Improving Surgical Safety of Seniors Through Preoperative Cognitive Screening

NCT02570438 | Terminated

• 1 other identifier: 2015P001020
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Cognitive Impairment

Keywords

postoperative outcomes; older surgical patients

Outcome Measures

Primary Outcomes (1)

• CAM score postoperative days 1-3

  patient score on the confusion assessment method on postoperative day 1, 2, and 3

  up to 3 days after surgery

Secondary Outcomes (5)

• Discharge location (defined home vs. other than home) on day of discharge from hospital

  up to 1 month from the date of surgery

• Number of newly diagnosed health complications following surgery

  up to 30 days after surgery

• 30 day readmission to the hospital or admission to the emergency room

  30 days post surgery

• 30 day mortality

  30 days post surgical procedure

• 6-month functional health assessment

  6 months post surgical procedure

Study Arms (1)

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Newton-Wellesley Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Deborah Culley, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 7, 2015
• Study Start: July 31, 2015
• Primary Completion: September 25, 2017
• Study Completion: December 31, 2017
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)