The Impact of a Patient Education Tool on Parental Productivity and Anxiety: A Non-Randomized Control Trail
Phase: NA
Conditions: Appendicitis
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 1 of 10 
Version date: November16, 2021  
 
 
 
 
 
RESEARCH PROTOCOL 
 
Study Title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A 
Prospective Cohort Study 
 
Principal Investigator: Sherif Emil, MD,CM, Professor & Director; Harvey E. Beardmore Division 
of Pediatric Surgery, The Montreal Children’s Hospital, McGill University Health Centre  
 
Co-investigators:  
Hussein Wissanji, MD, MPH, Assistant Professor and Staff Surgeon; Harvey E. Beardmore 
Division of Pediatric Surgery, Montreal Children’s Hospital, McGill University Health Centre 
 
Julia Loyola, MD, Harvey E. Beardmore Division of Pediatric Surgery, Montreal Children’s 
Hospital, McGill University 
 
Nadia Safa, MD,CM, Resident, General Surgery, McGill University Health Centre 
 
 
Study Coordinator: Elena Guadagno, Harvey E. Beardmore Division of Pediatric Surgery, 
Montreal Children’s Hospital, McGill University Health Centre 
 
 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 2 of 10 
Version date: November16, 2021  
 
 
 
1 BACKGROUND AND STUDY RATIONALE 
1.1 Background 
 
Terminology regarding how to measure the patient and family experience when a child receives 
medical or surgical care varies and includes patient-reported outcome measures (PROMs), 
patient-reported experience measures, and patient satisfaction.1,2 Preoperative patient 
education and postoperative patient participation are key components of the multimodal 
enhanced recovery after surgery (ERAS) protocols, which are gaining force in elective surgical 
procedures and impact both surgical outcomes and patient-reported outcomes.3-5 However, 
ERAS protocols and standardized care pathways have rarely been adopted in pediatric 
populations, and there exists a paucity of high-quality literature examining outcomes 
associated with implementation of enhanced recovery programs (ERPs) in children.6,7 Pediatric 
ERAS implementation has been met with many hurdles, including accounting for physiological 
differences between adults and children, the divergence of specific disease incidences between 
adults and children, and bridging the knowledge from adult pathways to pediatric-specific 
diseases which have no adult analogs.8  Therefore, specific pediatric preoperative 
patient/family education and postoperative patient/family participation needs to be developed 
to achieve reliable pediatric ERAS protocols. Medical procedures are considered especially 
stressful for children and parents9. From over 5 million children that undergo elective surgery in 
North America each year, almost 75% of them experience considerable anxiety9. Child anxiety is 
associated with many problems beginning with less cooperation with the anesthetic procedure, 
higher needs for analgesic usage, post-operative pain, slower recovery, delays in hospital 
discharge, and changes in behavior during the post-operative period. Also, preoperative anxiety 
can affect children’s future interactions with medical personnel representing a long-term 
consequence. A major risk factor for children's distress is parental anxiety, which is also linked 
to physical and mental health problems for parents themselves9. Based on these findings, 
different interventions have been studied in an attempt to reduce the burden for families. 
Audiovisual interventions for parents whose children were undergoing elective surgery had 
positive effects on both parental and children’s preoperative anxiety9.  However, there has 
been no study on interventions to reduce parental anxiety during a child’s surgical emergency. 
 
Moreover, there has been little research, both in adults and in children, on the applicability and 
effectiveness of these same ERAS protocols for patients undergoing emergency surgery.10 Many 
of the limitations in acute care surgery come from the unpredictability of the timing for surgery 
and the variability of preoperative care, making it difficult to standardize postoperative care 
and offer perioperative counseling. 
 
Although there are high numbers of surgical procedures performed in children, the impact on 
caregivers and families is poorly described. In the context of transitioning to same-day or early 
post-operative discharges, parents are facing the responsibility of having to care for their child 
early in the recovery process. This can lead to significant indirect costs associated with loss in 
productivity at work and at home, and increase caregiver anxiety and caregiver demands. The 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 3 of 10 
Version date: November16, 2021  
 
 
magnitude of these indirect costs and loss in productivity has never been measured in a 
pediatric surgical setting. In reference to the ERAS guidelines, specifically the pillar of 
preoperative counseling and education, our aim in this research study is to implement an 
education tool, developed in collaboration with the McGill University Health Center Patient 
Education Office, for patients and caregivers in both elective and emergency surgical contexts 
and report its impact on indirect costs and caregiver productivity during the post-operative 
period. We hypothesize that by providing consistent and accessible information to patients and 
caregivers we may minimize anxiety, maximize satisfaction, and mitigate   caregiver 
productivity loss  during the post-operative recovery period, specifically within 2 weeks of 
discharge from the hospital.   
 
We aim to examine the impact of a patient education tool in both the emergency and elective 
surgical settings: 
1.1.1 Emergency Surgery - Appendectomies  
We have chosen appendectomies for acute appendicitis as the emergency surgical setting given 
that appendicitis is one of the most common causes of acute abdominal pain, with a lifetime 
risk of 8.6% in males and 6.7% in females and has the highest incidence in children aged 10-19 
years old. 10,11 Laparoscopic appendectomy performed within the first 24 hours of diagnosis is 
the standard treatment for acute appendicitis, and hospital admission varies based on whether 
or not the appendix has perforated, with patients with simple appendicitis going home the 
same day or the day following operation.12,13 Around 25-30% of appendicitis presents with 
perforation and those patients require a longer hospital admission.14,15 At the Montreal 
Children’s Hospital (MCH) we perform approximately 300 appendectomies for acute 
appendicitis per year.  
1.1.2 Elective Surgery – Inguinal and Umbilical Hernias  
For the elective surgical setting, we have chosen to target patients with umbilical and inguinal 
hernias who are booked for elective surgical repairs. Inguinal hernias occur in approximately 3-
5% of term infants and 13% of infants born at less than 33 weeks gestational age.16 Inguinal 
hernias are commonly repaired to avoid incarceration of the hernia, and at the MCH we 
perform approximately 240 inguinal hernia repairs per year. Umbilical hernias are also one of 
the more common pediatric conditions, occurring in approximately 1 in every 6 children.17 
However, they are more likely to close spontaneously and resolve without surgery than inguinal 
hernias. Nevertheless, some umbilical hernias do cause symptoms and may also fail to regress, 
thus necessitating surgical repair. At the MCH, we perform approximately 140 umbilical hernia 
repairs per year.  
 
We hope that by testing the impact of education tools on such a large sample of patients, we 
will demonstrate an accurate measure of our primary outcome and continue to improve our 
patient-centered care practices in the realm of pediatric surgery. Furthermore, we believe that 
this study will serve as further evidence in support of a movement towards ERAS protocols and 
standardized care pathways in pediatric surgical centers.  
 
 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 4 of 10 
Version date: November16, 2021  
 
 
2 OBJECTIVES, HYPOTHESIS AND STUDY QUESTIONS 
2.1 Objectives 
• Create education tools for patients and caregivers to educate them on the 
diagnosis, surgical management, and post-operative recovery process for 
acute appendicitis, umbilical hernias, and inguinal hernias. 
 
• Test whether the education tool reduces parental anxiety and improves 
satisfaction with care during a child’s surgical illness.  
 
• Test whether the education tools impact caregiver productivity loss in the 
immediate post-operative period, specifically 10-14 days post-discharge. 
2.2 Hypothesis 
We hypothesize that implementing an education tool for patients and caregivers will 
decrease parental anxiety, improve satisfaction, and mitigate productivity loss among 
caregivers after hospital discharge.  
2.3 Study Question 
Does the implementation of an education tool for patients and caregivers decrease 
preoperative parental anxiety and caregiver productivity loss in the post-operative 
period in the realm of pediatric surgery? 
 
3 STUDY METHODS 
This study is a collaboration between the Harvey E. Beardmore Division of Pediatric Surgery and 
the Patient Education Office, with whom we have developed a plain-language patient education 
tool for appendectomies.  
 
This study has several phases, which will be similar for all three surgical procedures. For 
convenience, the phases have been described in relation to the first surgical procedure that will 
be examined, namely appendectomy: 
This study has several phases: 
 
1. Pilot Phase (2-3 weeks) – Validation of Questionnaire 
• A convenience sample of 5 patients with acute appendicitis and their families 
will be selected during their routine postoperative visits to provide input on the 
questionnaire. The preliminary questionnaire is attached, and was developed by 
the authors based on the Amsterdam Preoperative Anxiety and Information 
Scale (APAIS), Productivity and Disease Questionnaire (PRODISQ), the Health and 
Labor Questionnaire (HLQ), and a literature review.18-21 
• A convenience sample of 5 surgeons and 5 nurses will also be solicited to provide 
feedback. 
• The questionnaire will be adapted based on qualitative feedback from the 
participants listed above.  

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 5 of 10 
Version date: November16, 2021  
 
 
2. Pre-Implementation Phase (100 patient/approx. 6 months) 
• All patients with acute appendicitis who undergo appendectomies will be eligible 
to participate, and families will be consented prior to surgery. The parental 
anxiety assessment will be done only before surgery with the Amsterdam 
Preoperative Anxiety and Information Scale (APAIS). In addition, the email of one 
of the primary caregivers will be collected, and the caregiver will receive an 
email with a link to the post-operative questionnaire 10 days post-discharge. At 
14 days post-discharge, they will receive a reminder email with the link to the 
questionnaire. All responses to the questionnaire are voluntary and anonymous. 
 
Before Surgery 
Obtain Consent 
Amsterdam Preoperative Anxiety and Information Scale (APAIS) 
Collection of email of primary caregiver 
10 days Post-operative 
Link to Parental Productivity Survey will be sent 
14 days Post-discharge 
Reminder email with link to the questionnaire will be sent. 
 
3. Post-Implementation Phase (100 patient/approx. 6 months) 
• The education tool will be distributed to families whose child is undergoing an 
appendectomy. The parental anxiety assessment will be done in the same way as 
above, only before surgery with the Amsterdam Preoperative Anxiety and 
Information Scale (APAIS). In addition, the email of one of the primary caregivers 
will be collected, and the caregiver will receive an email with a link to the post-
operative questionnaire 10 days post-discharge. At 14 days post-discharge, they 
will receive a reminder email with the link to the questionnaire. All responses to 
the questionnaire are voluntary and anonymous. 
Before Surgery 
Obtain Consent 
Amsterdam Preoperative Anxiety and Information Scale (APAIS) 
Collection of email of primary caregiver 
10 days Post-operative 
Link to Parental Productivity Survey will be sent & 
Link to Patient Education Tool Survey will be sent 
14 days Post-discharge 
Reminder email with links to the questionnaires will be sent. 
 
 
 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 6 of 10 
Version date: November16, 2021  
 
 
3.1 Study Population 
3.1.1 Inclusion criteria:  
• Primary caregivers of all pediatric patients (0-17 years old) with acute 
appendicitis, including both perforated and non-perforated appendicitis 
cases, who have undergone an urgent appendectomy. 
• Primary caregivers of all pediatric patients (0-17 years old) with umbilical 
or inguinal hernias who have undergone an elective surgical repair. 
3.1.2 Exclusion criteria: 
• Patient or family does not understand English or French (education 
material available in only these two languages). 
• Patient presenting for an elective interval appendectomy. 
• Patient presenting with an incarcerated or strangulated hernia requiring 
emergency surgical repair. 
3.2 Period studied 
We anticipate a period of enrollment of approximately 6 months for each surgical procedure, as 
specified above in Section 3. We will aim to have 100 patients for the Pre-Implementation 
Phase & 100 patients for the Post-Implementation Phase.  
3.3 Description of data being retrieved 
For each patient, we plan to collect answers from the circulated questionnaires, which will 
include questions related to the child and caregiver. This survey will not collect any identifiable 
information. However, we will collect some patient/parent information including: 
• Age of the child and caregiver 
• Relation of the caregiver to the child 
• Caregiver’s education level 
• Caregiver’s yearly income 
• Caregiver’s work hours 
 
To assess indirect resource use (productivity losses) we will collect the following information: 
• Hours absence from paid or unpaid job 
• Loss of leisure time and sleep 
• Access to compensated or uncompensated help at home 
• Number of follow ups with medical personnel during the child’s recovery  
• Utility of education tool 
3.4 Duration of the study  
The study is expected to last approximately 12-24 months, depending on recruitment.  
 
 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 7 of 10 
Version date: November16, 2021  
 
 
4 DATA ANALYSIS 
The primary outcome that will be assessed is the loss of parental productivity measured in 
hours of paid or unpaid work missed due to caring for a child in the post-operative recovery 
period in caregivers who received the education tool compared to those who did not. 
Secondary outcomes that will be assessed include: household income (dollar amount) lost due 
to indirect productivity losses, hours of sleep lost, hours of leisure time lost, number of times 
that medical assistance is sought in the post-operative period, and need for compensated or 
non-compensated help at home.  
 
Bivariate analysis will be performed using 2 sample t-tests for dichotomous predictor variables, 
Fisher’s exact test or one-way ANOVA for categorical predictor variables, and Pearson 
correlation for continuous predictors where appropriate. A p-value of < 0.05 will be deemed 
statistically significant.  
 
5 ETHICAL CONSIDERATIONS 
5.1 Oversight 
This study will be conducted in accord with the Tri-Council Policy Statement: Ethical Conduct for 
Research Involving Humans (2018), as well as in respect of the requirements set out in the 
applicable standard operation procedures of the Research Institute of the McGill University 
Health Centre Research Institute and of the McGill University Health Centre Research Ethics 
Board. The McGill University Health Centre Research Ethics Board will review this study and will 
be responsible for monitoring it at all participating institutions in the health and social services 
network in Québec. 
5.2 Confidentiality 
Only data relevant to this study as outlined in this protocol will be collected by the research 
team. All the information collected during the research project will remain confidential to the 
extent required and provided by law.  
 
The data collected from the online surveys will be stored in a digital file on a password 
protected computer behind the MUHC firewall for 7 years following the completion of the 
study. The data will then be destroyed. No personal or identifiable information will be collected 
from patients.   
 
We foresee no ethical issues that would prevent the conduct of this study. The patient 
education tool is being implemented as part of a continuous process for ongoing improvement 
in our pediatric surgery division, with the ultimate goal of providing the highest quality of 
patient- and family-centered care. Survey participation is voluntary and anonymous, with no 
negative impact from non-participation. This study does not change the current clinical practice 
guidelines for appendicitis. 
 
 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 8 of 10 
Version date: November16, 2021  
 
 
5.3 Informed consent 
All patients and their families who undergo an operation for acute appendicitis, umbilical 
hernia, and inguinal hernia will be eligible for the research study and invited to complete the 
anxiety scale and to take the survey 10 days after discharge from the hospital. Informed 
consent will be obtained prior to surgery. The primary caregiver will be asked to provide us with 
their email address. 
 
They will be emailed a link to an online questionnaire(s) 10 days after their discharge. They will 
be emailed a reminder email and link to the online questionnaire 14 days after discharge. 
 
The answers collected from questionnaire will be anonymous, and no patient identifiable 
information will be collected. However, we will be collecting some sensitive information about 
the caregiver, including their average annual income. Furthermore, we require their email 
addresses to facilitate the distribution of the online surveys one week post-discharge of the 
child. Therefore, we will obtain informed consent from the patient and caregiver during the 
patient’s hospitalization.  
 
Participation in the survey is anonymous. This means that although emails will be obtained to 
facilitate the distribution of the surveys, the answers will not be linked to the patient or 
caregiver’s emails and therefore the research team will not be able to trace the answers back to 
the patients or caregivers. This ensures patient and caregiver anonymity.  
 
6 DISSEMINATION PLANS 
The results of this study will be used for publication.  It will also be used to improve the 
educational materials and culture of patient and family-centered care at our hospital. Results 
are also projected to be available to present at relevant conferences. 
 
 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 9 of 10 
Version date: November16, 2021  
 
 
7 REFERENCES 
 
1. Frank L, Basch E, Selby JV, Patient-Centered Outcomes Research I. The PCORI 
perspective on patient-centered outcomes research. JAMA. Oct 15 2014;312(15):1513-
1514. 
2. Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered 
outcomes for men with localized prostate cancer. Eur Urol. Mar 2015;67(3):460-467. 
3. Thiele RH, Rea KM, Turrentine FE, et al. Standardization of care: impact of an enhanced 
recovery protocol on length of stay, complications, and direct costs after colorectal 
surgery. J Am Coll Surg. Apr 2015;220(4):430-443. 
4. Lv L, Shao YF, Zhou YB. The enhanced recovery after surgery (ERAS) pathway for patients 
undergoing colorectal surgery: an update of meta-analysis of randomized controlled 
trials. Int J Colorectal Dis 2012; 27: 1549-54.  
5. Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus 
conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev 
2011; 2: CD007635.  
6. Leeds IL, Boss EF, George JA, Strockbine V, Wick EC, Jelin EB. Preparing enhanced 
recovery after surgery for implementation in pediatric populations. J Pediatr Sur. 2016; 
51: 2126-2129. 
7. Shinnick JK, Short HL, Heiss KF, et al. Enhancing recovery in pediatric surgery: a review of 
the literature. J Surg Res 2016;202(1):165–76.  
8. Short HL, Heiss KF, Burch K, Travers C, Edney J, Venable C, Raval MV. Implementation of 
an enhanced recovery protocol in pediatric colorectal surgery. J Pediatr Surg. 2018; 53: 
688-692. 
9. CHOW ET AL. Impact of AV on Parental Preoperative Anxiety: A Systematic Review and 
Meta-Analysis. Health Psychology, 2018, Vol. 37, No. 8, 746–758. 
10. Paduraru M, Ponchietti L, Casas IM, Svenningsen P, Zago M. Enhanced Recovery after 
Emergency Surgery: A Systematic Review. Bull Emerg Trauma. 2017; 5(2): 70-78. 
11. Buckius MT, McGrath B, Monk J, Grim R, Bell T, Ahuja V. Changing epidemiology of acute 
appendicitis in the United States: study period 1993-2008. J Surg Res. Jun 15 
2012;175(2):185-190. 
12. Al-Omran M, Mamdani MM, McLeod RS. Epidemiologic features of acute appendicitis in 
Ontatio. Canada. Can J Surg. 2003; 46: 263. 
13. Aguayo P, Alemayehu H, Desai AA, Fraser JD, St Peter SD. Initial experience with same 
day discharge after laparoscopic appendectomy for nonperforated appendicitis. J Surg 
Res. Jul 2014;190(1):93-97. 
14. Cameron DB, Williams R, Geng Y, et al. Time to appendectomy for acute appendicitis: A 
systematic review. J Pediatr Surg. Nov 20 2017. 
15. Cheong LH, Emil S. Determinants of appendicitis outcomes in Canadian children. J 
Pediatr Surg. May 2014;49(5):777-781. 
16. Cheong LH, Emil S. Outcomes of pediatric appendicitis: an international comparison of 
the United States and Canada. JAMA Surg. Jan 2014;149(1):50-55. 
17. Wang KS, Committee on Fetus and Newborn, Section on Surgery. Assessment and 
Management of Inguinal Hernia in Infants. Pediatrics. Oct 2012; 130(4): 768-773. 

Study title: The Impact of a Patient Education Tool on Parental Anxiety and Productivity: A Prospective 
Cohort Study 
 
 
Nagano #: 2019-5195 
Version number: 8 
 
 
Page 10 of 10 
Version date: November16, 2021  
 
 
18. Katz D. Evaluation and Management of Inguinal and Umbilical Hernias. Pediatric Annals. 
Dec 2001; 30(12): 729-735. 
19. Koopmanschap MA. PRODISQ: a modular questionnaire on productivity and disease for 
economic evaluation studies. Expert Rev Pharmacoeconomics Out- comes Res 
2005;5(1):23–8.   
20. Van Roijen L, Essink-Bot ML, Koopmanschap MA, Bonsel G, Rutten FFH. Labour and 
health status in economic evaluation of health care: the Health and Labour 
Questionnaire. Int J Technol Assess Health Care 1996;12:405–15.  
21. Wolleswinkel-van den Bosch JH, Stolk EA, Francois M, Gasparini R, Brosa M. The health 
care burden and societal impact of acute otitis media in seven European countries: 
Results of an Internet Survey. Vaccine. 2010; 28S: G39-G52. 
22. Wolleswinkel-van den Bosch JH, Speets AM, Rümke HC, Gumbs PD, Fortanier SC. The 
burden of varicella from a parent’s perspective and its societal impact in the 
Netherlands: an Internet survey. BMC Infectious Diseases. 2011; 11:320. 
23. Moerman et al. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). 
1996 Anesth Analg 1996; 82:445-51