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An emergency clinical pathway for stroke patients -- results of a cluster randomised trial ( isrctn41456865 ) . BACKGROUND Emergency Clinical Pathways ( ECP ) for stroke have never been tested in randomized controlled trials ( RCTs ) . OBJECTIVE To evaluate the effectiveness of an ECP for stroke patients in Latium ( Italy ) emergency system . METHODS cluster-RCT designed to compare stroke patient referrals by Emergency Medical Service ( EMS ) and Emergency Room ( ER ) health professionals trained in the ECP , with those of non-trained EMS and ER controls . Primary outcome measure was the proportion of eligible ( aged < /= 80 and symptom onset < /= 6 hours ) stroke patients referred to a stroke unit ( SU ) . Intention to treat ( ITT ) and per-protocol ( PP ) analyses were performed , and risk ratios ( RR ) adjusted by age , gender and area , were calculated . RESULTS 2656 patients in the intervention arm and 2239 in the control arm required assistance ; 78.3 % of the former and 80.6 % of the latter were admitted to hospitals , and respectively 74.8 % and 78.3 % were confirmed strokes . Of the eligible confirmed strokes , 106/434 ( 24.4 % ) in the intervention arm and 43/328 ( 13.1 % ) in the control arm were referred to the SU in the ITT analysis ( RR = 2.01 ; 95 % CI : 0.79-4.00 ) , and respectively 105/243 ( 43.2 % ) and 43/311 ( 13.8 % ) in the PP analysis ( RR = 3.21 ; 95 % CI : 1.62-4.98 ) . Of patients suitable for i.v . thrombolysis , 15/175 ( 8.6 % ) in the intervention arm and 2/115 ( 1.7 % ) in the control arm received thrombolysis ( p = 0.02 ) in the ITT analysis , and respectively 15/99 ( 15.1 % ) and 2/107 ( 1.9 % ) ( p = 0.001 ) in the PP analysis . CONCLUSION Our data suggest potenti efficiency and feasibility of an ECP . The integration of EMS and ERs with SU networks for organised acute stroke care is feasible and may ameliorate the quality of care for stroke patients . TRIAL REGISTRATION Current Controlled Trials ( ISRCTN41456865 ) .
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Intervention_Educational
Emergency Clinical Pathways ( ECP )
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Intervention_Educational
ECP
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Intervention_Other
ECP
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Outcome_Other
effectiveness
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Outcome_Other
proportion of eligible ( aged < /= 80 and symptom onset < /= 6 hours ) stroke patients referred to a stroke unit ( SU )
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Outcome_Other
Intention to treat ( ITT )
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Outcome_Other
per-protocol ( PP ) analyses
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Outcome_Physical
assistance
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Outcome_Other
admitted to hospitals
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Outcome_Physical
confirmed strokes
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Outcome_Physical
confirmed strokes
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Outcome_Other
SU
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Outcome_Other
efficiency and feasibility
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Outcome_Other
quality of care
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Participant_Condition
eligible ( aged < /= 80 and symptom onset < /= 6 hours ) stroke patients referred to a stroke unit ( SU ) .