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Improving Knowledge Translation Upon Emergency Department Discharge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02703389
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : August 8, 2019
Information provided by (Responsible Party):
Jeffrey Pernica, Hamilton Health Sciences Corporation

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Otitis Media Behavioral: Video Behavioral: Pamphlet Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Video, Ear Infections & Antibiotic Stewardship: Knowledge Translation Upon Emergency Department Discharge
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Video
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
Animated video explaining acute otitis media and antimicrobial stewardship.

Active Comparator: Pamphlet
Informative pamphlet containing the same information as the video.
Behavioral: Pamphlet
Contains same information as video.

No Intervention: No intervention
This is the reference standard currently.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02703389

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Contact: Jeffrey Pernica, MD MSc 905 521 2100 ext 76185
Contact: Stacey Clark 905 521 2100 ext 77577

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Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Jeffrey Pernica, MD    905 521 2100 ext 77577   
Principal Investigator: Jeffrey Pernica, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
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Principal Investigator: April Kam, MD Hamilton Health Sciences Corporation

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Responsible Party: Jeffrey Pernica, Head, Division of Pediatric Infectious Disease, Hamilton Health Sciences Corporation Identifier: NCT02703389     History of Changes
Other Study ID Numbers: NIF-2015-1123
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Keywords provided by Jeffrey Pernica, Hamilton Health Sciences Corporation:
knowledge translation
antimicrobial stewardship
Additional relevant MeSH terms:
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Otitis Media
Disease Attributes
Pathologic Processes
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents