Elsevier

The Lancet Neurology

Volume 12, Issue 2, February 2013, Pages 139-148
The Lancet Neurology

Articles
A multilevel intervention to increase community hospital use of alteplase for acute stroke (INSTINCT): a cluster-randomised controlled trial

https://doi.org/10.1016/S1474-4422(12)70311-3Get rights and content

Summary

Background

Use of alteplase improves outcome in some patients with stroke. Several types of barrier frequently prevent its use. We assessed whether a standardised, barrier-assessment, multicomponent intervention could increase alteplase use in community hospitals in Michigan, USA.

Methods

In a cluster-randomised controlled trial, we selected adult, non-specialty, acute-care community hospitals in the Lower Peninsula of Michigan, USA. Eligible hospitals discharged at least 100 patients who had had a stroke per year, had less than 100 000 visits to the emergency department per year, and were not academic comprehensive stroke centres. Using a computer-generated randomisation sequence, we selected 12 matched pairs of eligible hospitals. Within pairs, the hospitals were allocated to intervention or control groups with restricted randomisation in January, 2007. Between January, 2007, and December, 2007, intervention hospitals implemented a multicomponent intervention that included qualitative and quantitative assessment of barriers to alteplase use and ways to address the findings, and provided additional support. The primary outcome was change in alteplase use in patients with stroke in emergency departments between the pre-intervention period (January, 2005, to December, 2006) and the post-intervention period (January, 2008, to January, 2010). Physicians in participating hospitals and the coordinating centre could not be masked to group assignment, but were masked to progress made in paired control hospitals. External medical reviewers who were masked to group assignment assessed outcomes. We did intention-to-treat (ITT) and target-population (without one pair that was excluded after randomisation) analyses. This trial is registered at ClinicalTrials.gov, number NCT00349479.

Findings

All 24 hospitals completed the study. Overall, 745 of 40 823 patients with stroke received intravenous alteplase treatment. In the ITT analysis, the proportion of patients with stroke who were admitted and treated with alteplase increased between the pre-intervention and post-intervention periods in intervention hospitals (89 [1·25%] of 7119 patients to 235 [2·79%] of 8419) to a greater extent than in control hospitals (99 [1·25%] of 7946 to 194 [2·10%] of 9222), but the difference between groups was not significant (relative risk [RR] 1·37, 95% CI 0·96–1·93; p=0·08). In the target-population analysis, the increase in alteplase use in intervention hospitals (59 [1·00%] of 5882 to 191 [2·62%] of 7288) was significantly greater than in control hospitals (65 [1·09%] of 5957 to 120 [1·72%] of 6989; RR 1·68, 95% CI 1·09–2·57; p=0·02), but was still clinically modest.

Interpretation

The intervention did not significantly increase alteplase use in patients with ischaemic stroke. The increase in use of alteplase in the target population was significant, but smaller than the effect to which the study was powered. Additional strategies to increase acute stroke treatment are needed.

Funding

National Institutes of Health National Institute of Neurological Disorders and Stroke.

Introduction

Worldwide, stroke is the second leading cause of preventable death and the fourth leading cause of adult disability.1 Although intravenous tissue plasminogen activator (alteplase) increases the chance of a good outcome in some patients,2, 3 this treatment is underused. Estimates suggest that, although up to 11·5% of patients with stroke are eligible, 2% or less receive thrombolytics.4, 5 If delays in patient and physician recognition and response to the signs and symptoms of acute stroke could be eliminated, the proportion of patients with stroke who are eligible for alteplase could be as high as 24%.6

Designated stroke centres (ie, hospitals with specific accreditation to deliver stroke treatment) have improved alteplase delivery. However, less than one in four patients in the USA live where they could travel to one of these centres by land within 30 min.7 In view of the short treatment window in which alteplase can be given to individuals with stroke, many patients present to local community hospitals. Opportunities for effective treatment in these settings are poor. A national review showed that 64% of community hospitals in the USA reported no alteplase treatments of acute stroke between 2005 and 2007.8 Data suggest that neurologists are infrequently involved with acute stroke care in community emergency departments, and emergency physicians have expressed concerns about barriers to thrombolytic treatment (time, resources, organisation, and personal experience) and risk of haemorrhagic complications.9, 10, 11, 12 Similar difficulties in geographical and specialist access have been reported in other countries.13, 14

A previous study15, 16 showed that sustained increases in community alteplase delivery were possible with a rational behavioural intervention targeting both patients and providers. However, no randomised controlled trial has tested a practical intervention to increase stroke thrombolytic delivery in a representative sample of community hospitals as far as we are aware. Identification of a successful strategy could improve stroke care and serve as a model to enhance adoption of other high-risk treatments.

The aim of the INcreasing Stroke Treatment through INterventional Change Tactics (INSTINCT) trial was to assess the ability of a multilevel, barrier assessment–interactive educational intervention (BA-IEI) to increase alteplase use in community hospitals in Michigan, USA. We postulated that identification and addressing of local barriers to alteplase use in patients with stroke would increase thrombolytic use at intervention hospitals compared with matched control hospitals.

Section snippets

Study design

The INSTINCT trial was a cluster-randomised controlled trial. Because hospital personnel and systems were the target of the intervention, hospitals were used as the unit of randomisation to minimise contamination. The Biostatistics and Data Management Center (BDMC) at the University of Michigan, which is independent of the INSTINCT Clinical Coordinating Center, selected community hospitals from the list of 104 adult, non-specialty, acute-care hospitals in the Lower Peninsula of Michigan. We

Results

Of the initial 24 hospitals selected, five declined to participate (figure 1); we randomly selected five replacements from the list of eligible hospitals. All 24 hospitals assigned completed the study (figure 1). These hospitals represented 18% (24 of 137) of all adult, acute-care hospitals in Michigan and 39% (24 of 61) of all eligible hospitals. The pair of hospitals excluded after assignment in the target-population analysis were two of the largest hospitals in the sample and together

Discussion

Despite the use of comprehensive barrier assessments and targeted multilevel interventions, our pragmatic intervention did not significantly increase alteplase use in patients with ischaemic stroke. The data suggest that the intervention had a smaller, more heterogeneous effect than was that for which the study was powered. A significant increase in the proportion of patients treated with alteplase per month was identified in the target-population analysis. Possible explanations for the modest

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