Trial Outcomes & Findings for Medication Education for Dosing Safety (NCT NCT03223246)
NCT ID: NCT03223246
Last Updated: 2020-11-04
Results Overview
Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
48-72 hours
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Usual Care
Standard discharge care
|
Additional Teaching
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
48-72 Hours
STARTED
|
83
|
66
|
|
48-72 Hours
COMPLETED
|
62
|
35
|
|
48-72 Hours
NOT COMPLETED
|
21
|
31
|
|
5-7 Days
STARTED
|
83
|
66
|
|
5-7 Days
COMPLETED
|
41
|
35
|
|
5-7 Days
NOT COMPLETED
|
42
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medication Education for Dosing Safety
Baseline characteristics by cohort
| Measure |
Usual Care
n=83 Participants
Standard discharge care
|
Additional Teaching
n=66 Participants
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=99 Participants
|
34 years
n=107 Participants
|
33 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, White
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Black
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
43 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=99 Participants
|
66 participants
n=107 Participants
|
149 participants
n=206 Participants
|
|
Health literacy (as measured by Newest Vital Sign)
|
4 units on a scale
n=99 Participants
|
4 units on a scale
n=107 Participants
|
4 units on a scale
n=206 Participants
|
|
Language of study administration
English
|
59 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Language of study administration
Spanish
|
24 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48-72 hoursNumber of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours
Outcome measures
| Measure |
Usual Care
n=62 Participants
Standard discharge care
|
Additional Teaching
n=35 Participants
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Number of Participants Reporting Safe Dosing at 48-72 Hours
|
28 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 5-7 daysNumber of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days
Outcome measures
| Measure |
Usual Care
n=41 Participants
Standard discharge care
|
Additional Teaching
n=35 Participants
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 48-72 hoursNumber of participants reporting visit to primary care or emergency department providers at 48-72 hours
Outcome measures
| Measure |
Usual Care
n=62 Participants
Standard discharge care
|
Additional Teaching
n=35 Participants
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Number of Participants Reporting Contact With Other Providers at 48-72 Hours
|
29 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 5-7 daysNumber of participants reporting visit to primary care or emergency department providers at 5-7 days.
Outcome measures
| Measure |
Usual Care
n=41 Participants
Standard discharge care
|
Additional Teaching
n=35 Participants
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Number of Participants Reporting Contact With Other Providers at 5-7 Days
|
23 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48-72 hoursNumber 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).
Outcome measures
| Measure |
Usual Care
n=62 Participants
Standard discharge care
|
Additional Teaching
n=35 Participants
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours
High
|
9 participants
|
4 participants
|
|
Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours
Low
|
24 participants
|
8 participants
|
|
Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours
Did not know dose
|
9 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5-7 daysNumber 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).
Outcome measures
| Measure |
Usual Care
n=41 Participants
Standard discharge care
|
Additional Teaching
n=35 Participants
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days
High
|
6 participants
|
3 participants
|
|
Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days
Low
|
12 participants
|
5 participants
|
|
Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days
Did not know dose
|
2 participants
|
1 participants
|
Adverse Events
Usual Care
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Additional Teaching
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=83 participants at risk
Standard discharge care
|
Additional Teaching
n=66 participants at risk
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Social circumstances
Patient admitted
|
2.4%
2/83 • Number of events 2 • 7 days
|
3.0%
2/66 • Number of events 2 • 7 days
|
Other adverse events
| Measure |
Usual Care
n=83 participants at risk
Standard discharge care
|
Additional Teaching
n=66 participants at risk
Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
|
|---|---|---|
|
Social circumstances
Worsen at home
|
19.3%
16/83 • Number of events 16 • 7 days
|
28.8%
19/66 • Number of events 19 • 7 days
|
Additional Information
Dr. Margaret Samuels-Kalow
Massachusetts General Hospital
Phone: 6177262000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place