Trial Outcomes & Findings for Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination (NCT NCT04567342)
NCT ID: NCT04567342
Last Updated: 2024-08-12
Results Overview
MMR administered to child (Yes or No) based on electronic health record documentation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1312 participants
Primary outcome timeframe
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)
Results posted on
2024-08-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
329
|
328
|
328
|
327
|
|
Overall Study
COMPLETED
|
329
|
328
|
328
|
327
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
Baseline characteristics by cohort
| Measure |
Arm 1
n=329 Participants
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.
|
Arm 2
n=328 Participants
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.
|
Arm 3
n=328 Participants
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.
|
Arm 4
n=327 Participants
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.
|
Total
n=1312 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
12 m.o.
|
64 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Age, Customized
13 m.o.
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
156 Participants
n=21 Participants
|
|
Age, Customized
14 m.o.
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Age, Customized
4 y.o.
|
212 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
846 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
610 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
702 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
313 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
296 Participants
n=4 Participants
|
1233 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
241 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
973 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
329 participants
n=5 Participants
|
328 participants
n=7 Participants
|
328 participants
n=5 Participants
|
327 participants
n=4 Participants
|
1312 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Arm 1
n=329 Participants
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.
|
Arm 2
n=328 Participants
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.
|
Arm 3
n=328 Participants
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.
|
Arm 4
n=327 Participants
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.
|
|---|---|---|---|---|
|
Receipt of MMR Vaccination
|
92 Participants
|
77 Participants
|
99 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: Within 2 weeks of receiving interventionAppointment scheduled (Yes or No) based on electronic health record documentation
Outcome measures
| Measure |
Arm 1
n=329 Participants
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.
|
Arm 2
n=328 Participants
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.
|
Arm 3
n=328 Participants
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.
|
Arm 4
n=327 Participants
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.
|
|---|---|---|---|---|
|
Appointment Scheduled
|
50 Participants
|
41 Participants
|
96 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: Within 8 weeks of receiving interventionAppointment completed (Yes or No) based on electronic health record documentation
Outcome measures
| Measure |
Arm 1
n=329 Participants
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.
|
Arm 2
n=328 Participants
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.
|
Arm 3
n=328 Participants
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.
|
Arm 4
n=327 Participants
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.
|
|---|---|---|---|---|
|
Appointment Completed
|
90 Participants
|
73 Participants
|
105 Participants
|
96 Participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place