Clinical Complexity in Internal Medicine Wards. San MAtteo Complexity Study (SMAC)

Development of a Mathematical Model of Clinical Complexity and of an Index for Its Practical Evaluation in Observational Prospective Longitudinal Studies. San MAtteo Complexity Study

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).

Study Overview

• Status: Unknown
• Conditions: Health Knowledge, Attitudes, Practice; Multimorbidity
• Intervention / Treatment: Other: Clinical Complexity Index

Detailed Description

The Clinical Complexity Index (CCI) that will be validated is made of 25 different variables, divided into 5 domains (biological, socioeconomic, behavioral, environmental, cultural). All variables were dichotomised and were coded -1 (absence of the variable) and +1 (presence of the variable). For each variable, the answer "yes" increases the degree of complexity. See Citations for further details.

Here is the CCI that will be used in the study:

BIOLOGICAL DOMAIN Age > 75 years yes☐ +1 no☐ -1 Intake ≥ 5 medications yes☐ +1 no☐ -1 Cumulative Illness Rating Scale (CIRS) > 3 and/or CIRS severity >3 yes☐ +1 no☐ -1 ↑ frailty (Edmonton Frail Scale > 5) yes☐ +1 no☐ -1

↓ mobilization (Barthel<60) yes☐ +1 no☐ -1

SOCIO-ECONOMIC DOMAIN Living alone yes☐ +1 no☐ -1 Income < 1000 €/month yes☐ +1 no☐ -1 Unemployment/precarious work yes☐ +1 no☐ -1 Dependent/disabled family member yes☐ +1 no☐ -1 Need for a caregiver yes☐ +1 no☐ -1

BEHAVIOURAL DOMAIN Inadequate adherence to medications yes☐ +1 no☐ -1 Active smoking of at least 4 cigarettes/day yes☐ +1 no☐ -1 Alcohol (>3 Alcohol Units/day) and/or drug abuse yes☐ +1 no☐ -1 Inappropriate diet yes☐ +1 no☐ -1 Cognitive impairment (Short Blessed Test > 9) yes☐ +1 no☐ -1

ENVIRONMENTAL DOMAIN Institutionalization yes☐ +1 no☐ -1 Difficult access to healthcare yes☐ +1 no☐ -1 Presence of home architectural barriers yes☐ +1 no☐ -1 Occupational exposure to toxins yes☐ +1 no☐ -1 Air pollution yes☐ +1 no☐ -1

CULTURAL DOMAIN Schooling < 8 years yes☐ +1 no☐ -1 Insufficient access to information yes☐ +1 no☐ -1 Lack of adherence to health screening programs yes☐ +1 no☐ -1 Language barriers yes☐ +1 no☐ -1 Perceived discrimination yes☐ +1 no☐ -1

The investigators will administer the CCI to all patients admitted to the wards (Internal Medicine and Subacute ward), according the study protocol. All the enrolled patients will be followed-up with a phone call after after discharge (at 4-8-12 months) for collecting the following data: occurrence of hospital readmission within 1 month after discharge; the number of readmissions; the number of accesses to the emergency room (ER); the number of visits at the outpatient clinic; the number of different drugs prescribed; mortality. Mortality will also be assessed once a year for 5 years.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo
      • Contact: Gino R Corazza, MD; Phone Number: 00390382502973; Email: gr.corazza@smatteo.pv.it
      • Sub-Investigator: Marco V Lenti, MD
      • Sub-Investigator: Pietro Formagnana, MD
      • Sub-Investigator: Giampiera Bertolino, MD
      • Sub-Investigator: Francesco Falaschi, MD
      • Sub-Investigator: Mariella Ciola, MD
      • Sub-Investigator: Alice Brera
      • Sub-Investigator: Gabriele Croce, MD
      • Sub-Investigator: Franco Barzizza, MD
      • Sub-Investigator: Elisabetta Pagani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Internal Medicine ward; The Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward.	Other: Clinical Complexity Index; Clinical Complexity Index (CCI) will be administered at the time of admission to the ward.
Subacute ward; The Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward.	Other: Clinical Complexity Index; Clinical Complexity Index (CCI) will be administered at the time of admission to the ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	The investigators will measure the length of stay (unit of measurement: days) of each enrolled patient.	2 years
Healthcare expenditure and utilization	To demonstrate the association of the Clinical Complexity Index (CCI) with the use of health resources, including the occurrence of hospital readmission within 1 month; the number of readmissions during the first 12 months; the number of accesses to the emergency room (ER) during the first 12 months; the number of visits at the outpatient clinic during the first 12 months; the number of different drugs prescribed during the first 12 months; the hospital reimbursement according to the Regional DRG system for the index hospitalization. Each of these items will be separately analyzed.	1 year
Mortality	To evaluate the association between a higher Clinical Complexity Index (CCI) score and mortality at 1 and 5 years.	5 years

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Gino R Corazza, MD, Fondazione IRCCS Policlinico San Matteo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2017
• Primary Completion (ANTICIPATED): November 6, 2019
• Study Completion (ANTICIPATED): November 6, 2022

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Chronic disease; Internal medicine; Healthcare expenditure
• Other Study ID Numbers: SMAC Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
• IPD Sharing Time Frame: Only on future articles that will be published.
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No