Improving Knowledge Translation Upon Emergency Department Discharge

Video, Ear Infections & Antibiotic Stewardship: 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.

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Behavioral: Video; Behavioral: Pamphlet

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: April Kam, MD, Hamilton Health Sciences Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: antimicrobial stewardship; knowledge translation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Emergencies; Otitis Media
• Other Study ID Numbers: NIF-2015-1123