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

Subarachnoid Hemorrhage Clinical Trial

Official title:

IMPlementation of Best PRactices fOr Acute Stroke Care - Developing and Optimizing Regional Systems of Stroke Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242784
• Other study ID #: Pro00076593
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The design is based upon the implementation of best practice, that is, based on a comprehensive review of AHA guidelines regarding treatment of acute stroke, ICH (intracranial hemorrhage) and SAH(sub arachnoid hemorrhage). In the second phase, the project will be doing national and international surveys of best practices among comprehensive stroke centers and then combine evidence based guidelines and recommendation as well as expert consensus and guidelines when high level evidence is not available from the published literature. The aim to improve public stroke awareness, stroke symptom recognition within the time benefit window for treatment and calling 9-1-1, EMS transportation, and the proportion and speed of reperfusion therapy (fibrinolytic and in appropriate patients- endovascular treatment) in eligible patients. These improvements in acute stroke care delivery are expected to result in lower mortality, fewer recurrent strokes, and improved long term functional outcomes that we will measure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21646
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Stroke
• Hemorrhage
• Intracranial Hemorrhages
• Stroke
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
United States	Mission Health	Asheville	North Carolina
United States	Atrium Health's Carolinas Medical Center	Charlotte	North Carolina
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Prisma Health	Columbia	South Carolina
United States	Atrium Health Cabarrus	Concord	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Novant Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Chiesi Farmaceutici S.p.A., Daiichi Sankyo, Inc., Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. Review. — View Citation

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 à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van — View Citation

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, McGu — View Citation

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 — View Citation

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 i — View Citation

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 impr — View Citation

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, Cho — View Citation

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; — View Citation

Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Román L, Serena J, Abilleira S, Ribó M, Millán M, Urra X, Cardona P, López-Cancio E, Tomasello A, Castaño C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Pérez M, Goyal M, — View Citation

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: 10.101 — View Citation

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 Fo — View Citation

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 — View Citation

Schulman S. Clinical practice. Care of patients receiving long-term anticoagulant therapy. N Engl J Med. 2003 Aug 14;349(7):675-83. Review. — View Citation

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 an — View Citation

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. — View Citation

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 Car — View Citation

Xian Y, Xu H, Lytle B, Blevins J, Peterson ED, Hernandez AF, Smith EE, Saver JL, Messé 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 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Change in Number of Deaths from Stroke as measure by medical record	Count of number of deaths from stroke	From baseline (Q1, 2017) to Quarter 4 (2020)
Secondary	Change in Functional Long Term Outcomes as measured by Modified Rankin Scale	Modified Ranking Scale ranges from 0-6,; 0 No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	From baseline , 3 months