Improving Knowledge Translation Upon Emergency Department Discharge

Study Overview
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Brief Summary
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The amount and speed of emergency department (ED) discharge instructions often make it difficult for patients/caregivers to know the final diagnosis and to remember instructions. We hypothesize that a video on ear infections and antibiotics' role in their management will facilitate caregiver understanding and will increase the likelihood of caregivers properly following discharge instructions. To verify this hypothesis, a large multi-centre clinical trial is needed. Prior to this, it is only ethical to conduct a smaller 'pilot' trial. Previously healthy children (6 months-5 years) diagnosed with mild ear infections at the McMaster Children's Hospital ED will be eligible to participate. If the child and caregiver decide to participate, before discharge, the caregiver will either: 1)watch the aforementioned video, 2)be given a pamphlet with the same information, or 3)standard of care (no additional information). Participants will fill a knowledge survey before discharge. The research assistant will contact all participants by phone to determine if the caregiver followed the discharge instructions.

Detailed Description
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As most acute otitis media cases self-resolve, observation as initial management for mild acute otitis media (AOM) is recommended by Canadian and American authorities. However, North American children receive more antibiotics for AOM than for any other reason, making AOM-related prescribing a key focus for antimicrobial stewardship interventions. Low uptake of the ED suggested management strategies may be caused by caregiver under-appreciation of antibiotic-associated harms or from problems understanding the discharge plan, of which both could be remedied by a novel video-based knowledge translation platform. The aim of this pilot study is to determine the feasibility of a follow-up large trial. The main clinical research question is: for caregivers of previously healthy children aged 6-59 months who are diagnosed by the ED physician with acute otitis media and judged to be eligible for a watchful waiting approach, will the use of an innovative informative video lead to lower rates of unnecessary antibiotic use as compared to a pamphlet or no intervention (reference standard)? This will be a single-centre, randomized, controlled, pilot trial. Caregivers of previously well children aged 6-59 months presenting to the McMaster Children's Hospital (MCH) ED with non-severe AOM eligible for a watchful waiting approach will be enrolled and randomized to a video intervention, a pamphlet intervention, or standard care (no intervention). The primary outcome is the proportion of caregivers who fill a prescription for antimicrobials <48 hours after recruitment, as caregivers are generally advised to wait 48-72 hours prior to administering antibiotics to healthy children with mild AOM.

Official Title
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Video, Ear Infections & Antibiotic Stewardship: Knowledge Translation Upon Emergency Department Discharge

Conditions
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Otitis Media

Intervention / Treatment
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* Behavioral: Video
* Behavioral: Pamphlet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: caregivers of children aged 6-59 months diagnosed with non severe acute otitis media at the McMaster Children's Hospital ED Exclusion Criteria: caregivers of children with severe symptoms (severe otalgia, fever > 39 C, impending perforation of tympanic membrane) caregivers who cannot readily access medical care caregivers who may not be able to recognize signs of worsening illness caregivers of children with immunodeficiency, malignancy, chronic cardiac or pulmonary disorders, anatomical abnormalities of head/neck, trisomy 21, or previous complicated otitis media

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video<br>An innovative video will be developed to explain the nature of non-severe acute otitis media and the rationale for watchful waiting and antimicrobial stewardship. This video will be viewed at recruitment and will be available online for further viewing later. | Behavioral: Video<br>* Animated video explaining acute otitis media and antimicrobial stewardship.<br>|
| Active Comparator: Pamphlet<br>Informative pamphlet containing the same information as the video. | Behavioral: Pamphlet<br>* Contains same information as video.<br>|
| No Intervention: No intervention<br>This is the reference standard currently. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who fill antimicrobial prescription early | The number of participants in each arm who fill and start administering a prescription for antimicrobials less than 48 hours after recruitment will be recorded. | <48 hours after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who fill antimicrobial prescription inappropriately early | The number of participants in each arm who fill and start administering an 'inappropriate' prescription for antimicrobials - that is, if the child improves clinically - less than 48 hours after recruitment will be recorded. | <48 hours after recruitment | 
| Caregiver satisfaction with management plan (treatment arm) | Caregiver satisfaction with the 'watchful waiting' strategy will be assessed using a Likert scale measure. | 2-5 days after recruitment | 
| Caregiver retention of stewardship knowledge | A quiz relating to antimicrobial stewardship will be administered at baseline and again at 3 months post-recruitment. | 3 months after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knowledge translation, antimicrobial stewardship