Clinical Complexity in Internal Medicine Wards. San MAtteo Complexity Study

NCT03439410 | Unknown DMC

• 1 other identifier: SMAC Study
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The progressive rising of multimorbidity, which has been always considered the hallmark of clinical complexity (CC), has made management of the "complex" patient one of the most topical and challenging issues in medicine. However, patient-related factors (multimorbidity, age, frailty, disease severity) pertain only to the biological complexity, while CC is the result of the dynamic interaction between biological complexity and a number of other coexisting factors (socio-economic, cultural, behavioural, environmental). Starting from these premises, the investigators designed a five-year observational prospective longitudinal study that aims to validate and compare a CC score system on a large cohort of patients (n=1000) admitted in internal medicine wards. Clinicians, biostatisticians and epidemiologists will cooperate into the project. A questionnaire that encompasses the main biological and extra-biological factors was designed (Clinical Complexity Index, CCI) by a multiprofessional consensus. This questionnaire will be administered by the investigators to the patients and validated. Consecutive patients will be enrolled every other week for two years and followed-up for 5 years. The primary endpoint will be the validation of the CCI. Thereafter, the investigators will evaluate the correlation between the CCI and the length of stay of the index hospitalization, assuming that a higher CCI score is associated with longer length of stay. The secondary endpoints will be the demonstration of the association between higher CCI score and more health resources utilization (i.e., evaluating occurrence of hospital readmissions, number of accesses to the emergency room, visits at the outpatient clinic, different drugs prescribed and hospital reimbursement according to the local diagnosis-related group \[DRG\] system) along with worse prognosis (mortality at 1 and 5 years).

Conditions

Multimorbidity; Health Knowledge, Attitudes, Practice

Keywords

Internal medicine; Chronic disease; Healthcare expenditure

Outcome Measures

Primary Outcomes (1)

• Validation of the Clinical Complexity Index (CCI)

  Validation of the Clinical Complexity Index (CCI) proposed in the project (see first Citation and Study Description for further details). This index should measure patients' clinical complexity, including biological, socioeconomic, cultural, behavioral, and envirnomental domains. The total score range is -25 to +25 (-5 to +5 per each domain). The investigators expect that a higher value is associated with a worse outcome (higher clinical complexity).

  2 years

Secondary Outcomes (3)

• Length of stay

  2 years

• Healthcare expenditure and utilization

  1 year

• Mortality

  5 years

Study Arms (2)

Internal Medicine ward

The Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward.

Other: Clinical Complexity Index

Subacute ward

The Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward.

Other: Clinical Complexity Index

Interventions

Clinical Complexity Index OTHER

Clinical Complexity Index (CCI) will be administered at the time of admission to the ward.

Internal Medicine ward; Subacute ward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted in the aforementioned wards will be enrolled in the study during the time of the study

You may qualify if:

• Age ≥ 18
• Hospitalized in one of the participating Units (Internal Medicine wards or Subacute ward)

You may not qualify if:

• Already enrolled in the study during a previous hospitalization
• Denied informed consent

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

Related Publications (3)

• Palese A, Brusaferro S. A multidimensional vector model measuring clinical complexity may increase effectiveness in patient assessment. Intern Emerg Med. 2017 Dec;12(8):1287-1289. doi: 10.1007/s11739-017-1722-9. Epub 2017 Aug 4. No abstract available.

  PMID: 28779449 BACKGROUND

• Corazza GR, Klersy C, Formagnana P, Lenti MV, Padula D; Consensus Panel. A consensus for the development of a vector model to assess clinical complexity. Intern Emerg Med. 2017 Dec;12(8):1313-1318. doi: 10.1007/s11739-017-1709-6. Epub 2017 Jul 14.

  PMID: 28710713 RESULT

• Lenti MV, Brera AS, Ballesio A, Croce G, Padovini L, Bertolino G, Di Sabatino A, Klersy C, Corazza GR. Resilience is associated with frailty and older age in hospitalised patients. BMC Geriatr. 2022 Jul 10;22(1):569. doi: 10.1186/s12877-022-03251-9.

  PMID: 35818046 DERIVED

MeSH Terms

Conditions

Behavior; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gino R Corazza, MD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gino R Corazza, MD

CONTACT

00390382502973; gr.corazza@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Internal Medicine

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 20, 2018
• Study Start: November 6, 2017
• Primary Completion: November 6, 2019
• Study Completion: November 6, 2022
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Only on future articles that will be published.

Locations

IT (1)