Activity Monitor Feedback and Interactive Tours to Improve Postoperative Ambulation

Randomized Controlled Trial of Activity Monitor Feedback and Interactive Ambulation Tours to Improve Postoperative Ambulation and Efficiency Outcomes After Major Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Surgery
• Intervention / Treatment: Other: Activity monitor feedback loop

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.

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Mayra L Lopez, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Intervention: Activity monitor feedback loop: (1) Subjects will receive activity monitor with feedback on daily step count from the in-room TV screen, and (2) access to the Art Tour application	Other: Activity monitor feedback loop; The intervention arm will test if the feedback system (i.e., activity monitor, real-time feedback, and art tours) increases daily step count, decreases length of stay, and improves patient and provider communication, patient awareness of step count goals, and patient confidence in accomplishment of daily goals.
No Intervention: Standard-of-care Arm; Subjects in the control arm will receive a "blinded" activity monitor post-op (without feedback on step count) and the usual standard of care. Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods of observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Step Count	Daily step count will be captured with activity monitor	During hospitalization within approximately 1-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of stay in intervention arm compared to control	Within approximately 1-2 weeks, Date patient was admitted through hospital discharge
Patient Satisfaction	Patient satisfaction measured using likert-scale rated items. Scale measures patient/physician communication, patient awareness of step goals, and patient confidence in accomplishment of daily goals. The following scale ranges will be used: Never, Once a day, Twice a day, Three times a day, More than three times a day; Much lower, Lower, About the same, Higher, Much higher; Not at all, Slightly, Moderately, Very, Extremely Positive answer in likert-scales indicate higher patient/physician communication, patient awareness, and patient confidence in accomplishing daily step goals.	Within approximately 1-2 weeks, Day patient is discharged from hospital

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Timothy Daskivich, MD, MSHPM, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Anticipated): October 22, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Ambulation; Digital Health; Patient Satisfaction; Length of stay; Activity Monitor
• Other Study ID Numbers: Pro00051802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No