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OpenTrials
Completed

NCT Number: NCT02703389

Improving Knowledge Translation Upon Emergency Department Discharge

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.

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video

Behavioral

Animated video explaining acute otitis media and antimicrobial stewardship.

PAMPHLET

Behavioral

Contains same information as video.

Primary outcomes

  1. Proportion of participants who fill antimicrobial prescription early

    Time frame: <48 hours after recruitment

    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.

Secondary outcomes

  1. Proportion of participants who fill antimicrobial prescription inappropriately early

    Time frame: <48 hours after recruitment

    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.

  2. Caregiver satisfaction with management plan (treatment arm)

    Time frame: 2-5 days after recruitment

    Caregiver satisfaction with the 'watchful waiting' strategy will be assessed using a Likert scale measure.

  3. Caregiver retention of stewardship knowledge

    Time frame: 3 months after recruitment

    A quiz relating to antimicrobial stewardship will be administered at baseline and again at 3 months post-recruitment.

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2016
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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