Preoperative Cognitive Screening of Surgical Patients 65 Years of Age or Older

Mild Cognitive Impairment Clinical Trial

Official title:

Preoperative Cognitive Screening of Surgical Patients 65 Years of Age or Older: Feasibility of Routine Screening and Utility for Predicting Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570451
• Other study ID #: 2013P001214B
• Status: Completed
• Start date: September 2014
• Est. completion date: August 2020

Study information

• Verified date: April 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This will be a prospective, single-center observational study of patients 65 years of age or older undergoing elective surgical procedures. Phase 1 (Aims 1 and 2), will examine the prevalence of preoperative cognitive impairment and its relationship to postoperative outcome. In Phase 2 (Aim 3), will implement routine structured cognitive screening in a busy surgical preadmission evaluation center and confirm its utility for predicting adverse perioperative outcomes in elders. For Phase 1, 211 randomly selected patients 65 years of age or older of either gender will be enrolled presenting to the Brigham and Women's Hospital Weiner Center for Preoperative Evaluation (CPE) scheduled for elective joint replacement surgery. The Brigham and Women's Hospital performs more than 600 joint replacement procedures each year in patients 65 years of age or older. This is the age range where cognitive impairment becomes prevalent and postoperative cognitive and non-cognitive morbidity is common. Exclusion criteria will be patients diagnosed with dementia or cognitive impairment; scheduled for a procedure affecting the brain or cerebrovasculature (i.e. intracranial neurosurgery, carotid endarterectomy, cardiac surgery); planned to go to an ICU postoperatively; with uncorrected vision or hearing impairment (who cannot see the pictures or read or hear instructions); unable to use their dominant hand (limited ability to draw); and/or unable to speak, read or understand English. The investigators will use the CPE computerized scheduling system, which is updated continuously in real time and captures relevant information such as age and procedure to identify potential subjects. When patients check in with the receptionist for their appointment they will be notified that they may be eligible to participate in a study involving patients 65 years of age or older. The receptionist will then provide them with a brochure about the study that includes information about the purpose of the study, the risks to the patient, and potential benefits to society. The patient will then be asked if they are willing to speak with one of the study investigators and only those patients that agree to speak with a study investigator will be approached. A member of the study team will then contact the patient and verify that they satisfy the inclusion criteria and discuss the goals and risks of the study and ask them to participate. After all questions have been answered and the patient has had an opportunity to read the consent form, written consent will be obtained. After obtaining consent the patient will be interviewed by a member of the study team to obtain information about their years of education and self-reported functional status according to standardized scales for basic and instrumental activities of daily living (ADLs and IADLs, respectively). Grip strength as an index of frailty and mood assessed with the Geriatric Depression Scale-Short (GDS). An investigator will also administer a survey to assess the patient's perspective about the importance of preoperative cognitive screening. Information about ASA physical status, medications, and Charlson comorbidity index will be extracted subsequently from the patient's electronic medical record and patient interview. The patient will then be administered the MiniCog a simple cognitive screening tools that take just 2-4 min to complete and has little or no education, language, or race bias. During this phase of the project, a trained study team member will administer the test in the quiet of the evaluation room. The practitioner conducting the actual preoperative evaluation will be blinded to the cognitive test results and will complete a questionnaire about the patient's cognitive status based on their interactions during the visit. A trained, blinded member of the study team will score the test. Discharge to place other than home will be used as the primary outcome to determine the relationship between pre-existing cognitive impairment and patient outcome (Aim 2). As a secondary outcome delirium will be assessed once per day on postoperative days 1, 2, and 3 by a member of the study team using the Confusion Assessment Method (CAM) a well-validated measure of delirium in surgical patients. Other secondary outcomes that will be evaluated will include the use of restraints, hospital length of stay (LOS), complications (including in-hospital falls), 30 d readmission rate, and 30 d, 6 month, 1 year and 5 year mortality. Data will be extracted from the medical record and the BWH Balanced Scorecard. Phase 2 will examine the feasibility of implementing routine structured cognitive screening for elective surgical procedures into a busy preoperative evaluation center. 500 patients will be enrolled according to the criteria outlined above and ask CPE practitioners to administer the structured cognitive screen to all patient ≥ 65 years of age scheduled for a surgical procedure as part of their routine preoperative evaluation. A study team member will train the CPE staff in administration of the MiniCog prior to beginning this phase of the study; the test will be administered as part of the routine CPE visit. Outcome measures will be rate of successful testing (a score-able test), and impact of testing on patient flow. The latter will be obtained by extracting and comparing data from the CPE's computerized patient flow tracking system on time spent with a provider in a preoperative evaluation room and total duration of the CPE visit (check-in time to departure time) between enrolled subjects and age and procedure matched patients seen in the CPE the previous year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: August 2020
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years of age or older
• scheduled for elective joint replacement surgery

Exclusion Criteria:

• Known diagnosis of dementia or cognitive impairment
• Uncorrected vision or hearing impairment
• Unable to use dominant hand to write
• Unable to speak, read, or understand English

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Patient Survey
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.
• Mini Cog
The MiniCog is a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. This is a well-validated tool to assess mild cognitive impairment.
• Independent Activities of Daily Living Score Sheet
Questionnaire used to measure self-reported functional status for instrumental activities of daily living using standardized scales
• Activities of Daily Living Score Sheet
Questionnaire used to measure self-reported functional status for basic activities of daily living using standardized scores
• Geriatric Depression Scale Short Form
Questionnaire used to measure self-reported mood
• Confusion Assessment Method (CAM)
This well-validated measure of post-operative delirium will be utilized up to 3 days after surgery
• RAND 36-Item Short Form Health Survey
This measure is a generic, coherent, and easily administered health survey used to assess self-reported quality of life
• Grip Strength
Measured using the JAMAR dynamometer

Locations

Country	Name	City	State
United States	Weiner Center for Preoperative Evaluation	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Anesthesia Patient Safety Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient score on the confusion assessment method postoperative days 1-3	Delirium will be measured using the Confusion Assessment Method (CAM) by a member of the study team on postoperative days 1, 2 and 3	up to 3 days after surgery
Secondary	Number of newly diagnosed health complications following surgery	Number of newly diagnosed health complications will be recorded up to 30 days after surgery including: Myocardial Infarction, CHF, Cardiac Arrest, Arrythmia, Pneumonia, PE, Reintubation, Stroke, Delirium, Coma>24h, Postoperative deep wound infection, Superficial wound infection, Sepsis, Renal Failure, UTI, Reoperation, DVT, ICU admission	up to 30 days after surgery
Secondary	Readmission Rate	Whether or not patients are readmitted to the hospital within 30 days of discharge after surgery	up to 30 days after surgery
Secondary	Emergency Room Admit	Whether or not patients are admitted to the ER within 30 days of discharge after surgery	up to 30 days after surgery
Secondary	Mortality	Patient mortality within 30 days of being discharged from the hospital post surgery	up to 5 years after surgery