Clinical trial NCT04267718: Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients
Official title: Efficacy of the Use of Risk Scores in Reducing Important Clinical Outcomes in Hospitalized Medical Ill Patients: the RICO Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Venous Thromboembolism
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 2878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group includes a number of centres that will be randomized to systematically evaluate all eligible patients with the Padua and IMPROVE Bleeding scores within 48 h after hospitalization. The control group includes 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.
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of patients with major complications at a 90-day follow-up
timeFrame: 3 month from the discharge
Secondary outcomes:
measure: Clinical outcomes at hospital discharge
timeFrame: Time of hospitalization until discharge, up to 5 weeks
measure: Number of patients with antithrombotic prophylaxis during hospital stay and at discharge.
timeFrame: Time of hospitalization until discharge, up to 5 weeks
Other outcomes:
Locations:
city: Casale Monferrato
country: Italy
facility: Ospedale di Casale Monferrato
state: Alessandria
city: Tortona
country: Italy
facility: Ospedale "SS Antonio e Margherita"
state: Alessandria
city: Senigallia
country: Italy
facility: Ospedale di Senigallia
state: Ancona
city: Molfetta
country: Italy
facility: Ospedale di Molfetta
state: Bari
city: Marcianise
country: Italy
facility: Ospedale Civile
state: Caserta
city: Ceva
country: Italy
facility: Ospedale di Ceva
state: Cuneo
city: Mondovì
country: Italy
facility: Ospedale di Mondovì
state: Cuneo
city: San Giovanni Rotondo
country: Italy
facility: Osp. Casa Sollievo Della Sofferenza
state: Foggia
city: Legnano
country: Italy
facility: Ospedale Civile
state: Milano
city: Magenta
country: Italy
facility: Ospedale di Magenta
state: Milano
city: Todi
country: Italy
facility: Ospedale Media Valle del Tevere
state: Perugia
city: Lagonegro
country: Italy
facility: Ospedale Generale di Zona
state: Potenza
city: Grottaglie
country: Italy
facility: Ospedale San Marco
state: Taranto
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
state: Torino
city: Castelfranco Veneto
country: Italy
facility: Ospedale San Giacomo Apostolo
state: Treviso
city: Conegliano
country: Italy
facility: Ospedale di Conegliano Veneto
state: Treviso
city: Luino
country: Italy
facility: Ospedale "Luini Confalonieri"
state: Varese
city: Borgosesia
country: Italy
facility: Ospedale di Borgosesia
state: Vercelli
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Cosenza
country: Italy
facility: Ospedale "Beato Angelo"
city: Cremona
country: Italy
facility: Ospedale di Cremona
city: Fano
country: Italy
facility: Ospedale Santa Croce di Fano
city: Genova
country: Italy
facility: E.O. Ospedali Galliera
city: Milano
country: Italy
facility: Ospedale Maggiore Niguarda
city: Napoli
country: Italy
facility: Azienda Ospedaliera "Cardarelli"
city: Napoli
country: Italy
facility: Ospedale Fatebenefratelli
city: Perugia
country: Italy
facility: Ospedale Silvestrini di Perugia
city: Reggio Calabria
country: Italy
facility: Ospedale "Bianchi-Melacrino-Morelli"
city: Roma
country: Italy
facility: Ospedale "S. Giovanni Addolorata"
city: Roma
country: Italy
facility: Ospedale "Vannini"
city: Savona
country: Italy
facility: Ospedale "San Paolo"
city: Treviso
country: Italy
facility: Ospedale di Treviso
city: Varese
country: Italy
facility: Ospedale di Circolo "Macchi"
city: Vercelli
country: Italy
facility: Ospedale Sant'Andrea
city: Vicenza
country: Italy
facility: Ospedale "S. Bortolo"
Study officials:
affiliation: Fadoi Foundation
name: Mauro Campanini
role: STUDY_DIRECTOR
References: