Preoperative Cognitive Screening in Older Surgical Patients Utility for Predicting Morbidity

NCT02598050 | Completed

• 1 other identifier: 2014P002400
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this work is to determine whether preoperative cognitive screening of patients over the age of 65 can be used as predictor of postoperative outcomes in patients undergoing lower extremity surgical procedures. This work is important as it may aid patients, families and physicians about the appropriateness of the surgical procedure and in providing resources to patients who are at the highest risk of adverse outcomes.

Conditions

Cognitive Impairment

Keywords

postoperative health outcomes; older surgical patients

Outcome Measures

Primary Outcomes (1)

• CAM Score Postoperative Day 1-3

  patient score on the Confusion Assessment Method and comprehensive chart review up to 1, 2, or 3 days after surgery

  Up to 3 days after surgery

Secondary Outcomes (7)

• Number of newly diagnosed health complications

  up to 30 days after surgical procedure

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

  up to 30 days after the surgical procedure.

• Number of days between surgical procedure and day of discharge

  up to 30 days after surgical procedure

• 30 day mortality

  30 days after surgical procedure

• 30 day re-operation or readmission

  30 days after surgical procedure

Study Arms (1)

older surgical patients

Patients 65 years of age and older having lower extremity joint replacement surgery.

Other: No Interventions as this is a observational study

Interventions

No Interventions as this is a observational study OTHER

older surgical patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project is designed as a prospective, single-center observational study. The cohort will consist of 250 consenting subjects ≥ 65 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective lower extremity joint replacement surgery. Eligibility criteria include: patients ≥ 65 years of age with an ASA physical status of I-IV presenting for elective joint replacement. Exclusion criteria will include planned ICU admission postoperatively, 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:

• consenting patients ≥ 65 years of age
• undergoing upcoming elective lower joint replacement surgery

You may not qualify if:

• planned ICU admission postoperatively
• 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

Study Sites (1)

Weiner Center for Preoperative Evaluation

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

White blood cells and plasma

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: November 5, 2015
• Study Start: February 1, 2016
• Primary Completion: March 30, 2017
• Study Completion: December 31, 2017
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

US (1)