MEDS: Medication Education for Dosing Safety

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03223246
• Collaborator: (none)
• Enrollment: 149
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.9
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Fever	Other: Additional teaching	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Medication Education for Dosing Safety
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Aug 28, 2018
• Actual Study Completion Date: Aug 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care
Experimental: Additional teaching	Other: Additional teaching; A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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 Outcome Measures

1. 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).

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Margaret Samuels-Kalow, MD MSHP, MGH

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 15, 2018

More Information

Publications

None provided.

• Responsible Party: Margaret Samuels-Kalow, Assistant Professor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03223246
• Other Study ID Numbers: 2017P001482
• First Posted: Jul 21, 2017
• Last Update Posted: Nov 4, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Usual Care	Additional Teaching
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Period Title: 48-72 Hours
STARTED	83	66
COMPLETED	62	35
NOT COMPLETED	21	31
Period Title: 48-72 Hours
STARTED	83	66
COMPLETED	41	35
NOT COMPLETED	42	31

Baseline Characteristics

Arm/Group Title	Usual Care	Additional Teaching	Total
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.	Total of all reporting groups
Overall Participants	83	66	149
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	33	34	33
Sex: Female, Male (Count of Participants)
Female	61 73.5%	54 81.8%	115 77.2%
Male	22 26.5%	12 18.2%	34 22.8%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic, White	28 33.7%	25 37.9%	53 35.6%
Non-Hispanic, Black	7 8.4%	8 12.1%	15 10.1%
Hispanic	43 51.8%	30 45.5%	73 49%
Other	5 6%	3 4.5%	8 5.4%
Region of Enrollment (participants) [Number]
United States	83 100%	66 100%	149 100%
Health literacy (as measured by Newest Vital Sign) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	4	4	4
Language of study administration (Count of Participants)
English	59 71.1%	51 77.3%	110 73.8%
Spanish	24 28.9%	15 22.7%	39 26.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Safe Dosing at 48-72 Hours
Description	Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours
Time Frame	48-72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Additional Teaching
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Measure Participants	62	35
Count of Participants [Participants]	28 33.7%	25 37.9%

2. Secondary Outcome

Title	Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days
Description	Number of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days
Time Frame	5-7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Additional Teaching
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Measure Participants	41	35
Count of Participants [Participants]	22 26.5%	26 39.4%

3. Secondary Outcome

Title	Number of Participants Reporting Contact With Other Providers at 48-72 Hours
Description	Number of participants reporting visit to primary care or emergency department providers at 48-72 hours
Time Frame	48-72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Additional Teaching
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Measure Participants	62	35
Count of Participants [Participants]	29 34.9%	18 27.3%

4. Secondary Outcome

Title	Number of Participants Reporting Contact With Other Providers at 5-7 Days
Description	Number of participants reporting visit to primary care or emergency department providers at 5-7 days.
Time Frame	5-7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Additional Teaching
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Measure Participants	41	35
Count of Participants [Participants]	23 27.7%	16 24.2%

5. Other Pre-specified Outcome

Title	Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Additional Teaching
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Measure Participants	62	35
High	9 10.8%	4 6.1%
Low	24 28.9%	8 12.1%
Did not know dose	9 10.8%	1 1.5%

6. Other Pre-specified Outcome

Title	Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Additional Teaching
Arm/Group Description	Standard discharge care	Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
Measure Participants	41	35
High	6 7.2%	3 4.5%
Low	12 14.5%	5 7.6%
Did not know dose	2 2.4%	1 1.5%

Adverse Events

Time Frame	7 days
Arm/Group Title	Usual Care		Additional Teaching
Arm/Group Description	Standard discharge care		Additional teaching: A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
All Cause Mortality
	Usual Care		Additional Teaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/66 (0%)
Serious Adverse Events
	Usual Care		Additional Teaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/83 (2.4%)		2/66 (3%)
Social circumstances
Patient admitted	2/83 (2.4%)	2	2/66 (3%)	2
Other (Not Including Serious) Adverse Events
	Usual Care		Additional Teaching
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/83 (19.3%)		19/66 (28.8%)
Social circumstances
Worsen at home	16/83 (19.3%)	16	19/66 (28.8%)	19

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.