Status EpilepticusNCT03562351
Seizure Rescue Medication: Caregiver Education in a Simulation Setting
A study testing Verbal Instructions Educational Intervention, Video Educational Intervention and Mannequin Educational Intervention in people with Status Epilepticus, run by Boston Children's Hospital at 1 site in United States.
Trial summary
1. Design an educational quality improvement program to assess the most effective educational approach on caregiver seizure RM application. The investigators hypothesize that this educational program will improve caregiver comfort, knowledge of emergent seizure care, and time to medication application. Read more about this study
- Who is it for?
- Ages 2 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Verbal Instructions Educational Intervention, Video Educational Intervention and Mannequin Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 17 Sep 2019
- 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 2 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult caregivers of patients with epilepsy followed at BCH with the following:
- At least one seizure >5 minutes
- Prescription for rectal diazepam rescue medication
- Admission for seizure/neurologic problem or neurology/epilepsy clinic visit during the enrollment period
- Adult caregivers of patients without epilepsy
Who cannot join
- Adult caregivers of epilepsy patients without a rectal diazepam prescription
- Non-English-speaking caregivers
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
- Design an educational quality improvement program to assess the most effective educational approach on caregiver seizure RM application. The investigators hypothesize that this educational program will improve caregiver comfort, knowledge of emergent seizure care, and time to medication application.
Specifically, the aims include:
- Create an educational video reviewing RM administration
- Develop and validate a simulation training model/mannequin for rectal diazepam administration
- Expand training to other seizure RMs (e.g. intranasal midazolam, buccal lorazepam) and transition the most effective educational model back to the clinics/bedside to standardize caregiver teaching throughout the department/hospital
Read the detailed description
The investigators will implement an intervention jointly with a simulation program to determine the most effective training model: verbal instructions, instructional video, or use of a mannequin. Caregivers will undergo a training curriculum, and 60 caregivers (20 assigned to each educational model) will be matched into three groups and assigned to participate in one of three educational models in the SIM Center. Pre-and post-training questionnaires will be distributed to assess provider knowledge and comfort level. Scoring of caregiver technique administering rectal diazepam to a mannequin and time to RM administration will be obtained to compare between the three educational arms of the study. Thirty additional patients (10 per group) will not receive an assessment of caregiver technique administering RM to the mannequin prior to the educational intervention to control for exposure to the mannequin. Ultimately, the most effective educational method in this simulation pilot study will be expanded to other RM types (e.g. intranasal midazolam, buccal lorazepam), standardized, and brought back to the clinics/bedside throughout the hospital.
- Conditions
- Status Epilepticus
- Being tested
- Verbal Instructions Educational Intervention, Video Educational Intervention, Mannequin Educational Intervention
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal Instructions Educational InterventionOther
Caregivers will undergo training with verbal instructions
Video Educational InterventionOther
Caregivers will undergo training with an educational video
Mannequin Educational InterventionOther
Caregivers will undergo training with a mannequin
| Study group | Role | What they receive |
|---|---|---|
| Verbal Instructions on use of RM | Experimental | Caregivers will undergo an educational intervention with typical training with verbal instructions and use of a rectal diazepam trainer. Receives: Other: Verbal Instructions Educational Intervention |
| Video on use of RM | Experimental | Caregivers will undergo an educational intervention with training by watching an instructional video regarding rescue medication administration Receives: Other: Video Educational Intervention |
| Mannequin on use of RM | Experimental | Caregivers will undergo an educational intervention with training by use of a mannequin to practice administering the rescue medication Receives: Other: Mannequin Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time to RM Administration
As determined by time to administer RM to mannequin
Measured: Baseline and 30 minutes post-intervention
Secondary outcomes (7)
Change in "RM Score"
"RM Score" ("Rescue Medication Score") assessing caregivers' ability to administer RM with proper technique before/after training. This score will determine if caregivers were able to independently give the medication or if they required a prompt at any step. There is no maximum score, but 1 point will be given for every required prompt such that 0 is a perfect score and higher scores reflect requiring more prompts to administer the medication.
Measured: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Medication Name
Caregiver will be asked to provide medication name on a questionnaire.
Measured: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of When to Give Medication
Caregiver will be asked to provide time at which medication is to be given on a questionnaire.
Measured: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Route of Medication Administration
Caregiver will be asked to provide route of medication administration on a questionnaire.
Measured: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Medication Side Effects
Caregiver will be asked to provide medication side effects on a questionnaire.
Measured: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Comfort
Caregiver level of comfort with administration as determined by the pre- and post-questionnaires. Caregivers will report level of comfort before and after training based on a 4-point scale (very uncomfortable, somewhat uncomfortable, somewhat comfortable, very comfortable)
Measured: Baseline and 30 minutes post-intervention
Change in Caregiver Feeling of Ease with Administration
Caregiver level of ease with administration as determined by the pre- and post-questionnaires. Caregivers will fill out the short-form State-Trait Anxiety Inventory (STAI-6) on a 4-point scale (not at all, somewhat, moderately, very much)
Measured: Baseline and 30 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Jul 2018
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
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.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will implement an intervention jointly with our simulation program to determine the most effective training model: verbal instructions, instructional video, or use of a mannequin. Caregivers will undergo a training curriculum, and 90 caregivers (30 assigned to each educational model) will be matched into three groups and assigned to participate in one of three educational models in the SIM Center.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Loddenkemper, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562351
- Sponsor's protocol ID
- P00027241
- Status last verified
- Sep 2020
- First submitted
- 6 Mar 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seizure Rescue Medication: Caregiver Education in a Simulation Setting
- ClinicalTrials.gov ID
- NCT03562351
- Acronym / sponsor ID
- P00027241
- Conditions
- Status Epilepticus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- 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.
- Design an educational quality improvement program to assess the most effective educational approach on caregiver seizure RM application. The investigators hypothesize that this educational program will improve caregiver comfort, knowledge of emergent seizure care, and time to medication application.
Specifically, the aims include:
- Create an educational video reviewing RM administration
- Develop and validate a simulation training model/mannequin for rectal diazepam administration
- Expand training to other seizure RMs (e.g. intranasal midazolam, buccal lorazepam) and transition the most effective educational model back to the clinics/bedside to standardize caregiver teaching throughout the department/hospital
Detailed description
The investigators will implement an intervention jointly with a simulation program to determine the most effective training model: verbal instructions, instructional video, or use of a mannequin. Caregivers will undergo a training curriculum, and 60 caregivers (20 assigned to each educational model) will be matched into three groups and assigned to participate in one of three educational models in the SIM Center. Pre-and post-training questionnaires will be distributed to assess provider knowledge and comfort level. Scoring of caregiver technique administering rectal diazepam to a mannequin and time to RM administration will be obtained to compare between the three educational arms of the study. Thirty additional patients (10 per group) will not receive an assessment of caregiver technique administering RM to the mannequin prior to the educational intervention to control for exposure to the mannequin. Ultimately, the most effective educational method in this simulation pilot study will be expanded to other RM types (e.g. intranasal midazolam, buccal lorazepam), standardized, and brought back to the clinics/bedside throughout the hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators will implement an intervention jointly with our simulation program to determine the most effective training model: verbal instructions, instructional video, or use of a mannequin. Caregivers will undergo a training curriculum, and 90 caregivers (30 assigned to each educational model) will be matched into three groups and assigned to participate in one of three educational models in the SIM Center.
| Arm | Type | Receives |
|---|---|---|
| Verbal Instructions on use of RM | Experimental | Other: Verbal Instructions Educational InterventionCaregivers will undergo an educational intervention with typical training with verbal instructions and use of a rectal diazepam trainer. |
| Video on use of RM | Experimental | Other: Video Educational InterventionCaregivers will undergo an educational intervention with training by watching an instructional video regarding rescue medication administration |
| Mannequin on use of RM | Experimental | Other: Mannequin Educational InterventionCaregivers will undergo an educational intervention with training by use of a mannequin to practice administering the rescue medication |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult caregivers of patients with epilepsy followed at BCH with the following:
- Adult caregivers of patients without epilepsy
Key exclusion criteria (2 listed)
- Adult caregivers of epilepsy patients without a rectal diazepam prescription
- Non-English-speaking caregivers
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 |
|---|---|---|
| Verbal Instructions Educational InterventionCaregivers will undergo training with verbal instructions | Other | Verbal Instructions on use of RM |
| Video Educational InterventionCaregivers will undergo training with an educational video | Other | Video on use of RM |
| Mannequin Educational InterventionCaregivers will undergo training with a mannequin | Other | Mannequin on use of RM |
Primary outcome
Change in Time to RM Administration
Time frame: Baseline and 30 minutes post-intervention
As determined by time to administer RM to mannequin
7 secondary outcomes
Change in "RM Score"
Time frame: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Medication Name
Time frame: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of When to Give Medication
Time frame: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Route of Medication Administration
Time frame: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Medication Side Effects
Time frame: Baseline and 30 minutes post-intervention
Change in Caregiver Level of Comfort
Time frame: Baseline and 30 minutes post-intervention
Change in Caregiver Feeling of Ease with Administration
Time frame: Baseline and 30 minutes post-intervention
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 4 Sep 2020.
- 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 Verbal Instructions Educational Intervention, Video Educational Intervention and Mannequin Educational Intervention in people with Status Epilepticus, run by Boston Children's Hospital at 1 site in United States.
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 5 inclusion and 2 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 4 Sep 2020. 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 United States. 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?
Change in Time to RM Administration (time frame: Baseline and 30 minutes post-intervention). 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 4 Sep 2020.