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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Validation of the Clinical Complexity Index (CCI)
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized in one of the participating Units (Internal Medicine wards or Subacute ward)
排除标准
- •Already enrolled in the study during a previous hospitalization
- •Denied informed consent
结局指标
主要结局
Validation of the Clinical Complexity Index (CCI)
时间窗: 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).
次要结局
- Mortality(5 years)
- Length of stay(2 years)
- Healthcare expenditure and utilization(1 year)
研究者
Gino Roberto Corazza
Full Professor of Internal Medicine
Fondazione IRCCS Policlinico San Matteo di Pavia