Association of Frailty and Delirium in Elderly Hip Fracture Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Delirium in Old Age
• Intervention / Treatment: Diagnostic test: Frailty index scale

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Huan Zhang, PhD; Phone Number: (010)17600809297; Email: whta01956@btch.edu.cn
• Study Contact Backup: Name: Haotian Wu, MD; Phone Number: (010)56119357; Email: tatabox@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100018
      • Recruiting
      • Beijing Tsinghua Changgung Hospital
      • Contact: Huan Zhang, PhD; Phone Number: (010)17600809297; Email: whta01956@btch.edu.cn
      • Contact: Haotian Wu, MD; Phone Number: (010)56119357; Email: tatabox@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 65 who underwent surgery for hip fractures

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prefrailty group; According to the frailty index(FI) and FI =0.12~0.25	Diagnostic test: Frailty index scale; There are clinically common scales for assessing weakness and delirium.; Other Names: CAM scale; Nu-DESC sclae
Frailty group; According to the frailty index(FI) and FI≥ 0.25	Diagnostic test: Frailty index scale; There are clinically common scales for assessing weakness and delirium.; Other Names: CAM scale; Nu-DESC sclae
Nonfrailty group; According to the frailty index(FI) and FI<0.12	Diagnostic test: Frailty index scale; There are clinically common scales for assessing weakness and delirium.; Other Names: CAM scale; Nu-DESC sclae

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Collaborators: Beijing Municipal Administration of Hospitals
• Investigators: Principal Investigator: Huan Zhang, PhD, Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: frailty; elderly; hip fracture; postoperative delirium
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Frailty; Hip Fractures
• Other Study ID Numbers: BTCH-MZ-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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