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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06872632

Enrollment

2326

Registered

2025-03-12

Start date

2024-06-24

Completion date

2028-06-30

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complexity and Multiple Illnesses of 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* No specific

Design outcomes

Primary

Measure	Time frame	Description
to evaluate the correlation between clinical complexity/multimorbidity of the hospitalized internal medicine patient, defined by the Cumulative Illness Rating Scale (CIRS), and mortality.	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.

Secondary

Measure	Time frame	Description
to evaluate the correlation between pre-existing factors at hospitalization and clinical outcomes - to evaluate the association between disease severity parameters and clinical outcomes	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.

Countries

Italy

Contacts

Primary ContactNicola Montano, MD PhD

nicola.montano@simi.it0039 064434037

Outcome results