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Our objective is to determine the effectiveness of varied outreach methods (e.g. automated reminder calls/text messages with or without personalized calls/texts) to children age 12-14 months or 4 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the MMR vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
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| Arm 2 | Experimental |
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| Arm 3 | Experimental |
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| Arm 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 automated message | Other | Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of MMR Vaccination | MMR administered to child (Yes or No) based on electronic health record documentation | By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old) |
| Measure | Description | Time Frame |
|---|---|---|
| Appointment Scheduled | Appointment scheduled (Yes or No) based on electronic health record documentation | Within 2 weeks of receiving intervention |
| Appointment Completed | Appointment completed (Yes or No) based on electronic health record documentation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William B Brinkman, MD | Cincinnati Children's | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | 1 automated message: Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. No personal contact attempt: No personal contact attempts will be made. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2021 | Aug 7, 2024 |
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| 2 automated messages | Other | Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. |
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| No personal contact attempt | Other | No personal contact attempts will be made. |
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| 1 personal contact attempt | Other | Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. |
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| Within 8 weeks of receiving intervention |
| Arm 2 |
2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. No personal contact attempt: No personal contact attempts will be made. |
| FG002 | Arm 3 | 1 automated message: Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. |
| FG003 | Arm 4 | 2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | 1 automated message: Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. No personal contact attempt: No personal contact attempts will be made. |
| BG001 | Arm 2 | 2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. No personal contact attempt: No personal contact attempts will be made. |
| BG002 | Arm 3 | 1 automated message: Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. |
| BG003 | Arm 4 | 2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Receipt of MMR Vaccination | MMR administered to child (Yes or No) based on electronic health record documentation | Posted | Count of Participants | Participants | By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old) |
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| Secondary | Appointment Scheduled | Appointment scheduled (Yes or No) based on electronic health record documentation | Posted | Count of Participants | Participants | Within 2 weeks of receiving intervention |
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| Secondary | Appointment Completed | Appointment completed (Yes or No) based on electronic health record documentation | Posted | Count of Participants | Participants | Within 8 weeks of receiving intervention |
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3 months
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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 | Arm 1 | 1 automated message: Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. No personal contact attempt: No personal contact attempts will be made. | 0 | 329 | 0 | 329 | 0 | 329 |
| EG001 | Arm 2 | 2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. No personal contact attempt: No personal contact attempts will be made. | 0 | 328 | 0 | 328 | 0 | 328 |
| EG002 | Arm 3 | 1 automated message: Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. | 0 | 328 | 0 | 328 | 0 | 328 |
| EG003 | Arm 4 | 2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. | 0 | 327 | 0 | 327 | 0 | 327 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William B. Brinkman | Cincinnati Children's | 513-636-2576 | bill.brinkman@cchmc.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2023 | Aug 1, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000079263 | Vaccine-Preventable Diseases |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 13 m.o. |
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| 14 m.o. |
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| 4 y.o. |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 0.189 |
| Risk Ratio (RR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.09 |
| Superiority |
Arm 2 vs. Arm 1 |
| Regression, Logistic | 0.054 | Risk Ratio (RR) | 1.29 | 2-Sided | 95 | 0.10 | 1.66 | Superiority | Arm 3 vs. Arm 2 |
| Regression, Logistic | 0.654 | Risk Ratio (RR) | 1.05 | 2-Sided | 95 | 0.84 | 1.32 | Superiority | Arm 4 vs. Arm 3 |
| Regression, Logistic | 0.018 | Risk Ratio (RR) | 1.36 | 2-Sided | 95 | 1.05 | 1.74 | Superiority | Arm 4 vs. Arm 2 |
| Regression, Logistic | 0.283 | Risk Ratio (RR) | 1.14 | 2-Sided | 95 | 0.90 | 1.44 | Superiority | Arm 4 vs. Arm 1 |
| OG003 | Arm 4 | 2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. |
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| OG003 | Arm 4 | 2 automated messages: Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment. 1 personal contact attempt: Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment. |
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