MultimorbiditySMACNCT03439410
Clinical Complexity in Internal Medicine Wards. San MAtteo Complexity Study
An observational study of Multimorbidity and Health Knowledge, Attitudes, Practice, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity, Health Knowledge, Attitudes, Practice
- What is being tested?
- Clinical Complexity Index
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2017to 6 Nov 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted in the aforementioned wards will be enrolled in the study during the time of the study
Who may be able to join
- Age ≥ 18
- Hospitalized in one of the participating Units (Internal Medicine wards or Subacute ward)
Who cannot join
- Already enrolled in the study during a previous hospitalization
- Denied informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Gino R Corazza, MD, 00390382502973, gr.corazza@smatteo.pv.it
Marco V Lenti, MD
About this study
Official title: 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).
Read the 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.
- Being tested
- Clinical Complexity Index
- Keywords
- Internal medicine, Chronic disease, Healthcare expenditure
- Medical subject headings
- Behavior, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Complexity IndexOther
Clinical Complexity Index (CCI) will be administered at the time of admission to the ward.
| Study group | Role | What they receive |
|---|---|---|
| Internal Medicine ward | The Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward. Receives: Other: Clinical Complexity Index | |
| Subacute ward | The Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward. Receives: Other: Clinical Complexity Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (3)
Length of stay
The investigators will measure the length of stay (unit of measurement: days) of each enrolled patient.
Measured: 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.
Measured: 1 year
Mortality
To evaluate the association between a higher Clinical Complexity Index (CCI) score and mortality at 1 and 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start6 Nov 2017
- Primary completion6 Nov 2019 (estimated)
- Study completion6 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gino Roberto Corazza, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Gino R Corazza, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439410
- Sponsor's protocol ID
- SMAC Study
- Acronym
- SMAC
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
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.
PubMed 28779449Corazza 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.
PubMed 28710713Lenti 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.
PubMed 35818046
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03439410
- Acronym / sponsor ID
- SMAC / SMAC Study
- Keywords
- Internal medicine, Chronic disease, Healthcare expenditure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 6 Nov 2019 (estimated)
- Study completion
- 6 Nov 2022 (estimated)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal Medicine ward | – | Other: Clinical Complexity IndexThe Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward. |
| Subacute ward | – | Other: Clinical Complexity IndexThe Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in the aforementioned wards will be enrolled in the study during the time of the study
Key inclusion criteria (2 listed)
- Age ≥ 18
- Hospitalized in one of the participating Units (Internal Medicine wards or Subacute ward)
Key exclusion criteria (2 listed)
- Already enrolled in the study during a previous hospitalization
- Denied informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Complexity IndexClinical Complexity Index (CCI) will be administered at the time of admission to the ward. | Other | Internal Medicine ward, Subacute ward |
Primary outcome
Validation of the Clinical Complexity Index (CCI)
Time frame: 2 years
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).
3 secondary outcomes
Length of stay
Time frame: 2 years
Healthcare expenditure and utilization
Time frame: 1 year
Mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 28779449Palese 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.
- Results publication: PubMed 28710713Corazza 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.
- Derived from this study: PubMed 35818046Lenti 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.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gino R Corazza, MD principal investigator
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity and Health Knowledge, Attitudes, Practice, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gino R Corazza, MD (00390382502973, gr.corazza@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Clinical Complexity Index (CCI) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439410, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.