OPTIMISTmain
OPTIMISTmain is a National Institute of Health (NIHR), investigator-initiated and conducted, international, multicentre, stepped-wedge cluster, randomised controlled trial comparing the effects of different intensities of nursing care monitoring for patients with acute ischaemic stroke without critical care needs after thrombolysis treatment.
This project is set in stroke nursing care, looking at how we monitor acute stroke patients who have received thrombolysis or thrombectomy (clot busting or clot retrieval treatment) in the immediate hours following a stroke. It is concerned with intercranial haemorrhage, and aims to increase safety.
The monitoring schedule has not changed since thrombolysis was licensed in 2008, consisting of neurological observations, blood pressure, pulse and respiration rates, and oxygen saturations:
- Quarter-hourly for two hours
- Half-hourly for six hours
- Hourly for 18 hours
This is both time-consuming and has detrimental effects on patients’ rest and wellbeing. The trial is looking at reducing the observations to:
- Quarter-hourly for two hours
- Every two hours for six hours
- Every four hours
OPTIMISTmain is led by Prof Craig Anderson, Professor of Stroke Medicine in The George Institute, New South Wales, Australia. Diana Day, Senior Lecturer in Advanced Practice at ARU, is the joint country Lead Investigator for the UK.
The study is recruiting patients with medium to small strokes requiring thrombolysis treatment. It uses a cluster consent, whereby the participating hospitals give permission to change the monitoring for this defined group of patients, so the patients themselves only need to consent to the use of their data.
The step wedge design means that each site is its own control. The sites move from standard care to low intensity monitoring, with a period of training and awareness between the steps.
Diana's background as Consultant Nurse for Stroke at Addenbrookes, Cambridge, where she also led the hyperacute stroke research group, equipped her to join this study as joint country lead. As Clinical Lead, she supports the Principal Investigators, advising on clinical questions and queries and setting up sites and interviews, supported in turn by study coordinators at Leicester University Stroke Research Unit.
Her role in this study is to:
- Optimise patient care
- Involve nurses in research by a) raising visibility of research, b) bringing research into the clinical workplace, and c) encouraging and supporting nurse primary investigators at sites – an NIHR objective.
- Increase the evidence base underpinning nursing interventions.
- Measure the impact and conduct of the study on site through process outcomes, patient reported experiences (PREMS), and staff interviews.
Additionally, the investigators are conducting service evaluation interviews at selected sites to better understand the barriers to implementation and the cognitive and participatory engagement across the multi-disciplinary team.
The study includes 24 sites in the UK and is now closed to recruitment, with data lock in December 2024.
For further information, contact [email protected]
May 2023
As of May 2023, we:
- Have recruited 1,454 patients across 46 sites across the UK, Australia, Mexico and China.
- Are on target to open 30 sites in the UK, – our ninth site opened in the second week of May.
- Have recruited six new nursing Primary Investigators in the UK to lead at individual sites, with more sites opening soon.
Ouyang, M., Gonzalez, F., Montalbano, M., Pruski, A., Iacobelli, M., Wang, X., Faigle,R. R., Johnson B. J., Summers, D., Jan, S., Urrutia, V. C., Anderson, C. S. and Liu, H. (2023) 'Abstract WMP13: Implementation Issues Arising From Less-intense Monitoring In Routine Care: Process Evaluation Of The Optimial Post Rtpa-iv Monitoring In Acute Ischemic Stroke (OPTIMISTmain) Study', Stroke, 54. Available at: https://doi.org/10.1161/str.54.suppl_1.WMP13
Faigle, R., Johnson, B., Summers, D., Khatri, P., Anderson, C. S., Urrutia, V. C., OPTIMISTmain Steering Committee (2020) 'Low-Intensity Monitoring After Stroke Thrombolysis During the COVID-19 Pandemic', Neurocrit Care, 33(2), pp. 333-337. Available at: https://doi.org/10.1007/s12028-020-00998-0
Lim, J., Wang, X., Robinson, T., Urrutia, V. C., Johnson, B., Summers, D. V., Day, D., Dowlatshahi,. D, Khatri, P., Lindley, R., Munoz, P., Balicki, G., Jan, S. and Anderson, C. (2019) 'Optimal post Tpa-IV monitoring in ischemic stroke (OPTIMISTmain)', International Journal of Stroke, 14(1), pp. 18-19. Available at: https://doi.org/10.1177/1747493019858233
