Clinical trial NCT02741895: Using Fitbit to Monitor Ambulation in Patients After Surgery.
Official title: Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Surgery
Keywords: Biosensing Techniques
Patient Readmission
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical inpatients who have undergone one of the following: robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, or hip replacement.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Undergoing robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, or hip replacement
* Able to provide informed consent

Exclusion Criteria:

1. Unable to provide consent
2. Not undergoing procedure of interest
3. Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation)
4. Use of walker, cancer, or wheelchair at baseline
5. Presence of physical limitations on walking (i.e. amputation)
6. Usual place of residence is skilled nursing facility
7. Cognitive inability to follow directions to maintain biosensor in place
8. Unable to place biosensor on patient's wrist

Primary outcomes:
measure: Location of disposition
timeFrame: Through study completion, on average 1 week
measure: 30-day readmission
timeFrame: 30 days post discharge
measure: Number of steps
timeFrame: Through study completion, on average 1 week
measure: Active minutes
timeFrame: Through study completion, on average 1 week
measure: Physician daily assessment of ambulatory status
timeFrame: Through study completion, on average 1 week
measure: Length of stay
timeFrame: Through study completion, on average 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Timothy J Daskivich, MD, MSHPM
role: PRINCIPAL_INVESTIGATOR
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