search
Back to results

Improving Knowledge Translation Upon Emergency Department Discharge

Primary Purpose

Otitis Media

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Video
Pamphlet
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media focused on measuring knowledge translation, antimicrobial stewardship

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Video

Pamphlet

No intervention

Arm Description

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.

Informative pamphlet containing the same information as the video.

This is the reference standard currently.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Caregiver satisfaction with management plan (treatment arm)
Caregiver satisfaction with the 'watchful waiting' strategy will be assessed using a Likert scale measure.
Caregiver retention of stewardship knowledge
A quiz relating to antimicrobial stewardship will be administered at baseline and again at 3 months post-recruitment.

Full Information

First Posted
March 2, 2016
Last Updated
August 6, 2020
Sponsor
Hamilton Health Sciences Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02703389
Brief Title
Improving Knowledge Translation Upon Emergency Department Discharge
Official Title
Video, Ear Infections & Antibiotic Stewardship: Knowledge Translation Upon Emergency Department Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
knowledge translation, antimicrobial stewardship

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video
Arm Type
Experimental
Arm Description
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.
Arm Title
Pamphlet
Arm Type
Active Comparator
Arm Description
Informative pamphlet containing the same information as the video.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
This is the reference standard currently.
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
Animated video explaining acute otitis media and antimicrobial stewardship.
Intervention Type
Behavioral
Intervention Name(s)
Pamphlet
Intervention Description
Contains same information as video.
Primary Outcome Measure Information:
Title
Proportion of participants who fill antimicrobial prescription early
Description
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.
Time Frame
<48 hours after recruitment
Secondary Outcome Measure Information:
Title
Proportion of participants who fill antimicrobial prescription inappropriately early
Description
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.
Time Frame
<48 hours after recruitment
Title
Caregiver satisfaction with management plan (treatment arm)
Description
Caregiver satisfaction with the 'watchful waiting' strategy will be assessed using a Likert scale measure.
Time Frame
2-5 days after recruitment
Title
Caregiver retention of stewardship knowledge
Description
A quiz relating to antimicrobial stewardship will be administered at baseline and again at 3 months post-recruitment.
Time Frame
3 months after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April Kam, MD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Improving Knowledge Translation Upon Emergency Department Discharge

We'll reach out to this number within 24 hrs