Using Fitbit to Monitor Ambulation in Patients After Surgery.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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General Surgery

Intervention / Treatment
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* Behavioral: Fitbit monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative patients<br>The target populations for the study are patients undergoing robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, and hip replacement at Cedars-Sinai Medical Center. | Behavioral: Fitbit monitoring<br>* Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of disposition | Home, Rehab Facility, or Skilled Nursing Facility | Through study completion, on average 1 week | 
| 30-day readmission | Presence or absence of readmission to hospital or ER visit within 30 days of discharge. | 30 days post discharge | 
| Number of steps | Number of steps per day during hospitalization, per Fitbit data. | Through study completion, on average 1 week | 
| Active minutes | Active minutes per day during hospitalization, per Fitbit data. | Through study completion, on average 1 week | 
| Physician daily assessment of ambulatory status | Physician daily assessment of ambulatory status | Through study completion, on average 1 week | 
| Length of stay | Days from admission (end time of surgery) until discharge from hospital. | Through study completion, on average 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biosensing Techniques, Patient Readmission