Different Frailty Scores to Incidence of Post-operative Delirium and Cognitive Dysfunction

April 28, 2020 updated by: Dr Loh Pui San, University of Malaya

Comparing the Association of Different Frailty Scores to the Incidence of Post-operative Delirium and Cognitive Dysfunction

Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD).

So, it is crucial to find a suitable frailty assessment tool that can be incorporated into a guideline and reference for our local setting in geriatric peri-operative management. In the mean time, create awareness regarding the frailty elderly population with POD, POCD and other associated poor outcomes among our clinicians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Increasing life expectancy has led to increase in elderly populations, thus the elderly patients amounting for greater proportion of surgical cases. But, most of them are frail with multiple co-morbidities and are exposed to adverse outcome post-operatively. The commonest adverse outcomes is post-operative delirium (POD) in which clinicians often miss and often take lightly. If it is not treated, it will progress to post-operative cognitive dysfunction (POCD).

So, it is crucial to identify the risk factors pre-operatively to minimize the risk of POD and POCD. The frail patients are more likely to have pre-existing cognitive impairment with reduced cognitive reserve, hence, they are the most vulnerable to POCD and POD. One of the most commonly used frailty screening tools is Fried Frailty criteria which is an easily accessible tool that mainly screens and scores the patients physically. However, the investigators propose to use the Groningen Frailty scale as it can assess the patients in a more holistic approach, not only in physical, but also vision, heating, nutritional, co-morbidities, cognition, psychosocial and mobility of the patients.

Method:

Elderly patients >65 years old undergoing elective surgery under general or local anaesthesia in University Malaya Medical Centre will be recruited for this study, over a 6 months period from August 2019 to January 2020. Patients will be assessed with baseline cognitive assessment, nutritional status, psychological status, and frailty scores prior to the surgery. After the operation, patients will be assessed using 4AT and CAM for at least 5 days or until patients discharged. Cognitive functions will be assessed on post-operative 7th day, 1 month and 3 months with T-MOCA via phone.

All data will be analyzed using SPSS.

Impact of research:

A suitable frailty assessment tool will be identified to be used pre-operatively for elderly patients undergoing elective surgery. This tool will then be incorporated into a guideline and reference in our local setting for geriatric peri-operative management protocol.

Moreover, with the results, investigators hope to create awareness within our multidisciplinary care of elderly surgical population on frailty assessment and its correlation to post-operative delirium, cognitive dysfunction and associated poor outcomes.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
        • University Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients above 65 years of age undergoing elective surgery under anesthetic care for both general and regional anesthesia with or without sedation.

Description

Inclusion Criteria:

  • Age 65 years old and above
  • ASA 1 - 3
  • Full GCS
  • Elective surgery
  • Able to communicate well
  • Consented
  • Extubated at the end of surgery

Exclusion Criteria:

  • Cardiac and neurosurgery
  • On drugs affecting the central nervous system
  • Admission to ICU intubated to continue ventilation.
  • Refusal of consent
  • Severe hearing loss
  • Unable to use telephone/ mobile phone for communication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fried Frailty Phenotype
This group of patients will be assess by using 5 characteristics of Frailty which are weight loss, weakness, exhaustion, low activity and physical fitness of the patients. Patients classify as frail will have more than 3 criteria, intermediate or pre-frail will be 1 or 2 criteria present and robust will not have criteria.
Diagnostic test: Frailty Screening Tools
This is an observational and prospective study of patients who are going for elective surgery, thus no intervention will be given.
Groningen Frailty Index
GFI is a simple questionnaire consisting of 15 items which are classified into 8 groups, consistent of 4 domains of functioning. A score of 4 or more indicates a higher risk for frailty and possible delirium.
Diagnostic test: Frailty Screening Tools
This is an observational and prospective study of patients who are going for elective surgery, thus no intervention will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of confusion using Confusion Assessment Method (CAM) scores
Time Frame: Within 5 days after surgery

Delirium is present if the following are present:

Feature 1-Acute Change or/and Fluctuation (any symptom) AND Feature 2-Inattention AND EITHER Feature 3-Disorganized Thinking OR Feature 4-Altered Level of Consciousness
Within 5 days after surgery
Change in cognitive function using Telephone-Montreal Cognitive Assessment (T-MOCA)
Time Frame: Within 1 month
Cognitive function of the patients will be assessed after discharged and must achieved post-operative day 7 with T-MOCA via phone, subsequently assessed at 1 month and 3 month later.
Within 1 month
Occurence of delirium using 4AT scores
Time Frame: Within 5 days after surgery
A score of 4 or more suggests delirium but is not diagnostic: more detailed assessment of mental status may be required to reach a diagnosis. A score of 1-3 suggests cognitive impairment and more detailed cognitive testing and informant history-taking are required. A score of 0 does not definitively exclude delirium or cognitive impairment: more detailed testing may be required depending on the clinical context.
Within 5 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Pui San Loh, University Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1237-9788

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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