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Randomized Controlled Trial
. 2022 Feb 10;59(2):2100412.
doi: 10.1183/13993003.00412-2021. Print 2022 Feb.

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

David Jiménez  1   2   3 , Carmen Rodríguez  4 , Francisco León  4 , Luis Jara-Palomares  5 , Raquel López-Reyes  6 , Pedro Ruiz-Artacho  3   7   8   9 , Teresa Elías  5 , Remedios Otero  3   5 , Alberto García-Ortega  6 , Agustina Rivas-Guerrero  10 , Jaime Abelaira  11 , Sonia Jiménez  12 , Alfonso Muriel  13 , Raquel Morillo  4   3 , Deisy Barrios  4   3 , Raphael Le Mao  14 , Roger D Yusen  15 , Behnood Bikdeli  16   17   18 , Manuel Monreal  3   19   20 , José Luis Lobo  3   10 ; IPEP investigators
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Free article
Randomized Controlled Trial

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

David Jiménez et al. Eur Respir J. .
Free article

Abstract

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% versus 4.8%), all-cause mortality (2.4% versus 2.0%) or PE-related mortality (0.8% versus 1.2%) rates.

Conclusions: The use of a prognostic assessment and management pathway was effective in reducing the LOS for acute PE.

Trial registration: ClinicalTrials.gov NCT02733198.

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Conflict of interest statement

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.

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