The Cascade Feasibility Pilot (Ileostomy): Improving Care Processes for New Ileostomy Patients Using Continuous Remote Patient Monitoring and a Cascading Alert System
Phase: NA
Conditions: Ileostomy; Complications, Ileostomy - Stoma
Sponsor: Endeavor Health

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A pilot study to determine the efficacy of continuous ambulatory wearable technology and a 
cascading alert system in reducing 30d readmission in high risk medical and surgical patients.  
 
 
 
 
Revision number:  10.0 
Date:   03/08/2023 
 
 

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Contents 
1 
Research plan ........................................................................................................................................ 4 
1.1 
Summary ....................................................................................................................................... 4 
1.2 
Background and Significance ........................................................................................................ 4 
2 
Quantitative........................................................................................................................................... 6 
2.1 
Quantitative Research Aims .......................................................................................................... 6 
2.2 
Experimental Plan and Methods ................................................................................................... 6 
3 
Qualitative ........................................................................................................................................... 15 
3.1 
Qualitative Research Aims .......................................................................................................... 15 
3.2 
Experimental Plan and Methods ................................................................................................. 15 
3.3 
Content and focus of interviews ................................................................................................. 18 
3.3.1 
Patient ................................................................................................................................. 18 
3.3.2 
Provider ............................................................................................................................... 20 
3.4 
Interview methods ...................................................................................................................... 22 
3.5 
Codebook Development ............................................................................................................. 22 
3.6 
Analyses ...................................................................................................................................... 22 
4 
STUDY PROCEDURES ........................................................................................................................... 23 
4.1 
Recruitment Procedure ............................................................................................................... 23 
4.1.1 
Patients ............................................................................................................................... 23 
4.1.2 
Providers ............................................................................................................................. 23 
4.2 
Inclusion and Exclusion Criteria .................................................................................................. 23 
4.2.1 
Patients ............................................................................................................................... 23 
4.2.2 
Providers ............................................................................................................................. 24 
4.3 
Informed Consent Procedure...................................................................................................... 24 
4.3.1 
Patients ............................................................................................................................... 24 
4.3.1 
Providers ............................................................................................................................. 26 
4.4 
Semi-Structured Interview Process ............................................................................................. 27 
4.4.1 
Patients ............................................................................................................................... 27 
4.4.2 
Providers ............................................................................................................................. 27 
4.5 
Record keeping and transcripts .................................................................................................. 27 
4.6 
Provisions to Protect the Privacy Interests of Participants ......................................................... 28 
4.7 
Compensation and Economic Burden to Patients and Providers ............................................... 28 
5 
Data MANAGEMENT ........................................................................................................................... 30 

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5.1 
Data Security ............................................................................................................................... 30 
5.2 
Protection of Participant Privacy ................................................................................................ 31 
6 
DEVICE INFORMATION ........................................................................................................................ 32 
6.1 
DEVICE DESCRIPTION: ................................................................................................................. 32 
6.2 
Data Transport via physIQ Android Mobile App and physIQ Platform ....................................... 33 
6.3 
Analytics ...................................................................................................................................... 33 
6.4 
Regulatory Status ........................................................................................................................ 33 
7 
Bibliography ........................................................................................................................................ 35 
8 
Appendix 1 – Patient Questionnaire & Interview ............................................................................... 39 
8.1 
Demographic Survey (Ileostomy Cohort – Pre) .......................................................................... 39 
8.2 
Self-Care Self-Efficacy Scale (Ileostomy Cohort – Pre and Post) ................................................. 40 
8.3 
Monitoring Process Random Question Bank .............................................................................. 43 
8.4 
User Experience Survey (Ileostomy Cohort – Post) .................................................................... 44 
8.5 
City of Hope Quality of Life Ostomy (Ileostomy Cohort – Pre and Post) ...... Error! Bookmark not 
defined. 
8.6 
Semi-Structured Interviews ........................................................................................................ 47 
8.6.1 
Pre-discharge Interview Guide ............................................... Error! Bookmark not defined. 
8.6.2 
Study Endpoint Interview Guide ............................................ Error! Bookmark not defined. 
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Appendix 2 – Provider Survey and Interview ...................................................................................... 53 
9.1 
Study Start point (Demographic Survey + Interview) ................................................................. 53 
9.2 
End Point (Survey + phone follow up if survey incomplete) ....................................................... 55 
9.3 
Study Endpoint (User experience survey + Interview) ................................................................ 55 
 
 
 

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1 
RESEARCH PLAN 
1.1 
Summary 
We propose to test our central hypothesis that readmission and post-discharge utilization in high risk 
medical and surgical patients can be reduced by using a vendor platform (PinpointIQ from the company 
physIQ) that involves wearable sensors (Vital Patch) that collect real-time, continuous ambulatory vital 
signs, a mobile device that collects patient reported outcomes and machine learning algorithms in the 
cloud that identify patients at risk of physiologic perturbation. Data from this vendor platform will be tied 
to operational workflows at NorthShore that involve a monitoring nurse who then conveys information 
to the clinical team as necessary in a cascading alert system.  
1.2 
Background and Significance 
Hospital readmissions are common and costly and are increasingly being used as a metric for quality care. 
With the passing of the Affordable Care Act (ACA) hospital readmissions were targeted with the Hospital 
Readmission Reduction Program (HRRP) in which hospitals are penalized for higher than expected 
readmission rates.1 Significant effort has been devoted to understanding how to reduce readmissions and 
utilization. To date there has been limited work looking at how wearable sensors that monitor physiologic 
data continuously and remotely can identify physiologic perturbation allowing care providers ample time 
to intervene and prevent decompensation and readmission. 
Monitoring of vital signs for hospitalized patients to detect decompensation is checked manually and 
intermittently (spot check) for the majority of patients. When patients are discharged, vital signs are 
frequently not monitored in the 30-day readmission window. This lack of monitoring in the post discharge 
period may prevent identification of patients at risk of decompensation and readmission. When spot vitals 
are monitored at home, reductions in readmission rates for certain populations have been seen.2-4   
New technology in wearables coupled with machine learning algorithms is able to detect vital signs 
remotely and continuously and correlate the output with signals that may indicate risk of physiologic 
perturbation.5-17 Various studies have looked at how continuous monitoring of vitals can identify patients 
in the hospital quicker and more effectively than nurse driven spot checks of vital signs.18-28 There is a lack 
of data on using these devices upon discharge to evaluate for decompensation and prospectively trying 
to reduce readmissions. Similarly, there is a lack of data in tying these devices to a cascading and escalating 
alert system to identify patients at risk of decompensation. There is qualitative data on looking at how 
wearables are perceived by providers and patients in the hospital29-30 but there is a lack of data on 
perception of this technology for remote monitoring. 
Postoperative ileostomy patients are frequently readmitted because of physiologic perturbation31-35 and 
has readmission rates between 15-30% at NorthShore. Ileostomy patients are readmitted because of 
dehydration.33-35 There has been early work establishing the predictive potential of multivariate 
physiological telemetry (pinpointIQ) from a wearable sensor providing accurate early detection of 
impending rehospitalization for postoperative ileostomy  with a predictive accuracy comparable to 
implanted devices. 39 This population may benefit from remote continuous monitoring of vital signs tied 
to a cascading alert system to identify patients at risk of impending decompensation.  There is limited 
literature looking at how continuous monitoring, ambulatory wearable devices can improve outcomes in 
high risk patients.  

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We propose conducting a mixed-methods study that will use a wearable device to collect ambulatory 
physiological data analyzed by a machine-learning algorithm to identify readmission risk. The alerts will 
be tied to a cascading escalation pathway that involves monitoring nurse, mid-level providers, specialists, 
and surgeons. We describe the quantitative and qualitative aspects of the study in detail below. 

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2 
QUANTITATIVE 
 
2.1 
Quantitative Research Aims – Ileostomy Cohort 
 
Aim 1: Determine if wearable technology deployed for 30 days in a high-risk patient population can 
augment 30-day readmission risk prediction and improve care processes via an escalating feedback 
protocol.  
Aim 2: Understand and finalize thresholds and criteria for alert system at the levels of Vital Patch, 
physIQ’s pinpointIQ, monitoring RNs for ileostomy patients 
Aim 3: Finalize process maps and workflows for nurse navigators and clinical care teams that optimize 
identifying high risk patients while minimizing provider burden 
 
Aim 4: Calculate the return on investment of the remote monitoring solution 
Aim 5: Perform a deep analysis of the full process to understand effectiveness, feasibility, efficiency and 
bottlenecks 
2.2 
Experimental Plan and Methods 
The goal of the study is to reduce readmission rates for high risk medical and surgical patients. The goal 
of the study is to understand how physIQ’s platform Pinpoint IQ with a cascading set of alerts including 
the wearable device alerts, patient reported metrics, CAPE navigator or monitoring nurse alerts can be 
developed and improved upon to reduce the incidence of 30 day readmission. We will be enrolling  10 
colorectal (post ileostomy formation) patients who will be using a standardized set of cascading alerts 
that have been fine tuned with the goal of reducing decompensation and 30-day readmissions. 
Ileostomy 
For the colorectal patients, we will attempt to enroll every patient that has a colectomy followed by 
ileostomy formation. These will be patients of Drs. Joseph Muldoon, Monika Krezalek, and James Spitz 
and will be at Evanston, Glenbrook, and Highland Park hospitals. The colorectal surgeons will notify the 
study team when a patient has undergone surgery and the research coordinator will perform 
recruitment. Patients will be approached by the study coordinator who will perform informed consent. 
If the patient is agreeable the patient will receive a kit from physIQ prior to discharge. A Vital patch will 
be placed on the patient prior to discharge and the patch will be connected via blue tooth to the physIQ 
mobile device and pinpointIQ application. The study coordinator will teach the patient how to apply and 
remove the patch and what to do if there are issues with the patch. The study coordinator will also 
teach the patient how to use the mobile device and the physIQ application. This will also occur 
immediately prior to discharge. 
On discharge colorectal patients will be asked questions every morning and every afternoon from the 
pinpoint IQ application. The pintpoint IQ platform will query patients about their ostomy output every 

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morning. We would also ask if the patient has any infectious symptoms such as fever, discharge or 
redness around the incision site or stoma and if the patient has any dehydration symptoms such as 
decreased urine output, dark urine, or obstruction and other alarming symptoms that the team would 
like to know about. In the afternoon, the symptom questions will be asked again. The monitoring nurse 
will evaluate the pinpoint IQ in the morning after the patient has filled out the questionnaire and in the 
afternoon after the patient has filled out the symptom question again. They will evaluate the responses 
to the questions and the physiologic alerting system built by physIQ. There will again be an algorithm 
built within physIQ’s system that provides an alert to the monitoring nurse if the criteria from Table 4 
are met. 
 
 
physIQ Alert System – Ileostomy 
Patients: 

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Any positive symptom (dehydration,infection, or obstruction) 
≥1200 ml ostomy output over one day 
A high risk alert  
A predefined number of standard alerts in a day 
Table 4: PhysIQ alerts system for CAPE navigator or monitoring nurse for Ileostomy 
 
For ileostomy the thresholds for the high-risk alerts and the number of standard alerts may be changed 
from patient to patient based on how each case progresses and the density and frequency of alerts. 
Determining the optimal thresholds for these two types of alerts will be a key aim of this study The goal 
is again maximizing signal while minimizing noise.  
 
If any of these conditions listed in Table 4 are met the monitoring nurse will call the patient and go 
through a predefined note with the following data elements and questions. 
 
 
 

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Infection Symptom 
a) Fever 
b) Dysuria 
c) Redness at ostomy site 
d) Drainage or swelling at ostomy site 
e) Other (Free Text) 
 
Obstruction Symptom 
a) Nausea 
b) Vomiting 
c) Bloating 
d) Decreased or no ostomy output 
e) No gas through ostomy 
 
Dehydration Symptom 
a) Lightheadedness 
b) Dry mouth 
c) Low or dark urine output 
d) Dizziness 
e) Increased ostomy output 
 
Symptom Change (Obstruction, Dehydration, Infection) [This can show up if any symptom is picked] 
1. New 
2. Worsening 
3. Stable 
4. Improving 
5. Resolved 
Ostomy output 
a) 500-1200cc 
b) >1200cc 
c) <500cc 
Is patient NPO? Yes/No 
Is patient on antibiotics? Yes/No 
Patient is on stool thickening regimen?  
a) None 
b) Metamucil powder 1 tsp bid 
c) Immodium 2mg bid w/ meals (20 mins before meals) 
d) Immodium 2mg qid w/ meals (20 mins before meals) 
e) Immodium 4mg qid w/ meals (20 mins before meals) 
f) Stool thickening managed by clinical team 
 
Alerts: 
a) MCI alert  
b) Afib with RVR alert 
c) Tachypnea alert (First, frequent, increasing density, other alerts also present, no other 
concerning pulmonary comorbidities) 

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d) Tachycardia alert (First, frequent, increasing density, other alerts also present, no other 
concerning Comorbidities or ostomy output uptrending or near 1200cc threshold) 
e) Other physiologic alert  
FOLLOWUP PLAN 
1. Case Communication to Clinical RN 
2. Case Communication to Ostomy RN 
3. Call Clinical RN 
4. Call Ostomy RN 
5. Consider Call Clinical RN  
6. Evaluate trend of ostomy output 
7. Stool thickening initiation Metamucil powder 1 tsp bid 
8. Stool thickening escalation Immodium 2mg bid w/ meals (20 mins before meals) 
9. Stool thickening escalation Immodium 2mg qid w/ meals (20 mins before meals) 
10. Stool thickening escalation Immodium 4mg qid w/ meals (20 mins before meals) 
11. Stool thickening escalation management by clinical team 
12. IV fluids administration 
13. Consider IV fluids administration 
14. Consider Lab tests BMP, Mag, Phos 
15. Consider Lab test CBC 
16. Advance Diet as Tolerated (Clear liquids for 6 hours and then advance as tolerated to low 
residue diet) 
17. Continue NPO status 
18. Possible urgent clinic evaluation 
19. Assess for home visit 
LOGIC: 
a) MCI, Afib w/ RVR, Tachycardia, Tachypnea (1, 3, 6) 
b) Other physiologic alert (5) 
c) Ostomy output >1200cc and patient on no stool thickening regimen (1, 5, 7, 13) 
d) Ostomy output >1200cc and patient on metamucil stool thickening regimen (1, 5, 13, 8) 
e) Ostomy output >1200cc and patient on immodium 2mg bid stool thickening regimen (1, 5, 13, 
9) 
f) Ostomy output >1200cc and patient on immodium 2mg qid stool thickening regimen (1, 5, 13, 
10) 
g) Ostomy output >1200cc and patient on immodium 4mg qid stool thickening regimen (1, 3, 13, 
11) 
h) Ostomy output <500cc (1, 3) 
i) 
Has ANY Obstruction symptom, NEW, or WORSENING Obstructive Symptom, Patient not NPO 
(1, 3, 14) 
j) 
Has ANY Obstruction symptom, RESOLVED Obstructive Symptom, Patient not NPO (1) 
k) Has ANY Obstruction symptom, NEW or WORSENING Obstructive Symptoms, Patient NPO (1, 
3, 14, 17) 
l) 
Has ANY Obstruction symptom, STABLE or IMPROVING Obstructive Symptoms, Patient NPO 
(17) 
m) Has ANY Obstruction symptom, RESOLVED Obstructive Symptoms, Patient NPO and Ostomy 
output 500-1200 (1, 3, 16) 
n) Has ANY Obstruction symptom, RESOLVED Obstructive Symptoms, Patient NPO and Ostomy 
output >1200, patient not on stool thickening regimen (1, 3, 16) 

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o) Has the following Infectious symptoms (Redness at ostomy site, Drainage or swelling at 
ostomy site), NEW OR WORSENING Infectious Symptoms, Patient not on antibiotics (2, 4, 15) 
p) Has the following Infectious symptoms (Redness at ostomy site, Drainage or swelling at 
ostomy site), RESOLVED Infectious Symptoms, Patient not on antibiotics (2) 
q) Has the following Infectious symptoms (Redness at ostomy site, Drainage or swelling at 
ostomy site), NEW OR WORSENING Infectious Symptoms, Patient on antibiotics (2, 4, 15, 18) 
r) Has the following Infectious symptoms (Redness at ostomy site, Drainage or swelling at 
ostomy site), RESOLVED Infectious Symptoms, Patient on antibiotics (2) 
s) Has the following Infectious symptoms (Fever, Dysuria or Other), NEW,WORSENING, 
IMPROVING, OR STABLE Infectious Symptoms, Patient not on antibiotics (1,3, 15) 
t) Has the following Infectious symptoms (Fever, Dysuria or Other),  RESOLVED Infectious 
Symptoms, Patient not on antibiotics (1) 
u) Has the following Infectious symptoms (Fever, Dysuria or Other), NEW OR WORSENING 
Infectious Symptoms, Patient on antibiotics (1,3, 15, 18) 
v) Has the following Infectious symptoms (Fever, Dysuria or Other), RESOLVED Infectious 
Symptoms, Patient on antibiotics (1) 
w) Has ANY Dehydration symptom, NEW, or WORSENING Dehydration Symptom, Patient not 
NPO (1, 3, 12, 14) 
x) Has ANY Dehydration symptom, STABLE OR IMPROVING Dehydration Symptom, Patient not 
NPO (1, 5, 13) 
y) Has ANY Dehydration symptom, RESOLVED Dehydration Symptom, Patient not NPO (1) 
 
Table 5: CAPE Navigator or monitoring nurse alerts system for clinical team for Ileostomy 
Table 5 will be configured into a note template within EPIC that allows for data elements to be captured 
and have all the logics built in to automatically highlight the recommended options for the monitoring 
nurse. The EHR smart note will be tested out by the research team to ensure the logic is correct.  
 
If patients have any high risk alerts (MCI, Afib with RVR, Tachycardia, Tachypnea), the monitoring nurse 
will route a note and call clinical RN and evaluate the trend of ostomy output. All other physiological alerts 
will result in consideration call to clinical RN. 
 
If patient ostomy output >1200cc and patient not on stool thickening regimen yet, the monitoring nurse 
will send note and call clinical RN,  consider IV fluids administration and start stool thickening regimen 
escalation. Monitoring RNs will call cinical RNs for guidance on IV fluid administration guidance. The stool 
regimen escalation can occur daily while the output is ≥1200ml in 24 hours. There is no monitoring nurse 
de-escalation protocol, and this will be performed by the clinical team. If a patient is non-adherent to 
Metamucil and/or Imodium and output is ≥1200ml in 24 hours, medications will be maintained without 
escalation and patient will be counseled on the importance of adherence to medications. If the output 
continues to be greater than ≥1200ml in 24 hours and there are no further options for escalation, the 
monitoring nurse will call the clinical care team for further guidance.  
 
If ostomy output is <500cc, monitoring nurse will route note and call clinical RN. If patient has any new or 
worsening obstruction symptom but not NPO yet, monitoring nurse will route note and call clinical RN, 
and consider lab tests (BMP, Mag, Phos). If the obstructive symptoms resolve while patient is NPO, home 
healrh RNs will route not to clinical RN. 
If patient has new or worsening obstruction symptoms but is NPO already, monitoring nurse will note and 
call clinical RN, consider lab tests (BMP, Mag, Phos), and continue NPO status. If patient obstruction 

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symptom is stable or improving under the NPO status, monitoring nurse will keep patient NPO. If patient 
has resolved obstructive symptoms, still NPO and ostomy output is >1200 cc or between 500-1200 cc, 
monitoring nurse will note and call clinical RN, and instruct patients to advance diet as tolerated. 
 
Any new or worsening redness at ostomy site, drainage or swelling at ostomy site, but patient not on 
antibiotics, monitoring nurse will note and call the ostomy RN for guidance in management, and consider 
CBC labs. If the above symptoms resolve without antibiotics, home healrh RN will call ostomy RN to 
update. 
 
If patient has new or worsening redness at ostomy stite, drainage or swelling at ostomy site, and is already 
on antibiotics, home healrh RNs will note and call ostomy RN, consider CBC labs and urgent clinic 
evaluation. If above symptoms resolve with antibiotics, home healrh RN will call ostomy RN. 
 
Any new, worsening, improved or stable fever, dysuria or other infectious symptoms, but patient not on 
antibiotics, the monitoring nurse will note and call clinical RNs, and consider CBC labs. If the above 
symptoms resolve without antibiotics, the monitoring nurse will route note to clinical RN. 
 
If patient has any new, worsening, improved or stable fever, dysuria or other infectious symptoms, but is 
already on antibiotics, the monitoring nurse will note and call clinical RNs, and consider CBC labs and 
urgent clinic visits. If the above symptoms resolve with antibiotics, the monitoring nurse will route note 
to clinical RN. 
 
If patient has new or worsening dehydration symptoms, but not NPO, monitoring nurse will note and call 
clinical RN, consider IV fluids administration, and consider labs (BMP, Mag, Phos). If the dehydration 
symptoms are stable or improving while patient is not NPO, the home healrh nurses will route note to 
clinical RN, consider call clinical RN, and consider IV fluids administration under guidance of clinical team. 
When dehydration symptoms resolve, the home healrh RNs will route note to clinical RN. 
 
We will be evaluating the high risk alerts and other physiological alerts to find the optimal alert types, 
thresholds and alerting frequency to maximize signal and minimize noise. 
 
 
 

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Figure 2: Process map for Ileostomy Patients  
 
If care is escalated to the clinical care team which includes ostomy RNs, clinical RNs, and Physicians, the 
care team will pursue various interventions including counseling, altering medication therapy such as 
antibiotic therapy, procedures such as debridement or drainage, urgent visits to the colorectal surgery 
clinic ideally within 72 hours, and if no other available options readmission. These workflows will be left 

14 
 
to the discretion of the clinical care team given the nuance in taking care of these high-risk patients and 
the existing relationship and prior history with these providers. There are some standardized workflows 
that will be followed by the care team that are of note. Infusions of IV fluids will occur if the patient has 
≥1200 ml of ileostomy output and dehydration symptoms. If these symptoms are identified, the goal will 
be to have monitoring nurse perform infusion at the patient’s home. Also, all messaging from the 
monitoring nurses will be forwarded to the colorectal/ileostomy pool per protocol and logic in Table 5 to 
create the most rapid response back to the patient if required.  
The final specs of the study will include: 
1. Optimal inclusion/exclusion criteria. 
2. Specific thresholds for high risk alerts for each use case 
3. Specific thresholds for standard alerts (likely use physIQ standard thresholds) 
4. Finalized physIQ alerts to CAPE navigators and monitoring nurse 
5. Finalized CAPE navigator and monitoring nurse alerts to clinical care team 
6. Finalized EPIC note  
7. Finalized process maps  
8. Finalized workflows by clinical care team 
9. Discussion with physIQ to optimize the pinpointIQ portal to best support the CAPE navigators 
and monitoring nurse  
 
The recruitment goals for this study is 10 ileostomy patients each for 30d of monitoring to evaluate if 
the remote monitoring technology from physIQ and cascading alert system and process can reduce 30-
day readmissions. We will also perform economic calculations to determine if there is return on 
investment for this workflow tied to remote monitoring. Finally, we would like to do an in-depth analysis 
of the process to understand effectiveness, feasibility, efficiency, and bottlenecks. Some of the 
questions we would like to understand include: 1) What component of the cascading alert system 
provides the highest effectiveness of identifying patients at risk? 2) Can we reduce the number of 
monitored days and still effectively reduce 30 days of readmission? 3) Are there specific subgroups of 
patients who may benefit from the remote monitoring solution, or alternatively, are there subgroups 
who do not benefit from the remote monitoring solution? 4) Can we take our process maps and perform 
process simulation with data from the study and process mining to optimize our process and identify 
chokepoints with our current flow. 

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3 
QUALITATIVE 
3.1 
Qualitative Research Aims 
Receive provider and patient feedback on the application of wearable technology to post-discharge care 
to conduct a theory-driven evaluation of feasibility, usability, and effectiveness. We will address 
motivational and self-care issues at baseline, continuing and post-study from both providers and patients' 
viewpoints.  1) ascertain perceptions of telemonitoring and remote patient management of high-risk 
patients, of organization and effectiveness of care by providers using interviews and surveys; and 2) 
evaluate patient acceptance, perceptions of and satisfaction with wearable patches, with prompted 
requests for patient status information, and with escalation pathways for nurse navigators and physicians 
using interviews and survey tools. 
3.2 
Experimental Plan and Methods 
We will assess remote monitoring combined with non-invasive wearable technology's potential by 
applying the Affective Adaptation of the Technology Acceptance Model (A/TAM).52 We describe the 
approach to providers and patients in detail below. We stress that these will be linked to care delivery 
processes and the measures described above in the quantitative section to realize the full potential of a 
mixed-methods approach. 
I. 
 Ascertain providers' perceptions of telemonitoring and remote patient management of 
high-risk patients, organization, and effectiveness of care using interviews and surveys.  
Provider induction (prior to patient enrolment): Provider induction will include an in-depth review of the 
wearable device, remote management, and escalation pathway, followed by an interview informed by 
A/TAM to establish each provider's comfort level (i) with wearable technology and any experience of such 
a device (e.g., habitual use of wrist-worn activity monitoring), and (ii) with wearable technology as a 
means of monitoring a post-discharge patient's status, including (iii) anticipated challenges in technology-
mediated interaction with patients; and finally (iv) identification of any knowledge gaps that may need to 
be filled through the induction process. 
Provider progress monitoring (throughout the trial period): Providers' progress and experience of the 
program will be assessed through: (a) a survey including open-ended questions with each provider 
following the completion of the study, to evaluate the extent to which anticipated issues and challenges 
may be realized. (b) a partly randomized, recurring opportunity to respond to one question once at the 
point of interaction with the patient; based on a matrix of questions, patients and providers, a single 
multiple choice question appears as part of a best practice alert to ensure that it is seamlessly integrated; 
nevertheless, collectively, all questions, all providers and all patients will receive adequate coverage. 
Provider satisfaction (after the trial): At the conclusion of the study, providers: (a) will be debriefed 
through a comprehensive semi-structured interview to assess (i) their subjective perception of the 
effectiveness of wearable-mediated, post-discharge care; and (ii) actual challenges encountered in the 
course of the program (e.g., frequency of interaction, patients' comprehension of instructions, perception 
of patients' adherence, including any socio-emotional issues that may be impinging); (b) will participate 
in a post-trial half-day event to network with patients and the research team towards an open-ended 

16 
 
evaluation of the joint experience and to elicit opinions and contributions towards a follow-up randomized 
clinical trial proposal, and (c) will be invited to contribute to one or more joint evaluative publications. 
A timeline illustrating provider related study activities can be found in Figure 4.
 
Figure 4 Provider Interview Timeline 
II. 
To evaluate patients’ acceptance, perceptions of and satisfaction with wearable patches, 
with prompted requests for patient status information, and with escalation pathways for 
nurse navigators, midlevel providers and specialists.  
Patient enrollment (prior to discharge): Following a detailed presentation of the device and study, and 
informed consent, researchers will administer a questionnaire to establish the participant’s comfort and 
experience level with a wearable device and to ascertain that the participant has understood the 
limitations of the devices (e.g. that they provide continual but not constant, “real-time” monitoring) prior 
to hospital discharge. This will be followed by an in-person semi-structured interviewThe interview is 
informed by A/TAM to establish the patient’s readiness to use a wearable device as a means of monitoring 
their post-discharge status, including to establish any anticipated challenges in technology-mediated 
interaction with the care team; and finally, to identify any knowledge gaps that may need to be filled 
through the induction process. Paradata will be collected at the interview to assist with analysis.  
Patient progress (throughout the period of device use): Monitoring of the patient’s experience and 
satisfaction with the device and the study process will be combined with weekly monitoring questions 
focusing on the following aspects: (a) experience with physical use and tolerance of the device; assess any 
difficulty in keeping it in place, any skin reaction, possible somatization of health concerns; (b) experience 
of self-monitoring and communication with care team through the device (c) degree of reassurance or 
anxiety about the patient’s recovery process; finally, (e) paradata from device and interaction metrics, 
including possible sentiment analysis of interaction text. 
Conclusion (Study endpoint): (a) Surveys will be administered at study endpoint to assess each patient’s 
strength of feeling in each response by recording not only the response itself but also the “paradata”—
the researcher’s assessment of the patient’s affect in providing the response. On this basis, (b) in 
Prior to 
patient 
enrollement: 
Survey + 
Interview
Patient 
enrollment
Survey
Randomized, 
recurring 
questions
Study End 
Point: Survey 
+ Interview
Stakeholder 
Engagement 
Meeting

17 
 
conjunction with process measures captured through surveys, the first patient group participants will 
complete a post-study interview with the researcher. Using a mixed methods philosophy, the interview 
will seek links between performance measures and the experience of participants. (c) The interview will 
link to the quantitative results in terms of outcome and process measures, as well as to the patient status 
reports throughout the 30-day period to propose hypotheses for further study, e.g. on subjective 
tolerability of the wearable device or faith in a remote monitoring system and care process measures, 
such as unscheduled visits. (d) Patients will be invited to a post-trial half day event to network with their 
providers and the research team towards an open-ended evaluation of the joint experience and to elicit 
opinions and contributions towards a follow-up randomized clinical trial proposal; and (e) will be invited 
to contribute to a publication on the patient experience and to review scientific publications by the 
research team.  
For the ileostomy cohort, we will use think-aloud methods to compliment the semi-structured interviews 
during the study end-point interview. Patients will think-aloud and convey their thoughts and experience 
to interviewer while using the patch, phone, and physIQ app. The other topics during study end-point will 
continue with the semi-structured formats. 
A timeline illustrating patient related study activities can be found in Figure 5. 
Figure 5 Patient Interview Timeline 
Informed
Consent
Prior to 
Discharge
Survey + 
Interview
30 
Monitoring 
Period: 
Recurring 
questions
30 Day 
Study 
Endpoint
Survey + 
Interview
Data 
Analysis
Stakeholder 
Engagemen
t Meeting

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3.3 
Content and focus of interviews 
3.3.1 Patient 
Interview questions are developed based on A/TAM to elicit information. An example of the potential 
survey and interview questions the research team will use during the interview can be found in the 
appendices as Appendix 1.  
Table 8. Patient A/TAM Structure 
 
Positive 
Affect 
Negative 
Affect  
Perceived 
Usefulness 
Perceived 
Ease of Use 
Attitude 
Toward 
Using 
Behavioral 
Intention to 
Use 
Actual 
System Use 
 
Wearable 
Device 
Past positive 
experience 
with using 
wearable 
devices 
Past negative 
experience 
with using 
wearable 
devices 
(Technology 
anxiety) 
Perceived 
usefulness of 
the wearable 
technology 
improving 
life quality/ 
med 
adherence/ 
health 
management
/ health 
outcomes… 
 
Perceived 
benefits/barr
iers 
associated 
with 
wearable 
device 
 
Perceived 
ubiquity of 
the wearable 
technology 
 
Easiness of 
wearing/cha
nging the 
patch 
 
Easiness of 
using the 
mobile 
phone 
 
Easiness of 
answering 
the survey 
via mobile 
platform 
 
Positive 
attitude 
towards 
using the 
wearable 
device/mobil
e 
phone/techn
ology 
 
Negative 
attitude 
towards 
using the 
wearable 
device/mobil
e 
phone/techn
ology 
Compliant 
with device 
usage 
 
Non-
compliant 
with device 
usage 
Readmission 
Telemonit
oring 
Past positive 
experience 
with remote 
monitoring 
Past negative 
experience 
with remote 
monitoring 
Perceived 
usefulness of 
the 
telemonitori
ng process 
improving 
life quality/ 
med 
adherence/ 
health 
management
/ health 
outcomes.. 
 
Perceived 
easiness of 
communicati
ng with care 
team 
 
Perceived 
easiness of 
following 
care team 
instructions 
 
 
Positive 
attitude 
towards 
telemonitori
ng 
 
Negative 
attitude 
towards 
telemonitori
ng 
Compliant 
with clinical 
instructions 
 
Non-
compliant 
with clinical 
instructions 
Readmission 

19 
 
Perceived 
benefits/barr
iers 
associated 
with 
telemonitori
ng process 
 
 
 
Sociocultu
ral factors 
Positive 
disease 
management 
experience 
 
Language 
(English) 
 
Social 
support 
(Family/frien
d/PCP) 
 
Marital 
status 
(Married, 
good support 
system) 
 
Non-smoker 
 
Good control 
over diet 
 
Income 
status 
(Stable) 
 
Traditional/R
eligion 
values 
 
Good mental 
health status 
Negative 
disease 
management 
experience 
 
Language 
(Non-English) 
 
Social 
support 
(Family/frien
d/PCP) 
 
Marital 
status  
(Single, 
Widowed, no 
support) 
 
Smoking Hx 
 
Poor control 
over diet 
 
Income 
status 
(Unstable) 
 
Traditional/R
eligion 
values 
 
Depression 
 
Perceived 
control over 
the external 
factors 
Self-
motivation 
to tech usage 
adherence 
Positive/Neg
ative attitude 
towards 
technology 
and device 
acceptance 
Self-care 
 
Demographic Form – Sociodemographic information will cover gender, ethnicity, race, household 
income, education level and marital status. 

20 
 
The Self-Care Self-Efficacy Scale – The Self-Care Self-Efficacy Scale is authored by Dr. Barbara Riegel. 
Confidence is not part of self-care per se, but a factor that greatly influences self-care. For this reason, 
Dr. Riegel include a confidence (or self-efficacy) scale as part of the self-care scales. The Self-Care 
Confidence scale can be used alone. 
 
Stoma Quality of Life Scale – The QOL instrument is a 21-item questionnaire that mesures work/social 
function, secuality/body image, and stoma function.  
Device User Experience – These questions ask about patient’s experience on using the vital patch and 
physIQ platform. 
Telemonitoring Experience – These questions ask about patient’s experience the telemonitoring process. 
3.3.2 Provider 
The survey and interview questions for the provider cohort are developed based on A/TAM to elicit 
information. An example of the potential survey and interview questions the research team will use 
during the interview can be found in the appendices as Appendix 2. 
Table 8. Provider A/TAM structure 
 
Positive 
Affect 
Negative 
Affect  
Perceived 
Usefulness 
Perceiv
ed Ease 
of Use 
Attitude 
Toward 
Using 
Behavioral 
Intention 
to Use 
Actual 
System Use 
 
Wearable 
Device 
Past 
positive 
experience 
with using 
wearable 
devices 
with 
patients 
Past 
negative 
experience 
with using 
wearable 
devices 
(Technology 
anxiety) 
Perceived 
usefulness 
of 
monitoring 
patient 
vitals 
 
 
Easiness 
of using 
the 
physIQ 
portal 
to 
review 
vitals 
 
Easiness 
of using 
smart 
note 
templat
e in EPIC 
 
 
Positive 
attitude 
towards 
promoting 
the device 
for patient 
usage 
 
Negative 
attitude 
towards 
promoting 
the device 
for patient 
usage 
 
Intend to 
promote 
usage 
among 
patients 
Engagement 
in device 
monitoring 
Telemonit
oring 
Past 
positive 
experience 
with 
remote 
Past 
negative 
experience 
with remote 
Perceived 
usefulness 
of 
monitoring 
patient 
Easiness 
of 
commu
nication 
betwee
Positive 
attitude 
towards 
telemonitor
ing 
Intend to 
practice 
telemonito
ring as a 
method 
Engagement 
in patient 
remote 
monitoring 
process 

21 
 
patient 
monitoring 
patient 
monitoring 
disease 
progress 
n 
provider
s 
 
Easiness 
of 
commu
nication 
betwee
n 
patients 
 
Easiness 
of 
managi
ng 
patient 
medicat
ion 
 
Easiness 
of 
providin
g clinical 
instructi
ons 
 
 
Negative 
attitude 
towards 
telemonitor
ing 
for patient 
manageme
nt 
Sociocultu
ral factors 
Individual’s 
tendency 
to innovate 
in daily life 
 
Individual’s 
level of 
technology 
usage in 
personal 
life 
 
Organizatio
nal level 
factors 
Individual’s 
tendency to 
innovate in 
daily life 
 
Individual’s 
level of 
technology 
usage in 
personal life 
 
Organization
al level 
factors 
Will the 
usage of 
technology 
enable 
providers 
to reduce 
effort/ena
ble 
patients to 
better 
disease 
manage 
Organiz
ation 
support 
(educati
on on 
device/t
ech 
usage) 
Positive/Ne
gative 
attitude 
towards 
participatin
g in the 
program 
Intention 
to 
participate 
in the 
program 
Activeness 
in the 
program 
 
Demographic Form – Demographic form will cover position title and the target patient population they 
are caring for.  

22 
 
Device User Experience – These questions ask about providers’ experience on using the physIQ platform. 
We developed this questionnaire based on the systematic usability scale (SUS). 
Telemonitoring User Experience – These questions ask about providers’ experience in the telemonitoring 
process. 
3.4 
Interview methods 
Semi-structured individual interviews will be used to maximize depth of detail and minimize bias 
introduced with cross-contamination from other interviewees.53 Researchers trained in semi-structured 
interview techniques will conduct the interviews. They will use a nondirective interview style, with open-
ended questions, and allow the participant to adopt their own pace and style of response, along with 
freedom of subject matter, so that they may change and emphasize alternate points to those already 
brought up by the interviewer.  We will use probes and follow-up questions when indicated, and new 
constructs and ideas will be allowed to emerge.  The interviewer may take notes during interviews, but 
de-identified transcriptions will be the primary source for analysis.  
3.5 
Codebook Development 
The research team will develop study codebook based on the A/TAM theory: 
1. Codes will be generated from the A/TAM theory.  
2. Researchers will review and revise the code in context of the data. 
3. Researchers will determine the reliability of coders and the code 
3.6 
Analyses 
We will complete a systematic analysis of interview transcripts to identify specific themes guided by the 
A/TAM to inform future implementations of the wearable device and cascading alert system.  After the 
initial few interviews have been completed, two researchers, working independently, will use a 
codebook of constructs adapted from the A/TAM to identify significant phrases that exemplify each 
construct.  They will then independently review each other’s work and come together to discuss 
differences of opinion and achieve consensus.  The principal investigator will meet with the coders to 
review the codes, adding or consolidating as warranted.  The researchers will then continue to perform 
interviews, adding codes to the codebook as needed, and meeting as a team periodically to review the 
codes and achieve consensus.  We will use Atlas TI qualitative data analysis software to manage data 
and assist in analysis.  Finally, we will create an overview description of the important themes, and their 
relationship to A/TAM constructs. 
 

23 
 
4 
STUDY PROCEDURES 
4.1 
Recruitment Procedure 
4.1.1 Patients 
The participants will be recruited from Northshore University HealthSystem’s Evanston Hospital, 
Glenbrook and Highland Park hospitals by the study team. The recruitment process will follow protocol 
standards to ensure consistency in the recruitment process. The participants will be informed that their 
participation is completely voluntary and that they can drop out at any time. The participants will also 
be required to sign consent forms to participate. 
4.1.2 Providers 
Clinical team staff will be asked to participate in surveys and semi-structured interviews.  
4.2 
Inclusion and Exclusion Criteria 
4.2.1 Patients 
Ileostomy Cohort 
Inclusion Criteria:   
• 
Patient underwent a new ileostomy formation at index hospitalization 
• 
Patient is an inpatient at Evanston, Glenbrook, Highland Park hospitals 
• 
Patient of Drs. Joe Muldoon, Monika Krezalek and James Spitz 
• 
At least 18 years of age 
• 
Fluent in English 
• 
Patient is discharging with home health services 
• 
Patient agrees to protocol-required procedures 
Exclusion Criteria: 
• 
Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the 
patient’s ability to maintain patch/wrist device, phone 
• 
Patient has allergy to hydrocolloid adhesives 
• 
Patient has present skin damage preventing them from wearing a study device 
• 
 Patient discharges to a skilled nursing facility, or other subacute facilities 
• 
Pregnancy 
 

24 
 
4.2.2 Providers 
All members of the clinical care team staff will be asked to participate in the implementation of the 
project. We will include clinical team involved in the caring for ileostomy patients. We will recruit a total 
of 10 providers to participate in the semi-structured interviews.  
4.3 
Informed Consent Procedure 
4.3.1 Patients 
The research coordinator is responsible for explaining the study to potential and willing participants. The 
consent process begins once the participant is interested in being enrolled in the study. At this time, the 
research coordinator will conduct a thorough review of the consent details, including study procedure, 
risks, confidentiality, etc. with the potential participants. Participants will be given adequate time to 
think about their decision to participate without under coercion on the part of the researchers. Whether 
a patient wishes or not, to be enrolled, that patient’s medical care will not be affected. No consent will 
be completed if the participants have unanswered questions, and potential participants may talk over 
the details with the consent with whomever they wish, prior to giving consent.  
Participants will need to be consented in a face-to-face meeting with the research coordinator and if 
they wish to obtain a copy of the consent, they are free to do so. If there is a change in the consent 
during ongoing study activities, the participant may be asked to re-consent, if changes will have a direct 
effect on the participant.  
The research coordinator is responsible for explaining the study to potential and willing participants or 
to their Legally Authorized Representative (LAR). The consent process begins once the participant is 
interested in being enrolled in the study. At this time, the research coordinator will conduct a thorough 
review of the consent details, including study procedure, risks, confidentiality, etc. with the potential 
participants or if applicable, with their LAR. Participants will be given adequate time to think about their 
decision to participate without coercion on the part of the researchers. Whether a patient wish to be 
enrolled, that patient's medical care will not be affected. No consent will be completed if the 
participants have unanswered questions, and potential participants may talk over the details with the 
consent with whomever they wish prior to giving consent.  
Participants or when applicable, their LAR will need to consent in a face-to-face meeting with the 
research coordinator. If there is a change in the consent during ongoing study activities, the participant 
may be asked to re-consent if changes will directly affect the participant.  
 
If the participant cannot provide informed consent but are interested in the study, their LAR can sign the 
form on their behalf. The research coordinator will answer all study-related questions and communicate 
all study details before signing the consent form. In addition, the research coordinator will file all legal 
documents confirming LAR’s relation to the participant in the study binder.   

25 
 
During patient recruitment, if any of theapproached  eligible patients expresses interest in the study but 
is unwilling to participate in interviews, the research coordinator will present the no-interview consent 
form to patients as an alternative option. Once the no-interview group is full, patients will only be 
presented the consent form with interviews. 
 
As part of the informed consent process: 
1. 
The participant agrees to wear a total of 5 VCI VitalPatch for 7 days each adding up to 35 
total days of monitoring. The research coordinator will place the VitalPatch on patients 
when they are still hospitalized. Our goal is to collect 30 days of post-discharge data. 
2. 
The participant agrees to replace the VitalPatch every 7 days and to answer survey 
questions either daily (in the morning) or twice a day for the duration of the study in a 
timely fashion 
3. 
The participant agrees to follow directions on the pinpointIQ application 
4. 
The participant agrees to allow access to basic demographics, medical conditions, wearable 
and pinpointIQ platform data, other vital signs, medical care received during the 
hospitalization and subsequent 30 days, labs, medications, other procedures and surgeries, 
outcomes such as readmissions, surgical complications and mortality and clinical and 
nursing notes. 
5. 
Importantly, the research coordinator will emphasize that the physiological data are not 
being monitored continuously with the patient. Patients should still follow the instructions 
given by their care team on what symptoms should be reported immediately, and how to 
report them. 
6. 
Research coordinator documents informed consent process completion and files informed 
consent form 
7. 
VitalPatch is placed on participant and patch is paired with phone.  
8. 
Research coordinator teaches participant about VitalPatch, phone requirements, phone 
application and presents written information on wearing the devices and what is expected 
for the next 30 days 
9. 
For enrolled participants who are discharged over the weekend or discharged before 
research staff placed devices on them, research coordinators will mail the study kit and 
schedule a phone call to guide and educate patients on placing the patch and operating the 
study phone. The questionnaires or interviews may be completed over the phone if 
participants did not complete them before discharge.   
10. 
Participant agrees to complete required self-reported questionnaires and interviews if 
applicable. 
11. 
Participant agrees to mail back the phone and any unused supplemental patches in a pre-
paid mailer 
 
Once the patient agrees to the study, the patient will sign the consent form the next day. We will give 
every patient at least 24 hours to decide whether or not they are willing to participate in the study. The 

26 
 
research coordinator will follow up with potential participants after 24 hours. We will scan the signed 
consent form into EPIC and link the patient’s chart to the study. 
 
However, starting on 4/19/2021, the research team noticed that someileostomy patients were admitted 
over the weekend but discharged the following Monday. For sampling purposes, we will include these 
patients in the study. For patients who require a phone consent, research coordinators will follow the 
below process: 
1. Research coordinators will approach the eligible patients the day of discharge, introduce 
the study, and go over the consent form with patients 
2. Research coordinators will provide the patient with two copies of the consent form and 
a pre-paid mailing envelope  
3. Research coordinators will schedule a follow-up phone call with the patient for the next 
day 
4. Research coordinators will call patients the next day and answer any remaining 
questions the patients and caregivers might have about the study 
Suppose the patient is agreeable to participate in the study. In that case, the research 
coordinator will either (a) ask the patient for their email address and send a copy of the 
consent form to the patient’s email address via part 11 compliant DocuSign. The research 
coordinator will review the consent form with the patient over the phone and have the 
patient sign via DocuSign. Research coordinators and the patient will both receive a signed 
copy of the consent form. Research coordinators will schedule to overnight the study kit to 
the patient. (b) If the patient does not have an email address, the research coordinators will 
ask the patient to sign the consent form they received at discharge, and mail back the 
consent form using the prepaid mailing envelope provided by the research team. Upon 
receiving the signed consent form, coordinators will overnight the study kit to the patient. 
5. Once the patient receives the study kit, the coordinators will call the patient to guide 
them to put on the patches and pair the phone.  
6. Coordinators will also complete required questionnaires and interviews over the phone 
with the patient  
 
 
4.3.1 Providers 
The research coordinator will be responsible for the consent of the clinical team staff for enrollment in 
this study. The consent process begins once the participant is interested in being interviewed for the 
study. At this time, the researcher will conduct a thorough review of the consent details, including study 
procedure, risks, confidentiality, etc., with the potential participant. It is assumed that working providers 
in the field will be mentally capable of participating in the study; therefore, no screening measures will 
be undergone to obtain eligibility. Researchers and investigators will be available to answer any 
questions the professionals have prior to consenting. The consent must be done in a face to face 
meeting or via video conferencing by the researcher and the clinician. If consent is done through video 
conference, a signed consent form will still be collected by the research coordinator.  

27 
 
4.4 
Semi-Structured Interview Process 
4.4.1 Patients 
After obtaining informed consent, the research coordinator will set up a time to complete the 
questionnaire and a 30-minute semi-structured interview with the patient before discharge. Patients will 
be asked at the time of consent if they are willing to provide an email address for reminders and 
updates. After 30 days of remote monitoring, the research coordinator will contact patients via phone to 
complete the survey.  
At the study endpoint, the research team will make three phone attempts to reach the patient on 
different days and times. If unable to reach the patient, the patient will then be contacted by their 
provider to remind them of completing the survey and interview if applicable. 
Before the interview starts, the researcher will remind the participant not to use their name during the 
interview as it will be recorded.  These interviews will be transcribed and then de-identified by study 
staff.  They will also be reminded that recording is required for participation. 
4.4.2 Providers 
Upon signing the consent forms, the research coordinator will complete a self-administered survey and 
interview with the clinical team staff. After completion of the study, the research coordinator will send 
out a questionnaire link to the clinical staff to complete within five business days. The research 
coordinator may set up an appointment with the clinical team to complete the questionnaire via phone 
if the survey is not sent back, or if the survey contains skipped or missing questions. At the study 
endpoint, the research coordinator will set up appointments with the clinical staff for a 30-minute 
interview.  
Before the interview starts, the researcher will remind the provider not to use their name during the 
interview as it will be recorded.  These interviews will be transcribed and then de-identified by study 
staff.  They will also be reminded that recording is required for participation. 
4.5 
Record keeping and transcripts 
The interview recordings will be sent to a transcription service company with whom the research team 
has a strong working relationship. The transcription service company have a secure server for uploads of 
recordings and delete them after transcription is complete. If any patient’s name is recorded on the 
transcripts, we will have the transcription service replace the name with an abbreviation instead. 
Transcripts will be scrubbed of PHI during transcription and will be given a study ID number.  Quality 
control to make sure all PHI has been removed from each transcript will be conducted by the Research 
Coordinator prior to analysis.  The final transcripts will be analyzed by the study team. The list that links 
the transcripts to the research participants will also be stored on the secure collaboration portal. The 
recordings will be deleted once they have been transcribed and analyzed. The key for the study ID 
numbers will be destroyed once the analysis is complete.  

28 
 
4.6 
Provisions to Protect the Privacy Interests of Participants 
All study information will be stored on NorthShore University HealthSystem password-protected, 
encrypted computers and servers that are password protected. All of these will be stored in locked 
rooms and will not be accessible to those outside the study team 
 
Patients will be given a unique study record number that is not their medical record number. This 
unique record number will be given to physIQ for entering into their portal. No identifying information 
will be provided to physIQ. The key that identifies the unique study record number to the patient MRN 
will only be kept by the study team and by the NorthShore teams that operationalize the study (CAPE 
navigators, monitoring nurse and the clinical care team). 
 
In order to protect participant privacy, the research coordinator’s phone number and office address will 
be registered on the physIQ pinpointIQ portal for each participant. PhysIQ’s technical support team will 
contact the research coordinator with the subject ID to inform the research team of noncompliance use 
of device. The research coordinator will call participant to review device usage instruction and provide 
technical assistance as needed. 
 
No PHI will be provided to physIQ and other study team members outside of NorthShore. The study 
team will collect patient name, MRN, date of birth, phone number for the purpose of conducting the 
study. All patient information will be aggregated during study analysis and no identifiers will be provided 
in the analysis.  
 
Upon study completion all study data will be destroyed, and verification will be provided to data 
governance.  
 
During informed consent and enrollment, the study coordinator will make sure that patients are alone 
or in a room with family members that the patient agrees to participate in decision making around the 
study. The door will be closed, and any study-related information will be paused when other staff or 
visitors enter the room. We will allocate 1 hour for consent, and if required, we can extend the amount 
of time to make sure that the patient has all their questions answered and privacy maintained. 
4.7 
Compensation and Economic Burden to Patients and Providers 
There is no economic burden to patients who choose to participate in this study for the devices and 
remote monitoring. Participants will be responsible for all routine care if incurred, including home 
health, counseling by nurses and care providers, office visits, diagnostic tests and procedures, ER visits, 
and hospitalizations. If a participant is at risk of hospital readmission or has worsening conditions that 
require medical attention during the study period, in that case, participants will be responsible for all 
standard of care payments incurred during their escalation process. 
Patients enrolled in the Ileostomy cohorts who complete all interviews with the study team will be 
provided a gift card as compensation for their time and participation. 
There is no economic burden to care team members who choose to participate in the interview other 
than time spent answering questions to evaluate the process and wearable solution. We will provide a 
gift card to the providers as compensation for their time and participation. 

29 
 
 

30 
 
5 
DATA MANAGEMENT 
5.1 
Data Security 
Survey data will be recorded and managed using REDCap. REDCap will contain only a subject ID, assigned 
by the research coordinator. The PI, research coordinator and data scientist will maintain the only linking 
document between study ID and patient name. It will be password protected and stored on Northshore 
University HealthSystem’s secure internal server.  During the study period, the operational team will also 
receive access to the linking information to identify which patients are in the pinpointIQ portal. Other 
study team members will not have access to the key. 
PhysIQ’s solution, including wearable devices, mobile device and cloud platform on Microsoft Azure was 
evaluated and approved by data security (HIT) as part of a prioritized active project. No PHI will be 
uploaded to the physIQ platform. The vital and alert data will be transferred back to NorthShore for 
storage using an sFTP. PhysIQ’s telemonitoring platform will be used for the study procedure. PhysIQ 
will not receive any protected health information.  
PhysIQ operates in line with both HIPAA and GDPR. Neither HIPAA nor GDPR support an external authority 
that can formally attest to compliance, but physIQ does operate and measure its internal security and 
privacy program against both frameworks and is operating in line with each. 
There are three (3) core components of the physIQ product; 1) a 3rd party disposable patch worn by the 
patient, 2) a physIQ supplied mobile phone running as a data hub, and 3) a web browser-based clinical 
portal for viewing analytics and raw data. The data flow within these basic components is secure at all 
time. No sensitive and/or protected data resides in the physIQ offices nor on the corporate network. 
The sensor patch collects physiological data (not considered PHI) and through a 128-bit encrypted 
Bluetooth offload, transmits that data to an Android-based, dedicated lockdown (kiosk) mobile phone, 
which is validated and approved to interface and collect patient data. The device is provided by physIQ; 
this is not a bring-your-own-device (BYOD) system. In kiosk mode this device runs only the physIQ mobile 
application with no ability to make calls, SMS text, nor internet browsing. All Bluetooth offloaded 
physiological data is stored in Android’s encrypted memory. Furthermore, all data is deidentified; there is 
no PHI on the mobile device. The phone is assigned a “node ID” in the cloud platform which functions as 
the alias and link to the specific phone. Uploads are made to the cloud with the node ID credentials. The 
mobile phone then uploads the data through cellular connection to physIQ’s Google Cloud Services (GCS) 
cloud platform. 
The physIQ cloud architecture includes service relationships with certified partners. The production (VPC) 
stack is in GCS, with the back-up snapshot in Amazon Web Services (AWS). The physIQ platform is an 
isolated GCS network inside which servers communicate with limited pinholes to the outside world. Port 
443 is the “front door” and uses TLS encryption for all traffic. All data exchange is sanctioned and handled 
by the API. physIQ’s product is entirely API-enabled. Mobile phone (node) uploads of data and Clinical 
Portal browser sessions are both API calls. There are also two (2) VPN “back doors” for occasional 
maintenance of the VPC and for the read-only requests from AWS for back-ups.  
Other cloud security measures include; role-based-access-controls (RBAC) for all URL routes in the API and 
inside the product, all data-at-rest in GCS and AWS is encrypted by default schema, all patients in the 

31 
 
system are known by GUIDs and identity data is stored separately from medical data, and all servers (VMs) 
are instances of a security-hardened image  
Carnegie Mellon University (CMU) is a collaborating site and will have access to de-identified and date 
shifted patient and healthcare provider information. No HIPAA identifiers will be included in the data 
shared with CMU. Collaborators at CMU will be involved in developing and evaluating the 30-day 
readmission prediction model. Deidentified and date shifted data will be transferred to CMU over a 
Secure Sockets Layer (SSL) using a HIPAA compliant File Transfer Protocol (FTP). Data will be stored at 
NorthShore and at CMU on password-protected, encrypted computers. All research team members and 
graduate and doctoral students working with the data will complete Human Subjects Research 
certification. After completion of this project, all data at both NorthShore and CMU will be destroyed.  
5.2 
Protection of Participant Privacy 
Patient Privacy – During this study, non-invasive wearable devices will be provided to patients to collect 
continuous physiologic data. PhysIQ’s solution, including wearable patches, mobile device and Microsoft 
Azure cloud platform comply with the administrative safeguards and implementation specifications 
described in 45CFR§164.308, with respect to HIPAA. No PHI will be uploaded to the physIQ platform.  
The physiological data upload via digital cellular network is secured with TLS cryptographic protocol 
between the mobile phones and the server.  The physIQ platform is securely hosted in the Google cloud.  
The physIQ cloud stores the raw physiological telemetry data captured by the study device, and also 
stores analytical results generated by running that raw data through the physIQ Analytics Modules. All 
the telemetry and analytical results are stored separately from any personally identifiable information 
(PII) that an institution might choose to enter in the system.  There is no requirement to enter PII to use 
the platform, as all data can be tracked solely by random ID as well. PHI will not be transmitted to 
physIQ for this process and the only data that will be transmitted is a random study ID generated at 
NorthShore. NorthShore will maintain the key to the identifier. The data can only be obtained or viewed 
via secure authenticated login. 
The physiologic, alert, and patient reported status data will be transferred back to NorthShore for storage 
using a sFTP. Data from wearable devices and physIQ platfrom and EHR data from NorthShore will be 
linked, deidentified using standard NorthShore protocol prior to transfer to CMU via secure FTP. There is 
an existing Data Use Agreement in place between NorthShore and Carnegie Mellon University (CMU) 
which will be renewed for this project. Only the PI at NorthShore and Co-PI at CMU will have access to the 
sFTP site. Only named study personnel will have access to data. PhysIQ will not have access to any PHI. 
Northshore and CMU will delete all data after study termination. 
 
 

32 
 
6 
DEVICE INFORMATION 
 
COMPANY ADDRESS:   physIQ, Inc. 
200 West Jackson Blvd., Suite 550 
Chicago, IL 60606 
6.1 
DEVICE DESCRIPTION: 
The pinpointIQ Solution is a wireless remote patient monitoring system intended for use by healthcare 
professionals for continuous collection of physiological data in home and healthcare settings.  The 
pinpointIQ Solution consists of clinical-grade wearable sensors such as the VitalPatchTM Sensor (a 510k-
cleared disposable patch with integrated biosensors and a wireless transceiver) and the physIQ Platform 
(a mobile application for secure data transmission, cloud-based information-technology [IT] 
infrastructure, physiology analytics modules, and clinician user interface).  The patch is worn on the 
torso for up to 5 days and measures and records physiological variables that can include, but are not 
limited to, electrocardiography (ECG), vital signs and activity.  Data are transmitted wirelessly from the 
VitalPatchTM Sensor to the physIQ cloud for storage and analysis and presentation within the clinician 
user interface.  
 
INVESTIGATIONAL DEVICE: 
Device Description 
PinpointIQ is a wireless remote monitoring system intended for use by healthcare professionals for 
continuous collection of physiological data in home and healthcare settings.  PinpointIQ consists of: 
 
VitalPatchTM Sensor (chest-worn disposable biosensor patch) 
 
Mobile application (“app”) for secure data transmission 
 
Cloud-based IT infrastructure 
 
Physiology Analytics modules, comprising: 
o Personalized Physiology Analytics 
o Vital Sign Feature Analytics 
o Heart rhythm analytics 
o Actigraphy analytics 
o Clinician-defined rules 
 
Browser-based clinician user interface 
 
Biosensors 
Vital Connect VitalPatch 
VitalPatchTM (Vital Connect Inc) is an FDA 510(k)-cleared, wearable adhesive Band-Aid-like multi-sensor 
device which will be used to stream and collect continuous vital sign data from patients. The device is a 
disposable adhesive patch with an integral one-time-use battery and integrated electronics. The battery 
life of each disposable adhesive patch lasts about 7 days.   
The VitalPatchTM is generally applied to the skin of the patient’s left upper chest (worn diagonally on the 
chest above the heart or laterally on the rib cage just below the heart). Further VitalPatchTM description 

33 
 
and instructions for that application are shown in an attached document.  VitalPatchesTM can be worn 
continuously, including in the shower.  VitalPatchesTM should be replaced when adhesion or the battery 
fails.  In addition, physIQ recommends considering the use of UNI-SOLVE wipes to assist in the removal 
of the VitalPatchTM.  
6.2 
Data Transport via physIQ Android Mobile App and physIQ Platform 
The physIQ Android mobile app is loaded onto an Android-based phone or tablet mobile device.  The 
mobile device offloads vital sign data from the VitalPatchTM (via low energy Bluetooth) and uploads it 
using digital cellular or WiFi network to the cloud-based server. In addition to transmitting physiological 
data, the app also may present questionnaires to the patient that are answered directly within the app.  
Upload via digital cellular network is secured with TLS cryptographic protocol between the mobile 
phones and the server.  The physIQ platform is securely hosted in the Google cloud.  The physIQ cloud 
stores the raw physiological telemetry data captured by the study device, and also stores analytical 
results generated by running that raw data through the physIQ Analytics Modules. All the telemetry and 
analytical results are stored separately from any personally identifiable information (PII) that an 
institution might choose to enter in the system.  There is no requirement to enter PII in order to use the 
platform, as all data can be tracked solely by random ID as well. PHI will not be transmitted to physIQ for 
this process and the only data that will be transmitted is a random ID generated at NorthShore. 
NorthShore will maintain the key to the identifier. The data can only be obtained or viewed via secure 
authenticated login. 
6.3 
Analytics 
The study will utilize physIQ’s multivariate analytical methods that learn the behavior of an individual 
patient’s vital signs at a baseline, and then detect changes in the behavior of the vital signs compared to 
the baseline.  Changes in vital signs relationships may be indicative of current or future important 
clinical events.   These changes are indicated through the Multivariate Change Index (“MCI”), which is a 
scalar index between 0 and 1, where values close to 0 indicate no significant change from baseline and 
values close to 1 indicated greater changes from baseline.   
Additional “feature” analytics include atrial fibrillation detection, arrhythmia (ectopic beat) burden, 
Cheyne-Stokes respiration, sleep quantification, and walking detection.   Clinician-defined rules include 
applying thresholds to time series vital signs, sleep fragmentation, tachycardia, bradycardia, A-Fib with 
RVR, elevated respiration rate, and long-duration horizontal posture.  
6.4 
Regulatory Status    
This study is considered a non-significant risk (NSR) Investigational Device Exemption (IDE) study 
according to 21 CFR §812.2(b) to evaluate the clinical utility of PhysIQ vital patch solution. All FDA-
cleared devices in pinpointIQ will be used according to their intended use.  The components of this 
system and clearance status are described below:  
1. VitalPatch wearable biosensor:  FDA 510k-cleared Class II-regulated medical device – 
Vital Signs Biosensor (K190916) 
2. PhysIQ Cloud-based IT platform (physIQ mobile app, IT platform, Clinician User Interface): 
FDA Class I-regulated medical device – Medical device data system 

34 
 
3. PhysIQ Personalized Physiology Analytics: FDA 510k-cleared Class II-regulated medical 
device – Multivariate Change Index (K142512) 
4. PhysIQ feature analytics:  FDA 510K cleared Class II-regulated medical device – heart 
rate, heart rate variability, respiration rate and atrial fibrillation detection (K183322) 
5. PhysIQ actigraphy analytics: FDA Class-I-regulated medical device – walking, steps, 
posture, sleep, body tilt, gross activity, activity stratification.  
 
Potential Risks and Benefits 
When used in accordance with the clinical protocol, risks associated with pinpointIQ are 
considered low. To ensure proper use of the solution, subjects, patients and providers will be 
trained in accordance with the manufacturer’s instructions for use. In addition, clearly defined 
study eligibility criteria have been established to ensure that only appropriate patients are 
enrolled in the study. 
The potential risks of VitalPatch may include the following: adverse skin reactions, skin 
irritations, mild soreness, redness (see attached IFU). 
 
Device Packaging, Labeling and Use 
The VitalPatchTM and mobile phone will be shipped as a kit to NorthShore in the care of the 
PI/research coordinator. Device components will be labeled “For Prescribed Use in a Clinical 
Trial” and packaged by physIQ according to applicable regulations. Upon completion of data 
collection, the subject will mail back all study equipment in a pre-paid mailer that was provided 
in the kit. PhysIQ and NorthShore research team will maintain device accountability records for 
each study site and for each subject enrolled, pursuant to 21 CFR§812.110 and Good Clinical 
Practices (GCP). 
 

35 
 
7 
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Methods. Thousand Oaks, CA: SAGE Publications Inc; 2001 

39 
 
8 
APPENDIX 1 – PATIENT QUESTIONNAIRE & INTERVIEW 
 
8.1 
Demographic Survey (Ileostomy Cohort – Pre) 
 
What is your gender? 
1. Female 
2. Male 
3. Other (specify) :_______ 
 
Do you consider yourself to be of Hispanic, Latino/a, or Spanish origin? 
1. Yes 
2. No 
 
Which racial group or groups do you consider yourself to be in? 
1. American Indian or Alaska Native  
2. Asian  
3. Black or African American  
4. Native Hawaiian or Other Pacific Islander  
5. White 
6. Other 
 
What is the highest degree or education level you have completed? 
1. Some high school 
2. High School 
3. Some college/Associate’s degree 
4. Bachelor’s degree 
5. Master’s degree or higher 
6. Prefer not to say 
 
What is your marital status? 
1. Single 
2. Married 
3. Separated 
4. Divorced 
5. Widowed 
 
How many people live in your household with you? 
 
What was your total household income before taxes during the past 12 months? 
1. Less than $25,000. 
2. $25,000 to $34,999. 
3. $35,000 to $49,999. 
4. $50,000 to $74,999. 
5. $75,000 to $99,999. 
6. $100,000 to $149,999. 
7. $150,000 or more 
 
 

40 
 
8.2 
Self-Care Self-Efficacy Scale (Ileostomy Cohort – Post only) 
 
In general, how confident are you that you can:  
(Circle one number for each 
statement) 
1. Keep yourself stable and free of symptoms? 
1 
2 
3 
4 
5 
2. Follow the treatment plan you have been 
given? 
1 
2 
3 
4 
5 
3.  Persist in following the treatment plan   
even when difficult? 
1 
2 
3 
4 
5 
4. Monitor your condition routinely? 
1 
2 
3 
4 
5 
5. Persist in routinely monitoring your 
condition even when difficult? 
1 
2 
3 
4 
5 
6. Recognize changes in your health if they 
occur? 
1 
2 
3 
4 
5 
7. Evaluate the importance of your symptoms? 
1 
2 
3 
4 
5 
8. Do something to relieve your symptoms? 
1 
2 
3 
4 
5 
9. Persist in finding a remedy for your 
symptoms even when difficult?  
1 
2 
3 
4 
5 
10. Evaluate how well a remedy works? 
1 
2 
3 
4 
5 
8.2.1.1.1.  
 
© Dr. Barbara Riegel  
 
Device related questions: 
In general, how confident are you that you can: 
1. Continuously wear the device for 30 days? 
2. Follow the research study protocol for 30 days? 
 

41 
 
 
 

42 
 
Enrichd Social Support Instrument (Ileostomy cohort – Pre) 
 

43 
 
8.3 
Monitoring Process Random Question Bank 
 
Week 1 
 
I had difficulty learning to use the devices. 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
I felt safe being monitored through the system. 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
Week 2 
 
I experienced problems with the patch. 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
I felt reassured seeing my data on the phone. 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
Week 3 
 
I experienced problems with the phone application. 
 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
I felt more self-conscious of my symptoms as a result of the monitoring. 
 
o 
Not at all 
o 
A little bit 
o 
Somewhat 

44 
 
o 
Quite a bit 
o 
Very much 
 
Week 4 
 
Using the system requires a lot of technical support. 
 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
Using the devices helped me overall. 
 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
Week 5 
 
I am excited to be using a device to monitor my health.  
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
 
I think using devices to monitor my health is an advance in modern medicine. 
 
o 
Not at all 
o 
A little bit 
o 
Somewhat 
o 
Quite a bit 
o 
Very much 
8.4 
User Experience Survey (Ileostomy Cohort – Post) 
(5 point likert scale, 1=strongly disagree, 3=neither disagree/agree and 5=strongly agree) 
Definition of application: The mobile phone application downloaded on the smart phone. It is used by 
participant’s to respond to survey questions. 
Device 
1. I could use the patch anytime and anywhere throughout my daily life.  
2. The patch is easy to replace. 
3. The application is easy to use. 

45 
 
4. The patch makes me feel more secure. 
5. Using the application makes me feel more secure. 
6. I have doubts using the patch in the future. 
7. I have doubts using this application in the future. 
Home Health 
8. The home health nurses are responsive to my questions and concerns. 
9. My home health nurses are interested in my health.  
10. The instructions given by my home health nurses are easy to follow. 
11. I am satisfied with the amount of communication I receive from the home health nurses. 
12. I am satisfied with the quality of my interactions with my home health nurses. 
Clinical Care Team 
13. The care team is responsive to my questions and concerns. 
14. My care team is interested in my health.  
15. The instructions given by my care team are easy to follow. 
16. I am satisfied with the amount of communication I receive from the care team. 
17. I am satisfied with the quality of my interactions with my care team. 
Program 
18. I am satisfied with the remote monitoring program. 
19. The remote monitoring program allows me to stay better connected to my care team. 
20. The remote monitoring program helped me eat healthier. 
21. The remote monitoring program helped me take my medications on time. 
22. Participating in this program makes me feel more secure in detecting problems with my health 
in general.  
23. Participating in this program helped me stay out of hospital. 
24. I would recommend this program to other patients. 
 
8.5 
Stoma Quality of Life (Ileostomy Cohort – Post) 
 

46 
 
 
 

47 
 
 
8.6 
Semi-Structured Interviews 
Definitions 
Wearable Device: Electronic devices that a person can wear, like Fitbits and smartwatches (applewatch, 
Samsung watch), and are designed to collect someone’s personal health and exercise data, like how 
many steps you walked, or how fast your heart is beating.  
Telemonitoring: Clinical providers using information technology, such as phone calls, video calls, chat 
functions, to monitor patients at a distance.  
 
8.6.1 Ileostomy Pre-discharge Interview 
 

48 
 
Example of questions 
Example of probing questions 
What is your previous experience with using wearable 
devices? 
 
If no experience, probe why  
 
Did you find it useful? How was it useful? 
 
What were some of the challenges with it? 
 
What is your previous experience with 
telemonitoring? 
 
If no experience, probe why 
 
How did you feel about the telemonitoring? 
 
What were some of the challenges with 
telemonitoring? 
 
Can you describe your experiences living with XXX 
prior to the surgery? 
 
How do you manage your health conditions at home? 
 
Is there anything you do related to diet or 
medications? 
 
Tell me about some of the challenges with … 
 
Are your family/friends involved with 
managing your health? 
How do you feel about … 
What happened leading up to this ileostomy 
procedure? 
 
What physical symptoms of your illness did 
you experience? 
 
Who participated in the decision to go 
through with this procedure? 
 
What did they say? 
 
How do you feel about being in the hospital? 

49 
 
We know that managing your health condition could 
be very expensive.  
Can you give us some examples of what those 
expense are?  
Has that been a problem for you? 
 
Can you give us some examples of how you 
have dealt with those expenses? 
Can you describe your initial reaction to the stoma? 
 
In what way, if any, do you think participating in this 
study might be beneficial to you? 
 
 
How do you feel about the upcoming discharge? 
Negative feelings – Why? 
Positive feelings – Is being enrolled in the study part 
of the reason (of the positive feelings)? Why? 
 
Is there anything you would like to add? Or is there 
anything else you would like to discuss?  
 
 
8.6.2 Ileostomy Study Endpoint Interview 
 
Example of questions 
Example of probing questions 
Device 
 
Tell me about your experience using the device.  
How was the patch/phone/physIQ app? Tell me more 
about that.   

50 
 
Home Health 
Home health nurses are the nurses from Home Health 
that visits you at your house. 
Tell me about your experience working with the 
monitoring nurse.  
Were there any challenges?  
Please tell me more about that.  
Do you think the monitoring nurse have good 
awareness of your needs? 
Why or why not? 
In what ways, if any, did working closely with the 
monitoring nurse impact your health? 
 
Why or Why not? 
Care Team 
Clinical Care Team are the physicians, physician 
assistants, nurse practitioners and nurses who took care 
of you during hospitalization. 
Did your surgery team contact you, or did you contact 
your csurgery team during the 30 day remote 
monitoring period? 
Yes  Complete Care team question session 
No Skip entire Care team session 
Tell me about your experience working with the clinical 
care team (for the past 30 days) 
Were there any challenges?  
Please tell me more about that. 
 
In what ways, if any, did working closely with the 
clinical team impact your health? 
Why or Why not? 
Stoma 
 
Can you describe how daily life is now with the stoma? 
How does the change impact your social life? 
How does the change impact your work? (if applicable) 

51 
 
How would you compare your experience now with life 
prior to the colorectal surgery? 
 
Program 
By program, we mean the whole experience wearing 
the devices, interacting with home health, and clinical 
care team. 
What was it like to be part of this program? 
 
How practical do you think the program is? 
Were the instructions easy to follow? 
Were the daily requirements easy to complete? 
Why or why not? 
What do you think about the discharge care you 
received for the past month? 
 
 
Do you feel like this study prevented a hospital 
readmission?  
(Skip if patient is readmitted) 
Why or why not? 
Please walk me through how you (or your caregiver) 
managed your ostomy while enrolled in the program? 
Tell me more about that. 
 
Has being in this program led to any changes in how 
you feel about your ostomy? 
What kind of changes? Tell me more about that. 
Do you feel stressed about having an ostomy? 
Did the study help you reduce stress for the 
past month?  Why or why not? 
Do you feel down or depressed about having an 
ostomy? 
Did the study help you reduce depressing 
feelings for the past month? Why or why not? 

52 
 
Has the study made you feel more secure in the past 
month? 
Why or why not? 
Has the study empowered you to own and mange your 
care? 
Why or why not? Or How/In what ways did it… 
Were your family or friends assisting you with the 
devices? 
How does your family/friends feel about the program? 
Do they feel like the program is practical? Why or why 
not? 
Does it help ease burden of care? Why or why not? 
Do you think you could have done the study without 
their assistance? 
Please walk me through your feelings towards using the 
devices in the past month. 
(Ex. Enthusiastic in the beginning  felt bored later or 
worried at the beginning  felt comfortable later) 
 
I want to ask you a question for you to help us. How do 
you think we could make this program better? 
 
Is there anything you would like to add? 
 
 

53 
 
9 
APPENDIX 2 – PROVIDER SURVEY AND INTERVIEW 
 
9.1 
Study Start point (Demographic Survey + Interview) 
Demographic Survey: 
 
1. Please tell me your position title: ________________ 
Interview at Study Start Point 
 
 
Example of questions 
Example of probing questions 
What experience do you have with telemonitoring? 
 
Yes  Tell me more about that 
No  No probe 
Vague response  Probe to see if they have 
telemonitoring experience (Experience during COVID-
19 pandemic) 
When you first heard about the program, what did 
you think about it? 
What do you think about the workflow/protocol? 
What do you think about the monitoring platform? 
 
In what ways, if any, do you think the program could 
be beneficial to your patients? 
 
Why or why not? 
What expectations, if any, do you have about this 
program as this relates to your work? 
 

54 
 
What supports do you think you will need, if any, 
withimplementing remote monitoring? 
What do you think it will take for us to continue 
offering this as standard of care? 
 
For clinical team: How do you feel about 
implementing patient remote monitoring with Home 
Health? 
For home health: How do you feel about 
implementing patient remote monitoring with the 
regular care team? 
Why or why not? 
What concerns do you have about this program, if 
any? 
 
Yes  Tell me more about that  
No  No probe 
Vague response  Probe  
Is there anything you think we should have asked you 
and didn’t? 
 
For colorectal providers: 
 
What are you experiences with taking care of 
colorectal patients? 
What about new ileostomy patients? 
Can you walk me through taking care of a typical 
ileostomy patient after discharge? 
What were some challenges with patient care? 
How do you think this study would help with patient 
care? 
Sometimes patients have difficulty with treatment 
plan adherence and as a result they adapt based on 
their life situations.  
 
What do you think about this? 
Is this frequent in ileostomy patients? 
What tactics do you use to assist with adherence? 
How effective do you think they are? 

55 
 
What are you thoughts on the study helping with 
patient communication? 
Do you expect the communication to be more 
targeted and efficient? 
What are your thoughts on the study helping patients 
(and or patient family) transition to this new life? 
 
 
9.2 
End Point (Survey + phone follow up if survey incomplete) 
 
Experience Survey 
(5 point likert scale, 1=strongly disagree, 3=neither disagree/agree and 5=strongly agree) 
1. I received adequate support to participate in the program. 
2. The platform was easy to use. 
3. The workload was manageable. 
4. The protocol made sense to me. 
5. The escalation process was easy to follow. 
6. I had problems communicating with some patients. 
7. For home health: I had problems communicating with the clinical team. 
For clinical team: I had problems communicating with the home health team. 
8. The program improved patient care effectiveness. 
9. The program improved patient care timeliness. 
10. For home health: I experienced moments of uncertainty.  
For clinical team: I experienced occasions of doubts concerning the severity of the patient’s 
condition.  
11. I felt like this program is an improvement to usual care. 
12. What are some challenges you experienced so far? ________________ 
 
9.3 
Study Endpoint (User experience survey + Interview) 
 
Remote Monitoring Platform User Experience  
(5 point likert scale, 1=strongly disagree, 3=neither disagree/agree and 5=strongly agree) 
1. I think that I would like to use the platform frequently. 
2. I found the platform unnecessarily complex. 
3. I thought the platform were easy to use. 
4. I think that I would need the support of a technical person to be able to use the platform. 
5. I found the various functions in the platform were well integrated. 

56 
 
6. I thought there was too much inconsistency in the platform. 
7. I would imagine that most people would learn to use the platform very quickly. 
8. I found the platform very cumbersome to use. 
9. I felt very confident using the platform 
10. I needed to learn a lot of things before I could get going with the platform. 
Interview Guide at Study Endpoint 
Questions: Do providers feel that the wearable-mediated post-discharge care was effective in 
preventing readmission in patients with postoperative ileostomy formation. 
 
Questions for providers 
 Probing questions 
Platform: 
1. How would you describe your experience in the 
program? 
 
- 
Could you describe that more in detail? 
- 
Was that helpful/unhelpful?  
 
2  What features or capabilities are important to you 
in a monitoring platform? 
 
- 
Why is ______ important for you?  
- 
What does it help with?  
- 
What if that feature did not exist? 
Program:  
 
2. How would you describe your experience 
with the program?  
- 
Please tell me more about ___________.  
3. What are your impressions of what patients 
think about the program? 
- 
Why do you think that? 
- 
How did patients respond to the program? 
 
4. In your opinion, what is the impact of this 
program on patients’ ability to manage their 
condition at home? 
- 
Medication management 
- 
Monitoring symptoms  
- 
Reach out to providers  
- 
Engaging family members 
- 
Diet management  
5. How was your experience communicating 
with enrolled patients in this program? 
- 
Tell me more about that 
- 
How did the program change how you 
communicate with your patients? 
6. How did the program change how you 
communicate with your patients? 
- 
Method of communication  
- 
Frequency 

57 
 
- 
How do you feel about the changes? 
- 
How did it impact how you did your job? 
7. How did participating in this program affect 
your work load?  
 
 
Monitoring nurse only:  
a. What was your experience with escalating 
patient cases to the care team?  
b. What changes, if any, would you suggest for 
the escalation pathway?  
Note to interviewer: provide visual aid to interviewer 
 
- 
Timeliness of provider responses 
- 
Ability to get ahold of the pt 
- 
Methods to get ahold of pt / provider  
Clinicians only:  
c. What is your experience with handling the 
escalation to your team?  
- 
How was your experience working with the 
monitoring nurses? 
Please tell me more about:  
- 
Timeliness of escalation 
- 
Communication between providers involved 
 
8. How do you feel about this remote 
monitoring program compared to usual 
patient care?  
- 
How did it differ?  
- 
How was it the same?  
 
9. How did you feel about patient adherence to 
this program? 
- 
Monitoring symptoms  
- 
Taking medications as prescribed 
- 
Following new changes to their care plan (e.g. 
P.T, medication changes, ect.)  
10. What supports do you think patients need to 
continue with remote monitoring work?  
 
- 
Who do you think should provide _______ 
support? / whose role is it to provide that 
support?   
- 
What type training do patients need?  
11. What is your opinion on the effectiveness of 
this program preventing hospital admissions? 
- 
Please tell me more about _____________.  

58 
 
 
 
12. What resources or support would you require 
to continue with remote monitoring work?  
 
- 
Staff support 
- 
Hospital support 
- 
Clinician education  
13. What changes would you make to this 
program?  
- 
Could you go into more detail about that?  
- 
How would that change help?