Cognitive ImpairmentNCT04792983
Cognition and the Immunology of Postoperative Outcomes
An observational study of Cognitive Impairment and Frail Elderly Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This research will test the hypothesis that immune system disequilibrium / dysfunction explains why preoperative cognitive impairment is a strong predictor of postoperative morbidity in older surgical patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Frail Elderly Syndrome, Delirium
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 31 Jul 2025
- 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
- No healthy volunteers
- Older adult
Study population: The cohort will consist of 600 consenting subjects ≥ 65 years of age who present for preoperative evaluation prior to elective spine surgery.
Who may be able to join
- Patients ≥ 65 years of age
- American Society of Anesthesiologists (ASA) physical status of I-III
- Scheduled for elective spine surgery.
Who cannot join
- History of stroke (not including transient ischemic attacks, or TIAs)
- History of brain tumor
- History of autoimmune disorders
- Medications likely to significantly impact inflammation (e.g. steroids)
- Current infection
- Uncorrected vision or hearing impairment
- limited use of the dominant hand (limited ability to draw)
- inability to speak, read, or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Sierra J Loomis, BA, 617-278-0949, saloomis@bwh.harvard.edu
Erin J Kim, BA, 6177320949, ekim56@bwh.harvard.edu
About this study
This research will test the hypothesis that immune system disequilibrium / dysfunction explains why preoperative cognitive impairment is a strong predictor of postoperative morbidity in older surgical patients. The investigators propose that cognitive impairment influences surgical morbidity because of underlying immune disequilibrium / dysfunction (risk marker) and that this shapes the immune response to surgery and defines immunological hallmarks of postoperative morbidity (disease marker). The overarching goal of this application therefore is to define and better understand the clinical immunology underlying the relationship between cognition and geriatric surgical morbidity.
Read the detailed description
This project is designed as a prospective, single-center observational study. The cohort will consist of 600 consenting subjects ≥ 65 years of age that agree to have a study investigator speak with them during their preoperative evaluation prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 65 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spinal surgery. Exclusion criteria will include history of stroke (not including transient ischemic attacks, or TIAs) or brain tumor, a history of autoimmune disorders, medications likely to significantly impact inflammation (e.g. steroids), current infection, 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.
Patients will be introduced to the study through a flyer provided to them as part of a packet from their surgeon's office. A study team member will speak with those who have agreed during their preoperative evaluation to discuss studies from the department of Anesthesiology and satisfy eligibility criteria. After obtaining informed verbal consent over the telephone, study staff will gain information about the patient's age and years of education. Study staff will conduct the following preoperative measures over the telephone: the Geriatric Depression Scale-Short (GDS), the Beck Anxiety Inventory (BAI), the Visual Analog Scale for Pain (VAS), the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale (FRAIL), Instrumental Activities of daily living (IADLs), the Brief Pain Inventory (BPI), the World Health Organization Disability Assessment Schedule (WHODAS). In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members), and whether they have ever tested positive for COVID-19 in a patient survey. The study staff will administer the Montreal Cognitive Assessment (MOCA) simple cognitive screening tool that takes less than 10 minutes to complete and has little or no education, language, or race bias. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will be advised to expect a follow up telephone up to 3, 6, and 12- months after surgery to verify data elements and reassess functional outcome.
Delirium will be assessed prospectively once per day on postoperative days 1, 2, and/or 3 by a trained study team member using the Confusion Assessment Method [CAM] if the patient remains in the hospital and agrees to the evaluation. Delirium by chart review and CAM-ICU scores from the nursing staff will also be documented. Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. To evaluate cognition and functional status, the MOCA and the WHODAS will be administered 3, 6, and 12- months postoperatively by study staff over the telephone if the patient can be contacted and continue to agree to participate. The investigators will also collect information on secondary outcomes including whether they had a surgical procedure, time to postoperative anesthesia care unit (PACU) discharge, discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day, 6-month, and 1-year mortality when available. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.
- Conditions
- Cognitive Impairment, Frail Elderly Syndrome, Delirium, Surgery
- Being tested
- No intervention
- Keywords
- postoperative health outcomes, older surgical patients, delirium, spine surgery
- Medical subject headings
- Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study with no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Older (≥ 65 years of age) | Older surgical patients presenting for elective spine surgery. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCA Score, Delirium, and Plasma Inflammatory Mediators
The investigators will evaluate correlations between preoperative cognition, as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative plasma inflammatory markers by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
Measured: 5 years
MOCA Score, Delirium, and the Cellular Immune Response
The investigators will evaluate correlations between preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative monocyte immune gene transcriptome ex vivo to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
Measured: 5 years
MOCA Score, Delirium and Extracellular Vesicle Immune Responses to Surgery.
The investigators will evaluate correlations between poor preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative proteins found in circulating extracellular vesicles by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
Measured: 5 years
Secondary outcomes (8)
Newly diagnosed perioperative health complications
Newly diagnosed Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission following the subjects initial surgical procedure.
Measured: Up to 30 days after the surgical procedure
Discharge location (Home vs. other than home) on the day of patient discharge from hospital
Whether the patient was discharge to their home or discharged to a place other than home such as rehabilitation center or skilled nursing facility.
Measured: Up to 30 days after the surgical procedure
30 day mortality
Patient mortality 30 days after surgical procedure
Measured: 30 days after surgical procedure
30 day re-operation or readmission
Patient readmission to the hospital or reoperation 30 days after surgical procedure
Measured: 30 days after surgical procedure
6 month mortality
Patient mortality 6 months after surgical procedure
Measured: 6 months after surgical procedure
1 year mortality
Patient mortality 1 year after surgical procedure
Measured: 1 year after surgical procedure
Cognitive health outcome
Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) measured approximately 3, 6, and 12-months following the patient's surgical procedure if the participant is willing to participate.
Measured: 3, 6, and 12-months after surgical procedure.
Functional health outcome
Functional health outcome measured with the World Health Organization Disability Assessment Score (WHODAS, 12-item, minimum score 0 maximum score 110 with higher score reflecting more disability) approximately 6 months to 1 year following the patient's surgical procedure if the participant can be contacted by followup phone call and is willing to participate.
Measured: Between 6 and 12-months after surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start6 Sep 2019
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Culley, MD, Brigham and Women's Hospital
- Investigators
- Gregory J Crosby, MD, Principal investigator, Brigham & Women's Hospital; Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792983
- Sponsor's protocol ID
- 2019P000577
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and the Immunology of Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT04792983
- Acronym / sponsor ID
- 2019P000577
- Conditions
- Cognitive Impairment, Frail Elderly Syndrome, Delirium, Surgery
- Keywords
- postoperative health outcomes, older surgical patients, delirium, spine surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 11 Mar 2021 (actual)
- 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.
This research will test the hypothesis that immune system disequilibrium / dysfunction explains why preoperative cognitive impairment is a strong predictor of postoperative morbidity in older surgical patients. The investigators propose that cognitive impairment influences surgical morbidity because of underlying immune disequilibrium / dysfunction (risk marker) and that this shapes the immune response to surgery and defines immunological hallmarks of postoperative morbidity (disease marker). The overarching goal of this application therefore is to define and better understand the clinical immunology underlying the relationship between cognition and geriatric surgical morbidity.
Detailed description
This project is designed as a prospective, single-center observational study. The cohort will consist of 600 consenting subjects ≥ 65 years of age that agree to have a study investigator speak with them during their preoperative evaluation prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 65 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spinal surgery. Exclusion criteria will include history of stroke (not including transient ischemic attacks, or TIAs) or brain tumor, a history of autoimmune disorders, medications likely to significantly impact inflammation (e.g. steroids), current infection, 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.
Patients will be introduced to the study through a flyer provided to them as part of a packet from their surgeon's office. A study team member will speak with those who have agreed during their preoperative evaluation to discuss studies from the department of Anesthesiology and satisfy eligibility criteria. After obtaining informed verbal consent over the telephone, study staff will gain information about the patient's age and years of education. Study staff will conduct the following preoperative measures over the telephone: the Geriatric Depression Scale-Short (GDS), the Beck Anxiety Inventory (BAI), the Visual Analog Scale for Pain (VAS), the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale (FRAIL), Instrumental Activities of daily living (IADLs), the Brief Pain Inventory (BPI), the World Health Organization Disability Assessment Schedule (WHODAS). In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members), and whether they have ever tested positive for COVID-19 in a patient survey. The study staff will administer the Montreal Cognitive Assessment (MOCA) simple cognitive screening tool that takes less than 10 minutes to complete and has little or no education, language, or race bias. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will be advised to expect a follow up telephone up to 3, 6, and 12- months after surgery to verify data elements and reassess functional outcome.
Delirium will be assessed prospectively once per day on postoperative days 1, 2, and/or 3 by a trained study team member using the Confusion Assessment Method [CAM] if the patient remains in the hospital and agrees to the evaluation. Delirium by chart review and CAM-ICU scores from the nursing staff will also be documented. Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. To evaluate cognition and functional status, the MOCA and the WHODAS will be administered 3, 6, and 12- months postoperatively by study staff over the telephone if the patient can be contacted and continue to agree to participate. The investigators will also collect information on secondary outcomes including whether they had a surgical procedure, time to postoperative anesthesia care unit (PACU) discharge, discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day, 6-month, and 1-year mortality when available. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older (≥ 65 years of age) | – | Other: No interventionOlder surgical patients presenting for elective spine surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The cohort will consist of 600 consenting subjects ≥ 65 years of age who present for preoperative evaluation prior to elective spine surgery.
Key inclusion criteria (3 listed)
- Patients ≥ 65 years of age
- American Society of Anesthesiologists (ASA) physical status of I-III
- Scheduled for elective spine surgery.
Key exclusion criteria (8 listed)
- History of stroke (not including transient ischemic attacks, or TIAs)
- History of brain tumor
- History of autoimmune disorders
- Medications likely to significantly impact inflammation (e.g. steroids)
- Current infection
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 |
|---|---|---|
| No interventionThis is an observational study with no interventions. | Other | Older (≥ 65 years of age) |
Primary outcome
MOCA Score, Delirium, and Plasma Inflammatory Mediators
Time frame: 5 years
The investigators will evaluate correlations between preoperative cognition, as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative plasma inflammatory markers by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
MOCA Score, Delirium, and the Cellular Immune Response
Time frame: 5 years
The investigators will evaluate correlations between preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative monocyte immune gene transcriptome ex vivo to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
MOCA Score, Delirium and Extracellular Vesicle Immune Responses to Surgery.
Time frame: 5 years
The investigators will evaluate correlations between poor preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative proteins found in circulating extracellular vesicles by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.
8 secondary outcomes
Newly diagnosed perioperative health complications
Time frame: Up to 30 days after the surgical procedure
Discharge location (Home vs. other than home) on the day of patient discharge from hospital
Time frame: Up to 30 days after the surgical procedure
30 day mortality
Time frame: 30 days after surgical procedure
30 day re-operation or readmission
Time frame: 30 days after surgical procedure
6 month mortality
Time frame: 6 months after surgical procedure
1 year mortality
Time frame: 1 year after surgical procedure
Cognitive health outcome
Time frame: 3, 6, and 12-months after surgical procedure.
Functional health outcome
Time frame: Between 6 and 12-months after surgical procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
Gregory J Crosby, MD principal investigator
Brigham & Women's Hospital; Harvard Medical School
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 Cognitive Impairment and Frail Elderly Syndrome, 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory J Crosby, MD (617-732-7398, gcrosby@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOCA Score, Delirium, and Plasma Inflammatory Mediators (time frame: 5 years). The study lists 3 primary outcomes in all. 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 12 Mar 2021.