The Impact of a Patient Education Tool for Appendicitis

NCT05571566 | Completed

• 1 other identifier: 2019-5195
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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. 1.Utilize evidence-based methods to evaluate the success of implementation of a patient and family-centered education tool for appendicitis.
2. 2.Develop and validate a pre- and post- education patient satisfaction and experience survey in the realm of pediatric surgery.
3. 3.Inform the development of the education tool and survey through multidisciplinary and patient/family input.
4. 4.Implement a patient/family-centered education tool in an emergency surgical setting.

Conditions

Appendicitis

Keywords

Parental Productivity; Parental Anxiety; Simple Appendicitis; Perforated Appendicitis; Patient Education Material; Appendicitis; Patient Survey; Parental Survey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parental Productivity

  10 & 14 days postoperatively

Study Arms (2)

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.

Other: Educational Book

Interventions

Educational Book OTHER

An educational book with information about appendicitis for patients, parents and caregivers

Post-implementation phase

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patient or family does not understand English or French (education material available in only these two languages).
• Patient presenting for an elective interval appendectomy.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Research Institute of the McGill University Health Center/ Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Sherif Emil, MD,CM

  MUHC-RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Surgery, Surgery, and Pediatrics, McGill University

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 7, 2022
• Study Start: December 3, 2019
• Primary Completion: December 9, 2022
• Study Completion: February 28, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

CA (1)