The Impact of a Patient Education Tool for Appendicitis

Appendicitis Clinical Trial

Official title:

The Impact of a Patient Education Tool on Parental Productivity and Anxiety: A Non-Randomized Control Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571566
• Other study ID #: 2019-5195
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

1. Utilize evidence-based methods to evaluate the success of implementation of a patient and family-centered education tool for appendicitis.

2. Develop and validate a pre- and post- education patient satisfaction and experience survey in the realm of pediatric surgery.

3. Inform the development of the education tool and survey through multidisciplinary and patient/family input.

4. Implement a patient/family-centered education tool in an emergency surgical setting.

Description:

Methodology / Study design

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 28, 2023
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• Educational Book
An educational book with information about appendicitis for patients, parents and caregivers

Locations

Country	Name	City	State
Canada	Research Institute of the McGill University Health Center/ Montreal Children's Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour - during surgery
Secondary	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.	10 & 14 days postoperatively