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Video Discharge Instructions for Acute Otitis Media

Primary Purpose

Otitis Media

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Video discharge instructions
Standard of Care
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Daily self-reported Acute Otitis Media Symptom Severity Score
At 72 hours

Secondary Outcome Measures

Self-report State Trait Anxiety Inventory at discharge
Caregiver Satisfaction at 72 hours
Self-reported number of days of school/work/daycare missed at 72 hours
Self-reported medication administered daily for 72 hours
Number of doses and type of medication administered based on self-report
Self-reported return visits to a health care provider at 72 hours
Number of visits and type of health care provider and reason based on self-report
Number of times online video was viewed in 72 hours
Change in knowledge score on novel questionnaire before and after intervention in ED
Difference in knowledge questionnaire scores before and immediately following intervention

Full Information

First Posted
May 24, 2016
Last Updated
October 12, 2018
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02788422
Brief Title
Video Discharge Instructions for Acute Otitis Media
Official Title
The Effectiveness of Video Discharge Instructions for Acute Otitis Media on Knowledge Acquisition and Clinical Outcomes: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
March 17, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Providing patients with understandable, comprehensive discharge instructions improves compliance, thereby reducing symptoms and the functional impact of illness. Comprehensive discharge instructions also reduce patient anxiety and increases satisfaction. Unfortunately, in a busy emergency department (ED), discharge instructions are often incomplete. Furthermore, even when discharge instructions have been provided, patients often have difficulty comprehending and/or recalling them. Inadequate discharge instructions are linked to medication errors, suboptimal care post-discharge, and unnecessary return visits to the ED. Patient dissatisfaction with discharge instructions and anxiety have also been linked to poor medication compliance, and an increase in return visits. Studies have demonstrated that knowledge of pediatric medical conditions can be enhanced through the use of video technology. Specifically, it has been shown that when video discharge instructions are used in place of, or to complement written discharge instructions, patients have a better understanding of their illness and report higher rates of satisfaction. However, no studies to date have explored if clinically relevant outcomes such as symptomatology, function and recidivism can be improved. This study will examine the utility of video discharge instructions for the diagnosis of acute otitis media (AOM), a leading cause of health care visits among children. AOM affects up to 75% of children before school-age and is the most common illness for which antibiotics are prescribed to children in the United States. In Canada, AOM is associated with substantial use of health services (3.1 hours in an emergency department and 1.8 hours in an outpatient clinic on average per visit) and significantly burdens caregivers in the form of time spent on medical consultations, and time taken off from work. An American study estimated that the cost of one episode of AOM in a 3-month period following diagnosis was $1330.58, with the majority of that cost stemming from the indirect costs of illness, 90% of which was accrued primarily by parental time off work. In Quebec, the total annual cost to the health care system for otitis media and placement of tympanostomy tubes is more than $10 million dollars. Pain is often substantial in the early course of AOM. Poorly controlled pain is associated with suffering and can be emotionally traumatic, causing anxiety for patients and their caregivers. Efficacious treatment for child pain is paramount in preventing protracted sensitivity to pain. Despite the magnitude of effects that acute pain can have on a child, it is often inadequately assessed and treated. In children less than two years of age, 30% of children continue to experience pain, fever, or both for up to 7 into the illness, thus highlighting the importance of caregiver education on symptom management. Recurrent AOM is common, 5-15% of children under the age of 2 experience four or more episodes per year. Caregivers of children with recurrent AOM not only judge their child's quality of life markedly lower than caregivers of children of a general population, but also lower than those of children with mild-to-moderately severe chronic conditions. Although uncommon, AOM also has the potential to cause serious complications such as, mastoiditis and bacterial meningitis, if not treated and monitored appropriately. The investigators hypothesize that video discharge instructions directed at caregivers of children with AOM will be associated with improved symptomatology and functional outcomes, along with improved caregiver knowledge, satisfaction, and anxiety compared to the standard of care, paper-based discharge instructions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Video discharge instructions
Intervention Description
Online video containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
One page paper handout containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
Primary Outcome Measure Information:
Title
Daily self-reported Acute Otitis Media Symptom Severity Score
Description
At 72 hours
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Self-report State Trait Anxiety Inventory at discharge
Time Frame
72 hours
Title
Caregiver Satisfaction at 72 hours
Time Frame
72 hours
Title
Self-reported number of days of school/work/daycare missed at 72 hours
Time Frame
72 hours
Title
Self-reported medication administered daily for 72 hours
Description
Number of doses and type of medication administered based on self-report
Time Frame
72 hours
Title
Self-reported return visits to a health care provider at 72 hours
Description
Number of visits and type of health care provider and reason based on self-report
Time Frame
72 hours
Title
Number of times online video was viewed in 72 hours
Time Frame
72 hours
Title
Change in knowledge score on novel questionnaire before and after intervention in ED
Description
Difference in knowledge questionnaire scores before and immediately following intervention
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveen Poonai, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31742809
Citation
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.
Results Reference
derived

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Video Discharge Instructions for Acute Otitis Media

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