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Preoperative Cognitive Screening in Older Spinal Surgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922634
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Deborah Culley, MD, Brigham and Women's Hospital

Brief Summary:
The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.

Condition or disease Intervention/treatment
Cognitive Impairment Frail Elderly Syndrome Other: Mini Cog

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Preoperative Cognitive Screening in Older Spinal Surgical Patients: Feasibility and Utility for Predicting Morbidity
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : October 9, 2018
Estimated Study Completion Date : March 2019

Group/Cohort Intervention/treatment
older surgical patients
older surgical patients presenting for elective thoracic surgery (specifically, thoracoscopic lung resection, lobectomy, thoracotomy, or esophagectomy) and to neurological posterior thoracolumbar spine surgery by neurosurgeons Dr. Groff, Dr. Lu and Dr. Chi
Other: Mini Cog
short cognitive screen, short Frailty screen
Other Names:
  • Frailty
  • Animal Fluency




Primary Outcome Measures :
  1. Confusion Assessment Method (CAM) Score [ Time Frame: Up to 3 days after surgery ]
    patient score on the Confusion Assessment Method after surgery or chart review delirium


Secondary Outcome Measures :
  1. Number of newly diagnosed health complications [ Time Frame: up to 30 days after surgical procedure ]
    Newly diagnosed health complications up to 30 days after the surgical procedure including: 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,

  2. 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 ]
    day discharged to home or other than home

  3. 30 day mortality [ Time Frame: 30 days after surgical procedure ]
    patient mortality 30 days after surgical procedure

  4. 30 day re-operation or readmission [ Time Frame: 30 days after surgical procedure ]
    patient readmission to the hospital or reoperation 30 days after surgical procedure

  5. 1 year mortality [ Time Frame: 1 year after surgical procedure ]
    patient mortality 1 year after surgical procedure

  6. Functional health outcome [ Time Frame: 6 months-1 year after surgical procedure ]
    functional health outcome measured with the World Health Organization Disability Assessment Score (WHODAS) 6 months to 1 year following the patient's surgical procedure



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
500 consenting subjects ≥ 65 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective thoracic surgery (specifically, thoracoscopic lung resection, lobectomy, thoracotomy, or esophegectomy) and to neurological posterior thoracolumbar spine surgery by neurosurgeons Dr. Groff, Dr. Lu and Dr. Chi. 250 subjects undergoing thoracic surgery will be recruited and 250 subjects undergoing neurological posterior thoracolumbar spine surgery will be recruited (500 total)
Criteria

Inclusion Criteria:

  • patients 65 years of age and older presenting to the BWH Weiner Center for Preoperative Evaluation
  • undergoing elective thoracic surgery or neurological posterior thoracolumbar spine surgery

Exclusion Criteria:

  • include 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)
  • inability to speak, read, or understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922634


Locations
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United States, Massachusetts
Weiner Center for Preoperative Evaluation
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Deborah Culley, M.D. Brigham and Women's Hospital

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Responsible Party: Deborah Culley, MD, Dr., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02922634    
Other Study ID Numbers: 2016P000012
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Culley, MD, Brigham and Women's Hospital:
postoperative health outcomes
older surgical patients
delirium
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders