Using Fitbit to Monitor Ambulation in Patients After Surgery.

General Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741895
• Other study ID #: Pro00044059
• Status: Completed
• Phase: N/A
• First received: April 12, 2016
• Last updated: January 26, 2018
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Surgery

Intervention

Behavioral:
• Fitbit monitoring
Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Kalisch BJ, Tschannen D, Lee H, Friese CR. Hospital variation in missed nursing care. Am J Med Qual. 2011 Jul-Aug;26(4):291-9. doi: 10.1177/1062860610395929. Epub 2011 Jun 3. — View Citation

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Pearse EO, Caldwell BF, Lockwood RJ, Hollard J. Early mobilisation after conventional knee replacement may reduce the risk of postoperative venous thromboembolism. J Bone Joint Surg Br. 2007 Mar;89(3):316-22. — View Citation

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Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5. — View Citation

Topol EJ. The creative destruction of medicine : how the digital revolution will create better health care. 1st pbk. ed. New York: Basic Books; 2013.

* Note: There are 22 references in all — Click here to view all references

Outcome

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