Cognitive ImpairmentNCT02570438
Improving Surgical Safety of Seniors Through Preoperative Cognitive Screening
An observational study of Cognitive Impairment, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: patients 65 years of age or older presenting to Massachusetts General Hospital (MGH) or Newton-Wellesley Hospital (NWH) for elective noncardiac, non-neurological surgery requiring hospital admission. 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
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.
Read the detailed description
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).
- Conditions
- Cognitive Impairment
- Keywords
- postoperative outcomes, older surgical patients
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older surgical patients | older patients (≥ 65 years of age) presenting to Massachusetts General Hospital (MGH) or Newton-Wellesley Hospital (NWH) for elective noncardiac, non-neurological surgery requiring hospital admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAM score postoperative days 1-3
patient score on the confusion assessment method on postoperative day 1, 2, and 3
Measured: up to 3 days after surgery
Secondary outcomes (5)
Discharge location (defined home vs. other than home) on day of discharge from hospital
discharge location (home vs. other than home) will be recorded on the day the patient is discharged from the hospital
Measured: up to 1 month from the date of surgery
Number of newly diagnosed health complications following surgery
number of newly diagnosted health complications up to 30 days after surgery including: Myocardial Infarction, CHF, Cardiac Arrest, Arrythmia, Pneumonia, PE, Reintubation, Stroke, Delirium, Coma>24h, Postoperative deep wound infection, Superficial wound infection, Sepsis, Renal Failure, UTI, Reoperation, DVT, ICU admission
Measured: up to 30 days after surgery
30 day readmission to the hospital or admission to the emergency room
a patient's readmission to the hospital or admission to the emergency room
Measured: 30 days post surgery
30 day mortality
Patient mortality within 30 days after the surgical procedure
Measured: 30 days post surgical procedure
6-month functional health assessment
Follow up health assessment using the the SF36 or the World Health Organization Disability Assessment Schedule 2.0
Measured: 6 months post surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start31 Jul 2015
- Primary completion25 Sep 2017
- Study completion31 Dec 2017
Why it stopped: This study was terminated prior to its planned enrollment due to low recruitment rates at the time that the funding for the study was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Newton-Wellesley Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Gregory J. Crosby, M.D., Brigham and Women's Hospital
- Investigators
- Deborah Culley, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570438
- Sponsor's protocol ID
- 2015P001020
- Status last verified
- Apr 2021
- First submitted
- 30 Sep 2015
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical Safety of Seniors Through Preoperative Cognitive Screening
- ClinicalTrials.gov ID
- NCT02570438
- Acronym / sponsor ID
- 2015P001020
- Conditions
- Cognitive Impairment
- Keywords
- postoperative outcomes, older surgical patients
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated prior to its planned enrollment due to low recruitment rates at the time that the funding for the study was completed.
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Newton-Wellesley Hospital, Massachusetts General Hospital
- Study start
- 31 Jul 2015 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older surgical patients | – | –older patients (≥ 65 years of age) presenting to Massachusetts General Hospital (MGH) or Newton-Wellesley Hospital (NWH) for elective noncardiac, non-neurological surgery requiring hospital admission |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- patients 65 years of age or older presenting to Massachusetts General Hospital (MGH) or Newton-Wellesley Hospital (NWH) for elective noncardiac, non-neurological surgery requiring hospital admission. 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CAM score postoperative days 1-3
Time frame: up to 3 days after surgery
patient score on the confusion assessment method on postoperative day 1, 2, and 3
5 secondary outcomes
Discharge location (defined home vs. other than home) on day of discharge from hospital
Time frame: up to 1 month from the date of surgery
Number of newly diagnosed health complications following surgery
Time frame: up to 30 days after surgery
30 day readmission to the hospital or admission to the emergency room
Time frame: 30 days post surgery
30 day mortality
Time frame: 30 days post surgical procedure
6-month functional health assessment
Time frame: 6 months post surgical procedure
Results and safety
The study was stopped early (reason given: This study was terminated prior to its planned enrollment due to low recruitment rates at the time that the funding for the study was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Culley, M.D. principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was terminated prior to its planned enrollment due to low recruitment rates at the time that the funding for the study was completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAM score postoperative days 1-3 (time frame: up to 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.