Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients (RICO)

Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients: the RICO Cluster-randomized Controlled Trial

FADOI (Italian Scientific Society of Hospital Internal Medicine) has planned to promote a multicenter cluster-randomized controlled clinical study in order to evaluate the effects of a systematic assessment of patients by using the Padua prediction score and the IMPROVE Bleeding score vs clinical judgement on the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and hemorrhagic events).

Study Overview

• Status: Completed
• Conditions: Prevention of Venous Thromboembolism
• Intervention / Treatment: Other: Application of Padua and IMPROVE Bleeding scores

Detailed Description

The most recent guidelines suggest the use of prophylaxis in patients with a high thromboembolic risk, while taking into account the risk of bleeding.

It is known that patients admitted for acute pathology have an eight-fold higher incidence of thromboembolic events than the general population.

The Padua Prediction Score (PPS) is currently considered the best score available for the evaluation of thromboembolic risk in hospitalized patients, while the IMPROVE score was developed and validated for the assessment of bleeding risk in the same population of hospitalized patients.

In a recent study, data from the real world showed us how many of the patients admitted in Internal Medicine were at high thrombotic risk according to PPS and almost 90% of these were simultaneously at low hemorrhagic risk according to the IMPROVE score: in these patients pharmacological prophylaxis could therefore be prescribed during a safe stay.

Until now only a small prospective monocentric quasi-randomized study has shown that the use of systematic PPS reduces the incidence of thromboembolic events (symptomatic and non-symptomatic) upon discharge, compared to clinical judgment alone.

For these reasons, FADOI Foundation has promoted a multicenter controlled randomized cluster study in a real-life context among patients admitted to medical area departments. The aim of the study will be to analyze the effects of a systematic evaluation of patients (in centers that do not require the use of any score for the evaluation of thromboembolic risk), using the Padua Prediction Score (PPS) and the IMPROVE Bleeding score vs only clinical judgment for the use of antithrombotic prophylaxis and clinical outcomes (thromboembolic and haemorrhagic events). The main objective of the study is therefore to evaluate the effectiveness of a systematic evaluation of the thromboembolic and hemorrhagic risk in reducing the number of major complications in patients admitted to Internal Medicine, at a 90-day follow-up after hospital discharge.

• Study Type: Interventional
• Enrollment (Actual): 2878
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Dentali; Phone Number: +390248005140 +390248005140; Email: francesco.dentali@asst-settelaghi.it
• Study Contact Backup: Name: Antonella Valerio; Phone Number: +390248005140 +390248005140; Email: antonella.valerio@fadoi.org

Study Locations

• Italy
  • Asti, Italy
    • Ospedale Cardinal Massaia
  • Cosenza, Italy
    • Ospedale "Beato Angelo"
  • Cremona, Italy
    • Ospedale di Cremona
  • Fano, Italy
    • Ospedale Santa Croce di Fano
  • Genova, Italy
    • E.O. Ospedali Galliera
  • Milano, Italy
    • Ospedale Maggiore Niguarda
  • Napoli, Italy
    • Ospedale Fatebenefratelli
  • Napoli, Italy
    • Azienda Ospedaliera "Cardarelli"
  • Perugia, Italy
    • Ospedale Silvestrini di Perugia
  • Reggio Calabria, Italy
    • Ospedale "Bianchi-Melacrino-Morelli"
  • Roma, Italy
    • Ospedale "S. Giovanni Addolorata"
  • Roma, Italy
    • Ospedale "Vannini"
  • Savona, Italy
    • Ospedale "San Paolo"
  • Treviso, Italy
    • Ospedale di Treviso
  • Varese, Italy
    • Ospedale di Circolo "Macchi"
  • Vercelli, Italy
    • Ospedale Sant'Andrea
  • Vicenza, Italy
    • Ospedale "S. Bortolo"
  • Alessandria
    • Casale Monferrato, Alessandria, Italy
      • Ospedale di Casale Monferrato
    • Tortona, Alessandria, Italy
      • Ospedale "SS Antonio e Margherita"
  • Ancona
    • Senigallia, Ancona, Italy
      • Ospedale di Senigallia
  • Bari
    • Molfetta, Bari, Italy
      • Ospedale di Molfetta
  • Caserta
    • Marcianise, Caserta, Italy
      • Ospedale Civile
  • Cuneo
    • Ceva, Cuneo, Italy
      • Ospedale di Ceva
    • Mondovì, Cuneo, Italy
      • Ospedale di Mondovì
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy
      • Osp. Casa Sollievo Della Sofferenza
  • Milano
    • Legnano, Milano, Italy
      • Ospedale Civile
    • Magenta, Milano, Italy
      • Ospedale di Magenta
  • Perugia
    • Todi, Perugia, Italy
      • Ospedale Media Valle del Tevere
  • Potenza
    • Lagonegro, Potenza, Italy
      • Ospedale Generale di Zona
  • Taranto
    • Grottaglie, Taranto, Italy
      • Ospedale San Marco
  • Torino
    • Rivoli, Torino, Italy
      • Ospedale di Rivoli
  • Treviso
    • Castelfranco Veneto, Treviso, Italy
      • Ospedale San Giacomo Apostolo
    • Conegliano, Treviso, Italy
      • Ospedale di Conegliano Veneto
  • Varese
    • Luino, Varese, Italy
      • Ospedale "Luini Confalonieri"
  • Vercelli
    • Borgosesia, Vercelli, Italy
      • Ospedale di Borgosesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years
2. Hospitalized for any cause in Internal Medicine
3. Signature of informed consent

Exclusion Criteria:

1. Expected hospital stay < 48 h
2. Any indication for anticoagulant therapy
3. Life expectancy < 90 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with the Padua and IMPROVE Bleeding scores; A number of centres will be randomized to systematically evaluate all eligible patients with the Padua and IMPROVE Bleeding scores within 48 h after hospitalization.	Other: Application of Padua and IMPROVE Bleeding scores; Eligible patients hospitalized in centres randomized to the Experimental group will be evaluated, within 48 hours from admission to hospital, by means of the Padua predictive score and the IMPROVE Bleeding score.
No Intervention: Patients will be evaluated according to clinical judgment only; A number of centres will be randomized to the Control arm of the study, in which patients will be evaluated for their thrombotic and hemorrhagic risk according to clinical judgment only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with major complications at a 90-day follow-up	The percentage of patients with major complications (death, venous thromboembolism, major bleeding) at a 90-day follow-up in the group of patients who will be evaluated by means of the Padua and IMPROVE Bleeding scores vs those evaluated according to clinical judgment only	3 month from the discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes at hospital discharge	The percentage of patients with major complications (death, venous thromboembolism, major bleeding) at hospital discharge in the group of patients who will be evaluated by means of the Padua and IMPROVE Bleeding scores vs those evaluated according to clinical judgment only	Time of hospitalization until discharge, up to 5 weeks
Number of patients with antithrombotic prophylaxis during hospital stay and at discharge.	All the clinical characteristics of the patient collected, are compared between the experimental group and the clinical judgment group to understand the choice of an antithrombotic prophylaxis	Time of hospitalization until discharge, up to 5 weeks

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy
• Investigators: Study Director: Mauro Campanini, FADOI FOUNDATION

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: FADOI.04.2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No