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Trial registered on ANZCTR


Registration number
ACTRN12619001556134p
Ethics application status
Not yet submitted
Date submitted
22/10/2019
Date registered
12/11/2019
Date last updated
12/11/2019
Date data sharing statement initially provided
12/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal Post intravenous recombinant Tissue plasminogen activator (Tpa-Iv) Monitoring in Ischemic Stroke (OPTIMISTmain): effects of different intensities of nursing care monitoring for patients with acute ischemic stroke without critical care needs after thrombolysis treatment
Scientific title
Optimal Post Tpa-Iv Monitoring in Ischemic Stroke (OPTIMISTmain): An international, stepped-wedge, cluster randomised clinical trial to determine whether less-intense monitoring is at least as effective (‘non-inferior’) to standard monitoring in the functional recovery of ischaemic stroke patients.
Secondary ID [1] 299591 0
NCT03734640
Universal Trial Number (UTN)
Trial acronym
OPTIMISTmain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ischaemic stroke patients 314871 0
Condition category
Condition code
Stroke 313215 313215 0 0
Ischaemic
Neurological 313255 313255 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315845 0
Diagnosis / Prognosis
Comparator / control treatment
Guideline recommended standard monitoring-Neurological assessment (Glasgow coma scale [GCS] and/or NIHSS) and vital signs (heart rate [HR] and blood pressure [BP]) every 15 min for the first 2 hours at the beginning of rtPA infusion, then every 30 min for 6 hours, then every 60 min for 16 hours.

These monitoring care will be provided by the nurses in the participating sites such as Acute Stroke Unit (ASU) to acute ischemic stroke paitents post rtPA treatment.
Control group
Active

Outcomes
Primary outcome [1] 321717 0
Modified Rankin scale (mRS) according to shift analysis across full range of scores - a 7 level categorical scale, grading levels of physical function / dependency from 0 = no symptoms, 1 = symptoms, 2 = disability but independent, 3 = disability with some help, 4 = disability with moderate help, 5 = severe disability requiring full assistance, and 6 = death
Timepoint [1] 321717 0
At day 90 follow-up
Secondary outcome [1] 375998 0
Frequency of major Symptomatic intracerebral hemorrhage reported by investigators according to standard criteria (diagnosis confirmed by CT scan)
Timepoint [1] 375998 0
Within first 24 hours, at 7 days the begining of IV rtPA treatment after admissionand at 90 days follow-up
Secondary outcome [2] 375999 0
Measures of hospital costs - to allow economic analysis of treatment interventions at a country level. Measures of hospitalization costs will include personnel cost and time involved in delivering the monitoring strategy. These will be collected from facility financial statements from sites. Follow-up health care costs including inpatient and outpatient occasions of service, will be estimated from a case report forms random sample of patients in each of the trial clusters.
Timepoint [2] 375999 0
At 90 days of follow-up
Secondary outcome [3] 376000 0
Poor outcome measured by National Institute Health Stroke Scale (NIHSS) score of 15-42
Timepoint [3] 376000 0
At 7 days from the begining of IV rtPA treatment after admission
Secondary outcome [4] 376002 0
Length of hospital stay assessed by hospital records and Case Report Forms (CRFs)
Timepoint [4] 376002 0
At 90 days of follow-up
Secondary outcome [5] 376027 0
Poor functional outcome rate defined by modified Rankin Scale (mRS) scores of 2-6
Timepoint [5] 376027 0
At 90 days follow up
Secondary outcome [6] 376028 0
All Serious Adverse Events (SAEs) that occur up until the 90-day follow-up will be prospectively reported, monitored, and reviewed according to standard criteria. Medical records and Case Report Forms (CRFs) will be used to assess this outcome.

SAEs are defined as:
1. results in death,
2. is life-threatening,
3. requires inpatient hospitalization or causes prolongation of existing hospitalization,
4. results in persistent or significant disability/incapacity,
5. may have caused a congenital anomaly/birth defect, or
6. requires intervention to prevent permanent impairment or damage

Examples of adverse events that may occur include death, symptomatic intracerebral haemorrhage, gastrointestinal bleeding, recurrent of stroke etc.
Timepoint [6] 376028 0
Within 90 days from admission
Secondary outcome [7] 376372 0
Requested time to scan for presumed symptomatic intracerebral hemorrhage (sICH) from last physiological monitoring through hospital records and Case Report Forms (CRFs)
Timepoint [7] 376372 0
within 7 days after admission and reviewed at 90 days of follow up
Secondary outcome [8] 376373 0
Health related quality of life (HRQoL) assessed by the European Quality of Life Scale 5 Dimension (EQ-5D).
Timepoint [8] 376373 0
At 90 days follow-up
Secondary outcome [9] 376586 0
Death rate assessed by hospital records and modified Rankin Scale (mRS) of score 6 in the follow-up Case Report Forms (CRFs)
Timepoint [9] 376586 0
At 90 days follow up

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped-wedge cluster design
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21933 0
Chile
State/province [1] 21933 0
Santiago
Country [2] 21934 0
United Kingdom
State/province [2] 21934 0
Leicester
Country [3] 21935 0
United States of America
State/province [3] 21935 0
Baltimore

Funding & Sponsors
Funding source category [1] 304072 0
Government body
Name [1] 304072 0
National Health and Medical Research Council
Address [1] 304072 0
Level 1, 16 Marcus Clarke Street, Canberra ACT 2601
Country [1] 304072 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 10, King George V Building, 83-117 Missenden Road, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 304279 0
None
Name [1] 304279 0
Address [1] 304279 0
Country [1] 304279 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304564 0
Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Hospital (RPAH) zone)
Ethics committee address [1] 304564 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 304564 0
Australia
Date submitted for ethics approval [1] 304564 0
11/12/2019
Approval date [1] 304564 0
Ethics approval number [1] 304564 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97398 0
Prof Craig Anderson
Address 97398 0
The George Institute for Global Health, Australia
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown, NSW 2050
Country 97398 0
Australia
Phone 97398 0
+61 299934521
Fax 97398 0
Email 97398 0
canderson@georgeinstitute.org.au
Contact person for public queries
Name 97399 0
Ms Baldeep Kaur
Address 97399 0
The George Institute for Global Health, Australia
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown, NSW 2050
Country 97399 0
Australia
Phone 97399 0
+61280524533
Fax 97399 0
Email 97399 0
bkaur@georgeinstitute.org.au
Contact person for scientific queries
Name 97400 0
Prof Craig Anderson
Address 97400 0
The George Institute for Global Health, Australia
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown, NSW 2050
Country 97400 0
Australia
Phone 97400 0
+61 299934521
Fax 97400 0
Email 97400 0
canderson@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data is only available for internal investigators.
What supporting documents are/will be available?
No other documents available
Summary results
No Results