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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT02570451
Study groupRoleWhat they receive
undergoing any elective SDA surgical procedure500 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 surgeryPatient 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted7 Oct 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2015
  4. Study completionAug 2020

Resources

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)
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

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.

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