Otitis MediaNCT02788422
Video Discharge Instructions for Acute Otitis Media
A study testing Video discharge instructions in people with Otitis Media, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Thorough, understandable discharge instructions empower caregivers, allowing them to provide optimum care of their children during illness. Unfortunately discharge instructions are often incomplete and difficult to understand. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Video discharge instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All primary caregivers of children aged 6 months to 17 years presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario
- Clinical diagnosis of AOM in the context of an upper respiratory tract infection as determined by the treating emergency physician (staff physician or fellow). The treating physician will be asked to rate, using a 10 mm visual analog scale, the likelihood that the patient has AOM using previously published diagnostic criteria. - Physician reports being at least 50% certain, on a visual analog scale in the diagnosis of AOM.
Who cannot join
- Caregivers whose children have other diagnoses (pneumonia, urinary tract infection, gastroenteritis, or any other condition requiring antibiotics or admission to hospital)
- Previous diagnosis of AOM within 7 days
- Tympanostomy tubes
- Acute tympanic membrane perforation
- Attending caregiver who is not the primary care provider
- Poor English fluency
Show all 9Show fewer
- Lack of at least a grade 8 literacy level
- No Internet access
- No telephone access for 72 hours following discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Video Discharge Instructions for Acute Otitis Media on Knowledge Acquisition and Clinical Outcomes: a Randomized Controlled Trial
Thorough, understandable discharge instructions empower caregivers, allowing them to provide optimum care of their children during illness. Unfortunately discharge instructions are often incomplete and difficult to understand. The use of video discharge instructions has been shown to increase patient understanding of their illness. The investigators would like to know if using video discharge instructions for caregivers of children with middle ear infections helps to better understand how to take care of children at home, potentially allowing the child to feel better faster. The investigators will be comparing video discharge instructions to a paper handout to see if the former leads to improved well-being of the child and improved caregiver knowledge, satisfaction and anxiety.
Read the detailed description
Providing patients with understandable, comprehensive discharge instructions improves compliance, thereby reducing symptoms and the functional impact of illness. Comprehensive discharge instructions also reduce patient anxiety and increases satisfaction. Unfortunately, in a busy emergency department (ED), discharge instructions are often incomplete. Furthermore, even when discharge instructions have been provided, patients often have difficulty comprehending and/or recalling them. Inadequate discharge instructions are linked to medication errors, suboptimal care post-discharge, and unnecessary return visits to the ED. Patient dissatisfaction with discharge instructions and anxiety have also been linked to poor medication compliance, and an increase in return visits.
Studies have demonstrated that knowledge of pediatric medical conditions can be enhanced through the use of video technology. Specifically, it has been shown that when video discharge instructions are used in place of, or to complement written discharge instructions, patients have a better understanding of their illness and report higher rates of satisfaction. However, no studies to date have explored if clinically relevant outcomes such as symptomatology, function and recidivism can be improved.
This study will examine the utility of video discharge instructions for the diagnosis of acute otitis media (AOM), a leading cause of health care visits among children. AOM affects up to 75% of children before school-age and is the most common illness for which antibiotics are prescribed to children in the United States. In Canada, AOM is associated with substantial use of health services (3.1 hours in an emergency department and 1.8 hours in an outpatient clinic on average per visit) and significantly burdens caregivers in the form of time spent on medical consultations, and time taken off from work. An American study estimated that the cost of one episode of AOM in a 3-month period following diagnosis was $1330.58, with the majority of that cost stemming from the indirect costs of illness, 90% of which was accrued primarily by parental time off work. In Quebec, the total annual cost to the health care system for otitis media and placement of tympanostomy tubes is more than $10 million dollars.
Pain is often substantial in the early course of AOM. Poorly controlled pain is associated with suffering and can be emotionally traumatic, causing anxiety for patients and their caregivers. Efficacious treatment for child pain is paramount in preventing protracted sensitivity to pain. Despite the magnitude of effects that acute pain can have on a child, it is often inadequately assessed and treated. In children less than two years of age, 30% of children continue to experience pain, fever, or both for up to 7 into the illness, thus highlighting the importance of caregiver education on symptom management.
Recurrent AOM is common, 5-15% of children under the age of 2 experience four or more episodes per year. Caregivers of children with recurrent AOM not only judge their child's quality of life markedly lower than caregivers of children of a general population, but also lower than those of children with mild-to-moderately severe chronic conditions. Although uncommon, AOM also has the potential to cause serious complications such as, mastoiditis and bacterial meningitis, if not treated and monitored appropriately.
The investigators hypothesize that video discharge instructions directed at caregivers of children with AOM will be associated with improved symptomatology and functional outcomes, along with improved caregiver knowledge, satisfaction, and anxiety compared to the standard of care, paper-based discharge instructions.
- Conditions
- Otitis Media
- Being tested
- Video discharge instructions, Standard of Care
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video discharge instructionsOther
Online video containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
Standard of CareOther
One page paper handout containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Video discharge instructions developed using Easy Sketch Pro3TM software (Easy Sketch Pro, United Kingdom). It was created by the primary and co-investigator based results on a focus group consisting of two paediatric residents, two paediatric emergency medicine fellows, a paediatric emergency medicine nurse, and a paediatric emergency medicine staff physician. Receives: Other: Video discharge instructions |
| Standard of care | Active comparator | This is a one-page paper handout created by the primary and co-investigator based results on a focus group consisting of two paediatric residents, two paediatric emergency medicine fellows, a paediatric emergency medicine nurse, and a paediatric emergency medicine staff physician. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily self-reported Acute Otitis Media Symptom Severity Score
At 72 hours
Measured: 72 hours
Secondary outcomes (7)
Self-report State Trait Anxiety Inventory at discharge
Measured: 72 hours
Caregiver Satisfaction at 72 hours
Measured: 72 hours
Self-reported number of days of school/work/daycare missed at 72 hours
Measured: 72 hours
Self-reported medication administered daily for 72 hours
Number of doses and type of medication administered based on self-report
Measured: 72 hours
Self-reported return visits to a health care provider at 72 hours
Number of visits and type of health care provider and reason based on self-report
Measured: 72 hours
Number of times online video was viewed in 72 hours
Measured: 72 hours
Change in knowledge score on novel questionnaire before and after intervention in ED
Difference in knowledge questionnaire scores before and immediately following intervention
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start20 Mar 2017
- Primary completion17 Mar 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naveen Poonai, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788422
- Sponsor's protocol ID
- 10012437
- Status last verified
- Oct 2018
- First submitted
- 24 May 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belisle S, Dobrin A, Elsie S, Ali S, Brahmbhatt S, Kumar K, Jasani H, Miller M, Ferlisi F, Poonai N. Video Discharge Instructions for Acute Otitis Media in Children: A Randomized Controlled Open-label Trial. Acad Emerg Med. 2019 Dec;26(12):1326-1335. doi: 10.1111/acem.13839. Epub 2019 Nov 19.
PubMed 31742809
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Video Discharge Instructions for Acute Otitis Media on Knowledge Acquisition and Clinical Outcomes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02788422
- Acronym / sponsor ID
- 10012437
- Conditions
- Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 17 Mar 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thorough, understandable discharge instructions empower caregivers, allowing them to provide optimum care of their children during illness. Unfortunately discharge instructions are often incomplete and difficult to understand. The use of video discharge instructions has been shown to increase patient understanding of their illness. The investigators would like to know if using video discharge instructions for caregivers of children with middle ear infections helps to better understand how to take care of children at home, potentially allowing the child to feel better faster. The investigators will be comparing video discharge instructions to a paper handout to see if the former leads to improved well-being of the child and improved caregiver knowledge, satisfaction and anxiety.
Detailed description
Providing patients with understandable, comprehensive discharge instructions improves compliance, thereby reducing symptoms and the functional impact of illness. Comprehensive discharge instructions also reduce patient anxiety and increases satisfaction. Unfortunately, in a busy emergency department (ED), discharge instructions are often incomplete. Furthermore, even when discharge instructions have been provided, patients often have difficulty comprehending and/or recalling them. Inadequate discharge instructions are linked to medication errors, suboptimal care post-discharge, and unnecessary return visits to the ED. Patient dissatisfaction with discharge instructions and anxiety have also been linked to poor medication compliance, and an increase in return visits.
Studies have demonstrated that knowledge of pediatric medical conditions can be enhanced through the use of video technology. Specifically, it has been shown that when video discharge instructions are used in place of, or to complement written discharge instructions, patients have a better understanding of their illness and report higher rates of satisfaction. However, no studies to date have explored if clinically relevant outcomes such as symptomatology, function and recidivism can be improved.
This study will examine the utility of video discharge instructions for the diagnosis of acute otitis media (AOM), a leading cause of health care visits among children. AOM affects up to 75% of children before school-age and is the most common illness for which antibiotics are prescribed to children in the United States. In Canada, AOM is associated with substantial use of health services (3.1 hours in an emergency department and 1.8 hours in an outpatient clinic on average per visit) and significantly burdens caregivers in the form of time spent on medical consultations, and time taken off from work. An American study estimated that the cost of one episode of AOM in a 3-month period following diagnosis was $1330.58, with the majority of that cost stemming from the indirect costs of illness, 90% of which was accrued primarily by parental time off work. In Quebec, the total annual cost to the health care system for otitis media and placement of tympanostomy tubes is more than $10 million dollars.
Pain is often substantial in the early course of AOM. Poorly controlled pain is associated with suffering and can be emotionally traumatic, causing anxiety for patients and their caregivers. Efficacious treatment for child pain is paramount in preventing protracted sensitivity to pain. Despite the magnitude of effects that acute pain can have on a child, it is often inadequately assessed and treated. In children less than two years of age, 30% of children continue to experience pain, fever, or both for up to 7 into the illness, thus highlighting the importance of caregiver education on symptom management.
Recurrent AOM is common, 5-15% of children under the age of 2 experience four or more episodes per year. Caregivers of children with recurrent AOM not only judge their child's quality of life markedly lower than caregivers of children of a general population, but also lower than those of children with mild-to-moderately severe chronic conditions. Although uncommon, AOM also has the potential to cause serious complications such as, mastoiditis and bacterial meningitis, if not treated and monitored appropriately.
The investigators hypothesize that video discharge instructions directed at caregivers of children with AOM will be associated with improved symptomatology and functional outcomes, along with improved caregiver knowledge, satisfaction, and anxiety compared to the standard of care, paper-based discharge instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Other: Video discharge instructionsVideo discharge instructions developed using Easy Sketch Pro3TM software (Easy Sketch Pro, United Kingdom). It was created by the primary and co-investigator based results on a focus group consisting of two paediatric residents, two paediatric emergency medicine fellows, a paediatric emergency medicine nurse, and a paediatric emergency medicine staff physician. |
| Standard of care | Active comparator | Other: Standard of CareThis is a one-page paper handout created by the primary and co-investigator based results on a focus group consisting of two paediatric residents, two paediatric emergency medicine fellows, a paediatric emergency medicine nurse, and a paediatric emergency medicine staff physician. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All primary caregivers of children aged 6 months to 17 years presenting to the Emergency Department of the Children's Hospital, London Health Sciences Centre, London, Ontario
- Clinical diagnosis of AOM in the context of an upper respiratory tract infection as determined by the treating emergency physician (staff physician or fellow). The treating physician will be asked to rate, using a 10 mm visual analog scale, the likelihood that the patient has AOM using previously published diagnostic criteria. - Physician reports being at least 50% certain, on a visual analog scale in the diagnosis of AOM.
Key exclusion criteria (9 listed)
- Caregivers whose children have other diagnoses (pneumonia, urinary tract infection, gastroenteritis, or any other condition requiring antibiotics or admission to hospital)
- Previous diagnosis of AOM within 7 days
- Tympanostomy tubes
- Acute tympanic membrane perforation
- Attending caregiver who is not the primary care provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video discharge instructionsOnline video containing information on how to manage symptoms of acute otitis media and when to return to a health care professional. | Other | Video |
| Standard of CareOne page paper handout containing information on how to manage symptoms of acute otitis media and when to return to a health care professional. | Other | Standard of care |
Primary outcome
Daily self-reported Acute Otitis Media Symptom Severity Score
Time frame: 72 hours
At 72 hours
7 secondary outcomes
Self-report State Trait Anxiety Inventory at discharge
Time frame: 72 hours
Caregiver Satisfaction at 72 hours
Time frame: 72 hours
Self-reported number of days of school/work/daycare missed at 72 hours
Time frame: 72 hours
Self-reported medication administered daily for 72 hours
Time frame: 72 hours
Self-reported return visits to a health care provider at 72 hours
Time frame: 72 hours
Number of times online video was viewed in 72 hours
Time frame: 72 hours
Change in knowledge score on novel questionnaire before and after intervention in ED
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 31742809Belisle S, Dobrin A, Elsie S, Ali S, Brahmbhatt S, Kumar K, Jasani H, Miller M, Ferlisi F, Poonai N. Video Discharge Instructions for Acute Otitis Media in Children: A Randomized Controlled Open-label Trial. Acad Emerg Med. 2019 Dec;26(12):1326-1335. doi: 10.1111/acem.13839. Epub 2019 Nov 19.
- Individual participant dataSharing planned: No
Related trials for Otitis Media
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Active, not recruiting
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Acute Otitis Media
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
Acute Otitis Media (AOM)
Active, not recruitingObservational study
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Nasopharyngeal Colonization and Acute Otitis Media
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Poonai, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video discharge instructions in people with Otitis Media, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily self-reported Acute Otitis Media Symptom Severity Score (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.