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=5 Participants	34 years n=7 Participants	33 years n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	54 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic, White	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic, Black	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	43 Participants n=5 Participants	30 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants	66 participants n=7 Participants	149 participants n=5 Participants
Health literacy (as measured by Newest Vital Sign)	4 units on a scale n=5 Participants	4 units on a scale n=7 Participants	4 units on a scale n=5 Participants
Language of study administration English	59 Participants n=5 Participants	51 Participants n=7 Participants	110 Participants n=5 Participants
Language of study administration Spanish	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48-72 hours

Number 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 days

Number 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 hours

Number 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 days

Number 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 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).

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 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).

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: msamuels-kalow@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place