SAGES: Successful AGing after Elective Surgery Study

Study Information for Physicians

Summary

The Sucessful AGing after Elective Surgery (SAGES) study assesses cognitive and functional outcomes following surgery. The overall goal of SAGES is to find new ways to improve care after surgery.  Study sites include the Beth Israel Deaconess Medical Center (BIDMC), Brigham and Women's Hospital (BWH), and Hebrew SeniorLife.

Participant Description - Eligibility

Inclusion Criteria:

  1. Age ≥ 70 years
  2. English-speaking
  3. Scheduled for one of 7 procedures: total hip or knee replacement, lumbar laminectomy, lower extremity arterial bypass, open abdominal aortic aneurysm repair, lower extremity amputation, or colectomy
  4. Scheduled at least 7 days prior to surgery
  5. Planned general and regional  anesthesia
  6. Planned admission to the hospital for at least 2 days
  7. Living in 30 miles radius from the Longwood Medical area

Exclusion Criteria:

  1. Cognitive impairment at baseline
  2. Hospitalization within 6 months prior to enrollment
  3. Terminal condition
  4. Baseline hematocrit <24%
  5. Blindness or deafness

Study procedures

  • Operation room schedule (OR) and medical record (OMR):  to identify potentially eligible patients
  • Baseline:  Brief screening phone interview, followed by a home-based interview of eligible patients (85 minutes with neuropsychological testing)
  • Hospital: daily 10-15 minute interviews
  • In-Person follow-up:  home-based 45 minutes interviews 2 weeks, 1, 2, 6 months and then every six months
  • Telephone follow-up: 10-15 minute interviews at 4, 9, and 15 months after discharge
  • Phlebotomy: at baseline, time of surgery, hospital day 2, and 1 month after surgery
  • MRI:  Non-contrast MRI brain scans on 150 patients at baseline and one-year follow-up
  • Family/Proxy Interview: at baseline and every 6 months after discharge

Risks/Benefits

This is a minimal risk study.  Study data will be protected and de-identified. Minimal risks are associated with phlebotomy, related to pain or bruising and to the MRI brain scan related to potential claustrophobia or the loud sounds generated. 

This study is being performed to advance medical knowledge without direct participant benefit. Participants will receive incentives for each completed study procedure as follows: $40 for the baseline assessment, $20 for each proxy interview, $40 for all in-hospital assessments combined, $40 for the one-month assessment (including phlebotomy), and $30 for each face-to-face follow-up assessment (2, and every 6 months to 36 months), for an approximate amount of $440 upon completion of the entire study.  For the MRI study, the stipend is $100 per scan.  Transportation will be provided to all study procedures. 

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