Video Discharge Instructions for Acute Otitis Media

NCT02788422 | Completed

• 1 other identifier: 10012437
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

Thorough, understandable discharge instructions empower caregivers, allowing them to provide optimum care of their children during illness. Unfortunately discharge instructions are often incomplete and difficult to understand. The use of video discharge instructions has been shown to increase patient understanding of their illness. The investigators would like to know if using video discharge instructions for caregivers of children with middle ear infections helps to better understand how to take care of children at home, potentially allowing the child to feel better faster. The investigators will be comparing video discharge instructions to a paper handout to see if the former leads to improved well-being of the child and improved caregiver knowledge, satisfaction and anxiety.

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (1)

• Daily self-reported Acute Otitis Media Symptom Severity Score

  At 72 hours

  72 hours

Secondary Outcomes (7)

• Self-report State Trait Anxiety Inventory at discharge

  72 hours

• Caregiver Satisfaction at 72 hours

  72 hours

• Self-reported number of days of school/work/daycare missed at 72 hours

  72 hours

• Self-reported medication administered daily for 72 hours

  72 hours

• Self-reported return visits to a health care provider at 72 hours

  72 hours

Study Arms (2)

Video

EXPERIMENTAL

Video discharge instructions developed using Easy Sketch Pro3TM software (Easy Sketch Pro, United Kingdom). It was created by the primary and co-investigator based results on a focus group consisting of two paediatric residents, two paediatric emergency medicine fellows, a paediatric emergency medicine nurse, and a paediatric emergency medicine staff physician.

Other: Video discharge instructions

Standard of care

ACTIVE COMPARATOR

This is a one-page paper handout created by the primary and co-investigator based results on a focus group consisting of two paediatric residents, two paediatric emergency medicine fellows, a paediatric emergency medicine nurse, and a paediatric emergency medicine staff physician.

Other: Standard of Care

Interventions

Video discharge instructions OTHER

Online video containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.

Video

Standard of Care OTHER

One page paper handout containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.

Standard of care

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All primary caregivers of children aged 6 months to 17 years presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario
• Clinical diagnosis of AOM in the context of an upper respiratory tract infection as determined by the treating emergency physician (staff physician or fellow). The treating physician will be asked to rate, using a 10 mm visual analog scale, the likelihood that the patient has AOM using previously published diagnostic criteria. - Physician reports being at least 50% certain, on a visual analog scale in the diagnosis of AOM.

You may not qualify if:

• Caregivers whose children have other diagnoses (pneumonia, urinary tract infection, gastroenteritis, or any other condition requiring antibiotics or admission to hospital)
• Previous diagnosis of AOM within 7 days
• Tympanostomy tubes
• Acute tympanic membrane perforation
• Attending caregiver who is not the primary care provider
• Poor English fluency
• Lack of at least a grade 8 literacy level
• No Internet access
• No telephone access for 72 hours following discharge

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

Related Publications (1)

• Belisle S, Dobrin A, Elsie S, Ali S, Brahmbhatt S, Kumar K, Jasani H, Miller M, Ferlisi F, Poonai N. Video Discharge Instructions for Acute Otitis Media in Children: A Randomized Controlled Open-label Trial. Acad Emerg Med. 2019 Dec;26(12):1326-1335. doi: 10.1111/acem.13839. Epub 2019 Nov 19.

  PMID: 31742809 DERIVED

MeSH Terms

Conditions

Otitis Media

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Naveen Poonai, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 2, 2016
• Study Start: March 20, 2017
• Primary Completion: March 17, 2018
• Study Completion: August 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)