Improving Knowledge Translation Upon Emergency Department Discharge

Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703389
• Other study ID #: NIF-2015-1123
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: June 2020

Study information

• Verified date: August 2020
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Otitis Media

Intervention

Behavioral:
• Video
Animated video explaining acute otitis media and antimicrobial stewardship.
• Pamphlet
Contains same information as video.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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