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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Carroll, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38227315 | Derived | Carroll AR, Johnson JA, Stassun JC, Greevy RA, Mixon AS, Williams DJ. Health Literacy-Informed Communication to Reduce Discharge Medication Errors in Hospitalized Children: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350969. doi: 10.1001/jamanetworkopen.2023.50969. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants in this study are the caregivers of children discharged from the hospital. The children themselves are not enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Mean | Standard Deviation | percent difference | During follow-up survey assessment 48-72 hours following hospital discharge |
|
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Death, serious adverse events, and nonserious adverse events were not assessed for study participants as this was a minimal-risk, behavioral intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Carroll, MD, MPH | Vanderbilt University Medical Center | 615-875-5025 | alison.carroll@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2022 | Aug 17, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2022 | Sep 28, 2022 | ICF_000.pdf |
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Participants are randomized to control or intervention group.
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|
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| 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. | During follow-up survey assessment 48-72 hours following hospital discharge |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Uses medication(s) regularly | Count of Participants | Participants |
|
| 2+ hospitalizations in last year | Count of Participants | Participants |
|
| Complex chronic condition present | Count of Participants | Participants |
|
| Payer | Count of Participants | Participants |
|
| Discharge medication type | Count of Participants | Participants |
|
| Caregiver age | Mean | Standard Deviation | years |
|
| Cargiver sex | Count of Participants | Participants |
|
| Caregiver relationship to child | Count of Participants | Participants |
|
| Caregiver race | Count of Participants | Participants |
|
| Caregiver Hispanic/Latino | Count of Participants | Participants |
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| Caregiver language | Count of Participants | Participants |
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| Caregiver born outside of U.S. | Count of Participants | Participants |
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| Caregiver education | Count of Participants | Participants |
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| Caregiver difficulty paying bills at home | Count of Participants | Participants |
|
| Caregiver Newest Vital Sign score (max=6) | The Newest Vital Sign is a validated screening tool that identifies those at risk for low health literacy. [Weiss BD et al; Ann Fam Med. 2005 Nov-Dec;3(6):514-22.] Caregivers were given the three-minute screening test at the time of enrollment. | Count of Participants | Participants |
|
| OG001 | Intervention | 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. |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Mean | Standard Deviation | percent difference | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 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. | Number of participants analyzed represent those enrolled and randomized minus those withdrawn or lost to follow-up. | Posted | Count of Participants | Participants | During follow-up survey assessment 48-72 hours following hospital discharge |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| EG001 | Intervention | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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