HONOLULU — A relatively inexpensive intervention that involved hospitals in Latin America incorporating quality improvement measures significantly boosted adherence to evidence-based approaches to stroke care, a novel randomized trial has shown.
"The purpose of this trial was to tell us whether this intervention is effective, and the answer is yes," lead author M. Julia Machline-Carrion, MD, PhD, Albert Einstein Hospital, Sao Paulo, Brazil, told Medscape Medical News.
The trial, called BRIDGE Stroke, was presented at the 2019 International Stroke Conference.
Multiple studies have shown that interventions such as early use of antithrombotics and tissue plasminogen activator (tPA) can improve outcomes in patients with acute ischemic stroke (AIS) and transient ischemic attacks (TIA). But uptake of such interventions is "suboptimal," said Machline-Carrion.
"This is an issue especially in low- and middle-income countries" like those in Latin America and Asia, she said.
Lack of Education
Several factors contribute to this relatively low rate of adherence, including lack of education and operational issues faced by hospitals, she said.
The study included 36 hospital clusters in Brazil, Argentina, and Peru that have emergency department services. A total of 1624 consecutive AIS and TIA patients were admitted within 24 hours of symptom onset.
Researchers randomized these hospitals into two groups — one to continue with their usual care for stroke patients (17 clusters and 807 patients) and the other to introduce a multifaceted quality improvement program (19 clusters and 817 patients).
The mean age of patients in the study was 69 years, and about 58% were men.
The intervention focused on 10 quality improvement measures. These were:
tPA within therapeutic window
deep vein thrombosis (DVT) prophylaxis
door to needle time (DTNT) < 60 minutes
assessment for rehabilitation
antithrombotics at discharge
anticoagulants for atrial fibrillation or flutter
statins for low density lipoprotein (LDL) > 100 or not documented
smoking cessation education
Staff at hospitals randomized to the intervention received training and education before the study started. Each hospital could tailor the quality measures package to its own environment and work flow practices.
The intervention incorporated useful tactics to improve adherence to quality measures. These included a therapeutic plan algorithm, educational materials with evidence-based recommendations, printed reminders, and periodic feedback reports on adherence.
The primary outcome was adherence to the 10 in-hospital performance measures as indicated by a composite score.
The analysis found that the composite adherence score was 90.6% for the intervention hospitals and 77.5% for the control hospitals. The mean difference was 11.35% (95% confidence interval [CI], 3.32 - 19.37) over 1.5 years.
"That's a lot," commented Machline-Carrion. "One and a half years is not such a long time for these behavioral changes."
A secondary study outcome was complete adherence to quality measures. "This refers to the percentage of patients who receive everything they should, in other words, perfect care," said Machline-Carrion.
Here, 59.7% of the intervention hospitals and 23.1% of the control hospitals had complete adherence (odds ratio [OR], 5.53; 95% CI, 2.07 - 14.81).
"This is a very powerful message," said Machline-Carrion.
"When we just evaluate the individual rate for things like thrombolysis and antithrombotics, it sometimes doesn't tell us everything we need to know. These composite outcomes give us the whole picture as to whether we're treating every single patient the best way we can."
Researchers looked at the individual quality measures and found that for some, intervention hospitals did significantly better than control hospitals.
These included dysphagia screening (OR, 13.78; 95% CI, 2.78 - 68.41; P < .01), assessment for rehabilitation (OR, 8.41; 95% CI, 2.15 - 32.96; P < .01), smoking cessation education (OR, 7.08; 95% CI, 2.32 - 21.55; P < .01), and tPA within the therapeutic window (OR, 2.32; 95% CI, 1.06 - 5.11; P = .04).
Researchers assessed the rate of new vascular events, but the study was not powered to determine if the intervention resulted in a decreased rate of such events. "It would take more time and a much larger sample size to prove this," said Machline-Carrion.
But she noted that elements of the intervention, such as smoking cessation education, have already been proven to be effective in reducing the burden of stroke.
Also, it's not clear if hospitals will continue to endorse the quality improvement measures. "The next step will be a maintenance phase; so we will be doing a study where everyone is using the intervention," she said.
Asked by a delegate about the cost of the intervention, Machline-Carrion said "it's actually very cheap," as it involves not much more than the cost of training and printed materials.
But the intervention did require time for things like training and travel to every hospital involved in the project. It took about two months to visit and train hospital staff, said Machline-Carrion.
Another delegate asked about generalizability to regions outside Latin America. The materials were distributed in Portuguese and Spanish, but could be translated into other languages, said Machline-Carrion.
But she stressed that "one size does not fit all" when it comes to designing quality improvement programs.
"We should tailor the intervention to the cultural aspects of a region, and tailor it even more closely to the hospital environment."
Brazil, for example, is a very large country with "big differences" between the north and south, she added.
Approached for a comment, Ralph Sacco, MD, president of the American Academy of Neurology, and chair of neurology, University of Miami Miller School of Medicine, noted that the study's randomized design allowed for a relatively "rigorous comparison" between an intensive quality improvement program and routine practice.
"The authors nicely showed that those that were in the intervention did much better in terms of adherence score, adherence to the guidelines, and the quality measures."
And they showed this across the "usual measures" such as tPA utilization, early antithrombotics, dysphasia screening, smoking cessation, etc, said Sacco.
"To me, it's strong evidence that a quality improvement program works, and it helps affirm the value of the Get With The Guidelines program" in the US that "shares the same goals of improving quality in acute stroke centers."
Outcomes at hospitals in the Get With The Guidelines-Stroke program improve over time, noted Sacco.
"In our own work in Florida, we have been able to show that the longer you're part of a quality improvement program, the better your outcomes are, and the less stroke disparities you have."
The program has worked "incredibly well," said Sacco.
And it can save precious healthcare dollars. For example, the percentage of eligible patients receiving tPA "has gone up markedly" among Get With The Guidelines hospitals, said Sacco.
"Any kind of program that will increase the number of eligible people who get tPA can be cost-saving because of the amount of disability you prevent with tPA."
The Brazil Ministry of Health was the lead sponsor of the study. Machline-Carrion reports a research grant from Amgen and consultant/advisory board fees from Boerhinger Ingelheim.
International Stroke Conference 2019: Late Breaking Abstract #11. Presented February 7, 2019.
Medscape Medical News © 2019
Cite this: Pauline Anderson. BRIDGE Stroke: Intervention Boosts Evidence-Based Stroke Therapies - Medscape - Mar 08, 2019.