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Randomized Controlled Trial
. 2009 Jan 21:9:14.
doi: 10.1186/1472-6963-9-14.

An emergency clinical pathway for stroke patients--results of a cluster randomised trial (isrctn41456865)

Assunta De Luca  1 , Danilo Toni, Laura Lauria, Maria Luisa Sacchetti, Paolo Giorgi Rossi, Marica Ferri, Emanuele Puca, Massimiliano Prencipe, Gabriella Guasticchi; IMPLementazione Percorso Clinico Assistenziale ICtus Acuto (IMPLICA) Study Group
Collaborators, Affiliations
Randomized Controlled Trial

An emergency clinical pathway for stroke patients--results of a cluster randomised trial (isrctn41456865)

Assunta De Luca et al. BMC Health Serv Res. .

Abstract

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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Figures

Figure 1
Figure 1
Flowchart of randomisation procedures and cohorts of enrolled patients. The figure describes the entities' randomization results, with the description of cohorts of patients involved in the trial.
See this image and copyright information in PMC

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