CompletedNCT04994691Updated Aug 28, 2024Results posted

Effect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChart

An interventional study of No Message and Standard message in Health Care Utilization, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Health services research

Phase: Not applicable
Study type: Interventional
Enrollment: 945
Allocation: Randomized
Ages: 6 Years to 17 Years
Sex: All

Study summary

Our objective is to determine the effectiveness of varied outreach methods (e.g. standard versus tailored MyChart messaging) to children age 6-17 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 and appointment completion.

Conditions studied

Health Care Utilization

In context

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

age 6-17 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

Exclusion Criteria:

no active MyChart account

Study design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 945 participants (actual)

Study arms

Placebo comparator
No message
No message sent
Other: No Message
Active comparator
Standard message
2 MyChart reminders that child is overdue for well child check visit
Other: Standard message
Active comparator
Tailored message
2 MyChart reminders that child is overdue for well child check visit with date of last WCC and age
Other: Tailored message

Interventions

OtherNo Message
No messages are sent
OtherStandard message
2 MyChart reminders that child is overdue for well child check visit
OtherTailored message
2 MyChart reminders that child is overdue for well child check visit with date of last WCC and age

What researchers measure

Primary outcomes

Number of Participants Who Completed Well Child Check Visit
Participants completed well child check visit as determined by presence of a well visit billing code documentation in the electronic health record.
Time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group

Secondary outcomes

Number of Participants Who Scheduled an Appointment for a Well Child Check Visit.
Participant scheduled a well child check visit as determined by electronic health record documentation.
Time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group
Number of Participants Who Received Their First COVID-19 Vaccination
Participant receipt of their first COVID-19 vaccination as determined by presence of documentation of vaccine administration in the electronic health record.
Time frame: Within 8 weeks of the date of the intervention or the date of randomization for the control group

Results

Posted Aug 28, 2024

Participant flow

Participant flow — Overall Study
Milestone	No Message	Standard Message	Tailored Message
Started	315	315	315
Completed	315	315	315
Not completed	0	0	0

Outcome measures

PrimaryNumber of Participants Who Completed Well Child Check Visit

Participants completed well child check visit as determined by presence of a well visit billing code documentation in the electronic health record.

Time frame:: Within 8 weeks of the date of intervention or the date of randomization for the control group
Reported as:: Count of participants · Participants

Number of Participants Who Completed Well Child Check Visit
Participants	No Message	Standard Message	Tailored Message
Number of Participants Who Completed Well Child Check Visit	40	76	61

Statistical analysis

No Message vs Standard Message · Regression, Logistic · p = 0.000 · Risk ratio (rr): 1.92 · 95% CI 1.38 to 2.60Standard Message vs. No Message
No Message vs Tailored Message · Regression, Logistic · p = 0.023 · Risk ratio (rr): 1.52 · 95% CI 1.06 to 2.13Tailored Message vs. No Message
Standard Message vs Tailored Message · Regression, Logistic · p = 0.124 · Risk ratio (rr): 1.26 · 95% CI 0.94 to 1.66Standard Message vs. Tailored Message

SecondaryNumber of Participants Who Scheduled an Appointment for a Well Child Check Visit.

Participant scheduled a well child check visit as determined by electronic health record documentation.

Time frame:: Within 8 weeks of the date of intervention or the date of randomization for the control group
Reported as:: Count of participants · Participants

Number of Participants Who Scheduled an Appointment for a Well Child Check Visit.
Participants	No Message	Standard Message	Tailored Message
Number of Participants Who Scheduled an Appointment for a Well Child Check Visit.	30	58	47

Statistical analysis

No Message vs Standard Message · Regression, Logistic · p = 0.001 · Risk ratio (rr): 1.97 · 95% CI 1.32 to 2.84Standard Message vs. No Message
No Message vs Tailored Message · Regression, Logistic · p = 0.040 · Risk ratio (rr): 1.57 · 95% CI 1.02 to 2.34Tailored Message vs. No Message
Standard Message vs Tailored Message · Regression, Logistic · p = 0.202 · Risk ratio (rr): 1.26 · 95% CI 0.88 to 1.74Standard Message vs. Tailored Message

SecondaryNumber of Participants Who Received Their First COVID-19 Vaccination

Participant receipt of their first COVID-19 vaccination as determined by presence of documentation of vaccine administration in the electronic health record.

Time frame:: Within 8 weeks of the date of the intervention or the date of randomization for the control group
Reported as:: Count of participants · Participants

Number of Participants Who Received Their First COVID-19 Vaccination
Participants	No Message	Standard Message	Tailored Message
Number of Participants Who Received Their First COVID-19 Vaccination	3	14	4

Post-hocNumber of Participants Who Received DTaP Vaccination

Participant receipt of DTaP vaccination 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
Reported as:: Count of participants · Participants

Number of Participants Who Received DTaP Vaccination
Participants	No Message	Standard Message	Tailored Message
Number of Participants Who Received DTaP Vaccination	8	6	6

Post-hocNumber of Participants Who Received HPV Vaccination

Participant receipt of HPV vaccination 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
Reported as:: Count of participants · Participants

Number of Participants Who Received HPV Vaccination
Participants	No Message	Standard Message	Tailored Message
Number of Participants Who Received HPV Vaccination	7	13	9

Post-hocNumber of Participants Who Received MCV4 Vaccination

Participant receipt of MCV4 vaccination 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
Reported as:: Count of participants · Participants

Number of Participants Who Received MCV4 Vaccination
Participants	No Message	Standard Message	Tailored Message
Number of Participants Who Received MCV4 Vaccination	9	10	12

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
No Message	0/315 (0%)	0/315 (0%)	0/315 (0%)
Standard Message	0/315 (0%)	0/315 (0%)	0/315 (0%)
Tailored Message	0/315 (0%)	0/315 (0%)	0/315 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)	No Message	Standard Message	Tailored Message	Total
6-8y	137	133	134	404
9-11y	96	98	98	292
12-14y	33	40	38	111
15-17y	49	44	45	138

Sex: Female, Male
Sex: Female, Male(Participants)	No Message	Standard Message	Tailored Message	Total
Female	174	152	167	493
Male	141	163	148	452

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	No Message	Standard Message	Tailored Message	Total
Black or African American Non-Hispanic	211	184	195	590
White Non-Hispanic	71	82	73	226
Multiracial Non-Hispanic	15	21	15	51
Missing Data Hispanic	5	6	11	22
Asian Non-Hispanic	5	10	4	19
White Hispanic	3	5	10	18
Missing Data Non-Hispanic	1	3	3	7
Black or African American Hispanic	2	3	1	6
Multiracial Hispanic	1	1	1	3
American Indian and Alaska Native Non-Hispanic	0	0	1	1
Middle Eastern Non-Hispanic	0	0	1	1
Native Hawaiian and Other Pacific Islander Hispanic	1	0	0	1

Study locations

1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229, United States

References and documents

Publications

Berset AE, Burkhardt MC, Xu Y, Mescher A, Brinkman WB. Effect of Electronic Outreach Using Patient Portal Messages on Well Child Care Visit Completion: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242853. doi: 10.1001/jamanetworkopen.2022.42853. PubMed 36399342 ↗

Study documents

Protocol and statistical analysis plan · Jun 27, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04994691
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Responsible party: Sponsor
First posted: Aug 6, 2021
Start date: Jul 30, 2021
Primary completion: Oct 7, 2021
Completion: Feb 28, 2022
Results posted: Aug 28, 2024
Last update: Aug 28, 2024

Study contacts

William Brinkman, MD

principal investigator · Cincinnati Children's

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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