Improving Knowledge Translation Upon Emergency Department Discharge

NCT02703389 | Completed Phase 3

• 1 other identifier: NIF-2015-1123
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media

Keywords

knowledge translation; antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of participants who fill antimicrobial prescription inappropriately early

  <48 hours after recruitment

• Caregiver satisfaction with management plan (treatment arm)

  2-5 days after recruitment

• Caregiver retention of stewardship knowledge

  3 months after recruitment

Study Arms (3)

Video

EXPERIMENTAL

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

Pamphlet

ACTIVE COMPARATOR

Informative pamphlet containing the same information as the video.

Behavioral: Pamphlet

No intervention

NO INTERVENTION

This is the reference standard currently.

Interventions

Video BEHAVIORAL

Animated video explaining acute otitis media and antimicrobial stewardship.

Video

Pamphlet BEHAVIORAL

Contains same information as video.

Pamphlet

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• caregivers of children aged 6-59 months diagnosed with non severe acute otitis media at the McMaster Children's Hospital ED

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• April Kam, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Pediatric Infectious Disease

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 9, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

CA (1)