Key PointsQuestion
Can hospital stroke thrombolysis treatment rates be increased
by an enhanced paramedic assessment that includes additional prehospital
information collection, a structured hospital handover, practical
assistance after handover, a predeparture care checklist, and clinician
feedback?
Findings
In this cluster randomized clinical trial, fewer patients in
the intervention group (39.4%) received thrombolysis vs those in the
standard care group (44.7%), but there were fewer poor health outcomes
(disability or death) after 90 days (intervention group, 64.0% vs
standard care group, 66.8%). The results were not statistically
significant.
Meaning
This study found that the enhanced paramedic assessment should
not be used to increase thrombolysis volume but may influence the
quality of treatment decisions.
Importance
Rapid thrombolysis treatment for acute ischemic stroke reduces
disability among patients who are carefully selected, but service
delivery is challenging.
Objective
To determine whether an enhanced Paramedic Acute Stroke
Treatment Assessment (PASTA) intervention increased hospital
thrombolysis rates.
Design, Setting, and Participants
This multicenter, cluster randomized clinical trial took place
between December 2015 and July 2018 in 3 ambulance services and 15
hospitals. Clusters were paramedics based within ambulance stations
prerandomized to PASTA or standard care. Patients attended by study
paramedics were enrolled after admission if a hospital specialist
confirmed a stroke and paramedic assessment started within 4 hours of
onset. Allocation to PASTA or standard care reflected the attending
paramedic’s randomization status.
Interventions
The PASTA intervention included additional prehospital
information collection, a structured hospital handover, practical
assistance up to 15 minutes after handover, a predeparture care
checklist, and clinician feedback. Standard care reflected national
guidelines.
Main Outcomes and Measures
Primary outcome was the proportion of patients receiving
thrombolysis. Secondary outcomes included time intervals and day 90
health (with poor status defined as a modified Rankin Score >2, to
represent dependency or death).
Results
A total of 11 478 patients were screened following ambulance
transportation; 1391 were eligible and approached, but 177 did not
consent. Of 1214 patients enrolled (mean [SD] age, 74.7 [13.2] years;
590 women [48.6%]), 500 were assessed by 242 paramedics trained in the
PASTA intervention and 714 were assessed by 355 paramedics continuing
with standard care. The paramedics trained in the PASTA intervention
took a mean of 13.4 (95% CI, 9.4-17.4) minutes longer (
P < .001)
to complete patient care episodes. There was less thrombolysis among
the patients in the PASTA group, but this was not significant (PASTA
group, 197 of 500 patients [39.4%] vs the standard care group, 319 of
714 patients [44.7%]; adjusted odds ratio, 0.81 [95% CI, 0.61-1.08];
P = .15).
Time from a paramedic on scene to thrombolysis was a mean of 8.5
minutes longer in the PASTA group (98.1 [37.6] minutes) vs the standard
care group (89.4 [31.1] minutes;
P = .01). Poor health outcomes
did not differ significantly but occurred less often among patients in
the PASTA group (313 of 489 patients [64.0%]) vs the standard care group
(461 of 690 patients [66.8%]; adjusted odds ratio, 0.86 [95% CI,
0.60-1.20];
P = .39).
Conclusions and Relevance
An enhanced paramedic assessment did not facilitate
thrombolysis delivery. The unexpected combination of thrombolysis and
health outcomes suggests possible alternative influences on treatment
decisions by the intervention, requiring further evaluation.
Trial Registration
ISRCTN Registry Identifier:
ISRCTN12418919
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