Brief Summary

The overall objectives of this study are to improve outcomes of surgical patients 65 years of age or older through risk stratification based on preoperative screening of cognition / mental function. Aim 1 is to determine the prevalence of cognitive impairment among patients 65 years of age or older presenting for elective joint replacement surgery by structured cognitive screening versus standard practice. Aim 2 is to ascertain whether preoperative cognitive impairment in patients 65 years of age or older undergoing elective joint replacement surgery is an independent predictor of adverse postoperative events and/or mortality. Aim 3 is to implement routine structured preoperative cognitive screening of patients 65 years of age or older undergoing elective surgical procedures in a busy preoperative clinic.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

711

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.9 years study duration

Study Start

First participant enrolled

September 1, 2014

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed

1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed

4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed

Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

September 2, 2015

Last Update Submit

April 12, 2021

Conditions

Mild Cognitive Impairment

Keywords

cognitive impairmentpost surgical outcomeselective joint replacement surgery

Outcome Measures

Primary Outcomes (1)

Discharge location (defined home vs. other than home) on day of patient discharge from hospital
On the day the patient is discharged from the hospital, the discharge location (home vs. other than home) will be recorded
up to 30 days after surgery

Secondary Outcomes (5)

Patient score on the confusion assessment method postoperative days 1-3
up to 3 days after surgery
Number of newly diagnosed health complications following surgery
up to 30 days after surgery
Readmission Rate
up to 30 days after surgery
Emergency Room Admit
up to 30 days after surgery
Mortality
up to 5 years after surgery

Study Arms (2)

undergoing any elective SDA surgical procedure

500 patients Patient Survey Independent Activities of Daily Living Score Sheet Geriatric Depression Scale Short Form Activities of Daily Living Score Sheet Grip Strength Mini Cog RAND 36-Item Short Form Health Survey Confusion Assessment Method (CAM)

Other: Patient SurveyOther: Mini CogOther: Independent Activities of Daily Living Score SheetOther: Activities of Daily Living Score SheetOther: Geriatric Depression Scale Short FormOther: Confusion Assessment Method (CAM)Other: RAND 36-Item Short Form Health SurveyOther: Grip Strength

scheduled for elective joint replacement surgery

Patient Survey Independent Activities of Daily Living Score Sheet Geriatric Depression Scale Short Form 211 patients Activities of Daily Living Score Sheet Grip Strength Mini Cog RAND 36-Item Short Form Health Survey Confusion Assessment Method (CAM)

Interventions

Patient SurveyOTHER

This survey will assess patients' perspective about the importance of preoperative cognitive screening, information about living situation, information about who accompanied them to the preoperative visit, and level of perceived stress.