An individualized approach to monitoring patients who receive thrombolysis for acute ischemic stroke may improve patient satisfaction, reduce intensive care unit admissions, and lessen the burden on hospital staff.

An international trial called OPTIMISTmain finds that reducing the frequency of post-treatment monitoring in patients who had a mild to moderate stroke and who were treated with intravenous thrombolysis is as safe and effective  as standard protocols, gives patients more rest with less interference, and frees up critical nursing and intensive care unit resources. In U.S. hospitals that adopted the low-intensity protocol, ICU admissions dropped by 30%.

The collaborative study, published May 21 in The Lancet, was conducted at the Johns Hopkins University School of Medicine and The George Institute for Global Health.

Although regular monitoring in the first hours of stroke onset is vital to a patient’s recovery, the study results challenge guidelines developed in the 1990s, which recommend intensive monitoring after patients receive thrombolysis for acute ischemic stroke, regardless of individual risk level during recovery.

“This study provides robust support for a low-intensity monitoring protocol for patients with mild to moderate stroke treated with intravenous thrombolysis,” says Victor Urrutia, M.D., senior author and medical director of the Johns Hopkins Hospital Comprehensive Stroke Center. “Nurses are freed to conduct other important tasks such as mobility, rehabilitation, education of patients and families, and psychosocial support.”

The current, high-intensity monitoring protocol for patients who have had a stroke — specifically after they receive thrombolytic therapy — is designed to detect early signs of complications such as bleeding in the brain or changes in neurological function. Totaling 39 assessments in 24 hours, it calls for monitoring vital signs, neurological function, and signs of complications to detect hemorrhagic transformation, blood pressure spikes, and new or worsening neurological deficits.

“As well as shifting nurses’ attention away from other aspects of care, such as mobility, education, counseling and supporting anxious family members, this high level of monitoring disrupts patients’ sleep and may not even be needed for those considered to be low risk,” says Urrutia.

To test whether monitoring could be safely scaled back, researchers enrolled 4,515 patients across eight countries. Participants were randomized to either standard care or a low-intensity protocol involving 19 assessments over the same 24-hour period.

Both groups received identical monitoring during the first two hours post-treatment, with checks every 15 minutes. After that, patients in the low-intensity group were monitored every two hours for the next eight hours, then every four hours for the remaining 14 hours. By contrast, the standard group continued with monitoring every 30 minutes for the next six hours, then every hour for the following 16 hours.

After 90 days, the outcomes between the groups were nearly identical. Rates of poor functional recovery, including death or disability, were 31.7% in the low-intensity group and 30.9% in the standard group. Intracerebral hemorrhage, the most serious complication of thrombolytic therapy, occurred in 0.2% and 0.4% of patients respectively. Other serious adverse events were nearly equal across both groups, at 11.1% compared to 11.3%. Future studies will use data collected during OPTIMISTmain to report on the impact of low-intensity monitoring on patients’ sleep.

Researchers say authors of guidelines should consider incorporating this study’s findings, allowing hospitals to safely tailor stroke-monitoring intensity based on individual patient risk and available resources.

The study received funding from the National Health and Medical Research Council of Australia; a New South Wales Health Investigator Development Grant, a University of New South Wales Medicine Theme Collaborative Seed Grant, and the Medical Research Future Fund (ID F02176) in Australia; and from Genentech, Inc. in the United States.

Other Johns Hopkins researchers who contributed to this study include Brenda Johnson, Michael Iacobelli, Michelle Montalbano, Ronald Faigle and April Pruski. Craig Anderson and Debbie Summers are joint first authors.