Fever, Pain
Conditions
Brief summary
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.
Interventions
OTHERAdditional teaching
A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* parents of children between ages of 90 days to 11.9 years * being discharged with a plan for use of liquid acetaminophen (any age) or ibuprofen (limited to those \>6 months old). The clinical team will determine planned medication use. * parental fluency in English or Spanish * ability to be reached by telephone over the next 7 days * planned discharge home.
Exclusion criteria
* presence of a complex chronic condition in the child * planned use of a non-standard weight-based medication dose. * Families will also be excluded if the adult with the child is not a parent or legal guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Safe Dosing at 48-72 Hours | 48-72 hours | Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days | 5-7 days | Number of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days |
| Number of Participants Reporting Contact With Other Providers at 48-72 Hours | 48-72 hours | Number of participants reporting visit to primary care or emergency department providers at 48-72 hours |
| Number of Participants Reporting Contact With Other Providers at 5-7 Days | 5-7 days | Number of participants reporting visit to primary care or emergency department providers at 5-7 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | 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). |
| Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Standard discharge care | 83 |
| Additional Teaching Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding. | 66 |
| Total | 149 |
Baseline characteristics
| Characteristic | Usual Care | Additional Teaching | Total |
|---|---|---|---|
| Age, Continuous | 33 years | 34 years | 33 years |
| Health literacy (as measured by Newest Vital Sign) | 4 units on a scale | 4 units on a scale | 4 units on a scale |
| Language of study administration English | 59 Participants | 51 Participants | 110 Participants |
| Language of study administration Spanish | 24 Participants | 15 Participants | 39 Participants |
| Race/Ethnicity, Customized Hispanic | 43 Participants | 30 Participants | 73 Participants |
| Race/Ethnicity, Customized Non-Hispanic, Black | 7 Participants | 8 Participants | 15 Participants |
| Race/Ethnicity, Customized Non-Hispanic, White | 28 Participants | 25 Participants | 53 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 83 participants | 66 participants | 149 participants |
| Sex: Female, Male Female | 61 Participants | 54 Participants | 115 Participants |
| Sex: Female, Male Male | 22 Participants | 12 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 66 |
| other Total, other adverse events | 16 / 83 | 19 / 66 |
| serious Total, serious adverse events | 2 / 83 | 2 / 66 |
Outcome results
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
Time frame: 48-72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Reporting Safe Dosing at 48-72 Hours | 28 Participants |
| Additional Teaching | Number of Participants Reporting Safe Dosing at 48-72 Hours | 25 Participants |
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
Time frame: 48-72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Reporting Contact With Other Providers at 48-72 Hours | 29 Participants |
| Additional Teaching | Number of Participants Reporting Contact With Other Providers at 48-72 Hours | 18 Participants |
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.
Time frame: 5-7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Reporting Contact With Other Providers at 5-7 Days | 23 Participants |
| Additional Teaching | Number of Participants Reporting Contact With Other Providers at 5-7 Days | 16 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
Time frame: 5-7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days | 22 Participants |
| Additional Teaching | Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days | 26 Participants |
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).
Time frame: 48-72 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | High | 9 participants |
| Usual Care | Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | Low | 24 participants |
| Usual Care | Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | Did not know dose | 9 participants |
| Additional Teaching | Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | Low | 8 participants |
| Additional Teaching | Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | High | 4 participants |
| Additional Teaching | Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours | Did not know dose | 1 participants |
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).
Time frame: 5-7 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | Did not know dose | 2 participants |
| Usual Care | Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | Low | 12 participants |
| Usual Care | Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | High | 6 participants |
| Additional Teaching | Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | Low | 5 participants |
| Additional Teaching | Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | Did not know dose | 1 participants |
| Additional Teaching | Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days | High | 3 participants |