Trial Outcomes & Findings for Preoperative Cognitive Screening of Elderly Surgical Patients (NCT NCT01826825)

Last Updated: 2021-04-14

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

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.)

Results posted on

2021-04-14

Participant Flow

Patients were enrolled in the Preadmission Testing Center at BWH between 6/5/2013 and 7/31/2013 after completing the informed consent process.

2 patients initially agreed to participate in the study but then were called in for their preadmission appointment and were not enrolled.

Participant milestones

Participant milestones
Measure	Clock in the Box Results of the Clock in the box cognitive screening test. Cognitive Screen: Cognitive Screen	Mini-Cog Results of the mini-cog cognitive screen Mini-Cog: Cognitive Screen
Overall Study STARTED	100	100
Overall Study COMPLETED	100	98
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Clock in the Box Results of the Clock in the box cognitive screening test. Cognitive Screen: Cognitive Screen	Mini-Cog Results of the mini-cog cognitive screen Mini-Cog: Cognitive Screen
Overall Study Two patients consented and randomized to Mini-Cog did not have the Mini-Cog administered	0	2

Baseline Characteristics

2 Patients withdrew

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clock in the Box n=100 Participants Results of the Clock in the box cognitive screening test. Cognitive Screen: Cognitive Screen	Mini-Cog n=100 Participants Results of the mini-cog cognitive screen Mini-Cog: Cognitive Screen	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=100 Participants	0 Participants n=100 Participants	0 Participants n=200 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=100 Participants	0 Participants n=100 Participants	0 Participants n=200 Participants
Age, Categorical >=65 years	100 Participants n=100 Participants	100 Participants n=100 Participants	200 Participants n=200 Participants
Sex: Female, Male Female	50 Participants n=100 Participants • 2 Patients withdrew	50 Participants n=98 Participants • 2 Patients withdrew	100 Participants n=198 Participants • 2 Patients withdrew
Sex: Female, Male Male	50 Participants n=100 Participants • 2 Patients withdrew	48 Participants n=98 Participants • 2 Patients withdrew	98 Participants n=198 Participants • 2 Patients withdrew
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.)

Population: Mini-Cog less than or equal to 2, clock in the box scores less than or equal to 5 suggests probable cognitive impairment

Outcome measures

Outcome measures
Measure	Clock in the Box n=100 Participants Results of the Clock in the box cognitive screening test. Cognitive Screen: Cognitive Screen	Mini-Cog n=98 Participants Results of the mini-cog cognitive screen Mini-Cog: Cognitive Screen
Number of Patients With Probable Cognitive Impairment	23 Participants	22 Participants

SECONDARY outcome

Timeframe: duration of time undergoing preoperative evaluation in minutes.

Population: Study patients undergoing cognitive screening with either the MiniCog or Clock in the Box.

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.

Outcome measures

Outcome measures
Measure	Clock in the Box n=82 Participants Results of the Clock in the box cognitive screening test. Cognitive Screen: Cognitive Screen	Mini-Cog n=84 Participants Results of the mini-cog cognitive screen Mini-Cog: Cognitive Screen
Cost of Cognitive Screening in Terms of Time and Finances	90 Minutes Standard Deviation 38	90 Minutes Standard Deviation 38

SECONDARY outcome

Timeframe: The data was obtained at the time of initial enrollment

Population: Patient perspective of preoperative cognitive screening. Because 2 patients randomized to the MIni-Cog arm were taken in for their preoperative assessment neither the Mini-cog screen and the survey on their perceptions on preoperative cognitive screening were obtained.

Results of a patient survey about their perceptions on preoperative cognitive screening on a yes / no basis

Outcome measures

Outcome measures
Measure	Clock in the Box n=100 Participants Results of the Clock in the box cognitive screening test. Cognitive Screen: Cognitive Screen	Mini-Cog n=98 Participants Results of the mini-cog cognitive screen Mini-Cog: Cognitive Screen
Patient Perceptions of Preoperative Cognitive Screening Do you believe a short memory test should be performed before having a surgical procedure? · Yes	71 Participants	71 Participants
Patient Perceptions of Preoperative Cognitive Screening Do you believe a short memory test should be performed before having a surgical procedure? · No	19 Participants	9 Participants
Patient Perceptions of Preoperative Cognitive Screening Do you believe a short memory test should be performed before having a surgical procedure? · Refused to answer	10 Participants	18 Participants
Patient Perceptions of Preoperative Cognitive Screening If a memory test could help predict surgical outcomes would you want memory testing performed? · Yes	92 Participants	93 Participants
Patient Perceptions of Preoperative Cognitive Screening If a memory test could help predict surgical outcomes would you want memory testing performed? · No	3 Participants	3 Participants
Patient Perceptions of Preoperative Cognitive Screening If a memory test could help predict surgical outcomes would you want memory testing performed? · Refused to answer	5 Participants	2 Participants
Patient Perceptions of Preoperative Cognitive Screening If the results of memory testing suggested memory problems would you want to know? · Yes	93 Participants	93 Participants
Patient Perceptions of Preoperative Cognitive Screening If the results of memory testing suggested memory problems would you want to know? · No	5 Participants	5 Participants
Patient Perceptions of Preoperative Cognitive Screening If the results of memory testing suggested memory problems would you want to know? · Refused to answer	2 Participants	0 Participants
Patient Perceptions of Preoperative Cognitive Screening If the memory test suggested possible memory problems would you want a memory specialist referral? · Yes	80 Participants	75 Participants
Patient Perceptions of Preoperative Cognitive Screening If the memory test suggested possible memory problems would you want a memory specialist referral? · No	15 Participants	20 Participants
Patient Perceptions of Preoperative Cognitive Screening If the memory test suggested possible memory problems would you want a memory specialist referral? · Refused to answer	5 Participants	3 Participants

Adverse Events

Clock in the Box

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Mini-Cog

Serious events: 18 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Clock in the Box n=100 participants at risk Results of the Clock in the box cognitive screening test. Cognitive Screen: Cognitive Screen	Mini-Cog n=98 participants at risk Results of the mini-cog cognitive screen Mini-Cog: Cognitive Screen
Respiratory, thoracic and mediastinal disorders Pneumonia	2.0% 2/100 • Number of events 2 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	1.0% 1/98 • Number of events 1 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.
Respiratory, thoracic and mediastinal disorders Reintubation	1.0% 1/100 • Number of events 1 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	0.00% 0/98 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.
Nervous system disorders Stroke	1.0% 1/100 • Number of events 1 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	0.00% 0/98 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.
Nervous system disorders Delirium by Chart review	7.0% 7/100 • Number of events 7 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	8.2% 8/98 • Number of events 8 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.
Skin and subcutaneous tissue disorders Wound infection	0.00% 0/100 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	1.0% 1/98 • Number of events 1 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.
Skin and subcutaneous tissue disorders Sepsis	0.00% 0/100 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	1.0% 1/98 • Number of events 1 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.
Renal and urinary disorders Urinary tract infection	0.00% 0/100 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	3.1% 3/98 • Number of events 3 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.
Surgical and medical procedures Reoperation	2.0% 2/100 • Number of events 2 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.	4.1% 4/98 • Number of events 4 • In hospital, and up to 1 month postoperatively. This data was collected from the patients chart between 1 month and 2 months after their surgical procedure.

Other adverse events

Adverse event data not reported

Additional Information

Deborah J. Culley, M.D., Principal Investigator

Brigham and Women's Hospital

Phone: 6177327330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place