Web-based Education Module for Pain Management

A Web-based Education Module Versus Standard of Care for Pain Management Following a Fracture in Children: a Randomized Controlled Trial

This study's objectives are as follows:

1. To evaluate the utility of a website to provide information and guidance about pain management in children 2. To educate parents about the pathophysiology of pain, proper use of analgesic medications and signs of pain in children 3. To reduce the functional impact of pain in children following treatment for fracture 4. To endow parents with confidence to manage their child's pain at home 5. To dispel misconceptions about the use and safety of analgesics in children 6. To increase awareness of complications of fractures such as compartment syndrome

Study Overview

• Status: Completed
• Conditions: Bone Fractures
• Intervention / Treatment: Other: Interactive website; Other: Video; Other: Standard of care

Detailed Description

This study will compare the effectiveness of three mediums of parental education among parents of children treated for non-operative fractures in the emergency department (ED): 1) A novel website entitled, "Online User-Centered Home Pain Management for Fractures" (OUCH PMF) 2) An online educational video (OV) and 3) standard discharge instructions (SOC). The investigators primary goal is to see which modality results in a greater improvement in scores on a on a knowledge questionnaire. The investigators secondary goals are to see which modality results in better parental satisfaction, confidence in managing pain, and lower impact of injury on the child and family. As participants will receive the standard-of-care that includes a pamphlet on how to take care of the cast. During their stay in the ED, participants will be randomly assigned to one of the three aforementioned groups. Participants will then be given the pre-intervention knowledge questionnaire, followed by the intervention and then the post-intervention knowledge questionnaire, prior to being discharged. At 120 hours post-discharge, participants will be asked to access an online survey to obtain information about the functional impact of the injury on their child. The investigators goal is to compare online and video education tools in their ability to improve parental knowledge, confidence, and satisfaction regarding the treatment of fracture pain.

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • Children's Hospital, London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All caregivers who are in attendance with their child (any age) for a primary complaint of a non-operative fracture managed by the paediatric emergency physician AND will be the primary caregiver for the child at home.

Exclusion Criteria:

• Poor parental English fluency
• Lack of a home computer with Internet access
• Child with a history of renal disease, liver disease, bleeding diathesis, chronic pain issues, or pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive website; The interactive website called Online User Centered Home Pain Management for Fractures (OUCH PMF) will cover 4 domains of knowledge: 1. Fracture-related pain 2. Analgesic dosing regimens 3. Indications, risks and safety of analgesia in children 4. Signs and symptoms of pain in children	Other: Interactive website; The interactive website called Online User Centered Home Pain Management for Fractures (OUCH PMF) will cover 4 domains of knowledge: 1. Fracture-related pain 2. Analgesic dosing regimens 3. Indications, risks and safety of analgesia in children 4. Signs and symptoms of pain in children
Active Comparator: Video; The online video will contain the same information within the website.	Other: Video; The online video will contain the same information within the website.
Active Comparator: Standard of care; Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.	Other: Standard of care; Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 21-item knowledge questionnaire total score between groups	120 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of days of work missed for parent	120 hours
Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale	120 hours
Number of sleep-interrupted nights for child	120 hours
Number of days of school missed for child	120 hours
Number of days before resumption of normal diet for child	120 hours
Other educational resources used	120 hours

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Naveen Poonai, MD, Western University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 106402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO