Clinical trial NCT03711149: Activity Monitor Feedback and Interactive Tours to Improve Postoperative Ambulation
Official title: Randomized Controlled Trial of Activity Monitor Feedback and Interactive Ambulation Tours to Improve Postoperative Ambulation and Efficiency Outcomes After Major Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Keywords: Ambulation
Length of stay
Patient Satisfaction
Activity Monitor
Digital Health
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial will involve two arms: (1) and intervention arm consisting of activity monitor feedback loop and art tours and (2) control group consisting of standard of care.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized controlled trial that compares a system using activity monitors to provide real-time feedback on daily ambulation to patients undergoing major surgeries, paired with step-count-measured art tours of the surgical units, versus standard of care, on step count. The hypothesis is that the feedback system + art tours will encourage patients to ambulate more.

Detailed description: After major surgery, patients are encouraged to walk early and often, since early ambulation is linked with improved clinical and efficiency outcomes. This research study tests whether providing goal-directed feedback on daily ambulation to patients using activity monitors in combination with an app that provides step count-rated "art tours" of the surgical floors will increase the amount of steps taken after surgery. Upon enrollment, all patients will be assigned to either the control (no intervention) or experimental (activity monitor feedback + art tours) group, stratified by surgery type. This randomized controlled trial aims to determine if this feedback system/art tours approach improves: (1) daily step count, (2) length of stay, and (3) patient satisfaction compared with standard of care.

Eligibility criteria: Inclusion Criteria:

* Undergoing one of the 14 surgeries: Gynecological (Total Abdominal Hysterectomy, Gyn Ex Lap); Orthopedic (Total Hip Replacement, Total Knee Replacement); Minimally Invasive Surgery (Hiatal Hernia Repair/Fundoplication, Gastric Bypass, Gastric Sleeve); Colorectal Surgery (Lap/Robotic Colectomy, Ileocolic Resection, Open Colectomy); Thoracic (Lung Lobectomy); Urologic (Robotic Cystectomy, Radical Prostatectomy, Partial Nephrectomy).
* Able to provide informed consent
* Non-English speakers will be included with the use of short forms in the 7 available languages
* Must have access to an IOS or Android device

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, cane, 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 activity monitor in place
* Unable to place activity monitor on patient's wrist

Primary outcomes:
measure: Daily Step Count
timeFrame: During hospitalization within approximately 1-2 weeks
Secondary outcomes:
measure: Length of stay
timeFrame: Within approximately 1-2 weeks, Date patient was admitted through hospital discharge
measure: Patient Satisfaction
timeFrame: Within approximately 1-2 weeks, Day patient is discharged from hospital
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 Daskivich, MD, MSHPM
role: PRINCIPAL_INVESTIGATOR
References: