AppendicitisNCT05571566
The Impact of a Patient Education Tool for Appendicitis
A study testing Educational Book in people with Appendicitis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Hypothesis/Study question (brief introduction of the question studied; about 5 lines) Appendicitis is the most common acute surgical admission to the pediatric surgery service at the MCH. The need for surgery can provoke anxieties for patients. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Educational Book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- 3 Dec 2019to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Patient or family does not understand English or French (education material available in only these two languages).
- Patient presenting for an elective interval appendectomy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Institute of the McGill University Health Center/ Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
About this study
Official title: The Impact of a Patient Education Tool on Parental Productivity and Anxiety: A Non-Randomized Control Trail
Hypothesis/Study question (brief introduction of the question studied; about 5 lines)
Appendicitis is the most common acute surgical admission to the pediatric surgery service at the MCH. The need for surgery can provoke anxieties for patients. Patient education materials are meant to improve knowledge, set expectations, and improve the overall hospital experience for patients and their families, and are already being widely implemented for elective surgeries in the context of ERAS pathways. This study aims to develop an effective patient and family education tool, with the goal of improving patient education and satisfaction with care in the emergency surgery setting.
Read more
Study objectives
- Utilize evidence-based methods to evaluate the success of implementation of a patient and family-centered education tool for appendicitis.
- Develop and validate a pre- and post- education patient satisfaction and experience survey in the realm of pediatric surgery.
- Inform the development of the education tool and survey through multidisciplinary and patient/family input.
- Implement a patient/family-centered education tool in an emergency surgical setting.
Read the detailed description
Methodology / Study design
- Pilot phase Convenience sample of 10 patients diagnosed with acute appendicitis and their families will be selected to provide input on the patient and family experience survey tool. A convenience sample of 5 surgeons and 5 surgical nurses will also be solicited to provide feedback. The survey tool will be adapted based on the responses.
- Pre-implementation phase All patients and their families with acute appendicitis who present to clinic for their routine follow-up appointment or are called for their phone-call follow up will be eligible to take a survey. All responses are voluntary and anonymous. The survey swill be available on an online platform so invited participants may conveniently participate in the study.
- Post-implementation phase After the education pamphlet has been finalized and its distribution to families has begun, all patients and their families with simple or perforated appendicitis who had their initial presentation after the education pamphlet was available will be eligible to take a survey. All responses are voluntary and anonymous. The surveys will be available on an online platform so invited participants may conveniently and anonymously participate in the study.
Qualitative and descriptive statistics will be used to detect a difference in patient experience and satisfaction between the those who received the education tool and those who did not.
- Conditions
- Appendicitis
- Being tested
- Educational Book
- Keywords
- Parental Productivity, Parental Anxiety, Simple Appendicitis, Perforated Appendicitis, Patient Education Material, Appendicitis, Patient Survey, Parental Survey
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational BookOther
An educational book with information about appendicitis for patients, parents and caregivers
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation phase | No intervention | All patients with acute appendicitis who undergo appendectomies will be eligible to participate, and families will be consented prior to surgery. The explanation of the procedure will be done verbally by the surgeon as it is the standard care at the hospital. A parental anxiety assessment will be done before surgery with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). In addition, an email from 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 again with the link to the questionnaire. All responses to the questionnaire are voluntary and anonymous. |
| Post-implementation phase | Active comparator | The education tool will be distributed to families whose child is undergoing an appendectomy. The explanation of the procedure will also be done verbally by the surgeon as it is the standard care at the hospital. The parental anxiety assessment will be done in the same way as above, 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. Receives: Other: Educational Book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Anxiety
Scores from the anxiety scale from both phases - adapted from Parental Anxiety Scale based on Amsterdam Preoperative Anxiety and Information Scale (APAIS) - 9 questions.
The Parental Anxiety score is a Likert scale with 6 questions (each 1-5). The cutoff for anxiety is 13 points, anything over it is High anxiety.
Measured: 1 hour - during surgery
Secondary outcomes (1)
Parental Productivity
Results from the online survey on parental productivity - adapted from Productivity and Disease Questionnaire (PRODISQ), the Health and Labor Questionnaire (HLQ) \& additional literature. - 27 questions.
The Parental Productivity survey will be a descriptive analysis and does not contain scoring.
Measured: 10 & 14 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start3 Dec 2019
- Primary completion9 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Emil, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Sherif Emil, MD,CM, Principal investigator, MUHC-RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571566
- Sponsor's protocol ID
- 2019-5195
- Status last verified
- Mar 2023
- First submitted
- 3 Oct 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Patient Education Tool on Parental Productivity and Anxiety: A Non-Randomized Control Trail
- ClinicalTrials.gov ID
- NCT05571566
- Acronym / sponsor ID
- 2019-5195
- Conditions
- Appendicitis
- Keywords
- Parental Productivity, Parental Anxiety, Simple Appendicitis, Perforated Appendicitis, Patient Education Material, Appendicitis, Patient Survey, Parental Survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis/Study question (brief introduction of the question studied; about 5 lines)
Appendicitis is the most common acute surgical admission to the pediatric surgery service at the MCH. The need for surgery can provoke anxieties for patients. Patient education materials are meant to improve knowledge, set expectations, and improve the overall hospital experience for patients and their families, and are already being widely implemented for elective surgeries in the context of ERAS pathways. This study aims to develop an effective patient and family education tool, with the goal of improving patient education and satisfaction with care in the emergency surgery setting.
Study objectives
- Utilize evidence-based methods to evaluate the success of implementation of a patient and family-centered education tool for appendicitis.
- Develop and validate a pre- and post- education patient satisfaction and experience survey in the realm of pediatric surgery.
- Inform the development of the education tool and survey through multidisciplinary and patient/family input.
- Implement a patient/family-centered education tool in an emergency surgical setting.
Detailed description
Methodology / Study design
- Pilot phase Convenience sample of 10 patients diagnosed with acute appendicitis and their families will be selected to provide input on the patient and family experience survey tool. A convenience sample of 5 surgeons and 5 surgical nurses will also be solicited to provide feedback. The survey tool will be adapted based on the responses.
- Pre-implementation phase All patients and their families with acute appendicitis who present to clinic for their routine follow-up appointment or are called for their phone-call follow up will be eligible to take a survey. All responses are voluntary and anonymous. The survey swill be available on an online platform so invited participants may conveniently participate in the study.
- Post-implementation phase After the education pamphlet has been finalized and its distribution to families has begun, all patients and their families with simple or perforated appendicitis who had their initial presentation after the education pamphlet was available will be eligible to take a survey. All responses are voluntary and anonymous. The surveys will be available on an online platform so invited participants may conveniently and anonymously participate in the study.
Qualitative and descriptive statistics will be used to detect a difference in patient experience and satisfaction between the those who received the education tool and those who did not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation phase | No intervention | –All patients with acute appendicitis who undergo appendectomies will be eligible to participate, and families will be consented prior to surgery. The explanation of the procedure will be done verbally by the surgeon as it is the standard care at the hospital. A parental anxiety assessment will be done before surgery with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). In addition, an email from 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 again with the link to the questionnaire. All responses to the questionnaire are voluntary and anonymous. |
| Post-implementation phase | Active comparator | Other: Educational BookThe education tool will be distributed to families whose child is undergoing an appendectomy. The explanation of the procedure will also be done verbally by the surgeon as it is the standard care at the hospital. The parental anxiety assessment will be done in the same way as above, 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. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient or family does not understand English or French (education material available in only these two languages).
- Patient presenting for an elective interval appendectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational BookAn educational book with information about appendicitis for patients, parents and caregivers | Other | Post-implementation phase |
Primary outcome
Parental Anxiety
Time frame: 1 hour - during surgery
Scores from the anxiety scale from both phases - adapted from Parental Anxiety Scale based on Amsterdam Preoperative Anxiety and Information Scale (APAIS) - 9 questions. The Parental Anxiety score is a Likert scale with 6 questions (each 1-5). The cutoff for anxiety is 13 points, anything over it is High anxiety.
1 secondary outcome
Parental Productivity
Time frame: 10 & 14 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif Emil, MD,CM principal investigator
MUHC-RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Book in people with Appendicitis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Anxiety (time frame: 1 hour - during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.