Real-time Location System Feasibility Study Part 2
Phase: NA
Conditions: Surgery, Mobility
Sponsor: Wake Forest University Health Sciences

Feasibility Assessment of the Wake Forest Real-time Tracking System for Monitoring 
Patient Movement during Postoperative Recovery: Part 2 
IRB 00039439 
 
 
 
 
Documentation Date: 6/30/2019 
 
IRB: 00039439 
 
NCT03988751 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Feasibility Assessment of the Wake Forest Real-time Tracking System for Monitoring 
Patient Movement during Postoperative Recovery: Part 2 
IRB 00039439 
 
 
 
Principal Investigator: 
 
Clancy J. Clark, MD 
 
 
 
 
 
Department of General Surgery 
Section of Surgical Oncology 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
cjclark@wakehealth.edu 
336-716-7207 
 
Staff:  
 
 
 
Kathleen Cummins 
 
 
 
 
 
 
 
 
 
Biostatistician: 
Fang-Chi Hsu, PhD 
 
fhsu@wakehealth.edu  
 
 
 
Participating Institution(s): 
Wake Forest University 
 
 
Version Date: 
 
 
6/30/2019 
 
 
 
Confidential

Feasibility Assessment of the Wake Forest Real-time Tracking System for Monitoring 
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Summary 
 
The proposed study will investigate the feasibility of using the Wake Forest Real-time 
Location System (RTLS) in monitoring patient movement during their in-hospital 
postoperative recovery.  The study will involve patients who have undergone surgery 
requiring inpatient admission to the 9CC surgical ward.  Actual patient movement will be 
monitored during their postoperative recovery and compared with data recorded by the 
Wake Forest location system. 
1.0 
Introduction and Background 
 
Early mobilization after surgery can decrease postoperative complications and 
length of stay. Recognizing these improved outcomes, current enhanced-
recovery after surgery (ERAS) programs emphasize rapid mobilization during the 
postoperative period even on the day of surgery.(1–3)  Unfortunately, patients 
face numerous real and perceived barriers to early mobilization including 
postoperative pain; multiple intravenous catheters; drains; lines, and staff 
resource limitations.  Monitoring compliance with early mobilization programs rely 
on patient self-report, progress notes, and nursing documentation, all of which 
are unreliable.  Our team has used accelerometers (Fitbit Zip and Kenz 
Lifecorder) to monitor postoperative movement after major gastrointestinal 
oncology surgery (CCCWFU 02114).  Preliminary data from this study, 
demonstrates little to no movement by patients during their hospitalization.  
However, this may be an artifact of current accelerometer devices rather than 
lack of movement by patients.     
 
In an era of the Internet of Things (IoT) and emerging technologies, we 
recognized a unique opportunity to use the existing real-time location system 
(RTLS) at Wake Forest Baptist Health to monitor patient movement during 
postoperative recovery.(4)  The Wake Forest Office of Enterprise Visibility 
developed at program for the implementation of processes, supporting 
technologies, driving Service Excellence, Patient Safety and Satisfaction, 
Operational Excellence and Efficiency, and the Transformation of Healthcare 
Delivery (SPOT).  The SPOT program installed the current real-time location 
system throughout Wake Forest Baptist Health initially to track high valued 
hospital assets.  RTLS is a complex system of various tags and badges, 
platforms (Wi-Fi, Infrared, Ultrasound, and others), hardware 
infrastructure (readers & exciters) and other components (servers, middleware 
& end-user software).(5)  The Wake Forest RTLS solution consists of specialized 
fixed location sensors receiving wireless signals from small ID badges or tags 
attached to equipment or persons. Tags transmit a unique identifier in real-time 
that enable tracking.  The granularity of the RTLS program varies throughout the 
health system with room-level tracking capabilities in the wards of the Wake 
Forest Comprehensive Cancer Center.    

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The RTLS program at Wake Forest Baptist Health was introduced for asset 
tracking and not developed for monitoring patient movement. Therefore, the 
reliability of this system is unknown but has great potential for numerous quality 
improvement initiatives particularly focused on decreased postoperative 
complications and successful implementation of early recovery after surgery 
programs.   
2.0 
Objectives 
 
The main objective of the proposed study is to investigate the feasibility of using 
the Wake Forest RTLS to monitor movement of hospitalized patients after 
surgery.   Preliminary data from this prospective cohort study will help determine 
reliability, accuracy, sensitive and specificity of the RTLS system during the 
implementation of an in-patient postoperative exercise program.  
3.0 
Aims 
 
3.1 
Primary Aim 
 
3.1.1 To demonstrate the feasibility of using the Wake Forest RTLS to 
track patient movement during the postoperative period. 
 
3.2 Secondary Aims 
 
3.2.1 To evaluate the accuracy of the RTLS to track distance and time 
traveled during a patient walk on the hospital ward.  
3.2.2 To characterize daily movement (speed, steps, frequency, 
distance) of in-hospital post-surgery patients. 
3.2.3 To evaluate patient perspective on in-hospital exercise programs. 
3.2.4 To characterize provider perspective on in-hospital exercise 
programs, monitoring patient movement, and reporting patient 
movement. 
3.2.5 To evaluate the accuracy of the RTLS to track patient movement at 
variable patterns of movement. 
3.2.6 To evaluate patient tolerance of continuous verses interval exercise 
program. 
3.2.7 To characterize subject readiness for discharge. 
4.0 
Study Population 
 

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The proposed study is a prospective, observational cohort study investigating 
the feasibility of using the Wake RTLS to monitor postoperative patient 
movement. All patients will be recruited from the surgical ward of the Wake 
Forest Baptist Health (9cc).  All patients will have undergone elective surgical 
intervention with anticipated minimum of 24 hours hospitalization.  We plan to 
enroll 40 patients.   
 
All eligible subjects will be asked to participate in the study regardless of race, 
gender, age, or other characteristic except those outlined in the exclusion criteria 
below.   Patients who meet inclusion criteria will be asked to participate in the 
study by the study team after permission obtained from the treating provider.  If 
they agree, informed consent will be obtained by a study team member. 
 
An additional cohort of providers care for patients on 9cc including nurses, 
nursing assistants, physicians, advanced practice providers, physical therapists, 
occupational therapists, students and residents will be asked to participate in the 
study.  If they agree, informed consent will be obtained by a study team member.  
A maximum of 50 providers were be included in provider cohort. 
 
Given feedback from providers and findings through analysis of RTLS, the study 
recognizes the need to confirm the validity of RTLS during various ambulatory 
patterns.  This requires enrollment of an additional 22 patients.  This additional 
cohort--High Intensity Interval Training (HIIT) Cohort)--will be randomly 
divided into two cohorts: Group 1, Continuous Ambulation (n = 12), and Group 2, 
Interval Ambulation (n =10).   
 
4.1 
Inclusion criteria -- Patient 
 
4.1.1 Male or female patients between the ages of 18 and 90. 
4.1.2 Admitted to 9cc. 
4.1.3 Recovering from surgery.  
4.1.4 Ability to understand and the willingness to sign an IRB-approved 
informed consent document. 
4.1.5 Ability to understand and complete the study survey instruments in 
English. 
 
4.2 Exclusion criteria -- Patient 
 
4.2.1 Non-surgical patient. 
4.2.2 Emergency surgical procedure. 
4.2.3 Anticipated discharge less than 24 hours. 
4.2.4 Unable to ambulate or ambulation not permitted by treating 
provider. 
4.2.5 Unable to understand and complete the study survey instruments in 
English. 

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4.2.6 Post-operative complications that in the opinion of the study 
investigator would impair the ability of the patient to adhere to the 
study procedures. 
 
4.3 Inclusion of women and minorities 
 
Men and women of all races and ethnicities who meet the above-
described eligibility criteria are eligible to participate in this study.  
5.0 
Methods 
 
The proposed study will be completed on 9cc in Wake Forest Baptist Health.  
Study subjects will be recruited on 9cc in Wake Forest Baptist Health after 
approval from the treating physician.  Recruitment, consent, and data collection 
will be completed in the privacy of the patient’s room. 
 
The nature, purpose, and risks of all procedures and protocols will be explained to 
each participant prior to obtaining written consent.  All examiners are trained in the 
standardized conduction of all assessments before data collection.  Standardized 
written instructions will be provided.   
 
Subjects will not be recruited for the observational study cohort as this cohort is 
closed to enrollment.   
Enrollment will be limited to the additional the expanded HIIT Cohort (n= 22).  Using 
random number generator, eligible patients will be randomized into two groups: Group 
1, Continuous Ambulation (n = 12), and Group 2, Interval Ambulation (n =10). 
Assignment will be provided by the study coordinator.  The study PI will be 
blinded to this randomization.  
Provider participants will be enrolled if they are caring for patients on 9cc during the 
study period. 
 
5.1a Study timeline (Observational Cohort) 
 
 
 
Initial Visit Day 1 
Day 2 
Day 3 
Informed Consent 
X 
 
 
 
Medical Record Review 
X 
 
 
 
Vital Signs 
X 
X 
X 
X 
Walking Assessment  
 
X 
X 
X 
Fatigue Assessment 
 
X 
X 
X 
Pain Assessment 
 
X 
X 
X 
Walking Distance Measurement 
 
X 
X 
X 
Step/Pedometer Evaluation1 
 
X 
X 
X 

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Distribution of SPOT Badge 
X 
 
 
 
Physical Activity in Hospital Survey 
 
 
 
X 
1 Patients will wear a Fitbit ZipTM and Kenz Lifecorder EX Accelerometer for pedometer 
evaluation. 
 
5.1b Study timeline (HIIT Cohort) 
 
 
 
Initial Visit 
Ambulatory Evaluation 
Informed Consent 
X 
 
Medical Record Review 
X 
 
Vital Signs 
X 
X 
Walking Assessment  
 
X 
Grip Assessment 
 
X 
Pedometer Evaluation1 
 
X 
Distribution of SPOT Badge2 
na 
 
Patient Survey 
 
X 
1 Patients will wear a Kenz Lifecorder EX Accelerometer for pedometer evaluation during 
walking assessment. 
2 SPOT badges are now worn by all inpatients at WFBH and no longer require badging 
specifically for this project. 
 
5.2 
Informed consent 
 
Signed informed consent will be obtained from each subject.  The informed consent 
process will follow the procedures of the WFU Institutional Review Board.  The study 
team member will explain the purpose, methods and extent of the study to 
prospective participants.  The potential participant is asked to read the informed 
consent form and ask questions.  The form is written in simple, easy to understand 
language.  We require study staff to review all of the key aspects of the study 
verbally with the potential participants. The staff will be provided with a structured 
checklist for this purpose. The study staff will question potential participants to 
ascertain whether s/he has understood the information.  Potential participants who 
are illiterate or have impaired vision must have the consent read to them, followed 
by review of the checklist, opportunity for questions, and discussion.  This process 
will take place in the patient’s private room in 9cc of Wake Forest Baptist Health.  
For providers, the process will take place in the conference or workroom on 9cc of 
Wake Forest Baptist Health. A copy of the signed and dated consent form will be 
given to participants, and the original document will be placed in subjects’ individual 
study files, which will be stored in a secure location.  In compliance with the Health 
Insurance Portability and Accountability Act (HIPAA) and the Standards for Privacy 
of Individually Identifiable Health Information of the Department of Health and 
Human Services, we will access personal health information only after obtaining 
informed consent. 
 
 

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5.3 
Pedometer and Step Data 
 
The Fitbit ZipTM (Fitbit Inc., San Francisco, CA; www.fitbit.com) is a lightweight, 
portable pedometer device that contains a tri-axial accelerometer.  The device is 
commercially available to consumers and is considered a recreational device.  It is 
capable of tracking multiple measures of physical activity including steps and 
distance traveled.  Tracking data is stored on the device for several weeks and is 
capable of being downloaded to a computer for analysis using USB or wireless 
connection.  The accuracy of the Fitbit OneTM and Fitbit UltraTM have been 
independently validated.15,16  The Fitbit device can be worn on various body 
locations (hip vs. pocket) and maintains a high level of accuracy.16   
 
The Kenz Lifecorder EX Accelerometer is an accurate and reliable research grade 
activity monitor that, in addition to counting steps, calculates calories expended, 
monitors the intensity and duration of physical activity, computes basal metabolic 
rate (BMR) and stores 200 days of data. Each participant’s height, weight, age, 
gender, as well as the time of day will be programmed into the device before given 
to the participant. 
 
Each participant will wear the pedometer devices during their daily walk with 
research staff.  Programming of the Fitbit ZipTM and Kenz Lifecorder EX 
Accelerometer will be performed by research staff.  
 
The pedometer data will be stored in a secure, password-protected file behind 
the WFBH firewall. 
 
5.4 
Patient Medical Record Review 
 
All participants will have medical records reviewed to determine specific details 
regarding their medical condition, diagnosis, co-morbidities, laboratory data 
(nutritional status), medications, social history, past operations, and operation. If 
barriers to successfully completing the study are identified, the participant may 
be dismissed from the study.  Relevant clinical data will be collected and stored 
in RedCap.   
 
5.5 
SPOT/RTLS Badges and Data 
 
All participants will wear a SPOT badge provided by the study team throughout the 
study period.  Research staff will stress that participants should wear the pedometer 
during the study period.  Participants will be asked to wear the activity monitors at all 
times except while bathing or showering. SPOT badge data is collected continuously 
by the SPOT team independent of the study team.  This is standard procedures for 
Wake Forest Baptist Health.  The study team will coordinate with the SPOT team to 
extract data specific for this study. The extracted data will be stored in secure, 
password-protect files behind the WFBH firewall using excel files.   

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5.6 
Walking Assessment and Physical Activity Survey (Observational 
Cohort) 
 
All participants will receive a visit by a study team member each day for maximum of 
3 days.  If discharge is less than 24 hours after enrollment, the participant will be 
excluded from study.  Study participants will be invited by a study team member to 
join them on a walk.  Time, distance, and duration will be determined by the patient.  
If nursing staff or treating provider determines that walking is not safe or 
inappropriate, walk will not be performed and rationale documented. If patient 
declines to walk, rationale will be documented.  For all patients who decline, a 
second visit by a study team member will occur later in the day.  Participants will be 
encouraged to walk by study team members emphasizing the importance of walking 
after surgery.  Each participant will complete a pre- and post-walk assessment 
including measurement of pain and fatigue.  Pre- and post-walk vital signs will be 
recorded.  Participants will also be asked to report number of walks completed in the 
last 24 hours along with distance traveled.  At completion of walk, the study team will 
record exact time of walk, distance, and duration.   At conclusion of walk 
assessment, the patient will complete a physical activity in hospital survey.   Survey 
data will be collected in the subject’s private room. 
 
5.7 HIIT Cohort  
 
5.7.1 Physical Activity Survey 
 
Prior to the ambulatory session, the subject will receive information 
regarding the type of exercise they will be engaging in (continuous or 
HIIT). The subject will also complete a questionnaire regarding their 
current level of physical fitness to determine his/her qualitative baseline. 
 
5.7.2 Vital signs 
 
The subject’s heart rate, blood pressure, pulse, and respiratory rate will be 
collected before and after each ambulatory session. 
  
5.7.3 Grip Strength 
 
Grip strength will be measured as a baseline. Two trials will be measured 
and then averaged together for the right and left arm. This will provide a 
baseline objective measure of subject frailty. 
 
5.7.4 Ambulatory Session 
 
Each subject perform one ambulatory session during the study.  This will 
include walking 40 meters. Gait speed will be calculated using the speed 

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in which the subject walked 40 meters.  Alternative exercise (hand bike) 
will be provided if subject declines ambulation or unable to ambulate out of 
their room.  Demonstration of the hand bike will be provided by the study 
team member and subjects will be allowed to practice with the bike prior to 
exercise session.  For subjects unable to perform the ambulatory session, 
a study team member will return on a subsequent hospital day to complete 
this portion of the study.  If patient unable to perform the ambulatory 
session during their hospitalization or during the study period, the reason 
will be documented.   
 
1. Walking Continuous Training (Group 1):  The total distance will be 
40 meters. Study team members will walk, support, and coach the 
subject to walk as slow as he/she wants.    
2. Walking Interval Training (Group 2):  The subject will walk a total 
distance of 40 meters.  This distance will be divided into four 
intervals of 10 meters to equal the same measured distance as the 
continuous group. The subject will receive two minutes of rest 
between each interval and will be supported and coached to walk 
as fast as they can.   
3. Hand Bike Continuous Training (Group 1, alternative option until 
able to participate in ambulatory session): The subject will be asked 
to bike for 5 minutes continuously with coaching “go as slow as you 
want.” 
4. Hand Bike Interval Training (Group 2, alternative option until able to 
participate in ambulatory session): The subject will be asked to bike 
in 10 second intervals (“as fast as they want to go”) and rest for 50 
seconds for five rounds (i.e. every minute on the minute (EMOM).  
5.7.5  Perceived Exertion 
 
Subject perceived exertion will be evaluated at the beginning, at 20 
meters, and at the end of the ambulatory session using a standard RPE 
scale. 
 
5.7.6 Gait Speed 
 
Gait speed (meters/second) will be calculated at the end of each session 
based on distance traveled over time. 
 
5.8  Provider Physical Activity Survey 
 
All provider participants will complete a physical activity survey and repeat the 
survey after 30 days of providing care for patients on 9cc.  During the study period, 
patient mobility data will be available to providers.   

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6.0 
Outcome Measures 
 
6.1 
Primary Outcome: Determine if the SPOT system can detect movement in 
and out of a patient’s room.   
 
6.2       Secondary Outcomes: 
6.2.1 Characterize patterns of patient movement after surgery. 
6.2.2 Characterize number of times of patient exits a room per day after 
surgery. 
6.2.3 Characterize distances traveled per time out of room per day after 
surgery. 
6.2.4 Characterize patient opinion regarding exercise after surgery. 
6.2.5 Characterize provider opinion regarding in-hospital exercise 
programs, monitoring patient movement, and reporting patient 
movement.  
6.2.6 Determine if the SPOT system can detect movement when a 
patient varies their ambulatory behavior. 
6.2.7 Characterize patient’s ability to tolerate various ambulatory 
intensities after surgery.   
6.2.8 Describe patient readiness for discharge. 
7.0 
Analytic Plan 
 
7.1 
Sample size 
 
40 subjects will be included in initial observational study.  Preliminary tests 
of SPOT badges indicate sensitivity and specificity nearly 100% using 
controlled movements on 9cc. Assuming type I error of 0.05, a two-sided 
test, 20 subjects, the sensitivity or specificity under the null equal to 0, and 
prevalence of 0.3, we have more than 90% power to detect the sensitivity 
of specificity under the alternative hypothesis equal to 0.9. If we use a 
range of prevalence from 0.1 to 0.9, we still have more than 90% power.  
However, the positioning of SPOT badge may decrease the sensitivity and 
specificity of the movement readings. Review of preliminary survey data 
indicates significant variability in response indicating need for expansion of 
sample size for secondary study objectives.  With 40 subjects being 
recruited, we will be sure to have enough power to demonstrate the 
feasibility of this study and provide appropriate confidence intervals for 
future studies. 
 
For provider participants, a maximum of 50 respondents will be included in 
the study.  Based on staffing, resource demands, and learner rotations, 
the exact number of respondents available may be lower than 50 
respondents.   With 50 subjects being recruited, we will be sure to have 

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enough power to demonstrate the feasibility of exercise and patient 
mobility monitoring programs.  This number will also provide appropriate 
confidence intervals for future studies. 
 
For the additional HITT cohort, we will enroll a maximum of 22 subjects.  
This sample size will have sufficient power to demonstrate the feasibility of 
this study and provide appropriate confidence intervals for future studies.    
 
In total, targeted study enrollment will be 62 patients and 50 providers.  
 
7.2 
Feasibility analysis and statistics. 
 
The study team will also capture information from this pilot study that will 
be used to improve the efficiency of larger studies. We will evaluate the 
capabilities of the SPOT system to monitor patient movement.  Feasible 
study will be defined as more than 80% of badges assigned to the 
observational study participants will detect movement in and out a room.  
All data will be descriptive in nature and will focus on patterns of 
movement and presence or absence of data. Summary statistics such as 
means and standard deviations will be calculated for continuous measures 
and counts and percentages will be calculated for discrete measures. 
Agreement statistics, including kappa statistics, sensitivity, and specify, 
will be calculated. Changes of pre- and post- vital signs will be calculated 
and graphical display will be performed to show the changes over time. 
The correlation between walking distance as well as pain and fatigue will 
be calculated each day. Mixed effects models will be used to study the 
association over time.  Since the sample size is small, we are aware that 
the models may not be stable.  Thus, descriptive analysis will be our 
primary analysis.   
 
The additional HITT study cohort will enable validation of SPOT system to 
capture out of room events under various ambulatory patterns. This will 
build on the current cohort that validated simple in and out of room events.  
Feasible study will be defined as more than 80% of badges assigned to 
participants detect movement in and out a room during continuous and 
interval movement patterns. 
 
7.3 
Data management 
 
Clinical Data Collection Form REDCap 
Tag Tracking Data 
Excel 
8.0 
Potential Risks 
 

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8.1 
Wearable SPOT badges and activity monitors 
 
We are currently not aware of any risks associated with activity monitors, 
including the Fitbit, Kenz Lifecorder, or SPOT badges.  Pedometers are 
available to the public without restrictions and SPOT badges are deployed 
throughout WFBH and worn by medical staff.  Data collected on the 
pedometers are stored on the device and retrievable only by staff team 
members.  Downloaded data will be stored using a secure server in 
WFBH.  Data collected by the SPOT badge is stored electronically on a 
secure served managed by WFBH SPOT team.  If the SPOT badge was 
to be lost by a participant, no data is retrievable from the device.   
 
8.2 
Walk Assessment 
 
There is a risk of the participant losing their balance and falling associated 
with the walking after surgery.  In rare instances, persons could 
experience leg or chest pain, heart palpitations, shortness of breath.  In 
very rare situations exercise can result in heart attack or sudden death. 
We will minimize this risk by: (1) safely escorting participants to chairs 
located along the walking course should they become unsteady; (2) 
following them at a close distance; and, (3) being at their side should they 
need assistance. There is a risk that participants may experience muscle 
soreness or discomfort as a result of physical activity.  However, walking 
is regarded as an important component of postoperative recovery. 
9.0 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess 
study outcomes, minimizing to the fullest extent possible the collection of any 
information that could directly identify subjects, and maintaining all study 
information in a secure manner.  To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection 
form.  No patient identifying information will be collected or stored.  Data access 
will be limited to study staff.  Data and records will be kept locked and secured, 
with any computer data password protected.  No reference to any individual 
participant will appear in reports, presentations, or publications that may arise 
from the study. 
10.0 Data Safety and Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data 
and safety of study participants. The principal investigator will be assisted by 
other members of the study staff. 

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11.0 Reporting of Unanticipated Problems, Adverse Events or 
Deviations 
 
Any unanticipated problems, serious and unexpected adverse events, deviations 
or protocol changes will be promptly reported by the principal investigator or 
designated member of the research team to the IRB and sponsor or appropriate 
government agency if appropriate.

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