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Completed

NCT Number: NCT05571566

The Impact of a Patient Education Tool for Appendicitis

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.

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Key information

Conditions

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

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Montreal, Quebec, H4A 3J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational book

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Parental Productivity

    Time frame: 10 & 14 days postoperatively

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 7, 2022
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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