Health Care Utilization, Preventable Disease, Vaccine
Conditions
Brief summary
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.
Interventions
OTHER1 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.
OTHER2 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.
OTHERNo personal contact attempt
No personal contact attempts will be made.
OTHER1 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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 4 Years
Healthy volunteers
No
Inclusion criteria
* Age: 12-14 months old OR 4 years old * Has not yet received first MMR (for 12-14 month olds) OR second MMR (for 4 year olds) * Has not had a well child check in past 365 days (for 4 year olds) * No appointment scheduled in the next 45 days * Parent preferred language = English or Spanish
Exclusion criteria
* Phone number not available in electronic medical record
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of MMR Vaccination | 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) | MMR administered to child (Yes or No) based on electronic health record documentation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appointment Scheduled | Within 2 weeks of receiving intervention | Appointment scheduled (Yes or No) based on electronic health record documentation |
| Appointment Completed | Within 8 weeks of receiving intervention | Appointment completed (Yes or No) based on electronic health record documentation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 329 |
| 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. | 328 |
| 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. | 328 |
| 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. | 327 |
| Total | 1,312 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Total |
|---|---|---|---|---|---|
| Age, Customized 12 m.o. | 64 Participants | 62 Participants | 61 Participants | 60 Participants | 247 Participants |
| Age, Customized 13 m.o. | 38 Participants | 40 Participants | 37 Participants | 41 Participants | 156 Participants |
| Age, Customized 14 m.o. | 15 Participants | 15 Participants | 18 Participants | 15 Participants | 63 Participants |
| Age, Customized 4 y.o. | 212 Participants | 211 Participants | 212 Participants | 211 Participants | 846 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 10 Participants | 16 Participants | 23 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 313 Participants | 315 Participants | 309 Participants | 296 Participants | 1233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 3 Participants | 3 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 1 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 241 Participants | 252 Participants | 248 Participants | 232 Participants | 973 Participants |
| Race (NIH/OMB) More than one race | 19 Participants | 18 Participants | 16 Participants | 14 Participants | 67 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 9 Participants | 16 Participants | 21 Participants | 59 Participants |
| Race (NIH/OMB) White | 54 Participants | 45 Participants | 47 Participants | 53 Participants | 199 Participants |
| Region of Enrollment United States | 329 participants | 328 participants | 328 participants | 327 participants | 1312 participants |
| Sex: Female, Male Female | 137 Participants | 164 Participants | 152 Participants | 157 Participants | 610 Participants |
| Sex: Female, Male Male | 192 Participants | 164 Participants | 176 Participants | 170 Participants | 702 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 329 | 0 / 328 | 0 / 328 | 0 / 327 |
| other Total, other adverse events | 0 / 329 | 0 / 328 | 0 / 328 | 0 / 327 |
| serious Total, serious adverse events | 0 / 329 | 0 / 328 | 0 / 328 | 0 / 327 |
Outcome results
Primary
Receipt of MMR Vaccination
MMR administered to child (Yes or No) based on electronic health record documentation
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Receipt of MMR Vaccination | 92 Participants |
| Arm 2 | Receipt of MMR Vaccination | 77 Participants |
| Arm 3 | Receipt of MMR Vaccination | 99 Participants |
| Arm 4 | Receipt of MMR Vaccination | 104 Participants |
p-value: 0.53195% CI: [0.85, 1.37]Regression, Logistic
p-value: 0.18995% CI: [0.65, 1.09]Regression, Logistic
p-value: 0.05495% CI: [0.1, 1.66]Regression, Logistic
p-value: 0.65495% CI: [0.84, 1.32]Regression, Logistic
p-value: 0.01895% CI: [1.05, 1.74]Regression, Logistic
p-value: 0.28395% CI: [0.9, 1.44]Regression, Logistic
Secondary
Appointment Completed
Appointment completed (Yes or No) based on electronic health record documentation
Time frame: Within 8 weeks of receiving intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Appointment Completed | 90 Participants |
| Arm 2 | Appointment Completed | 73 Participants |
| Arm 3 | Appointment Completed | 105 Participants |
| Arm 4 | Appointment Completed | 96 Participants |
p-value: 0.19295% CI: [0.92, 1.48]Regression, Logistic
p-value: 0.13295% CI: [0.62, 1.06]Regression, Logistic
p-value: <0.0195% CI: [1.11, 1.86]Regression, Logistic
p-value: 0.46295% CI: [0.73, 1.16]Regression, Logistic
p-value: 0.03995% CI: [1.01, 1.72]Regression, Logistic
p-value: 0.5795% CI: [0.84, 1.37]Regression, Logistic
Secondary
Appointment Scheduled
Appointment scheduled (Yes or No) based on electronic health record documentation
Time frame: Within 2 weeks of receiving intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Appointment Scheduled | 50 Participants |
| Arm 2 | Appointment Scheduled | 41 Participants |
| Arm 3 | Appointment Scheduled | 96 Participants |
| Arm 4 | Appointment Scheduled | 103 Participants |
p-value: <0.0195% CI: [1.42, 2.62]Regression, Logistic
p-value: 0.31895% CI: [0.56, 1.21]Regression, Logistic
p-value: <0.0195% CI: [1.68, 3.26]Regression, Logistic
p-value: 0.53595% CI: [0.85, 1.36]Regression, Logistic
p-value: <0.0195% CI: [1.82, 3.5]Regression, Logistic
p-value: <0.0195% CI: [1.53, 2.8]Regression, Logistic