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Preoperative Cognitive Screening of Elderly Surgical Patients

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ClinicalTrials.gov Identifier: NCT01826825
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : April 1, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Anesthesia Patient Safety Foundation
Information provided by (Responsible Party):
Gregory J. Crosby, M.D., Brigham and Women's Hospital

Brief Summary:

The objectives of this pilot study are:

  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. to evaluate the cost of cognitive screening in the preoperative testing center in terms of time and finances.
  3. to evaluate patient perceptions about the use of preoperative cognitive screening and their outcome expectations from their surgical procedure.

Subsequent investigations may evaluate whether preoperative cognitive screening is a predictor of postoperative morbidity and mortality in elderly surgical patients and whether a short cognitive screen administered in the preadmission testing center could be used to identify individuals with baseline cognitive impairments that should be refered for more formal cognitive evaluation.


Condition or disease Intervention/treatment
Cognitive Impairment Behavioral: Cognitive Screen Behavioral: Mini-Cog

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Cognitive Screening of Elderly Surgical Patients
Actual Study Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : August 2015

Group/Cohort Intervention/treatment
Clock in the box
Those patients with and without probable cognitive impairment based on the Clock-in-the-box assessment.
Behavioral: Cognitive Screen
Cognitive Screen
Other Name: Clock-in-the-Box

Mini-Cog
Those patients with and without probable cognitive impairment based on the Mini-Cog assessment.
Behavioral: Mini-Cog
Cognitive Screen
Other Name: Mini-Cog cognitive screen




Primary Outcome Measures :
  1. Number of Patients With Probable Cognitive Impairment [ Time Frame: 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.) ]
    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


Secondary Outcome Measures :
  1. Cost of Cognitive Screening in Terms of Time and Finances [ Time Frame: duration of time undergoing preoperative evaluation in minutes. ]
    To evaluate the cost of cognitive screening in the preoperative testing center in terms of time and finances. We were unable to determine differences in cost and did not track time to administer specifically the screening tools but rather the time of the entire preoperative evaluation. We gathered information on time spent in the preoperative testing center between patients who had MiniCog or Clock-in-the box testing.

  2. Patient Perceptions of Preoperative Cognitive Screening [ Time Frame: The data was obtained at the time of initial enrollment ]
    Results of a patient survey about their perceptions on preoperative cognitive screening on a yes / no basis



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:.

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826825


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Anesthesia Patient Safety Foundation
Investigators
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Study Chair: Angela Bader, MD, MPH Brigham and Women's Hospital
Study Chair: James Rudolph, MD Brigham Hospital
Principal Investigator: Deborah J Culley, MD Brigham Hospital
Study Director: Devon M Flaherty, MD, MPH Brigham and Women's Hospital
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Responsible Party: Gregory J. Crosby, M.D., Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01826825    
Other Study ID Numbers: Culley_01
First Posted: April 9, 2013    Key Record Dates
Results First Posted: April 1, 2021
Last Update Posted: April 14, 2021
Last Verified: April 2021
Keywords provided by Gregory J. Crosby, M.D., Brigham and Women's Hospital:
aging
cognition
surgery
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders