Medication Management
Conditions
Brief summary
Our objective is to design and test the efficacy of a health-literacy-informed discharge medication counseling intervention in the inpatient setting to reduce medication dosing errors and improve adherence in hospitalized children discharged on a new liquid medication.
Detailed description
The goal of this research is to improve discharge medication adherence and reduce medication dosing errors following pediatric hospitalization. Medication errors are one of the most common healthcare-associated adverse events in pediatrics, with approximately one out-of-hospital medication error occurring every 8 minutes among children \< 6 years of age. Liquid medications account for the majority of pediatric dosing errors which is likely due to liquid medications' inherent dosing complexities, including the need for weight-based dosing, different concentrations of medications, and parental use of unstandardized dosing instruments. The increased stress and exhaustion that many caregivers experience during a hospitalization, coupled with the need to assimilate large amounts of information pertaining to post-discharge care, makes transitioning to home from an inpatient stay a particularly high risk period for medication errors. Communication challenges, particularly failure to consider caregiver health literacy, further compounds the risk for medication errors due to poor caregiver comprehension and adherence to discharge instructions.
Interventions
BEHAVIORALMedication 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.
Sponsors
The Gerber Foundation
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants are randomized to control or intervention group.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Caregivers of children up to 6 years old who are hospitalized on a general inpatient hospital medicine teams * Caregivers must speak English or Spanish * Participants' children must be discharged home on new scheduled liquid medication for minimum 3 days.
Exclusion criteria
* Medication will be administered by home health nurse * Child is in state/protected custody * Medication prescription is prescribed to pharmacy other than hospital outpatient pharmacy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Dosing Accuracy | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correct Medication Name | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
| Correct Medication Indication | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
| Correct Medication Dose | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
| Correct Medication Frequency | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
| Reported Dosing Accuracy | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correct Medication Storage | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
| Correct Medication Side Effects | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
| Correct Medication Duration | During follow-up survey assessment 48-72 hours following hospital discharge | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 99 |
| 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. | 99 |
| Total | 198 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| 2+ hospitalizations in last year | 14 Participants | 19 Participants | 33 Participants |
| Age, Continuous | 2.4 years STANDARD_DEVIATION 2.1 | 2.4 years STANDARD_DEVIATION 2 | 2.4 years STANDARD_DEVIATION 2.1 |
| Caregiver age | 32.1 years STANDARD_DEVIATION 7 | 30.6 years STANDARD_DEVIATION 5.9 | 31.4 years STANDARD_DEVIATION 6.5 |
| Caregiver born outside of U.S. | 14 Participants | 26 Participants | 40 Participants |
| Caregiver difficulty paying bills at home | 14 Participants | 21 Participants | 35 Participants |
| Caregiver education College degree | 22 Participants | 16 Participants | 38 Participants |
| Caregiver education Graduate degree | 10 Participants | 8 Participants | 18 Participants |
| Caregiver education High school degree or equivalent | 23 Participants | 31 Participants | 54 Participants |
| Caregiver education Less than high school diploma | 14 Participants | 16 Participants | 30 Participants |
| Caregiver education Some college, no degree | 30 Participants | 28 Participants | 58 Participants |
| Caregiver Hispanic/Latino | 12 Participants | 24 Participants | 36 Participants |
| Caregiver language English | 91 Participants | 80 Participants | 171 Participants |
| Caregiver language Spanish | 8 Participants | 19 Participants | 27 Participants |
| Caregiver Newest Vital Sign score (max=6) Adequate Health Literacy (score = 4-6) | 57 Participants | 42 Participants | 99 Participants |
| Caregiver Newest Vital Sign score (max=6) Low Health Literacy (score = 0-1) | 11 Participants | 15 Participants | 26 Participants |
| Caregiver Newest Vital Sign score (max=6) Marginal Health Literacy (score = 2-3) | 31 Participants | 42 Participants | 73 Participants |
| Caregiver race Asian | 1 Participants | 0 Participants | 1 Participants |
| Caregiver race Black/African American | 13 Participants | 15 Participants | 28 Participants |
| Caregiver race More than one race | 1 Participants | 2 Participants | 3 Participants |
| Caregiver race Native Hawaiian/Pacific Islander | 3 Participants | 0 Participants | 3 Participants |
| Caregiver race Prefer not to answer | 1 Participants | 4 Participants | 5 Participants |
| Caregiver race White | 80 Participants | 78 Participants | 158 Participants |
| Caregiver relationship to child father | 7 Participants | 7 Participants | 14 Participants |
| Caregiver relationship to child grandmother | 0 Participants | 1 Participants | 1 Participants |
| Caregiver relationship to child legal guardian | 1 Participants | 0 Participants | 1 Participants |
| Caregiver relationship to child mother | 91 Participants | 91 Participants | 182 Participants |
| Cargiver sex female | 92 Participants | 94 Participants | 186 Participants |
| Cargiver sex male | 7 Participants | 5 Participants | 12 Participants |
| Complex chronic condition present | 27 Participants | 20 Participants | 47 Participants |
| Discharge medication type Anticonvulsants | 2 Participants | 2 Participants | 4 Participants |
| Discharge medication type Antimicrobials | 85 Participants | 85 Participants | 170 Participants |
| Discharge medication type Gastrointestinal agents/antacids | 4 Participants | 3 Participants | 7 Participants |
| Discharge medication type Other medications | 6 Participants | 5 Participants | 11 Participants |
| Discharge medication type Steroids | 2 Participants | 4 Participants | 6 Participants |
| Payer Government | 52 Participants | 72 Participants | 124 Participants |
| Payer No insurance | 1 Participants | 0 Participants | 1 Participants |
| Payer Other | 0 Participants | 1 Participants | 1 Participants |
| Payer Private | 46 Participants | 26 Participants | 72 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 10 Participants | 16 Participants | 26 Participants |
| Race/Ethnicity, Customized Hispanic/Latino ethnicity | 19 Participants | 25 Participants | 44 Participants |
| Race/Ethnicity, Customized More than one race | 9 Participants | 12 Participants | 21 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 75 Participants | 67 Participants | 142 Participants |
| Sex: Female, Male Female | 43 Participants | 45 Participants | 88 Participants |
| Sex: Female, Male Male | 56 Participants | 54 Participants | 110 Participants |
| Uses medication(s) regularly | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Observed Dosing Accuracy
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Observed Dosing Accuracy | 3.3 percent difference | Standard Deviation 5.1 |
| Intervention | Observed Dosing Accuracy | 1.0 percent difference | Standard Deviation 2.2 |
p-value: <0.001t-test, 2 sided
Secondary
Correct Medication Dose
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Correct Medication Dose | 55 Participants |
| Intervention | Correct Medication Dose | 71 Participants |
p-value: 0.03Fisher Exact
Secondary
Correct Medication Frequency
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Correct Medication Frequency | 65 Participants |
| Intervention | Correct Medication Frequency | 74 Participants |
p-value: 0.42Fisher Exact
Secondary
Correct Medication Indication
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Correct Medication Indication | 59 Participants |
| Intervention | Correct Medication Indication | 71 Participants |
p-value: 0.17Fisher Exact
Secondary
Correct Medication Name
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Correct Medication Name | 60 Participants |
| Intervention | Correct Medication Name | 70 Participants |
p-value: 0.42Fisher Exact
Secondary
Reported Dosing Accuracy
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Reported Dosing Accuracy | 2.0 percent difference | Standard Deviation 6 |
| Intervention | Reported Dosing Accuracy | 0.4 percent difference | Standard Deviation 3 |
p-value: 0.04t-test, 2 sided
Other Pre-specified
Correct Medication Duration
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Correct Medication Duration | 49 Participants |
| Intervention | Correct Medication Duration | 65 Participants |
p-value: 0.04Fisher Exact
Other Pre-specified
Correct Medication Side Effects
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Correct Medication Side Effects | 13 Participants |
| Intervention | Correct Medication Side Effects | 60 Participants |
p-value: <0.001Fisher Exact
Other Pre-specified
Correct Medication Storage
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.
Time frame: During follow-up survey assessment 48-72 hours following hospital discharge
Population: Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Correct Medication Storage | 67 Participants |
| Intervention | Correct Medication Storage | 76 Participants |
p-value: 0.22Fisher Exact