Clinical trial NCT06872632: How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: a Multicenter Study
Official title: EFFETTI DELLA COMPLESSITÀ E MULTIMORBIDITÀ SUGLI ESITI CLINICI NEL PAZIENTE INTERNISTICO OSPEDALIZZATO: STUDIO MULTICENTRICO, OSSERVAZIONALE E PROSPETTICO - EFFECTS of COMPLEXITY and MULTIMORBIDITY on CLINICAL OUTCOMES in HOSPITALIZED INTERNAL MEDICINE PATIENTS: a MULTICENTER, OBSERVATIONAL and PROSPECTIVE STUDY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complexity and Multiple Illnesses of Adult Hospitalized Internal Medicine Patient
Lead sponsor: Società Italiana di Medicina Interna
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 2326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult hospitalized internal medicine patient

Brief summary: The goal of this observational study is to evaluate the association between complexity and multiple illnesses of adult hospitalized internal medicine patient and mortality. The observational study will also evaluate the association between pre-existing factors at hospitalization and clinical outcomes such as mortality, length of hospital stay, intensity of care (transfer to units with higher clinical intensity), complications and rehospitalization.

For data collection, four index weeks will be identified during the year in which the participating Centers will have to sequentially enroll all the participants who will be admitted to the Internal Medicine units, until reaching, for each index week, 10 participants for each of the Participating Centers.

Each enrolled participant will undergo a 12-month follow-up. The study foresees the enrollment of 2326 participants.


Eligibility criteria: Inclusion Criteria:

1. Patients of legal age (age \>= 18 years).
2. Informed consent according to Italian law.

Exclusion Criteria:

* No specific exclusion criteria were identified.

Primary outcomes:
measure: to evaluate the correlation between clinical complexity/multimorbidity of the hospitalized internal medicine patient, defined by the Cumulative Illness Rating Scale (CIRS), and mortality.
timeFrame: 12 months
Secondary outcomes:
measure: to evaluate the correlation between pre-existing factors at hospitalization and clinical outcomes - to evaluate the association between disease severity parameters and clinical outcomes
timeFrame: 12 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOU Policlinico di Bari- Unità Operativa di Medicina Interna "Guido Baccelli
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola - Malpighi- UO Medicina interna, malattie epatobiliari e immunoallergologiche
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia- Medicina Generale 2
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria S. Anna di Ferrara- Clinica Medica
city: Firenze
country: Italy
facility: Ospedale Santa Maria Annunziata, Bagno a Ripoli, Firenze- Medicina 1
city: Messina
country: Italy
facility: AOU G. Martino- UOC Medicina Interna
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco- Struttura Complessa di Medicina Interna
city: Modena
country: Italy
facility: AOU Modena - Policlinico di Modena - S.C. Medicina Interna
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II, Napoli- UOC Medicina Interna ad indirizzo metabolico e riabilitativo
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità di Novara- SCDU Medicina Interna 1, AOU Maggiore della Carità
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico di Roma- UOC Medicina Interna
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea- UOC Medicina Interna
Study officials:
References: