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



Status:Active, not recruiting
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:1/7/2017
Start Date:September 2014
End Date:December 2017

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

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.

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.

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
We found this trial at
1
site
Boston, Massachusetts 02115
?
mi
from
Boston, MA
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