The Impact of a Patient Education Tool for Appendicitis

NCT ID: NCT05571566

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2023-02-28

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. 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.

Detailed 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.

Conditions

Appendicitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pre-implementation phase

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-implementation phase

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.

Group Type: ACTIVE_COMPARATOR

Educational Book

Intervention Type: OTHER

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

Interventions

Educational Book

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Sherif Emil

Professor of Pediatric Surgery, Surgery, and Pediatrics, McGill University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif Emil, MD,CM

Role: PRINCIPAL_INVESTIGATOR

MUHC-RI

Locations

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

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-5195

Identifier Type: -

Identifier Source: org_study_id