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Clinical Trials/NCT02741895
NCT02741895
Completed
Not Applicable

Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery

Cedars-Sinai Medical Center1 site in 1 country135 target enrollmentMay 2016
ConditionsGeneral Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Surgery
Sponsor
Cedars-Sinai Medical Center
Enrollment
135
Locations
1
Primary Endpoint
Number of steps
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Timothy J. Daskivich

Assistant Professor, Urology Academic Practice

Cedars-Sinai Medical Center

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

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

Outcomes

Primary Outcomes

Number of steps

Time Frame: Through study completion, on average 1 week

Number of steps per day during hospitalization, per Fitbit data.

Length of stay

Time Frame: Through study completion, on average 1 week

Days from admission (end time of surgery) until discharge from hospital.

Location of disposition

Time Frame: Through study completion, on average 1 week

Home, Rehab Facility, or Skilled Nursing Facility

Physician daily assessment of ambulatory status

Time Frame: Through study completion, on average 1 week

Physician daily assessment of ambulatory status

Active minutes

Time Frame: Through study completion, on average 1 week

Active minutes per day during hospitalization, per Fitbit data.

30-day readmission

Time Frame: 30 days post discharge

Presence or absence of readmission to hospital or ER visit within 30 days of discharge.

Study Sites (1)

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