The main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): Protocol for a Pragmatic, Stepped Wedge, Cluster Randomized Controlled Trial
Journal
Cerebrovascular Diseases
ISSN
1015-9770
1421-9786
Date Issued
2023
Author(s)
Menglu Ouyang
Roland Faigle
Xia Wang
Brenda Johnson
Debbie Summers
Pooja Khatri
Laurent Billot
Hueiming Liu
Alejandra Malavera
Francisca Urrutia
Diana Day
Lili Song
Yi Sui
Candice Delcourt
Thompson Robinson
Alice C. Durham
Ahtasam Ebraimo
Wan Asyraf Wan Zaidi
Stephen Jan
Richard I. Lindley
Victor C. Urrutia
Craig S. Anderson
Type
Resource Types::text::journal::journal article
URL Institutional Repository
Abstract
<jats:p>Introduction: Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low risk of symptomatic intracerebral hemorrhage (sICH) and other complications. Methods: OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe, and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically stable adult patients with mild AIS (defined by a NIHSS <10) who do not require intensive care within 2 h post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, USA, and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7,200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 min for 2 h, 2 hourly (vs. every 30 min) for 8 h, and 4 hourly (vs. every 1 h) until 24 h, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH, and serious adverse events. Conclusion: OPTIMISTmain will provide level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS. </jats:p>
Cite this document
Ouyang, M., Faigle, R., Wang, X., Johnson, B., Summers, D., Khatri, P., Billot, L., Liu, H., Malavera, A., Muñoz-Venturelli, P., González, F., Urrutia, F., Day, D., Song, L., Sui, Y., Delcourt, C., Robinson, T., Durham, A. C., Ebraimo, A., … the OPTIMISTmain Investigators. (2023). The main optimal post rtpa-iv monitoring in ischemic stroke trial (Optimistmain): Protocol for a pragmatic, stepped wedge, cluster randomized controlled trial. Cerebrovascular Diseases, 53(5), 635-642. https://doi.org/10.1159/000534706
Subjects
acute care
;
health systems
;
ischemic stroke
;
nursing care
;
thrombolysis