Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01826825 |
| Other study ID # |
Culley_01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2013 |
| Est. completion date |
August 2015 |
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 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.
Description:
Detailed Description: Background and Significance: Approximately one-third of elective
surgical patients seen in the BWH Preoperative Test Center are 65 years of age or older and
national trends are similar. 15-30% of community dwelling elders have cognitive impairment.
Such impairment cannot be identified based on chronologic age alone because there is
considerable heterogeneity in cognitive abilities within and between age groups. In clinical
practice, however, the brain is one major organ system that is not assessed formally
preoperatively, so those with pre-existing cognitive deficits often go unrecognized. This is
a potentially important deficiency given the advanced age of many surgical patients, the
difficulty cognitive impairment may impose on ability to follow postoperative instructions,
and the fact that research studies show an association between pre-existing cognitive
impairment and risk for perioperative morbidity and mortality. Thus, preoperative cognitive
performance may be a predictor and/or modifier of postoperative outcomes.1,2,3 Interestingly,
no studies have documented patient perceptions regarding relationships between cognitive
performance and patient outcomes among elders presenting for elective surgical procedures.
Objectives:
Objective 1: To determine whether each of two short cognitive tests administered in the
preadmission test center are equally useful in cognitively stratify elderly patients
presenting for elective surgical procedures.
Objective 2: To evaluate the cost of cognitive screening in the preoperative testing center
in terms of time and finances.
Objective 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.
Subject Selection: Two hundred patients over age 65 years scheduled for an elective surgical
procedure without a planned postoperative admission to the ICU will be identified by the
Weiner Center for Preoperative Evaluation (PATC). The study will include patients of both
genders scheduled for surgery without planned admission to an ICU. Exclusion criteria include
a formal diagnosis of dementia (e.g. Alzheimer's disease), uncorrected vision or hearing
impairment (as it is necessary to see pictures and hear instructions), inability to speak,
read or understand English, and scheduled surgical procedures affecting the brain or
cerebrovasculature (i.e. intracranial neurosurgery, carotid endarterectomy). These ages are
chosen because cognitive impairment becomes more prevalent after age 65 years of age and
patients in this age group are at greatest risk for developing serious postoperative
complications.
Subject Enrollment: The Brigham and Women's Hospital is the only study site. When the
patients check in for their preoperative evaluation they will be asked by the registration
desk whether a study investigator can discuss the objectives and risks of a study that is
being performed in the preadmission testing center. If the patient agrees a member of the
investigative team will greet the patient and describe the purpose of study to them along
with its risk and benefits and provide them with the consent form for them to read. After the
patient has read the consent form they will be asked if they have any additional questions.
Once all questions have been answered the patient will be given the opportunity to decline or
provide written informed consent to the study.
Study Procedures: After consent is obtained the investigator will thank the patient and open
the next available sealed envelop which will contain a study registration ID number and open
the envelope wherein the group to which the patient has been randomized will be displayed
along with 3 stickers with the registration ID that will be placed on the testing
documentation. The Registration ID's will be randomly assigned to a group based on the
results of a random number generator.
After randomization the investigator will hand the patient the Patient Survey (see Patient
Survey attached) on a clipboard with a pen attached and the patient will compete the survey
in the waiting room of the preadmission testing center. Once completed the investigator will
collect the survey. If the patient has been randomized to the Clock-in-the-box test they will
be handed the instructions to the test and be allowed to read them. After the patient has
read the instructions the patient will hand the instructions to the investigator who will
place a copy of the test form on the clipboard for the patients use. After the patient has
completed the clock-in-a-box test they will return it to the investigator who will thank the
patient for their participation in the study. A trained member of the investigative team will
score the clock-in-a-box test after the preadmission test center visit. (See attachment A for
the Clock-in-the-Box test and scoring).
For patients randomized to the Mini-Cog, a trained member of the preadmission test center
team who is involved in the patients routine preoperative evaluation will administer the test
during the course of the patients preoperative evaluation in a quiet room. They will first
instruct the patient to remember 3 unrelated words (egg, apple, table, penny). The patient
will be requested to repeat the words back to the clinician to ensure they heard the words.
Next the patient is instructed to draw the face of a clock with the hands on a specific time
(the time 11:10 has been endorsed). Finally the patient is instructed to recall the 3 words.
The Mini-Cog is scored by giving 1 point for each word recalled, a normal clock is scored as
2 points and an abnormal clock receives 0 points. Mini-Cog scores can range from 0 (worst
score) to 5 (best score). Because these studies are not intended to detect dementia nor
impact current medical care the test scores will not be released to the patient nor will
there be a referral to a neurologist for more formal cognitive evaluation although subsequent
investigations may study the value of doing so (see Attachment 2 for Mini-Cog test and
scoring).
Other data to be collected will include the age of the patient, the total duration of time
the patient spent in the preadmission test center (check-in time to departure time), the
duration of their preoperative evaluation (time in the preoperative evaluation room) as
identified by the CPE tracking system and the monetary cost of this time in each area and
compared to those variables in patients over age 65 presenting for preoperative evaluation
the week before and the week after the study period and compared using a Student's t-test.
Biostatistical Analysis: For the Clock-in-the-Box test the number of patients with scores of
0-8 between the ages of 65-74 vs 75 and above will be determined and analyzed using a chi
square analysis. For the Mini-Cog test the number of patients with scores of 0-5 for ages
65-74 vs 75 and above will be determined and analyzed using a chi square analysis to
determine whether this tool can be used for cognitive stratification in patients in the
preadmission testing center. One would expect that older patients would score lower on this
test when compared to younger patients.
This study does not involve a medical intervention or treatment or diagnosis of a disease
process but rather will determine whether cognitive stratification of elders is feasible
within the established flow of the preoperative testing center process of the Brigham and
Women's Hospital, the cost of such testing, and patient perceptions regarding the value.
Survey data will be presented as the percentage of patients agreeing with each statement when
binary and will provide valuable patient centered insight about their perceptions of
preoperative cognitive stratification and their outcome goals resulting from their upcoming
surgical procedure.
Data on duration of time spent in the preadmission testing center and duration of 1:1
preoperative evaluation for study versus non-study patients over the age of 65 will be
analyzed using a Student's t-test.
Risks and Discomforts:
Risks to patients are minimal, as the cognitive screening results will only be reported in
aggregate with no personally identifiable information. The cognitive screen will have no
impact on patient care and thus should not alter patient outcomes although some patients may
experience stress if they are having difficulty with the cognitive exam. All efforts will be
made to minimize risks by selecting investigators who are trained to the protocol and cued to
monitor the patient for undo stress. Patient participation in the study can be discontinued
at any time if the opinion of the investigator is that it is in the best interest of the
patient to discontinue participation or if the patient requests withdrawal from the study
Potential Benefits:
There are no expected benefits to individual subjects participating in the study. This study
has the potential to aid and improve decision-making by physicians and elderly patients in
the future if they reveal a relationship between poor preoperative cognitive status and
adverse postoperative outcomes in elders.
Monitoring and Quality Assurance:
Regardless of monitoring plans, the principal investigator is ultimately responsible for
ensuring that the study is conducted at his/her investigative site in accordance with the
IRB-approved protocol and applicable regulations and requirements of the IRB.
The Principal Investigator or a member of the investigative team will monitor each subject at
this single site, and will review the accuracy and completeness of Clock-in the Box, Mini-cog
and survey reports, source documents and informed consent.
There will be no Data Safety Monitoring Board as the results of these studies will have no
impact on the care that patients receive. The outcomes of the study are intended to be
published in a peer-reviewed manuscript. All adverse events will be reported to the Partners
the Human Research Committee (HRC) in accordance HRC guidelines. A 24-hour/7-day telephone or
pager number will be provided for contacting the licensed physician investigator for this
purpose.
The research staff will monitor all subjects during the course of study involvement for
evidence of any adverse events such as unexpected stress and the testing discontinued and the
incident reported to Partners the Human Research Committee within 24 hours of local event
awareness (but no later than the next business day). The report will include a complete
description of the event, use of all concomitant medications, and the local investigator's
assessment of causality of the adverse event. Follow-up evaluations will be done until there
is resolution of the adverse events, which are unlikely as this protocol is non-invasive
