Association of Frailty and Delirium in Elderly Hip Fracture Patients

Study Overview
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Brief Summary
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Several studies have shown that frailty can be used as a marker for risk of adverse outcomes in elderly patients such as falls, disability, hospitalization, mortality, and can be used to predict patient clinical outcomes. The purpose of this study is to determine whether preoperative frailty can be used as a diagnostic and predictive factor for postoperative delirium in elderly patients with hip fracture.

Detailed Description
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Frailty index (FI) is a reliable method to determine the assessment of frailty in elderly patients. Multiple prospective cohort studies have shown that frailty can be used as a marker for risk of adverse outcomes in older adults such as falls, disability, hospitalization, and mortality, and can be used to predict patient clinical outcomes. Whether frailty could be used as a diagnostic and predictive factor for delirium is urgently needed in a large population. Therefore, this project intends to conduct a prospective cohort study. Patients will be divided into three groups according to frailty index (FI) before surgery, and delirium status will be evaluated by using scales after surgery, so as to explore the diagnostic and predictive value of frailty on POD. Once confirmed, the results of this study will be helpful for the early identification, screening, diagnosis and evaluation of treatment effect of POD. It is of great scientific significance and social benefit to reduce the incidence of POD, improve the prognosis of vulnerable patients and reduce the burden of disease.

Official Title
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The Association of Preoperative Frailty Index and Incidence of Postoperative Delirium in Elderly Patients With Hip Fracture: a Prospective Cohort Study

Conditions
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Frailty, Delirium in Old Age

Intervention / Treatment
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* Diagnostic Test: Frailty index scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects were patients with hip fracture; Older than 65 years; Patients signed informed consent; American Society of Anesthesiologist (ASA) Rated I- III; The surgery was performed by the same anesthesia and surgical team. Exclusion Criteria: Patients cannot sign the consent form or refuse to participate; A history of cognitive impairment; Unable to complete the cognitive function test; Mental disorder during initial assessment; Patients suffering from mental illness or substance use disorder; Incomplete or lost data during follow-up.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prefrailty group<br>According to the frailty index(FI) and FI =0.12 0.25 | Diagnostic Test: Frailty index scale<br>* There are clinically common scales for assessing weakness and delirium.<br>* Other names: Nu-DESC sclae;|
| Frailty group<br>According to the frailty index(FI) and FI≥ 0.25 | Diagnostic Test: Frailty index scale<br>* There are clinically common scales for assessing weakness and delirium.<br>* Other names: Nu-DESC sclae;|
| Nonfrailty group<br>According to the frailty index(FI) and FI<0.12 | Diagnostic Test: Frailty index scale<br>* There are clinically common scales for assessing weakness and delirium.<br>* Other names: Nu-DESC sclae;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium（POD） in elderly patients with hip fracture | The percentage of the study population who developed delirium within seven days of surgery,postoperative delirium（POD） is defined according to the CAM criterion | Postoperative 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of delirium | The time between the first appearance of delirium | Postoperative 7 days | 
| Delirium drug use | dosage and name of medication prescribed by a neurologist | Postoperative 7 days | 
| Length of hospital stay (HLOS) | Collection of clinical data in the medical record | Postoperative 30 days | 
| Length of ICU stay | Collection of clinical data in the medical record | Postoperative 30 days | 
| Hospital cost | Expenses during hospitalization | Postoperative 30 days | 
| Dindo-Clavien Classification{References:Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240(2):205-213.} | Incidence of serious adverse reactions within 30 days after operation （the therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge are highlighted in the present classification by a suffix (d for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.） | Postoperative 30 days | 
| Death before and 30 days after discharge | Collection of clinical data in the medical record and follow-up update through telephone | 30 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, postoperative delirium, hip fracture, elderly