Status EpilepticusSMARTERNCT02958605
Smartphone Apps for Pediatric Resuscitation
A study testing Smartphone apps and Handbook in people with Status Epilepticus and Anaphylaxis, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Medication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Status Epilepticus, Anaphylaxis
- What is being tested?
- Smartphone apps and Handbook
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Sep 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents (PGY1 to PGY4)
- Completing a rotation in pediatric emergency
Who cannot join
- Residents who previously participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone Medical Applications to Reduce Treatment Dosage Errors in Pediatric Resuscitation; a Randomized Simulation Trial
Medication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown.
Many smartphone apps have been suggested over the last years with some of them designed to calculate medication dosage for children. The impact of these apps to decrease dosage error has never been evaluated in resuscitation setting.
Read more
The aim of the study is to evaluate whether the use of a smartphone application designed to calculate medication doses decreases prescribing errors among residents during pediatric simulated resuscitations.
This will be a crossover-randomized trial using high fidelity simulation among 40 residents rotating in the pediatric emergency department.
- Conditions
- Status Epilepticus, Anaphylaxis
- Being tested
- Smartphone apps, Handbook
- Keywords
- Children, resuscitation, smartphone
- Medical subject headings
- Status Epilepticus, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone appsDevice
If already own a smartphone application dedicated to calculate medication dosage for children, the participant will be allowed to use his/her own application. Otherwise, the resident will be offered to chose among a list of applications paid by the research team (PediSafe, PediStat, Palm Pedi, Safedose, EZdrip peds). He/she will be instructed to practice with a few time at home before doing the simulations.
HandbookDevice
Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone | Experimental | Smartphone application Receives: Device: Smartphone apps |
| Handbook | Experimental | Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000. Receives: Device: Handbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication error
The primary outcome is the presence of a medication error. An error will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.
Measured: During resuscitation
Secondary outcomes (6)
Proportion of tenfold error
A tenfold error will be defined as a drug dose varying by a factor of 10 compared to the recommended dose.
Measured: During resuscitation
Time for prescribing the first medication
Time from the beginning of the simulation and complete prescription (oral or written) of the first medication.
Measured: During the simulation (10 minutes)
Error in bolus medication
An error in bolus medication will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.
Measured: during simulation
Error in perfusion medication
An error in perfusion medication will be defined as a drug dose varying by more than 20% from the recommended dose. This can be related to a preparation error or a flow error.
Measured: during simulation
User satisfaction
Satisfaction of the resident with both tools using a Visual analog scale
Measured: 2 weeks
User confidence
Confidence of the resident while using both tools using a Visual analog scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Medical Protective Association
- Responsible party
- Principal investigator, Jocelyn Gravel, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958605
- Sponsor's protocol ID
- SMARTER1
- Acronym
- SMARTER
- Status last verified
- Oct 2017
- First submitted
- 4 Nov 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Medical Applications to Reduce Treatment Dosage Errors in Pediatric Resuscitation; a Randomized Simulation Trial
- ClinicalTrials.gov ID
- NCT02958605
- Acronym / sponsor ID
- SMARTER / SMARTER1
- Conditions
- Status Epilepticus, Anaphylaxis
- Keywords
- Children, resuscitation, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Canadian Medical Protective Association
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Nov 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.
Medication errors are common in children. Characteristics of errors during critical situations in the Emergency Department are ill-defined and might be more frequent than previously thought. However, optimal strategies to eliminate the risk of prescribing errors remain unknown.
Many smartphone apps have been suggested over the last years with some of them designed to calculate medication dosage for children. The impact of these apps to decrease dosage error has never been evaluated in resuscitation setting.
The aim of the study is to evaluate whether the use of a smartphone application designed to calculate medication doses decreases prescribing errors among residents during pediatric simulated resuscitations.
This will be a crossover-randomized trial using high fidelity simulation among 40 residents rotating in the pediatric emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone | Experimental | Device: Smartphone appsSmartphone application |
| Handbook | Experimental | Device: HandbookResuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents (PGY1 to PGY4)
- Completing a rotation in pediatric emergency
Key exclusion criteria (1 listed)
- Residents who previously participated in this study
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 |
|---|---|---|
| Smartphone appsIf already own a smartphone application dedicated to calculate medication dosage for children, the participant will be allowed to use his/her own application. Otherwise, the resident will be offered to chose among a list of applications paid by the research team (PediSafe, PediStat, Palm Pedi, Safedose, EZdrip peds). He/she will be instructed to practice with a few time at home before doing the simulations. | Device | Smartphone |
| HandbookResuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000. | Device | Handbook |
Primary outcome
Medication error
Time frame: During resuscitation
The primary outcome is the presence of a medication error. An error will be defined as a drug dose varying by more than 20% from the recommended dose or by incorrect route.
6 secondary outcomes
Proportion of tenfold error
Time frame: During resuscitation
Time for prescribing the first medication
Time frame: During the simulation (10 minutes)
Error in bolus medication
Time frame: during simulation
Error in perfusion medication
Time frame: during simulation
User satisfaction
Time frame: 2 weeks
User confidence
Time frame: 2 weeks
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 6 Oct 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone apps and Handbook in people with Status Epilepticus and Anaphylaxis, run by St. Justine's Hospital 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 1 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 6 Oct 2017. 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?
Medication error (time frame: During resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2017.