None listed
Conditions
Brief summary
Acute ischemic stroke (AIS) is the most frequent pathological subtype of stroke affecting millions of people worldwide. Timely reperfusion treatment with the intravenous (IV) thrombolytic agent, recombinant tissue plasminogen activator ([rtPA] or alteplase) in carefully selected patients, offers them the potential benefit of surviving free of major disability. Clinical practice guidelines recommend that post-rtPA patients are closely observed and monitored over at least the subsequent 24 hours to allow early detection. However, it is unclear whether the standard intensive nursing monitoring protocol that forms the basis of guideline recommendations for the last 20 years should continue to be routinely applied to stable ‘low-risk’ post-rtPA patients with mild neurological deficits who do not require critical care intervention. OPTIMISTmain is an investigator-initiated and conducted, international, multicentre, stepped wedge cluster randomized controlled trial to determine whether compared to standard monitoring, less-intense monitoring is at least as effective ('non-inferior') on the functional recovery of acute ischaemic stroke patients post-rtPA infusion with mild-moderate neurological deficit. The study also aims to establish that less-intense monitoring can be safe, provides economic and resource benefits, relative to standard monitoring.
Interventions
Less-intense monitoring care strategy-Neurological assessment (Glasgow coma scale [GCS] and/or National Institute of Health Stroke Scale [NIHSS]) and vital signs (Heart Rate [HR], Blood Pressure [BP]) every 15 min for the first 2 hours at the beginning of rtPA infusion (intravenous infusion of thrombolysis medication after acute stroke), then every 2 hours for 8 hours, then every 4 hour for 14 hours.
These monitoring care will be provided by the nurses in the participating sites (e.g. Acute Str
Less-intense monitoring care strategy-Neurological assessment (Glasgow coma scale [GCS] and/or National Institute of Health Stroke Scale [NIHSS]) and vital signs (Heart Rate [HR], Blood Pressure [BP]) every 15 min for the first 2 hours at the beginning of rtPA infusion (intravenous infusion of thrombolysis medication after acute stroke), then every 2 hours for 8 hours, then every 4 hour for 14 hours. These monitoring care will be provided by the nurses in the participating sites (e.g. Acute Stroke Unit) to acute ischemic stroke patients post intravenous rtPA infusion. The GCS and/or NIHSS will be measured depending on the scales used for neurological assessment at the sites routinely, since some sites are only using GCS but others are using NIHSS. The HR and BP will be measured using the vital signs monitor devices available at the sites. All assessments will be collected using clinical record and case report forms (CRFs). A stepped-wedge cluster randomized design has been chosen to avoid contamination, facilitate hospital-wide implementation, and maximise adherence, to the intervention. The process moving in one direction (from control to intervention) is to facilitate the less-intense monitoring strategies being applied in clinical practice. The stepped-wedge design means that all sites (hospitals) will be randomly allocated to 3 groups and recruiting in 4 steps. Regarding the time for changing to intervention phase, the time limit is 4 months after initiation for Group 1; for Groups 2 and 3, the time periods are 8 months and 12 months, after activation, respectively. An average of 15 patients will be enrolled for each step at each site but the recruitment number will be pre-determined according to the volume of stroke patients at each participating site.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults (age more than 18 years); • Diagnosis of AIS and have been given intravenous (IV) bolus infusion of rtPA; • Clinically stable with mild-moderate neurological deficit (e.g. National Institutes of Health Stroke Scale [NIHSS] score less than 10) within 2 hours post IV tPA bolus dose in the opinion of the treating clinician • Provide informed consent (or via an appropriate proxy, according to local requirements) and remain in follow-up for 90 days
Exclusion criteria
• Definite contraindication for less intense monitoring, in the opinion of the treating clinician( i.e needs monitoring of co-morbid conditions such as renal failure, palliative care, ICU admission); • Immediate transfer for medical treatment (e.g. for haemodialysis) or surgery (e.g. carotid endarterectomy, hematoma evacuation) where adherence to less-intense monitoring is not possible.
Outcome results
None listed