Trial Outcomes & Findings for Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination (NCT NCT04904744)
NCT ID: NCT04904744
Last Updated: 2024-10-28
Results Overview
Participant completed adolescent well-care visit as determined by the presence of well-visit billing code documented in the electronic health record
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1235 participants
Primary outcome timeframe
Within 8 weeks of the date of intervention or the date of randomization for the control group
Results posted on
2024-10-28
Participant Flow
Participant milestones
| Measure |
No Message
No message sent
No message: No reminders are sent
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
412
|
412
|
411
|
|
Overall Study
COMPLETED
|
412
|
412
|
411
|
|
Overall Study
NOT COMPLETED
|
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 COVID-19 Vaccination
Baseline characteristics by cohort
| Measure |
No Message
n=412 Participants
No message sent
No message: No reminders are sent
|
Low Tailored Message
n=412 Participants
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
|
Low Tailored Message Plus COVID-19 Vaccine Message
n=411 Participants
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
|
Total
n=1235 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
12
|
78 participants
n=5 Participants
|
74 participants
n=7 Participants
|
72 participants
n=5 Participants
|
224 participants
n=4 Participants
|
|
Age, Customized
13
|
99 participants
n=5 Participants
|
103 participants
n=7 Participants
|
110 participants
n=5 Participants
|
312 participants
n=4 Participants
|
|
Age, Customized
14
|
98 participants
n=5 Participants
|
105 participants
n=7 Participants
|
106 participants
n=5 Participants
|
309 participants
n=4 Participants
|
|
Age, Customized
15
|
61 participants
n=5 Participants
|
57 participants
n=7 Participants
|
54 participants
n=5 Participants
|
172 participants
n=4 Participants
|
|
Age, Customized
16
|
33 participants
n=5 Participants
|
39 participants
n=7 Participants
|
29 participants
n=5 Participants
|
101 participants
n=4 Participants
|
|
Age, Customized
17
|
43 participants
n=5 Participants
|
34 participants
n=7 Participants
|
40 participants
n=5 Participants
|
117 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
598 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
637 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
396 Participants
n=5 Participants
|
390 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
1182 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
315 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
947 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 8 weeks of the date of intervention or the date of randomization for the control groupParticipant completed adolescent well-care visit as determined by the presence of well-visit billing code documented in the electronic health record
Outcome measures
| Measure |
No Message
n=412 Participants
No message sent
No message: No reminders are sent
|
Low Tailored Message
n=412 Participants
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
|
Low Tailored Message Plus COVID-19 Vaccine Message
n=411 Participants
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
|
|---|---|---|---|
|
Number of Participants Who Completed an Adolescent Well-care Visit
|
43 Participants
|
56 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Within 2 weeks of the date of intervention or the date of randomization for the control groupParticipant scheduled an adolescent well-care appointment as determined by documentation in electronic health record
Outcome measures
| Measure |
No Message
n=412 Participants
No message sent
No message: No reminders are sent
|
Low Tailored Message
n=412 Participants
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
|
Low Tailored Message Plus COVID-19 Vaccine Message
n=411 Participants
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
|
|---|---|---|---|
|
Number of Participants Who Scheduled an Adolescent Well-care Appointment
|
22 Participants
|
43 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Within 8 weeks of the date of intervention or the date of randomization for the control groupParticipant received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record.
Outcome measures
| Measure |
No Message
n=412 Participants
No message sent
No message: No reminders are sent
|
Low Tailored Message
n=412 Participants
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
|
Low Tailored Message Plus COVID-19 Vaccine Message
n=411 Participants
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
|
|---|---|---|---|
|
Participant Receipt of COVID-19 Vaccine
|
8 Participants
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Within 8 weeks of the date of intervention or the date of randomization for the control groupPopulation: 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.
Family member received COVID-19 vaccine as determined by presence of documentation of vaccine administration in the electronic health record.
Outcome measures
| Measure |
No Message
n=412 Participants
No message sent
No message: No reminders are sent
|
Low Tailored Message
n=412 Participants
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
|
Low Tailored Message Plus COVID-19 Vaccine Message
n=411 Participants
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
|
|---|---|---|---|
|
Family Member Receipt of COVID-19 Vaccine
|
2 Participants
|
5 Participants
|
3 Participants
|
Adverse Events
No Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Tailored Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Tailored Message Plus COVID-19 Vaccine Message
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