Trial Outcomes & Findings for Discharge Medication Counseling in Hospitalized Children (NCT NCT05143047)
NCT ID: NCT05143047
Last Updated: 2024-08-19
Results Overview
Participants (caregivers) will be asked to draw up a dose of their child's liquid medication using the provided oral dosing syringe and send a secure picture of the syringe via myCap (secure phone application designed to collect patient-centered outcomes for research studies) to research study staff. The primary outcome will be assessed as a continuous percent difference from the prescribed dose (in milliliters) documented in the electronic health record. Study staff assessing amount in picture are blinded to group assignment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
198 participants
Primary outcome timeframe
During follow-up survey assessment 48-72 hours following hospital discharge
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Control
Participants (caregivers) in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
Participants (caregivers) in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
99
|
|
Overall Study
COMPLETED
|
72
|
79
|
|
Overall Study
NOT COMPLETED
|
27
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Discharge Medication Counseling in Hospitalized Children
Baseline characteristics by cohort
| Measure |
Control
n=99 Participants
Participants (caregivers) in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=99 Participants
Participants (caregivers) in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.4 years
STANDARD_DEVIATION 2.0 • n=99 Participants
|
2.4 years
STANDARD_DEVIATION 2.1 • n=107 Participants
|
2.4 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
67 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino ethnicity
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Uses medication(s) regularly
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
2+ hospitalizations in last year
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Complex chronic condition present
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Payer
Government
|
72 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Payer
Private
|
26 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Payer
No insurance
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Payer
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Discharge medication type
Antimicrobials
|
85 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Discharge medication type
Anticonvulsants
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Discharge medication type
Steroids
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Discharge medication type
Gastrointestinal agents/antacids
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Discharge medication type
Other medications
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Caregiver age
|
30.6 years
STANDARD_DEVIATION 5.9 • n=99 Participants
|
32.1 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
31.4 years
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Cargiver sex
male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Cargiver sex
female
|
94 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Caregiver relationship to child
mother
|
91 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Caregiver relationship to child
father
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Caregiver relationship to child
grandmother
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Caregiver relationship to child
legal guardian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Caregiver race
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Caregiver race
Black/African American
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Caregiver race
Native Hawaiian/Pacific Islander
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Caregiver race
White
|
78 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Caregiver race
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Caregiver race
Prefer not to answer
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Caregiver Hispanic/Latino
|
24 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Caregiver language
English
|
80 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Caregiver language
Spanish
|
19 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Caregiver born outside of U.S.
|
26 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Caregiver education
Less than high school diploma
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Caregiver education
High school degree or equivalent
|
31 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Caregiver education
Some college, no degree
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Caregiver education
College degree
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Caregiver education
Graduate degree
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Caregiver difficulty paying bills at home
|
21 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Caregiver Newest Vital Sign score (max=6)
Low Health Literacy (score = 0-1)
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Caregiver Newest Vital Sign score (max=6)
Marginal Health Literacy (score = 2-3)
|
42 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Caregiver Newest Vital Sign score (max=6)
Adequate Health Literacy (score = 4-6)
|
42 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked to draw up a dose of their child's liquid medication using the provided oral dosing syringe and send a secure picture of the syringe via myCap (secure phone application designed to collect patient-centered outcomes for research studies) to research study staff. The primary outcome will be assessed as a continuous percent difference from the prescribed dose (in milliliters) documented in the electronic health record. Study staff assessing amount in picture are blinded to group assignment.
Outcome measures
| Measure |
Control
n=72 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=79 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Observed Dosing Accuracy
|
3.3 percent difference
Standard Deviation 5.1
|
1.0 percent difference
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked to report the prescribed volume (in milliliters) of medication to be given with each dose during the follow-up myCap survey. This will be compared to the prescribed dose in the electronic medical record.
Outcome measures
| Measure |
Control
n=68 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=75 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Reported Dosing Accuracy
|
2.0 percent difference
Standard Deviation 6.0
|
0.4 percent difference
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked in a follow-up survey to provide the name of their child's discharge medication. This will be scored as correct if it matches the name of the medication prescribed in the electronic health record.
Outcome measures
| Measure |
Control
n=69 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=76 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Correct Medication Name
|
60 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked in a follow-up survey to provide the indication for their child's discharge medication. This will be scored as correct if it matches the indication for the medication prescribed in the electronic health record.
Outcome measures
| Measure |
Control
n=69 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=76 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Correct Medication Indication
|
59 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked in a follow-up survey to provide the dosage for their child's discharge medication. This will be scored as correct if it matches the indication for the medication prescribed in the electronic health record.
Outcome measures
| Measure |
Control
n=69 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=76 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Correct Medication Dose
|
55 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked in a follow-up survey to provide the frequency of their child's discharge medication. This will be scored as correct if it matches the frequency of the medication prescribed in the electronic health record.
Outcome measures
| Measure |
Control
n=69 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=76 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Correct Medication Frequency
|
65 Participants
|
74 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked in a follow-up survey to provide the total duration of their child's discharge medication. This will be scored as correct if it matches the duration of the medication prescribed in the electronic health record.
Outcome measures
| Measure |
Control
n=69 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=76 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Correct Medication Duration
|
49 Participants
|
65 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked in a follow-up survey to provide the medication side effects of their child's discharge medication. Caregivers will receive 1 point for every correctly identified side effect as it matches a list of pre-specified side effects determined by the study team. Caregivers will receive no points if they are unable to name any side effects on the prespecified list.
Outcome measures
| Measure |
Control
n=69 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=76 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Correct Medication Side Effects
|
13 Participants
|
60 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During follow-up survey assessment 48-72 hours following hospital dischargePopulation: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
Participants (caregivers) will be asked in a follow-up survey to provide the correct recommended storage location of their child's discharge medication. This will be scored as correct if it matches the recommended storage location of the medication prescribed in the electronic health record.
Outcome measures
| Measure |
Control
n=69 Participants
Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.
|
Intervention
n=76 Participants
Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.
Medication counseling: Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.
|
|---|---|---|
|
Correct Medication Storage
|
67 Participants
|
76 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alison Carroll, MD, MPH
Vanderbilt University Medical Center
Phone: 615-875-5025
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place