Health Care Utilization, Vaccine Preventable Disease
Conditions
Brief summary
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.
Interventions
OTHERLow tailored message
2 low tailored text or phone message reminders that child is overdue for well child check visit
OTHERNo message
No reminders are sent
OTHERLow 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
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* age 12-17 years * has not had a well child check in past 365 days * no future well child check visit scheduled * parent preferred language = English or Spanish
Exclusion criteria
* phone number not available in electronic health record
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed an Adolescent Well-care Visit | Within 8 weeks of the date of intervention or the date of randomization for the control group | Participant completed adolescent well-care visit as determined by the presence of well-visit billing code documented in the electronic health record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Scheduled an Adolescent Well-care Appointment | Within 2 weeks of the date of intervention or the date of randomization for the control group | Participant scheduled an adolescent well-care appointment as determined by documentation in electronic health record |
| Participant Receipt of COVID-19 Vaccine | Within 8 weeks of the date of intervention or the date of randomization for the control group | Participant received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record. |
| Family Member Receipt of COVID-19 Vaccine | Within 8 weeks of the date of intervention or the date of randomization for the control group | Family member received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Message No message sent
No message: No reminders are sent | 412 |
| 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 | 412 |
| 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 | 411 |
| Total | 1,235 |
Baseline characteristics
| Characteristic | No Message | Low Tailored Message | Low Tailored Message Plus COVID-19 Vaccine Message | Total |
|---|---|---|---|---|
| Age, Customized 12 | 78 participants | 74 participants | 72 participants | 224 participants |
| Age, Customized 13 | 99 participants | 103 participants | 110 participants | 312 participants |
| Age, Customized 14 | 98 participants | 105 participants | 106 participants | 309 participants |
| Age, Customized 15 | 61 participants | 57 participants | 54 participants | 172 participants |
| Age, Customized 16 | 33 participants | 39 participants | 29 participants | 101 participants |
| Age, Customized 17 | 43 participants | 34 participants | 40 participants | 117 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 21 Participants | 15 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 396 Participants | 390 Participants | 396 Participants | 1182 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 315 Participants | 313 Participants | 319 Participants | 947 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 10 Participants | 17 Participants | 40 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 16 Participants | 13 Participants | 42 Participants |
| Race (NIH/OMB) White | 65 Participants | 69 Participants | 60 Participants | 194 Participants |
| Sex: Female, Male Female | 196 Participants | 192 Participants | 210 Participants | 598 Participants |
| Sex: Female, Male Male | 216 Participants | 220 Participants | 201 Participants | 637 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 412 | 0 / 412 | 0 / 411 |
| other Total, other adverse events | 0 / 412 | 0 / 412 | 0 / 411 |
| serious Total, serious adverse events | 0 / 412 | 0 / 412 | 0 / 411 |
Outcome results
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
Time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Message | Number of Participants Who Completed an Adolescent Well-care Visit | 43 Participants |
| Low Tailored Message | Number of Participants Who Completed an Adolescent Well-care Visit | 56 Participants |
| Low Tailored Message Plus COVID-19 Vaccine Message | Number of Participants Who Completed an Adolescent Well-care Visit | 55 Participants |
p-value: 0.16595% CI: [0.88, 2.06]Regression, Logistic
p-value: 0.19395% CI: [0.87, 2.03]Regression, Logistic
p-value: 0.9395% CI: [0.68, 1.52]Regression, Logistic
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.
Time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Message | Family Member Receipt of COVID-19 Vaccine | 2 Participants |
| Low Tailored Message | Family Member Receipt of COVID-19 Vaccine | 5 Participants |
| Low Tailored Message Plus COVID-19 Vaccine Message | Family Member Receipt of COVID-19 Vaccine | 3 Participants |
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
Time frame: Within 2 weeks of the date of intervention or the date of randomization for the control group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Message | Number of Participants Who Scheduled an Adolescent Well-care Appointment | 22 Participants |
| Low Tailored Message | Number of Participants Who Scheduled an Adolescent Well-care Appointment | 43 Participants |
| Low Tailored Message Plus COVID-19 Vaccine Message | Number of Participants Who Scheduled an Adolescent Well-care Appointment | 27 Participants |
p-value: 0.00895% CI: [1.21, 3.52]Regression, Logistic
p-value: 0.45795% CI: [0.7, 2.23]Regression, Logistic
p-value: 0.04995% CI: [1, 2.74]Regression, Logistic
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.
Time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Message | Participant Receipt of COVID-19 Vaccine | 8 Participants |
| Low Tailored Message | Participant Receipt of COVID-19 Vaccine | 16 Participants |
| Low Tailored Message Plus COVID-19 Vaccine Message | Participant Receipt of COVID-19 Vaccine | 10 Participants |
p-value: 0.10495% CI: [0.86, 4.82]Regression, Logistic
p-value: 0.63195% CI: [0.49, 3.22]Regression, Logistic
p-value: 0.23895% CI: [0.73, 3.61]Regression, Logistic