Video Discharge Instructions for Acute Otitis Media
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|ClinicalTrials.gov Identifier: NCT02788422|
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media||Other: Video discharge instructions Other: Standard of Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effectiveness of Video Discharge Instructions for Acute Otitis Media on Knowledge Acquisition and Clinical Outcomes: a Randomized Controlled Trial|
|Actual Study Start Date :||March 20, 2017|
|Actual Primary Completion Date :||March 17, 2018|
|Actual Study Completion Date :||August 1, 2018|
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
Online video containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
Active Comparator: Standard of care
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
One page paper handout containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
- Daily self-reported Acute Otitis Media Symptom Severity Score [ Time Frame: 72 hours ]At 72 hours
- Self-report State Trait Anxiety Inventory at discharge [ Time Frame: 72 hours ]
- Caregiver Satisfaction at 72 hours [ Time Frame: 72 hours ]
- Self-reported number of days of school/work/daycare missed at 72 hours [ Time Frame: 72 hours ]
- Self-reported medication administered daily for 72 hours [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 72 hours ]
- Change in knowledge score on novel questionnaire before and after intervention in ED [ Time Frame: 30 minutes ]Difference in knowledge questionnaire scores before and immediately following intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788422
|London Health Sciences Centre|
|London, Ontario, Canada|
|Principal Investigator:||Naveen Poonai, MD||London Health Sciences Centre|