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

Assunta De Luca, Danilo Toni, Laura Lauria, Maria Luisa Sacchetti, Paolo Giorgi Rossi, Marica Ferri, Emanuele Puca, Massimiliano Prencipe, Gabriella Guasticchi, Cinzia Barletta, Beniamino Susi, Pierluigi Tasciotti, Franco Antimi

Research output: Contribution to journalArticle

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).

Original languageEnglish
Article number14
JournalBMC Health Services Research
Volume9
Issue number1
DOIs
Publication statusPublished - 2009

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Critical Pathways
Emergencies
Stroke
Emergency Medical Services
Intention to Treat Analysis
Odds Ratio
Hospital Emergency Service
Randomized Controlled Trials
Quality of Health Care
Italy
Referral and Consultation
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Health Policy

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An emergency clinical pathway for stroke patients - Results of a cluster randomised trial (isrctn41456865). / De Luca, Assunta; Toni, Danilo; Lauria, Laura; Sacchetti, Maria Luisa; Giorgi Rossi, Paolo; Ferri, Marica; Puca, Emanuele; Prencipe, Massimiliano; Guasticchi, Gabriella; Barletta, Cinzia; Susi, Beniamino; Tasciotti, Pierluigi; Antimi, Franco.

In: BMC Health Services Research, Vol. 9, No. 1, 14, 2009.

Research output: Contribution to journalArticle

De Luca, A, Toni, D, Lauria, L, Sacchetti, ML, Giorgi Rossi, P, Ferri, M, Puca, E, Prencipe, M, Guasticchi, G, Barletta, C, Susi, B, Tasciotti, P & Antimi, F 2009, 'An emergency clinical pathway for stroke patients - Results of a cluster randomised trial (isrctn41456865)', BMC Health Services Research, vol. 9, no. 1, 14. https://doi.org/10.1186/1472-6963-9-14
De Luca, Assunta ; Toni, Danilo ; Lauria, Laura ; Sacchetti, Maria Luisa ; Giorgi Rossi, Paolo ; Ferri, Marica ; Puca, Emanuele ; Prencipe, Massimiliano ; Guasticchi, Gabriella ; Barletta, Cinzia ; Susi, Beniamino ; Tasciotti, Pierluigi ; Antimi, Franco. / An emergency clinical pathway for stroke patients - Results of a cluster randomised trial (isrctn41456865). In: BMC Health Services Research. 2009 ; Vol. 9, No. 1.
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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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T1 - An emergency clinical pathway for stroke patients - Results of a cluster randomised trial (isrctn41456865)

AU - De Luca, Assunta

AU - Toni, Danilo

AU - Lauria, Laura

AU - Sacchetti, Maria Luisa

AU - Giorgi Rossi, Paolo

AU - Ferri, Marica

AU - Puca, Emanuele

AU - Prencipe, Massimiliano

AU - Guasticchi, Gabriella

AU - Barletta, Cinzia

AU - Susi, Beniamino

AU - Tasciotti, Pierluigi

AU - Antimi, Franco

PY - 2009

Y1 - 2009

N2 - 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).

AB - 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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