Health Care UtilizationNCT04904744
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
A study testing Low tailored message, No message and Low tailored message plus COVID-19 vaccine message in people with Health Care Utilization and Vaccine Preventable Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Health Care Utilization, Vaccine Preventable Disease
- What is being tested?
- Low tailored message, No message and Low tailored message plus COVID-19 vaccine message
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,235 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2021to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- phone number not available in electronic health record
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
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.
- Being tested
- Low tailored message, No message, Low tailored message plus COVID-19 vaccine message
- Medical subject headings
- Patient Acceptance of Health Care, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low tailored messageOther
2 low tailored text or phone message reminders that child is overdue for well child check visit
No messageOther
No reminders are sent
Low tailored message plus COVID-19 vaccine messageOther
2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available
| Study group | Role | What they receive |
|---|---|---|
| No message | Placebo comparator | No message sent Receives: Other: No message |
| Low tailored message | Active comparator | 2 text or phone reminders that child is overdue for well child check visit Receives: Other: Low tailored message |
| Low tailored message plus COVID-19 vaccine message | Active comparator | 2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available Receives: Other: Low tailored message plus COVID-19 vaccine message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 8 weeks of the date of intervention or the date of randomization for the control group
Secondary outcomes (3)
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
Measured: Within 2 weeks of the date of intervention or the date of randomization for the control group
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.
Measured: Within 8 weeks of the date of intervention or the date of randomization for the control group
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.
Measured: Within 8 weeks of the date of intervention or the date of randomization for the control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start28 May 2021
- Primary completion31 Oct 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Brinkman, MD, Principal investigator, Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904744
- Sponsor's protocol ID
- 2020-0769-1
- Status last verified
- Aug 2024
- First submitted
- 25 May 2021
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burkhardt MC, Berset AE, Xu Y, Mescher A, Brinkman WB. Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial. J Pediatr. 2023 Feb;253:158-164.e1. doi: 10.1016/j.jpeds.2022.09.035. Epub 2022 Oct 4.
PubMed 36202236
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT04904744
- Acronym / sponsor ID
- 2020-0769-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,235 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No message | Placebo comparator | Other: No messageNo message sent |
| Low tailored message | Active comparator | Other: Low tailored message2 text or phone reminders that child is overdue for well child check visit |
| Low tailored message plus COVID-19 vaccine message | Active comparator | Other: Low tailored message plus COVID-19 vaccine message2 text or phone reminders that child is overdue for well child check visit AND COVID-19 vaccine is available |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- phone number not available in electronic health record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low tailored message2 low tailored text or phone message reminders that child is overdue for well child check visit | Other | Low tailored message |
| No messageNo reminders are sent | Other | No message |
| Low tailored message plus COVID-19 vaccine message2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available | Other | Low tailored message plus COVID-19 vaccine message |
Primary outcome
Number of Participants Who Completed an Adolescent Well-care Visit
Time frame: 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
3 secondary outcomes
Number of Participants Who Scheduled an Adolescent Well-care Appointment
Time frame: Within 2 weeks of the date of intervention or the date of randomization for the control group
Participant Receipt of COVID-19 Vaccine
Time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group
Family Member Receipt of COVID-19 Vaccine
Time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36202236Burkhardt MC, Berset AE, Xu Y, Mescher A, Brinkman WB. Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial. J Pediatr. 2023 Feb;253:158-164.e1. doi: 10.1016/j.jpeds.2022.09.035. Epub 2022 Oct 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Brinkman, MD principal investigator
Cincinnati Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low tailored message, No message and Low tailored message plus COVID-19 vaccine message in people with Health Care Utilization and Vaccine Preventable Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed an Adolescent Well-care Visit (time frame: Within 8 weeks of the date of intervention or the date of randomization for the control group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.