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Our objective is to determine the effectiveness of varied outreach methods to children age 12-17 years old who are due for a well child check visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the COVID-19 vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No message | Placebo Comparator | No message sent |
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| Low tailored message | Active Comparator | 2 text or phone reminders that child is overdue for well child check visit |
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| Low tailored message plus COVID-19 vaccine message | Active Comparator | 2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low tailored message | Other | 2 low tailored text or phone message reminders that child is overdue for well child check visit |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed an Adolescent Well-care Visit | Participant completed adolescent well-care visit as determined by the presence of well-visit billing code documented in the electronic health record | Within 8 weeks of the date of intervention or the date of randomization for the control group |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Scheduled an Adolescent Well-care Appointment | Participant scheduled an adolescent well-care appointment as determined by documentation in electronic health record | Within 2 weeks of the date of intervention or the date of randomization for the control group |
| Participant Receipt of COVID-19 Vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Brinkman, MD | Cincinnati Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36202236 | Derived | Burkhardt MC, Berset AE, Xu Y, Mescher A, Brinkman WB. Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial. J Pediatr. 2023 Feb;253:158-164.e1. doi: 10.1016/j.jpeds.2022.09.035. Epub 2022 Oct 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Message | No message sent No message: No reminders are sent |
| FG001 | Low Tailored Message | 2 text or phone reminders that child is overdue for well child check visit Low tailored message: 2 low tailored text or phone message reminders that child is overdue for well child check visit |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2022 |
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| No message | Other | No reminders are sent |
|
| Low tailored message plus COVID-19 vaccine message | Other | 2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available |
|
Participant received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record. |
| Within 8 weeks of the date of intervention or the date of randomization for the control group |
| Family Member Receipt of COVID-19 Vaccine | Family member received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record. | Within 8 weeks of the date of intervention or the date of randomization for the control group |
| FG002 | Low Tailored Message Plus COVID-19 Vaccine Message | 2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available Low tailored message plus COVID-19 vaccine message: 2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Message | No message sent No message: No reminders are sent |
| BG001 | Low Tailored Message | 2 text or phone reminders that child is overdue for well child check visit Low tailored message: 2 low tailored text or phone message reminders that child is overdue for well child check visit |
| BG002 | Low Tailored Message Plus COVID-19 Vaccine Message | 2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available Low tailored message plus COVID-19 vaccine message: 2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available |
| BG003 | 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 | Number | 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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| 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 | Number of Participants Who Completed an Adolescent Well-care Visit | Participant completed adolescent well-care visit as determined by the presence of well-visit billing code documented in the electronic health record | Posted | Count of Participants | Participants | Within 8 weeks of the date of intervention or the date of randomization for the control group |
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| Secondary | Number of Participants Who Scheduled an Adolescent Well-care Appointment | Participant scheduled an adolescent well-care appointment as determined by documentation in electronic health record | Posted | Count of Participants | Participants | Within 2 weeks of the date of intervention or the date of randomization for the control group |
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| Secondary | Participant Receipt of COVID-19 Vaccine | Participant received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record. | Posted | Count of Participants | Participants | Within 8 weeks of the date of intervention or the date of randomization for the control group |
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| Secondary | Family Member Receipt of COVID-19 Vaccine | Family member received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record. | Data was only available for parents that received a COVID-19 vaccine at one of our academic primary care offices. Thus, information about household members receiving vaccination is likely incomplete due to lack of access to adult medical records and vaccinations administered outside our health system. | Posted | Count of Participants | Participants | Within 8 weeks of the date of intervention or the date of randomization for the control group |
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8 weeks
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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 | No Message | No message sent No message: No reminders are sent | 0 | 412 | 0 | 412 | 0 | 412 |
| EG001 | Low Tailored Message | 2 text or phone reminders that child is overdue for well child check visit Low tailored message: 2 low tailored text or phone message reminders that child is overdue for well child check visit | 0 | 412 | 0 | 412 | 0 | 412 |
| EG002 | Low Tailored Message Plus COVID-19 Vaccine Message | 2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available Low tailored message plus COVID-19 vaccine message: 2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available | 0 | 411 | 0 | 411 | 0 | 411 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William B. Brinkman | Cincinnati Children's | 513-636-2576 | bill.brinkman@cchmc.org |
| Dec 22, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000079263 | Vaccine-Preventable Diseases |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C093953 | NMT1 protein, S pombe |
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| 13 |
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| 14 |
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| 15 |
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| 16 |
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| 17 |
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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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| 0.193 |
| Odds Ratio (OR) |
| 1.33 |
| 2-Sided |
| 95 |
| 0.87 |
| 2.03 |
Low tailored message plus COVID-19 vaccine message vs. No Message |
| Superiority |
| Regression, Logistic | 0.930 | Odds Ratio (OR) | 1.02 | 2-Sided | 95 | 0.68 | 1.52 | Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message | Superiority |
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