NCT Number: NCT06872632
How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: a Multicenter 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.
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
AOU Policlinico di Bari- Unità Operativa di Medicina Interna "Guido Baccelli, Bari, Italy
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients of legal age (age >= 18 years).
- Informed consent according to Italian law.
Exclusion criteria
- No specific exclusion criteria were identified.
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Società Italiana di Medicina Interna
Other
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Mar 12, 2025
- Registry last updated
- Mar 12, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.