Clinical trial NCT05571566: The Impact of a Patient Education Tool for Appendicitis
Official title: The Impact of a Patient Education Tool on Parental Productivity and Anxiety: A Non-Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Parental Productivity
Parental Anxiety
Simple Appendicitis
Perforated Appendicitis
Patient Education Material
Appendicitis
Patient Survey
Parental Survey
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Parental Anxiety
timeFrame: 1 hour - during surgery
Secondary outcomes:
measure: Parental Productivity
timeFrame: 10 & 14 days postoperatively
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Center/ Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: MUHC-RI
name: Sherif Emil, MD,CM
role: PRINCIPAL_INVESTIGATOR
References: