Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02570451 |
Other study ID # |
2013P001214B |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 2014 |
Est. completion date |
August 2020 |
Study information
Verified date |
April 2021 |
Source |
Brigham and Women's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.