Mild Cognitive ImpairmentNCT02570451
Preoperative Cognitive Screening of Surgical Patients 65 Years of Age or Older
An observational study of Mild Cognitive Impairment, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Patient Survey, Mini Cog and Independent Activities of Daily Living Score Sheet
- How many people
- 711 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2020
- 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 or older in the Weiner Center for Preoperative Evaluation presenting for elective joint replacement surgery
Who may be able to join
- 65 years of age or older
- scheduled for elective joint replacement surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weiner Center for Preoperative Evaluation
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Patient Survey, Mini Cog, Independent Activities of Daily Living Score Sheet, Activities of Daily Living Score Sheet, Geriatric Depression Scale Short Form
- Keywords
- cognitive impairment, post surgical outcomes, elective joint replacement surgery
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient SurveyOther
This survey will assess patients' perspective about the importance of preoperative cognitive screening, information about living situation, information about who accompanied them to the preoperative visit, and level of perceived stress.
Mini CogOther
The MiniCog is a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. This is a well-validated tool to assess mild cognitive impairment.
Independent Activities of Daily Living Score SheetOther
Also called IADLs
Questionnaire used to measure self-reported functional status for instrumental activities of daily living using standardized scales
Activities of Daily Living Score SheetOther
Also called ADLs
Questionnaire used to measure self-reported functional status for basic activities of daily living using standardized scores
Geriatric Depression Scale Short FormOther
Also called GDS
Questionnaire used to measure self-reported mood
Confusion Assessment Method (CAM)Other
This well-validated measure of post-operative delirium will be utilized up to 3 days after surgery
RAND 36-Item Short Form Health SurveyOther
This measure is a generic, coherent, and easily administered health survey used to assess self-reported quality of life
Grip StrengthOther
Measured using the JAMAR dynamometer
| Study group | Role | What they receive |
|---|---|---|
| undergoing any elective SDA surgical procedure | 500 patients Patient Survey Independent Activities of Daily Living Score Sheet Geriatric Depression Scale Short Form Activities of Daily Living Score Sheet Grip Strength Mini Cog RAND 36-Item Short Form Health Survey Confusion Assessment Method (CAM) Receives: Other: Patient Survey; Other: Mini Cog; Other: Independent Activities of Daily Living Score Sheet; Other: Activities of Daily Living Score Sheet; Other: Geriatric Depression Scale Short Form; Other: Confusion Assessment Method (CAM); Other: RAND 36-Item Short Form Health Survey; Other: Grip Strength | |
| scheduled for elective joint replacement surgery | Patient Survey Independent Activities of Daily Living Score Sheet Geriatric Depression Scale Short Form 211 patients Activities of Daily Living Score Sheet Grip Strength Mini Cog RAND 36-Item Short Form Health Survey Confusion Assessment Method (CAM) Receives: Other: Patient Survey; Other: Mini Cog; Other: Independent Activities of Daily Living Score Sheet; Other: Activities of Daily Living Score Sheet; Other: Geriatric Depression Scale Short Form; Other: Confusion Assessment Method (CAM); Other: RAND 36-Item Short Form Health Survey; Other: Grip Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge location (defined home vs. other than home) on day of patient discharge from hospital
On the day the patient is discharged from the hospital, the discharge location (home vs. other than home) will be recorded
Measured: up to 30 days after surgery
Secondary outcomes (5)
Patient score on the confusion assessment method postoperative days 1-3
Delirium will be measured using the Confusion Assessment Method (CAM) by a member of the study team on postoperative days 1, 2 and 3
Measured: up to 3 days after surgery
Number of newly diagnosed health complications following surgery
Number of newly diagnosed health complications will be recorded 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
Readmission Rate
Whether or not patients are readmitted to the hospital within 30 days of discharge after surgery
Measured: up to 30 days after surgery
Emergency Room Admit
Whether or not patients are admitted to the ER within 30 days of discharge after surgery
Measured: up to 30 days after surgery
Mortality
Patient mortality within 30 days of being discharged from the hospital post surgery
Measured: up to 5 years after surgery
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 startSep 2014
- Primary completionAug 2015
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Responsible party
- Principal investigator, Gregory J. Crosby, M.D., Brigham and Women's Hospital
- Investigators
- Deborah J Culley, M.D., Principal investigator, Brigham and Women's Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570451
- Sponsor's protocol ID
- 2013P001214B
- Status last verified
- Apr 2021
- First submitted
- 2 Sep 2015
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Preoperative Cognitive Screening of Surgical Patients 65 Years of Age or Older: Feasibility of Routine Screening and Utility for Predicting Morbidity
- ClinicalTrials.gov ID
- NCT02570451
- Acronym / sponsor ID
- 2013P001214B
- Conditions
- Mild Cognitive Impairment
- Keywords
- cognitive impairment, post surgical outcomes, elective joint replacement surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2020 (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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| undergoing any elective SDA surgical procedure | – | Other: Patient Survey, Other: Mini Cog, Other: Independent Activities of Daily Living Score Sheet, Other: Activities of Daily Living Score Sheet, Other: Geriatric Depression Scale Short Form, Other: Confusion Assessment Method (CAM), Other: RAND 36-Item Short Form Health Survey, Other: Grip Strength500 patients Patient Survey Independent Activities of Daily Living Score Sheet Geriatric Depression Scale Short Form Activities of Daily Living Score Sheet Grip Strength Mini Cog RAND 36-Item Short Form Health Survey Confusion Assessment Method (CAM) |
| scheduled for elective joint replacement surgery | – | Other: Patient Survey, Other: Mini Cog, Other: Independent Activities of Daily Living Score Sheet, Other: Activities of Daily Living Score Sheet, Other: Geriatric Depression Scale Short Form, Other: Confusion Assessment Method (CAM), Other: RAND 36-Item Short Form Health Survey, Other: Grip StrengthPatient Survey Independent Activities of Daily Living Score Sheet Geriatric Depression Scale Short Form 211 patients Activities of Daily Living Score Sheet Grip Strength Mini Cog RAND 36-Item Short Form Health Survey Confusion Assessment Method (CAM) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients 65 years or older in the Weiner Center for Preoperative Evaluation presenting for elective joint replacement surgery
Key inclusion criteria (2 listed)
- 65 years of age or older
- scheduled for elective joint replacement surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient SurveyThis survey will assess patients' perspective about the importance of preoperative cognitive screening, information about living situation, information about who accompanied them to the preoperative visit, and level of perceived stress. | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
| Mini CogThe MiniCog is a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. This is a well-validated tool to assess mild cognitive impairment. | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
| Independent Activities of Daily Living Score SheetAlso: IADLsQuestionnaire used to measure self-reported functional status for instrumental activities of daily living using standardized scales | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
| Activities of Daily Living Score SheetAlso: ADLsQuestionnaire used to measure self-reported functional status for basic activities of daily living using standardized scores | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
| Geriatric Depression Scale Short FormAlso: GDSQuestionnaire used to measure self-reported mood | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
| Confusion Assessment Method (CAM)This well-validated measure of post-operative delirium will be utilized up to 3 days after surgery | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
| RAND 36-Item Short Form Health SurveyThis measure is a generic, coherent, and easily administered health survey used to assess self-reported quality of life | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
| Grip StrengthMeasured using the JAMAR dynamometer | Other | scheduled for elective joint replacement surgery, undergoing any elective SDA surgical procedure |
Primary outcome
Discharge location (defined home vs. other than home) on day of patient discharge from hospital
Time frame: up to 30 days after surgery
On the day the patient is discharged from the hospital, the discharge location (home vs. other than home) will be recorded
5 secondary outcomes
Patient score on the confusion assessment method postoperative days 1-3
Time frame: up to 3 days after surgery
Number of newly diagnosed health complications following surgery
Time frame: up to 30 days after surgery
Readmission Rate
Time frame: up to 30 days after surgery
Emergency Room Admit
Time frame: up to 30 days after surgery
Mortality
Time frame: up to 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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 J Culley, M.D. principal investigator
Brigham and Women's Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Brigham and Women's Hospital at 1 site 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 2 inclusion and 4 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: finished, 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 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Discharge location (defined home vs. other than home) on day of patient discharge from hospital (time frame: up to 30 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.