Randomised controlled trial of a prognostic assessment and management pathway to reduce the length of hospital stay in normotensive patients with acute pulmonary embolism.


Journal

The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460

Informations de publication

Date de publication:
02 2022
Historique:
received: 11 02 2021
accepted: 18 06 2021
pubmed: 14 8 2021
medline: 7 4 2022
entrez: 13 8 2021
Statut: epublish

Résumé

The length of hospital stay (LOS) for acute pulmonary embolism (PE) varies considerably. Whether the upfront use of a PE prognostic assessment and management pathway is effective in reducing the LOS remains unknown. We conducted a randomised controlled trial of adults hospitalised for acute PE: patients were assigned either to a prognostic assessment and management pathway involving risk stratification followed by predefined criteria for mobilisation and discharge (intervention group) or to usual care (control group). The primary end-point was LOS. The secondary end-points were the cost of prognostic tests and of hospitalisation, and 30-day clinical outcomes. Of 500 patients who underwent randomisation, 498 were included in the modified intention-to-treat analysis. The median LOS was 4.0 days (interquartile range (IQR) 3.7-4.2 days) in the intervention group and 6.1 days (IQR 5.7-6.5 days) in the control group (p<0.001). The mean total cost of prognostic tests was EUR 174.76 in the intervention group, compared with EUR 233.12 in the control group (mean difference EUR -58.37, 95% CI EUR -84.34- to -32.40). The mean total hospitalisation cost per patient was EUR 2085.66 in the intervention group, compared with EUR 3232.97 in the control group (mean difference EUR -1147.31, 95% CI EUR -1414.97- to -879.65). No significant differences were observed in 30-day readmission (4.0% The use of a prognostic assessment and management pathway was effective in reducing the LOS for acute PE.

Sections du résumé

BACKGROUND
The length of hospital stay (LOS) for acute pulmonary embolism (PE) varies considerably. Whether the upfront use of a PE prognostic assessment and management pathway is effective in reducing the LOS remains unknown.
METHODS
We conducted a randomised controlled trial of adults hospitalised for acute PE: patients were assigned either to a prognostic assessment and management pathway involving risk stratification followed by predefined criteria for mobilisation and discharge (intervention group) or to usual care (control group). The primary end-point was LOS. The secondary end-points were the cost of prognostic tests and of hospitalisation, and 30-day clinical outcomes.
RESULTS
Of 500 patients who underwent randomisation, 498 were included in the modified intention-to-treat analysis. The median LOS was 4.0 days (interquartile range (IQR) 3.7-4.2 days) in the intervention group and 6.1 days (IQR 5.7-6.5 days) in the control group (p<0.001). The mean total cost of prognostic tests was EUR 174.76 in the intervention group, compared with EUR 233.12 in the control group (mean difference EUR -58.37, 95% CI EUR -84.34- to -32.40). The mean total hospitalisation cost per patient was EUR 2085.66 in the intervention group, compared with EUR 3232.97 in the control group (mean difference EUR -1147.31, 95% CI EUR -1414.97- to -879.65). No significant differences were observed in 30-day readmission (4.0%
CONCLUSIONS
The use of a prognostic assessment and management pathway was effective in reducing the LOS for acute PE.

Identifiants

pubmed: 34385269
pii: 13993003.00412-2021
doi: 10.1183/13993003.00412-2021
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT02733198']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright ©The authors 2022. For reproduction rights and permissions contact permissions@ersnet.org.

Déclaration de conflit d'intérêts

Conflict of interest: D. Jiménez has served as an advisor or consultant for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Leo Pharma, Pfizer, ROVI and Sanofi; served as a speaker or a member of a speakers’ bureau for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Leo Pharma, ROVI and Sanofi; and has received grants for clinical research from Daiichi Sankyo, Sanofi and ROVI. Conflict of interest: C. Rodríguez has nothing to disclose. Conflict of interest: F. León has nothing to disclose. Conflict of interest: L. Jara-Palomares has served as an advisor or consultant for Actelion Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Leo Pharma, Menarini, Pfizer, GSK and ROVI. Conflict of interest: R. López-Reyes has nothing to disclose. Conflict of interest: P. Ruiz-Artacho has nothing to disclose. Conflict of interest: T. Elías has nothing to disclose. Conflict of interest: R. Otero has served as an advisor or consultant for Bayer HealthCare Pharmaceuticals, Leo Pharma, Janssen Pharmaceutical Companies, Merck Sharp & Dohme Corp, ROVI and Sanofi; and received grants for clinical research from Leo Pharma and Bayer Hispania SL. Conflict of interest: A. García-Ortega has nothing to disclose. Conflict of interest: A. Rivas-Guerrero has nothing to disclose. Conflict of interest: J. Abelaria has nothing to disclose. Conflict of interest: S. Jiménez has nothing to disclose. Conflict of interest: A. Muriel has nothing to disclose. Conflict of interest: R. Morillo has nothing to disclose. Conflict of interest: D. Barrios has nothing to disclose. Conflict of interest: R. Le Mao has nothing to disclose. Conflict of interest: R.D. Yusen has received research funding from Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb, Pfizer and Portola in the past 3 years; and has served as a consultant for Bayer HealthCare, Inc., Bristol-Myers Squibb, GlaxoSmithkline, Janssen, Johnson and Johnson, Ortho Pharmaceuticals, Organon, Pfizer, Portola, Sanofi and SCIOS in the past 3 years. Conflict of interest: B. Bikdeli reports that he is a consulting expert, on behalf of the plaintiff, for litigation related to two specific brand models of inferior vena cava filters. Conflict of interest: M. Monreal has served as an advisor or consultant for Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Leo Pharma and Sanofi; served as a speaker or a member of a speakers’ bureau for Bayer HealthCare Pharmaceuticals, Daiichi Sankyo, Leo Pharma and Sanofi; and received grants for clinical research from Sanofi and Bayer. Conflict of interest: J.L. Lobo has nothing to disclose.

Auteurs

David Jiménez (D)

Respiratory Dept, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain djimenez.hrc@gmail.com.
Medicine Dept, Universidad de Alcalá, Madrid, Spain.
CIBER en Enfermedades Respiratorias (CIBERES), Madrid, Spain.

Carmen Rodríguez (C)

Respiratory Dept, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.

Francisco León (F)

Respiratory Dept, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.

Luis Jara-Palomares (L)

Respiratory Dept, Virgen del Rocío Hospital and Instituto de Biomedicina, Sevilla, Spain.

Raquel López-Reyes (R)

Respiratory Dept, Hospital La Fe, Valencia, Spain.

Pedro Ruiz-Artacho (P)

CIBER en Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Dept of Internal Medicine, Clinica Universidad de Navarra, Madrid, Spain.
CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
Interdisciplinar Teragnosis and Radiosomics Research Group (INTRA-Madrid), Universidad de Navarra, Madrid, Spain.

Teresa Elías (T)

Respiratory Dept, Virgen del Rocío Hospital and Instituto de Biomedicina, Sevilla, Spain.

Remedios Otero (R)

CIBER en Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Respiratory Dept, Virgen del Rocío Hospital and Instituto de Biomedicina, Sevilla, Spain.

Alberto García-Ortega (A)

Respiratory Dept, Hospital La Fe, Valencia, Spain.

Agustina Rivas-Guerrero (A)

Respiratory Dept, Hospital Araba, Vitoria, Spain.

Jaime Abelaira (J)

Emergency Dept, Hospital Clínico San Carlos, Madrid, Spain.

Sonia Jiménez (S)

Emergency Dept, Hospital Clinic, Grupo UPP, Área 1 IDIBAPS, Barcelona, Spain.

Alfonso Muriel (A)

Biostatistics Dept, Ramón y Cajal Hospital and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, CIBERESP, Madrid, Spain.

Raquel Morillo (R)

Respiratory Dept, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.
CIBER en Enfermedades Respiratorias (CIBERES), Madrid, Spain.

Deisy Barrios (D)

Respiratory Dept, Hospital Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.
CIBER en Enfermedades Respiratorias (CIBERES), Madrid, Spain.

Raphael Le Mao (R)

EA3878, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université Européenne de Bretagne, Brest, France.

Roger D Yusen (RD)

Divisions of Pulmonary and Critical Care Medicine and General Medical Sciences, Washington University School of Medicine, St. Louis, MO, USA.

Behnood Bikdeli (B)

Division of Cardiology, Dept of Medicine, Columbia University Medical Center, New York-Presbyterian Hospital, New York, NY, USA.
Center for Outcomes Research and Evaluation (CORE), Yale University School of Medicine, New Haven, CT, USA.
Cardiovascular Research Foundation, New York, NY, USA.

Manuel Monreal (M)

CIBER en Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Dept of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Universidad Católica de Murcia, Murcia, Spain.

José Luis Lobo (JL)

CIBER en Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Respiratory Dept, Hospital Araba, Vitoria, Spain.

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