Improving Surgical Safety of Seniors Through Preoperative Cognitive Screening



Status:Recruiting
Conditions:Cognitive Studies, Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:4/21/2016
Start Date:July 2015
End Date:March 2016
Contact:Deborah Culley, M.D.
Email:dculley@partners.org
Phone:617-732-7330

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The hypothesis is that structured preoperative cognitive screening of seniors is feasible
without specialized staff and can help preoperatively identify persons at high risk of
complications. To demonstrate generalizability of the single center experience, and
strengthen the case for routine preoperative cognitive screening of seniors, the aims of
this proposal are to implement preoperative cognitive screening of seniors in the
preoperative clinics of a community hospital (NWH) and a 2nd tertiary care institution
(MGH); and determine whether impairment is an independent predictor of adverse perioperative
events.

The overriding hypothesis is that structured preoperative cognitive screening of seniors is
feasible without specialized staff and can help preoperatively identify persons at high risk
of complications. To demonstrate generalizability of the single center experience, and
strengthen the case for routine preoperative cognitive screening of seniors, the aims of
this proposal are to implement preoperative cognitive screening of seniors in the
preoperative clinics of a community hospital (NWH) and a 2nd tertiary care institution
(MGH); and determine whether impairment is an independent predictor of adverse perioperative
events. We will enroll seniors (≥ 65 years of age) presenting to Massachusetts General
Hospital (MGH) or Newton-Wellesley Hospital (NWH) for elective noncardiac, non-neurological
surgery requiring hospital admission (N = 250 each). Study staff will be deployed to one of
the sites each day according to a randomization scheme to avoid bias (thus, at each site,
recruitment will on average occur 10 d per month). A study team member will obtain informed
consent if the patient agrees to participate and satisfies eligibility criteria. Exclusion
criteria will be planned ICU admission postoperatively; history of stroke or brain tumor;
uncorrected vision or hearing impairment (unable to see pictures or read or hear
instructions); limited use of the dominant hand (limited ability to draw); and/or inability
to speak, read or understand English.Study staff will use the 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 in the CPE involving patients over the age of 65. 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 the 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.
The staff member will then describe the goals and risks of the study in a quiet room and ask
the patient if they choose to participate. After all questions have been answered and the
patient has the opportunity to read the consent form, written consent will be obtained by
one of the study investigators. After obtaining informed consent, the interviewer will ask
the patient and informant (if available) "Have you spoken to your doctor about or been
evaluated for a change in memory or thinking?" Study staff will also gather a variety of
demographic, functional, and medical information by direct questioning and review of the
medical record. Specifically, we will collect data on age, years of education, living
situation, history of falls, ASA physical status, metabolic equivalents (METS), medication
history, and Charlson Comorbidity index. We will administer standard instruments to assess
mood (Geriatric Depression Scale-Short [GDS], a 15-item self-report questionnaire, and
health and functional status (basic and instrumental activities of daily living [ADLs and
IADLs, respectively, and the SF36]), and measure grip strength with a Jamar hand dynamometer
as an index of frailty.The SF36 survey profiles physical and mental health and
quality-of-life. In addition, it will take one-minute to administer the Animal Fluency Test.
This is a cognitive screen that has been shown to be useful in identifying patients at risk
of developing postoperative delirium. The World Health Organization Disability Assessment
Schedule 2.0 will also be administered as a potential alternative to the SF36 in measuring
physical health and disability. Each enrolled patient will also receive a business card
listing the investigators' contact information and be advised to expect a follow up
telephone call 6 months after surgery to verify data elements and reassess functional
outcome.The MiniCog will be used for preoperative cognitive screening. Preoperative clinic
staff will perform and score the MiniCog during the preoperative visit, and a study staff
member will independently score each test subsequently. The MiniCog involves 3-item recall
for memory and a clock drawing test that serves as a distractor. The MiniCog tests
visuospatial representation, recall, and executive function. The MiniCog takes just 2-4 min
to complete but has been validated in community-based populations, has minimal education,
language, or ethnic bias, high sensitivity and specificity for impaired cognition, and
age-adjusted normative data are available. Moreover, the pilot data at BWH show the MiniCog
is well accepted by geriatric surgical patients, is easy for caregivers of different types
to administer and score, and has high inter-rater reliability in a preoperative clinic
setting. Probable cognitive impairment will be defined as a MiniCog score ≤ 2 (out of 5) but
ordinal scores will also be considered in the data analysis. A score ≤ 2 is a standard
cutoff and has ~75% sensitivity and ~90% or greater specificity for MCI or dementia when
compared to longer screening and assessment instruments.

Primary outcome measures for feasibility (Aim 1) will be rate of successful testing (a
score-able test) and accuracy of scoring (vs. an investigator). Secondary feasibility
outcome measures will be perspective of the practitioner about cognitive screening (survey
of MGH and NWH CPE staff) and the impact of testing on patient flow at each institution. 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. The primary
patient outcomes (Aim 2) will be delirium, discharge to a place other than home, and
functional outcome (change in SF36); secondary outcomes will be hospital length of stay
(LOS), complications (including in-hospital falls), and 30 d readmission rate or mortality.
Delirium will be assessed directly 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.The remaining outcomes data will be extracted from the medical record
or electronic databases. Both institutions track time spent in the CPE (with provider, in
the lab, in the waiting room, etc.) and have databases that tabulate numerous elements of
the hospital event such as age, gender, and race, surgical service, procedure, DRG codes,
admit and discharge dates (LOS), and discharge disposition (home, home with services,
rehabilitation, skilled nursing facility).

Inclusion Criteria:

- patients 65 years of age or older

- presenting to Massachusetts General Hospital (MGH) or Newton-Wellesley Hospital (NWH)

- scheduled for elective noncardiac, non-neurological surgery requiring hospital
admission

Exclusion Criteria:

- planned ICU admission postoperatively

- history of stroke or brain tumor

- uncorrected vision or hearing impairment

- limited use of the dominant hand

- inability to speak, read or understand English
We found this trial at
2
sites
2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Phone: 617-243-6031
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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