Preoperative Cognitive Screening of Elderly Surgical Patients

NCT01826825 | Completed Results

• 1 other identifier: Culley_01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this pilot study are:

1. 1.to determine whether a short cognitive test battery administered in the preadmission test center can be used to cognitively stratify elderly patients presenting for elective surgical procedures.
2. 2.to evaluate the cost of cognitive screening in the preoperative testing center in terms of time and finances.
3. 3.to evaluate patient perceptions about the use of preoperative cognitive screening and their outcome expectations from their surgical procedure.

Conditions

Cognitive Impairment

Keywords

aging; cognition; surgery

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Probable Cognitive Impairment

  Potential baseline predictors of the MiniCog and CIB scores on a risk ratio scale, Clock in box 0-8, Mini-Cog 0-5, higher values represent better scores. For the Mini-cog a score of less than or equal to 2 suggests probable cognitive impairment. For the Clock in the box, a score of less than or equal to 5 suggests probable cognitive impairment. The number of participants that scored less than or equal to 2 on the Mini-cog or less than or equal to 5 on the clock in the box are presented in the data table

  Cognitive stratification occurred on the date the patient consented to the study at baseline. This data was presented in a publication in 2017 (Anesthesiology. 2017 Nov;127(5):765-774.)

Secondary Outcomes (2)

• Cost of Cognitive Screening in Terms of Time and Finances

  duration of time undergoing preoperative evaluation in minutes.

• Patient Perceptions of Preoperative Cognitive Screening

  The data was obtained at the time of initial enrollment

Study Arms (2)

Clock in the box

Those patients with and without probable cognitive impairment based on the Clock-in-the-box assessment.

Behavioral: Cognitive Screen

Mini-Cog

Those patients with and without probable cognitive impairment based on the Mini-Cog assessment.

Behavioral: Mini-Cog

Interventions

Cognitive Screen BEHAVIORAL

Cognitive Screen

Also known as: Clock-in-the-Box

Clock in the box

Mini-Cog BEHAVIORAL

Cognitive Screen

Also known as: Mini-Cog cognitive screen

Mini-Cog

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

200 patients over the age of 65 that have provided informed consent will be randomly assigned to either the mini-cog or the clock in the box cognitive screen.

You may qualify if:

• Patients 65 years and over were enrolled either to be screened with the Clock in the Box or MiniCog cognitive screening tools

You may not qualify if:

• Patients under age 65 Patients with visual or hearing impairments that are not corrected Patients who do not speak and read English Patients having a formal diagnosis of dementia Patients with scheduled surgical procedures affecting the brain or cerebrovasculature (i.e. intracranial neurosurgery, carotid endarterectomy).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Anesthesia Patient Safety Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Deborah J. Culley, M.D., Principal Investigator
• Organization: Brigham and Women's Hospital

dculley@bwh.harvard.edu

6177327330

Study Officials

• Angela Bader, MD, MPH

  Brigham and Women's Hospital

  STUDY CHAIR

• James Rudolph, MD

  Brigham Hospital

  STUDY CHAIR

• Deborah J Culley, MD

  Brigham Hospital

  PRINCIPAL INVESTIGATOR

• Devon M Flaherty, MD, MPH

  Brigham and Women's Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 9, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2015
• Last Updated: April 14, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-04

Locations

US (1)