Activity Monitor Feedback and Interactive Tours to Improve Postoperative Ambulation

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711149
• Other study ID #: Pro00051802
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2019
• Source: Cedars-Sinai Medical Center
• Contact: Timothy Daskivich, MD, MSHPM
• Phone: (310) 423-4700
• Email: timothy.daskivich[@]csmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 30, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Step Count	Daily step count will be captured with activity monitor	During hospitalization within approximately 1-2 weeks
Secondary	Length of stay	Length of stay in intervention arm compared to control	Within approximately 1-2 weeks, Date patient was admitted through hospital discharge
Secondary	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