meta-analysis. Ann Emerg Med. 2018 Jan;71(1):44-53.e4. doi: 10.1016/j.annemergmed.2017.06.041. Epub 2017 Aug 12.

  PMID: 28811122 RESULT

MeSH Terms

Conditions

Stroke; Intracranial Hemorrhages; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmelo Graffagnino, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Bradley Kolls, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)