An observational study in Multimorbidity and Health Knowledge, Attitudes, Practice, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational
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).
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.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 235 across 341 observational studies indexed under Behavior.
Browse Behavior studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
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All patients admitted in the aforementioned wards will be enrolled in the study during the time of the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Clinical Complexity Index (CCI) will be administered to all patients admitted to the ward.
Other: Clinical Complexity Index
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.
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).
Time frame: 2 years
Length of stay
The investigators will measure the length of stay (unit of measurement: days) of each enrolled patient.
Time frame: 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.
Time frame: 1 year
Mortality
To evaluate the association between a higher Clinical Complexity Index (CCI) score and mortality at 1 and 5 years.
Time frame: 5 years
Plan to share: Yes — All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: Only on future articles that will be published.
Started Nov 2017 (actual). Primary completion is estimated for Nov 2019, 24 months after the start.
Of 113 non-industry observational studies under Behavior, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 57. This study's planned 24 months is above that.
Counting every sponsor, half of 119 studies reached it within 17 months; a quarter within 6 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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