General Surgery Clinical Trial
Official title:
Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery
This study will evaluate whether information on postoperative ambulation from Fitbits can improve surgeons' ability to monitor ambulation and identify patients at risk for prolonged length of stay, 30-day readmissions, and discharge to transitional care after major surgery.
After the patient is awake and alert after surgery, a study team member will place the Fitbit
device on participants' wrists. Investigators will then monitor daily steps taken and active
minutes for the duration of hospitalization, with the option to discontinue if clinically
required or requested by the patient or provider. Investigators will record the wearable
biosensor number and subject study number on a secure spreadsheet.
To supplement Fitbit data, a research coordinator will collect clinical data from chart
review of the electronic health record (age, gender, race/ethnicity, body mass index,
comorbid health conditions), and enter the data into a secure spreadsheet.
Physicians will also be participating in the study by providing data on estimated daily
ambulation, using a standard formatted scale. Surgeons currently assess daily ambulation in
the medical record, but assessments are not uniform, which precludes meaningful comparisons
between providers. Investigators will therefore ask physicians to record daily estimates of
ambulatory status according to standardized terms that are commonly used in the medical
record (nonambulatory; out of bed to chair; out of bed to ambulate (QD, BID, TID); and
ambulating ad lib). Investigators will also collect information on daily ambulation orders as
entered by the provider team as part of routine practice. This information will be
ascertained by chart review and entered into the secure spreadsheet along with the additional
patient data.
The Fitbit device has a battery life of approximately 7 days, so investigators will plan to
recharge and download information every 5 days.
At the time of discharge, a study team member will remove the device and download the
information from the device to a secure spreadsheet. The wearable biosensor will be reset at
that time and the information will be erased from its memory. Investigators will also clean
the wearable biosensors with disinfectant used for durable medical equipment.
Investigators will also query the medical record for information regarding disposition
outcomes, including length of stay (from end of surgery to discharge from the hospital) and
location of disposition (to home, rehab facility, or skilled nursing facility). Investigators
will then contact the patients by phone after 30 days have elapsed since discharge to inquire
whether they have been readmitted to the hospital or ER within the 30 days of their discharge
date.
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