The main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): Protocol for a Pragmatic, Stepped Wedge, Cluster Randomized Controlled Trial

dc.contributor.authorOuyang, Menglu
dc.contributor.authorFaigle, Roland
dc.contributor.authorWang, Xia
dc.contributor.authorJohnson, Brenda
dc.contributor.authorSummers, Debbie
dc.contributor.authorKhatri, Pooja
dc.contributor.authorBillot, Laurent
dc.contributor.authorLiu, Hueiming
dc.contributor.authorMalavera, Alejandra
dc.contributor.authorMunoz Venturelli, Paula
dc.contributor.authorGonzalez, Francisca
dc.contributor.authorUrrutia, Francisca
dc.contributor.authorDay, Diana
dc.contributor.authorSonga, Lili
dc.contributor.authorSui, Yi
dc.contributor.authorDelcourt, Candice
dc.contributor.authorRobinson, Thompson
dc.contributor.authorDurham, Alice
dc.contributor.authorEbraimo, Ahtasam
dc.contributor.authorWan Asyraf Wan Zaidin
dc.contributor.authorJan, Stephen
dc.contributor.authorLindley, Richard
dc.contributor.authorUrrutia, Victor
dc.contributor.authorAnderson, Craig
dc.description.abstractIntroduction 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 hours post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, US and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7200 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 minutes for 2 hours, 2 hourly (versus every 30 minutes) for 8 hours, and 4 hourly (versus every 1 hour) until 24 hours, 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.
dc.identifier.citationOuyang M, Faigle R, Wang X, Johnson B, Summers D, Khatri P, Billot L, Liu H, Malavera A, Munoz-Venturelli P, Gonzalez F, Urrutia F, Day D, Song L, Sui Y, Delcourt C, Robinson T, Durham AC, Ebraimo A, Wan Zaidi WA, Jan S, Lindley RI, Urrutia VC, Anderson CS. The main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): protocol for a pragmatic, stepped wedge, cluster randomized controlled trial. Cerebrovasc Dis. 2023 Oct 26. doi: 10.1159/000534706
dc.subjectIschemic stroke
dc.subjectAcute care
dc.subjectHealth systems
dc.subjectNursing care
dc.titleThe main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): Protocol for a Pragmatic, Stepped Wedge, Cluster Randomized Controlled Trial
dcterms.accessRightsAcceso Abierto
dcterms.sourceCerebrovascular diseases


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