Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Surgical Safety of Seniors Through Preoperative Cognitive Screening

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: NCT02570438
Recruitment Status : Terminated (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.)
First Posted : October 7, 2015
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
Newton-Wellesley Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Deborah Culley, MD, Brigham and Women's Hospital

Brief 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. 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.

Condition or disease
Cognitive Impairment

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Improving Surgical Safety of Seniors Through Preoperative Cognitive Screening
Actual Study Start Date : July 31, 2015
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    discharge location (home vs. other than home) will be recorded on the day the patient is discharged from the hospital

  2. Number of newly diagnosed health complications following surgery [ Time Frame: up to 30 days after 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

  3. 30 day readmission to the hospital or admission to the emergency room [ Time Frame: 30 days post surgery ]
    a patient's readmission to the hospital or admission to the emergency room

  4. 30 day mortality [ Time Frame: 30 days post surgical procedure ]
    Patient mortality within 30 days after the surgical procedure

  5. 6-month functional health assessment [ Time Frame: 6 months post surgical procedure ]
    Follow up health assessment using the the SF36 or the World Health Organization Disability Assessment Schedule 2.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02570438


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462
Sponsors and Collaborators
Brigham and Women's Hospital
Newton-Wellesley Hospital
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Deborah Culley, M.D. Brigham and Women's Hospital
Layout table for additonal information
Responsible Party: Deborah Culley, MD, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02570438    
Other Study ID Numbers: 2015P001020
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Deborah Culley, MD, Brigham and Women's Hospital:
postoperative outcomes
older surgical patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders