How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: a Multicenter Study

March 10, 2025 updated by: Società Italiana di Medicina Interna

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

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.

Study Overview

Status

Recruiting

Conditions

Complexity and Multiple Illnesses of Adult Hospitalized Internal Medicine Patient

Study Type

Observational

Enrollment (Estimated)

2326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nicola Montano, MD PhD
Phone Number: 0039 064434037
Email: nicola.montano@simi.it

Study Locations

Italy
- - Bari, Italy, 70124
    - Recruiting
    - AOU Policlinico di Bari- Unità Operativa di Medicina Interna "Guido Baccelli
    - Contact:
      
      Angelo Vacca, MD PhD
      
      Phone Number: 00390805478057
      
      Email: angelo.vacca@uniba.it
  - Bologna, Italy, 40138
    - Recruiting
    - Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola - Malpighi- UO Medicina interna, malattie epatobiliari e immunoallergologiche
    - Contact:
      
      Fabio Piscaglia, MD PhD
      
      Phone Number: 0039390512142542
      
      Email: fabio.piscaglia@unibo.it
  - Brescia, Italy, 25121
    - Recruiting
    - ASST degli Spedali Civili di Brescia- Medicina Generale 2
    - Contact:
      
      Maria Lorenza Muiesan, MD
      
      Phone Number: 00390303998721
      
      Email: marialorenza.muiesan@unibs.it
  - Ferrara, Italy, 44124
    - Recruiting
    - Azienda Ospedaliero-Universitaria S. Anna di Ferrara- Clinica Medica
    - Contact:
      
      Roberto Manfredini, MD PhD
      
      Phone Number: 00390532237166
      
      Email: roberto.manfredini@unife.it
  - Firenze, Italy, 50012
    - Recruiting
    - Ospedale Santa Maria Annunziata, Bagno a Ripoli, Firenze- Medicina 1
    - Contact:
      
      Plinio Fabiani, MD
      
      Phone Number: 00390556810633
      
      Email: plinio.fabiani@gmail.com
  - Messina, Italy, 98124
    - Recruiting
    - AOU G. Martino- UOC Medicina Interna
    - Contact:
      
      Giovanni Squadrito, MD PhD
      
      Phone Number: 00390902212359
      
      Email: gsquadrito@unime.it
  - Milano, Italy, 20157
    - Recruiting
    - ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco- Struttura Complessa di Medicina Interna
    - Contact:
      
      Chiara Beatrice Cogliati
      
      Email: chiara.cogliati@unimi.it
  - Modena, Italy, 44124
    - Recruiting
    - AOU Modena - Policlinico di Modena - S.C. Medicina Interna
    - Contact:
      
      Antonello Pietrangelo, MD PhD
      
      Phone Number: 00390594222714
      
      Email: pietra@unimore.it
  - Napoli, Italy, 80131
    - Recruiting
    - Azienda Ospedaliera Universitaria Federico II, Napoli- UOC Medicina Interna ad indirizzo metabolico e riabilitativo
    - Contact:
      
      Antonio Cittadini, MD
      
      Phone Number: 00390817464375
      
      Email: antonio.cittadini@unina.it
  - Novara, Italy, 28100
    - Recruiting
    - Ospedale Maggiore della Carità di Novara- SCDU Medicina Interna 1, AOU Maggiore della Carità
    - Contact:
      
      Mario Pirisi, MD
      
      Phone Number: 003903213733361
      
      Email: mario.pirisi@med.uniupo.it
  - Roma, Italy, 00128
    - Recruiting
    - Policlinico Universitario Campus Bio-Medico di Roma- UOC Medicina Interna
    - Contact:
      
      Raffaele Antonelli Incalzi, MD
      
      Phone Number: 003906225411365
      
      Email: r.antonelli@policlinicocampus.it
  - Roma, Italy, 00189
    - Recruiting
    - Azienda Ospedaliero-Universitaria Sant'Andrea- UOC Medicina Interna
    - Contact:
      
      Alessandro Laviano, MD PhD
      
      Phone Number: 00390649973902
      
      Email: alessandro.laviano@uniroma1.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

adult hospitalized internal medicine patient

Description

Inclusion Criteria:

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

Exclusion Criteria:

No specific exclusion criteria were identified.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate the correlation between clinical complexity/multimorbidity of the hospitalized internal medicine patient, defined by the Cumulative Illness Rating Scale (CIRS), and mortality. Time Frame: 12 months	to evaluate the correlation between clinical complexity/multimorbidity of the hospitalized internal medicine patient, defined by the Cumulative Illness Rating Scale (CIRS), and mortality. Cumulative Illness Rating Scale: severity index (minimum value is 1, maximum value is 5), comorbidity index (minimum value is 0, maximum value is 13). Higher scores mean worse outcome.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate the correlation between pre-existing factors at hospitalization and clinical outcomes - to evaluate the association between disease severity parameters and clinical outcomes Time Frame: 12 months	to evaluate the correlation between pre-existing factors at hospitalization, such as polypharmacy, age, prevalent chronic diseases (e.g. heart failure, respiratory failure and pneumonia, decompensated diabetes, etc.) and clinical outcomes such as mortality, length of hospital stay, intensity of care (transfer to units with higher clinical intensity), complications and rehospitalization to evaluate the association between disease severity parameters (e.g. biohumoral, score, etc.) and clinical outcomes.	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Società Italiana di Medicina Interna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)