Improving Knowledge Translation Upon Emergency Department Discharge
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|ClinicalTrials.gov Identifier: NCT02703389|
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : August 8, 2019
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|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Animated video explaining acute otitis media and antimicrobial stewardship.
Active Comparator: Pamphlet
Informative pamphlet containing the same information as the video.
Contains same information as video.
No Intervention: No intervention
This is the reference standard currently.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02703389
|Contact: Jeffrey Pernica, MD MSc||905 521 2100 ext email@example.com|
|Contact: Stacey Clark||905 521 2100 ext firstname.lastname@example.org|
|McMaster Children's Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8S 4K1|
|Contact: Jeffrey Pernica, MD 905 521 2100 ext 77577 email@example.com|
|Principal Investigator: Jeffrey Pernica, MD|
|Principal Investigator:||April Kam, MD||Hamilton Health Sciences Corporation|