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Acetaminophen and ibuprofen are two of the most commonly used medication products among children <12 years old, and these medications are frequently prescribed for patients leaving the emergency department (ED), but previous studies have shown that parents often leave the ED unsure of how to safely dose these medications at home. This study will be a randomized controlled trial of a brief medication safety intervention, and examining parental knowledge and implementation of appropriate weight-based dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | ||
| Additional teaching | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional teaching | Other | A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Safe Dosing at 48-72 Hours | Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours | 48-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days | Number of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days | 5-7 days |
| Number of Participants Reporting Contact With Other Providers at 48-72 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Samuels-Kalow, MD MSHP | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32807539 | Derived | Naureckas Li C, Camargo CA Jr, Faridi M, Espinola JA, Hayes BD, Porter S, Cohen A, Samuels-Kalow M. Medication Education for Dosing Safety: A Randomized Controlled Trial. Ann Emerg Med. 2020 Nov;76(5):637-645. doi: 10.1016/j.annemergmed.2020.07.007. Epub 2020 Aug 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Standard discharge care |
| FG001 | Additional Teaching | Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 48-72 Hours |
| |||||||||||||
| 5-7 Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Standard discharge care |
| BG001 | Additional Teaching | Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Safe Dosing at 48-72 Hours | Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours | Posted | Count of Participants | Participants | 48-72 hours |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Standard discharge care | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient admitted | Social circumstances | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsen at home | Social circumstances | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margaret Samuels-Kalow | Massachusetts General Hospital | 6177262000 | msamuels-kalow@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2018 | Oct 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D005334 | Fever |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
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Number of participants reporting visit to primary care or emergency department providers at 48-72 hours |
| 48-72 hours |
| Number of Participants Reporting Contact With Other Providers at 5-7 Days | Number of participants reporting visit to primary care or emergency department providers at 5-7 days. | 5-7 days |
| 48-72 hours |
| Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen). | 5-7 days |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Health literacy (as measured by Newest Vital Sign) | Health literacy was measured by the Newest Vital Sign, which is scored from a minimum of 0 points to a maximum of 6 points. Higher scores represent higher health literacy. | Median | Inter-Quartile Range | units on a scale |
|
| Language of study administration | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days | Number of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days | Posted | Count of Participants | Participants | 5-7 days |
|
|
|
| Secondary | Number of Participants Reporting Contact With Other Providers at 48-72 Hours | Number of participants reporting visit to primary care or emergency department providers at 48-72 hours | Posted | Count of Participants | Participants | 48-72 hours |
|
|
|
| Secondary | Number of Participants Reporting Contact With Other Providers at 5-7 Days | Number of participants reporting visit to primary care or emergency department providers at 5-7 days. | Posted | Count of Participants | Participants | 5-7 days |
|
|
|
| Other Pre-specified | Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen). | Posted | Number | participants | 48-72 hours |
|
|
|
| Other Pre-specified | Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen). | Posted | Number | participants | 5-7 days |
|
|
|
| 83 |
| 2 |
| 83 |
| 16 |
| 83 |
| EG001 | Additional Teaching | Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding. | 0 | 66 | 2 | 66 | 19 | 66 |
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| Did not know dose |
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| Did not know dose |
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