Patient-Centered Perioperative Care Through Mobile Application: Patient Engagement Prospective Cohort Study in Elective Cesarean Delivery Patients
Conditions: Cesarean Delivery
Sponsor: IWK Health Centre

 
 
 
Patient-centered perioperative care through mobile 
application: patient engagement prospective cohort 
study in elective Cesarean delivery patients 
 
Brief title: Patient-Centred Perioperative Mobile Application 
 
 
 
Study Protocol 
 
 
 
 
Principal Investigator: 
Xue Chen (Janny) Ke, MD, Anesthesiology Resident, Dalhousie University  
 
Supervising Investigator: 
Ron George, MD, FRCPC, Anesthesiologist, Associate Professor, IWK Health Centre 
 
Co-investigator: 
Lori Wozney, PhD, Centre for Research in Family Health, IWK Health Centre  
 
Research Coordinators: 
Lorraine Chiasson, B.Sc, MA, Department of Women’s and Obstetric Anesthesia, IWK   
   Health Centre 
 
Aryn Benoit, BA, MA, Department of Women’s and Obstetric Anesthesia, IWK Health Centre 
 
Site of Investigation: 
IWK Health Centre, Halifax, Nova Scotia, Canada 
 
Oct 15, 2018   
ID: IWK1023201 

 
 
 
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1. Research Problem 
With increasingly more complex surgical patients and the trend toward decreased hospital stay after 
operations, continuity of care and prompt management of symptoms and side effects perioperatively 
are ever more crucial. Our goal is to improve perioperative care with a patient-centred mobile 
application, starting with a pilot in patients undergoing elective Cesarean delivery. We have 
completed a research study where we created a prototype based on feedback from patients and 
anesthesiologists. In this study, we would like to learn about how patients use our mobile application 
after delivery and how the mobile application can be integrated into daily practice.  
 
2. Background Including Relevant Literature 
Perioperative care has been changing in terms of patient population, number of surgeries, and 
practice setting. With the aging population brings ever more complex surgical patients and increased 
need for surgeries. According to the Canadian Institute for Health Information (CIHI), comparing 
2005-2006 with 1995-1996, the total number of surgeries in Canada rose by 17.3% (1). With 
increasingly more complex surgical patients and the trend toward decreased hospital stay after 
operations, continuity of care and prompt management of symptoms and side effects perioperatively 
are ever more crucial. These changes have necessitated multidisciplinary collaboration and programs 
such as Enhanced Recovery after Surgery (ERAS) to facilitate comprehensive perioperative care in 
the outpatient setting. CIHI reports that giving birth is the most common reason for hospital 
admission, and that CD is the most commonly performed inpatient surgery (2). The average length 
of stay is 3.3 days (2), which means that most of the recovery process will be at home, giving an 
opportunity for mobile application to bridge recovery care in the outpatient setting. The Canadian 
rate of Emergency Room visits within seven days following CD is 8.7% (3), and it may improve 
outcomes to identify patients with complications earlier before they become serious.  
Mobile communication provides an immense opportunity for health care providers to connect with 
patients in the perioperative setting, presenting an accessible, versatile platform for care and 
research. Smartphone ownership is prevalent: the Canadian Wireless Telecommunications 
Association data shows the mobile subscribership to be more than 24 million (4). Despite the wide 
breadth of subscribers there have been few mobile applications directed at perioperative medicine.  
Our aim has been to design a mobile application for perioperative care. While our goal is to 
eventually build a multidisciplinary perioperative platform that can be easily customized to any 
surgery at any institution, we have chosen to focus on the obstetric anesthesiology perioperative of 
cesarean delivery patients due to the technology-savvy nature of this age group and the prevalence 
of the surgery. We have focused on obstetric anesthesiology as the healthcare provider in this study 
since there is little existing mechanism for routine surveillance of potential anesthesiology-related 
complications, such as permanent nerve injury from neuraxial techniques.  
Funded by the Dalhousie Department of Anesthesiology, Perioperative Medicine, and Pain 
Management, we have completed a pilot study “Designing a perioperative mobile application: pilot 
in anesthesiology postoperative care of cesarean delivery patients”. This qualitative, iterative design 
study involved three cycles of individual structured interviews with patients (total 15) and 
anesthesiologists (total 9). The interview explored participant perspectives about the role of mobile 
technology in perioperative care. Participants also interacted with the prototypes and gave feedback. 
Our previous study was the first completed to explore the use of mobile applications for cesarean 

 
 
 
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delivery patients. Interviews revealed that mobile technology can play a key role in bridging the gap 
in the perioperative care of cesarean patients, especially in providing reliable sources of information, 
identifying and following patients with complications, and research in perioperative outcomes. Our 
final prototype focused on timely, concise information and self-monitoring. This study has been 
presented as a poster at the 2017 Canadian Anesthesiologists’ Society Conference and is currently at 
the stage of manuscript preparation. 
The objective of this prospective cohort study is to build the mobile application (C-Care) and 
evaluate its feasibility in providing patient education and reminders for self-monitoring for cesarean 
delivery patients. We will measure the extent of patient engagement with our application through in-
app usage data, as well as receive quantitative and qualitative feedback regarding feasibility. By 
understanding user behavior and needs through questionnaires and application usage data, we could 
design more effective and tailored interventions for patients. Results of this study will help further 
development and implementation of an interdisciplinary mobile monitoring and communication 
platform for perioperative care.  
 
3. Study Objectives 
The primary objective is to measure patient engagement and obtain qualitative feedback on patient 
experience with the application (please see Methodology for outcomes).  
 
4. Hypothesis to be Tested 
No specific hypothesis will be tested.  
 
5. Study Design  
Thirty-six patients will be recruited on the day of delivery.  After consent, they will receive hands-on 
guidance to download the application from the mobile Application Stores and an overview of the 
application. The application contains topics relevant to Cesarean delivery and the recovery process, 
which the patient could access at anytime. Patient engagement with the application will be 
monitored (please see Methodology for details) anonymously for 30 days after delivery. On days one 
to five after delivery, patients will receive a short self-monitoring questionnaire (approximately 1 
minute). At the end of two weeks (14 days after surgery), patients will complete an online survey 
regarding overall satisfaction, potential impact on care, usability and feasibility problems. At any 
point during the study, patients can email us to report any problems with the application.  
 
 
 
 

 
 
 
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6. Sample  
6.1 Inclusion and Exclusion Criteria 
 
Inclusion criteria: 
Part 1 (screened by asking nurse) 
Patient scheduled for elective CD 
Age equal or greater than 18 
American Society of Anesthesiologists (ASA) Physical Status I-III (i.e. not in life-threatening 
situation) 
Part 2 (screened in person) 
Possesses an iOS Smartphone with active data plan and access to WiFi and self-reported use 
of it on a regular basis (at this stage in development, the mobile application prototype is only 
available on iOS) 
Self-reported proficiency with Smartphone and mobile applications 
Reported fluency in English 
Exclusion criteria: 
 Self-reported physical or psychiatric condition that may impair the ability to use the mobile 
application, answer questionnaires and surveys, and/or provide insights representative of the 
general population, such as blindness, under current influence of recreational drugs or 
alcohol.  
 
 
6.2 Sample Size and Justification  
While there is no specific guidance on the sample size of an iterative feasibility trial, a recent review 
showed that the median size of feasibility trials is 36 (5). We chose a sample size of 36 since it would 
provide us with a representative sample of feedback while being feasible (there is on average 10 
elective CD per week as a conservative estimate). 
 
6.3 Withdrawals  
The participant can withdraw from the study at any time.  
 

 
 
 
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7.  Methodology 
7.1 Overview 
Through a patient-driven design process, we have previously created a mobile application prototype 
for patient education and self-monitoring around the time of cesarean delivery. We have now been 
building this application to be freely available in the iPhone iOS Application Stores via Optio 
Publishing. A prototype can be accessed here [hyperlinked]. The developed application will be 
improved visually and more patient-friendly graphics and language, but will not have major changes 
in content.  
In this prospective cohort study, thirty-six patients will be recruited before their scheduled Cesarean 
delivery. After consent, a paper demographics questionnaire will be recorded, and patients will 
receive hands-on guidance to download the application from the mobile Application Stores and an 
overview of the application. The application contains optional topics relevant to Cesarean delivery 
and the recovery process, which the patient could access at any time. Each topic takes less than 2 
minutes to read through. 
Patient engagement with the application will be monitored. This includes the number of topics 
viewed, time of visit, and number of self-monitoring questionnaires completed. All this data is 
recorded anonymously within the application for 30 days after delivery.  
On the first day after the surgery, patients will receive an email welcoming them to the study with 
brief instructions about the questionnaires and surveys. On days one to five after delivery, patients 
will receive a short self-monitoring questionnaire (approximately 1 minute, through the app) to ask 
about important symptoms. Seven days after the surgery, patients will receive an email thanking 
them and reminding them of the upcoming survey. At the end of two weeks (14 days after surgery), 
patients will complete an online survey (open for one week) regarding overall satisfaction, potential 
impact on care, usability and feasibility problems. After four days, a reminder check in phone call 
will be performed. Standardized scripts for email and phone contact are found in Appendix 6. At 
any point during the study, patients can email us to report any problems with the application.  
Interim analysis will be performed after the completion of 18 patients. This will consist of ensuring 
that 50% or more of the patients have logged into the application more than once (the first log in 
will be orientation by the coordinator). If less than 50% patients logged in more than once, we will 
pause the study for prototype improvement.  
This study will be registered at clinicaltrials.gov.  
7.2 Outcomes 
Primary outcomes: 
From mobile application engagement metrics (within 30 days after delivery) 
1. Median number of information topics viewed per participant  
2. Median number and percentage of self-monitoring questionnaires completed (out of 5) per 
participant  

 
 
 
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3. Median number of total visits to the mobile application per participant  
From Survey (Appendix 4, fillable at two-three weeks) 
1. Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied) 
2. % participants who would recommend the C-Care App to other women undergoing 
Cesarean delivery.  
 
Secondary outcomes: 
From mobile application engagement metrics (30-day) 
4. Which topics were viewed the most (rank by topic name and by postoperative day) 
5. Which self-monitoring questionnaires were filled the most (rank by postoperative day 
number) 
6. Incidence of important potential anesthetic-related problems entered by the patient (pain, 
headache, weakness and numbness)  
7. Time of the day patient visited site (scatter plot of Nova Scotia time vs. # visits) – one visit 
= at least one interaction within app, e.g. opening a topic, navigating within app 
8. Time (Nova Scotia) of the day patient filled out the questionnaire 
9. Number of visits vs. postoperative day   
10. Median duration (number of days starting from delivery date until the last day of visit) 
patient interacted with application within 30 days. 
 
From survey (Appendix 4) 
1. % participant who responded “yes” to the question that C-Care App provided them with 
knowledge about 
a. Cesarean delivery and anesthesia 
b. potential complications to monitor for 
c. the recovery process after Cesarean delivery  
2. Anything the patient wanted to change about this application, such as in terms of content, 
navigation, appearance, and overall experience? (open comment box) 
3. If the patient did not use the mobile application, what were the reasons? (open comment 
box) 
4. How could we make the mobile application more helpful for the patient? (open comment 
box) 
5. What do patients think about the name of this App, "C-Care"? Do they have any other 
suggestions for our name/logo? 
6. Any other comments and/or suggestions (open comment box) 

 
 
 
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Survey design viewable at https://survey.nshealth.ca/TakeSurvey.aspx?SurveyID=724L5mm2 
 
Other qualitative feedback 
Patients can email the research team with any feedback, feasibility/usability problems, and 
suggestions at any time during the study period.   
 
7.3 Eligibility screening and Recruitment 
Relevant members of the health care team, including obstetric anesthesiologists, obstetricians, 
nurses, and resident physicians at the IWK Health Centre will receive information about the study 
and the patient recruitment process through emails and posters in the work area.  
Due to institutional logistical limitations, patients will be recruited day of scheduled delivery, before 
their surgery. Efforts will be made to contact the patient as early as possible prior to their surgery. A 
member of the patient’s health care team (circle of care) will ask the patient verbally for permission 
of the research coordinators to discuss with her potential participation in the study. The research 
coordinator will then screen for whether the patient meets the Part 1 of the eligibility criteria (please 
see 6.1). The research coordinator will then approach the patient in person to introduce her to the 
study, as well as complete Part 2 of the eligibility screening. If the patient is eligible, the research 
coordinator will give the patient full information about the study and answer any questions before 
obtaining informed, written consent. The research coordinator will use an infographic to help 
illustrate what the study involves (Appendix 7). If research coordinators are not available, Principal 
Investigator, Sub-investigator, and/or Supervising Investigator will talk to the patients and obtain 
informed consent. 
All research related discussions, including time to consider research participation, verbal explanation 
of the consent, time to read the consent and answering any questions that the subject may have 
about research, all occur before subjects are given any pre-medication. We note that consent for the 
surgical procedure itself can be obtained by the surgical staff the morning of the operative 
procedure. The Canadian Anesthesiologists‘ Society believes that pre-operative consent for clinical 
research in anesthesia may be obtained after admission to hospital on the day of the scheduled 
surgery provided that; 1) subjects are not under the influence of pre- medication, 2) risk to the 
subject and time commitment to the study are not significantly different from routine clinical care, 
3) after verbal explanation from the investigator and in the absence of the investigator, subjects are 
given time to read the information sheet and consider the risks and benefits. Subjects should have an 
opportunity to raise any further questions or seek clarification on any points concerning the nature 
of the study, alternatives, risks, benefits, etc, and 4) subjects who feel they are under duress, or 
require more time to make a decision, should be advised to decline participation in the study 
(Guidelines on the Ethics of Clinical Research in Anesthesia, www.cas.ca). 
If the patient agrees to participate, the research coordinator will proceed to explain more about the 
study and obtain consent. Patients who have marked functional limitations, or a self-reported 
physical or psychiatric condition that may impair the ability to participate in the interview process 

 
 
 
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will be excluded. All participants will be checked that they are able to understand the information 
about the study presented to them and appreciate their roles, benefits, and risks of participating in 
this study.    
 
7.4 Honorarium   
Participants will receive no reimbursement. There is no cost to participate in the study.  
 
7.5 Duration 
Patient engagement data within the application will be collected for 30 days.  
 
8.  Data Analysis 
Descriptive statistics will be performed. Continuous data will be presented as mean/median and 
standard deviation as appropriate. Thematic analysis will be performed on the qualitative data.  
Interim analysis will be performed after the completion of 18 patients. This will consist of ensuring 
that 50% or more of the patients have logged into the application more than once (the first log in 
will be orientation by the coordinator). If less than 50% patients logged in more than once, we will 
pause the study for prototype improvement.  
8.1 Demographics 
Patient characteristics to be collected and analyzed include age, gravidity, parity, education level, 
income, marriage status.  
8.2 Quantitative outcomes 
From mobile application engagement metrics (30-day) 
1. Median number of information topics viewed per participant 
2. Median number and percentage of self-monitoring questionnaires completed (out of 5) per 
participant  
3. Median number of total visits to the mobile application per participant  
4. Which topics were viewed the most (rank by topic name and by postoperative day) 
5. Which self-monitoring questionnaires were filled the most (rank by postoperative day 
number) 
6. Incidence of important potential anesthetic-related problems entered by the patient (pain, 
headache, weakness and numbness)  
7. Time of the day patient visited site (scatter plot of Nova Scotia time vs. # visits) – one visit 
= at least one interaction within app, e.g. opening a topic, navigating within app 
8. Time of the day patient filled out the questionnaire 
9. Number of visits vs. postoperative day   

 
 
 
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10. Median duration (number of days starting from delivery date until the last day of visit) 
patient interacted with application within one month. 
 
From survey 
1. Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied) 
2. % participants who would recommend the C-Care App to other women undergoing 
Cesarean delivery.  
3. % participant who responded that the C-Care App provided them with knowledge about 
a. Cesarean delivery and anesthesia?  
b. potential complications to monitor for?  
c. the recovery process after Cesarean delivery  
 
8.3 Qualitative outcomes 
From Survey  
1. Was there anything you would like to change about this application, such as in terms of 
content, navigation, appearance, and overall experience? (open comment box) 
2. If you did not use the mobile application, what were the reasons? (open comment box) 
3. How could we make the mobile application more helpful for you? (open comment box) 
4. What do you think about the name of this App, "C-Care"? Do you have any other 
suggestions for our name/logo? 
5. Please note here any other comments and/or suggestions. Thank you for your time! (open 
comment box) 
 
Qualitative feedback 
Patients can email the research team with any feedback, feasibility/usability problems, and 
suggestions at any time during the study period.   
Qualitative analysis will focus on comments on overall usability and identifying key issues and 
suggestions. Thematic analysis on global feedback, appearance, navigation, and content will be 
performed.  
 
9. Management of Personal Health Information and Study Data 
9.1 Collection of Personal Health Information 

 
 
 
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Personal health information (PHI) of patients are reviewed during the recruitment process in order 
to identify potential participants and ensure that they fit Part One of the Inclusion Criteria, which 
includes 
• 
Patient undergoing elective cesarean delivery 
• 
American Society of Anesthesiologists (ASA) Physical Status I-III (i.e. not in life-threatening 
situation) 
Once the participant fits the above inclusion criteria, only the name of the participant in order for 
the research coordinator to contact the patient in person regarding the study. Once the patient has 
consented, her name, phone numbers, email address, date of surgery, age, gravidity, parity, education 
level, income, and marriage status will be collected. 
All data collected will be anonymized so that there will be no PHI during data analysis and 
publication. Each participant will be identified by a unique code to log in to the mobile application 
that is randomly generated and the use of the app is blinded to the investigators. There will be no 
PHI transmitted or stored in the mobile application.  
 
9.2 Measures Taken to Protect Personal Health Information and Study Data 
 Controlled access: All electronic data will be securely stored on the secure H-drive in a 
locked office in the Department of Women’s & Obstetric Anesthesia at the IWK Health 
Centre, accessible only by research staff.  All study staff will have signed a Non-Disclosure 
Agreement Form and the IWK Health Centre Confidentiality Form. Paper data (consent 
forms) will be stored in a locked cabinet in the locked office in the Department of Women’s 
& Obstetric Anesthesia at the IWK Health Centre.  
 Removal of all personal identifiers in electronic data 
 Patients will receive a code to access their mobile application account, thus there will be no 
personal data collected or stored in the mobile application. The data in the mobile 
application will be compliant with Canadian privacy laws and encrypted. The application 
server will be outside of Canada but there will be no identifiable personal information 
contained on the application: patients will be given a unique 4-digit code to access the 
mobile application without having to register for any account.   
 The results of the study (prototypes, publications, posters, presentations) will not 
contain any personal data  
 
9.3 Storage and Retention of Personal Health Information and Study Data 
 All electronic data will be securely stored in a password protected file in a password 
protected computer on the H-drive in a locked office in the Department of Women’s & 
Obstetric Anesthesia at the IWK Health Centre, accessible only by research staff. Paper data 

 
 
 
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(consent forms) will be stored in a locked cabinet in a locked office in the Department of 
Women’s & Obstetric Anesthesia at the IWK Health Centre.  
 The mobile application will be compliant to Canadian and provincial privacy laws. An 
encrypted server will be used. The application server will be outside of Canada but there will 
be no identifiable personal information contained on the application: patients will be given a 
unique 4-digit code to access the mobile application without having to register for any 
account.   
 The survey will be emailed securely to the participants and their responses will be de-
identified and encrypted. Optio publishing (the company developing our mobile application) 
will not have any access to any identifiable information.  
 Relevant paper data will be scanned, de-identified then shredded.  All electronic data will be 
de-identified and kept for further research purposes, for five years after publication or until 
the end of application development, securely in the H-drive in a locked office in the 
Department of Women’s & Obstetric Anesthesia at the IWK Health Centre. Five years after 
publication, the data will be deleted permanently in accordance with IWK IT policy.  
 
 
 

 
 
 
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10. Timeline 
 
Task 
Deadline 
Ethics approval (minimal risk) 
Per REB approval, Aug 2018 
Development of iOS mobile application   
Completed June 2018   
Patient recruitment and data collection  
After ethics approval, starting approximately 
beginning of Aug 2018. The anticipated 
recruitment would be 5-10 patients per week. 
The study recruitment data collection period is 
estimated conservatively to be 3 months (ending 
approximately end of November 2018). 
Analysis, manuscript, knowledge translation  November 2018 – June 2019 
 
 
 
 
 
 
 
 
 
 

 
 
 
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11. Budget 
 
Item 
Description 
Cost 
Research coordinator 
(recruitment, consent, 
scheduling interviews, 
interviews and post-interview 
debriefing) 
In Kind from Department of 
Women’s & Obstetric 
Anesthesia 
$0.00 
iOS mobile application 
development  
(Internal Funding approved, 
from the Department of 
Anesthesia, Pain Management) 
Optio publishing  
$5000 
 
 
 
Total: $5000  
 
 
 
 
 
 
 

 
 
 
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12. Ethical Considerations 
12.1 Potential Benefits to Subjects and Others  
Patients may find the education topics within the mobile application helpful. The questionnaire may 
alert patients to potentially abnormal symptoms and seek early medical attention. The information 
gained from this study may be very helpful to other patients and patients may gain personal 
satisfaction from this. 
 
12.2 Potential Harms to Subject and Others and How They Will be Minimized 
This is a minimal-risk study. There is no adverse event, harm, or risk anticipated. In the unlikely 
event that a participant is distressed, the research team will thoroughly investigate the situation 
immediately and make the appropriate amendments and referrals, such as family doctor, counsellor, 
psychologist, and/or psychiatrist.  
 
12.3 Participant Withdrawal 
Participants can withdraw from the study at any time. Data with all personal information removed 
up to that point may be retained for data analysis.   
 
12.4 Alternative Treatments or Procedures  
Not applicable. 
 
12.5 Process for Seeking Consent and Assent.  
At the pre-op assessment either in the pre-anesthetic clinic or in the hospital, the patient who fits the 
inclusion criteria will be invited to participate in the study. Please see details in recruitment section 
above.  
 
 
 
 
 

 
 
 
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13. Appendices List 
• Appendix 1. Patient consent for study 
• Appendix 2. Demographic information 
• Appendix 3. Self-check questionnaire (days 1 to 5 after delivery) 
• Appendix 4. Survey (14 days after delivery, available for 7 days)  
• Appendix 5: App orientation guide 
• Appendix 6: Standardized email/phone scripts  
• Appendix 7: App study infographic 
 
 

 
 
 
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14. References  
 
1. Canadian Institute for Health Information. Trends in Acute Inpatient Hospitalizations and 
Day Surgery Visits in Canada, 1995–1996 to 2005–2006. 2007 Jan 10. Retrieved from 
https://secure.cihi.ca/free_products/cad_analysis_in_brief_e.pdf. 
2. Canadian Institute for Health Information. Inpatient Hospitalizations, Surgeries and 
Childbirth Indicators in 2013–2014. Retrieved from 
https://secure.cihi.ca/free_products/CAD_Hospitalization%20and%20Childbirth_Infoshee
t_ENrev-web.pdf 
3. Canadian Institute for Health Information. All-Cause Readmission to Acute Care and Return 
to the Emergency Department. Retried from 
https://secure.cihi.ca/free_products/Readmission_to_acutecare_en.pdf 
4. ComScore, Inc. Digital Future in Focus 2015 Canada. 2015. Retrieved 
from http://www.cwta.ca/wp-content/uploads/2015/06/Digital-Future-in-Focus-2015-
CANADA.pdf 
5. Billingham SA, Whitehead AL, Julious SA. 
An audit of sample sizes for pilot and feasibility trials being undertaken in 
the United Kingdomregistered in the United Kingdom Clinical Research Network database. 
BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.