Immunization ProgramsNCT05317884
Email-based Reminders Promoting Recommended Pediatric Preventative Visits
A study testing Reminder in people with Immunization Programs, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess, prospectively, the effect of email reminders for well-child check (WCC) visits on adherence to these visits among those who have not yet scheduled the visit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunization Programs
- What is being tested?
- Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,186 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents (or contact on record) of children aged 5, 8, 11, 14, or 17 months
- No WCC visits scheduled 30 days after the child's monthly birthday (for 5 month-olds) or 60 days (for all other ages) ahead of their due date for a WCC (i.e., month 6, 9, 12, 15, or 18)
- Has an email address on record
- Child is currently seen in Pediatric clinics under the Geisinger umbrella (has at least one prior visit)
Who cannot join
- Did not opt out of emails
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Email-based Reminders in Promoting Adherence to the Recommended Pediatric Preventative-visit Schedule Among Rural Patients
The purpose of this study is to assess, prospectively, the effect of email reminders for well-child check (WCC) visits on adherence to these visits among those who have not yet scheduled the visit. The investigators hypothesize that sending reminders will increase scheduling WCC visits, attending WCC visits, and being up to date for the child's required immunizations beyond what occurs in the absence of these reminders.
Read the detailed description
Regular attendance at recommended WCC visits is associated with having up-to-date immunizations. Standard care involves scheduling a follow-up WCC visit at the end of the current visit. However, if the child's parents do not choose to schedule a follow-up visit at that time or miss a WCC visit, they may not be offered another easy opportunity to schedule one. That is, they would have to remember to schedule a visit and contact the clinic proactively.
In this study, 30 days before a child is due for their WCC visit, parents who have not yet scheduled a WCC visit for up to 30 days (for 5-month-olds) or 60 days (for all other ages) after their child is due for a visit will be randomly assigned to two groups with a random number generator. One group will receive an email reminder, while the other group will not receive any reminder.
The randomization of participants to different conditions will be in place until 800 participants have been identified and randomly assigned to one of the arms (estimated sample to detect at least a 10% absolute difference) or 180 days, whichever comes first. To account for delays in updating clinical databases, the final outcome data will be checked 90 days after the last eligible visit (for a maximum study period of 270 days).
- Conditions
- Immunization Programs
- Being tested
- Reminder
- Keywords
- Pediatrics, Reminder Systems, Preventive Medicine, Child Health, Appointments and Schedules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminderBehavioural
Email
| Study group | Role | What they receive |
|---|---|---|
| No Contact | No intervention | No reminder sent |
| Reminder | Experimental | Reminder email with contact information to set an appointment will be sent 12 weeks before the appointment. Receives: Behavioral: Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
WCC visit scheduled
Binary variable of scheduling a WCC visit as established by visit type, visit reasons, and billing codes (if available)
Measured: 30-60 days from the email send date
Secondary outcomes (2)
WCC visit made
Binary variable of going to a WCC visit as established by billing codes
Measured: 30-60 days from the email send date
Immunization status
Binary variable indicating whether pediatric vaccinations are up to date, defined as having no current immunization care gaps
Measured: 60 days from the email send date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start16 May 2022
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization ProgramsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- No reminder group vs. reminder group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Goren, Geisinger Clinic
- Investigators
- Amir Goren, PhD, Principal investigator, Program Director, Behavioral Insights Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317884
- Sponsor's protocol ID
- 2021-0106
- Status last verified
- Nov 2022
- First submitted
- 22 Mar 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Email-based Reminders in Promoting Adherence to the Recommended Pediatric Preventative-visit Schedule Among Rural Patients
- ClinicalTrials.gov ID
- NCT05317884
- Acronym / sponsor ID
- 2021-0106
- Conditions
- Immunization Programs
- Keywords
- Pediatrics, Reminder Systems, Preventive Medicine, Child Health, Appointments and Schedules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,186 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess, prospectively, the effect of email reminders for well-child check (WCC) visits on adherence to these visits among those who have not yet scheduled the visit. The investigators hypothesize that sending reminders will increase scheduling WCC visits, attending WCC visits, and being up to date for the child's required immunizations beyond what occurs in the absence of these reminders.
Detailed description
Regular attendance at recommended WCC visits is associated with having up-to-date immunizations. Standard care involves scheduling a follow-up WCC visit at the end of the current visit. However, if the child's parents do not choose to schedule a follow-up visit at that time or miss a WCC visit, they may not be offered another easy opportunity to schedule one. That is, they would have to remember to schedule a visit and contact the clinic proactively.
In this study, 30 days before a child is due for their WCC visit, parents who have not yet scheduled a WCC visit for up to 30 days (for 5-month-olds) or 60 days (for all other ages) after their child is due for a visit will be randomly assigned to two groups with a random number generator. One group will receive an email reminder, while the other group will not receive any reminder.
The randomization of participants to different conditions will be in place until 800 participants have been identified and randomly assigned to one of the arms (estimated sample to detect at least a 10% absolute difference) or 180 days, whichever comes first. To account for delays in updating clinical databases, the final outcome data will be checked 90 days after the last eligible visit (for a maximum study period of 270 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- No reminder group vs. reminder group
| Arm | Type | Receives |
|---|---|---|
| No Contact | No intervention | –No reminder sent |
| Reminder | Experimental | Behavioral: ReminderReminder email with contact information to set an appointment will be sent 12 weeks before the appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parents (or contact on record) of children aged 5, 8, 11, 14, or 17 months
- No WCC visits scheduled 30 days after the child's monthly birthday (for 5 month-olds) or 60 days (for all other ages) ahead of their due date for a WCC (i.e., month 6, 9, 12, 15, or 18)
- Has an email address on record
- Child is currently seen in Pediatric clinics under the Geisinger umbrella (has at least one prior visit)
Key exclusion criteria (1 listed)
- Did not opt out of emails
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 |
|---|---|---|
| ReminderEmail | Behavioural | Reminder |
Primary outcome
WCC visit scheduled
Time frame: 30-60 days from the email send date
Binary variable of scheduling a WCC visit as established by visit type, visit reasons, and billing codes (if available)
2 secondary outcomes
WCC visit made
Time frame: 30-60 days from the email send date
Immunization status
Time frame: 60 days from the email send date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: Yes. Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings. The PI did not examine or analyze any data from this study prior to this registration.
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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.
Amir Goren, PhD principal investigator
Program Director, Behavioral Insights Team
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder in people with Immunization Programs, run by Geisinger Clinic 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 23 Nov 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WCC visit scheduled (time frame: 30-60 days from the email send date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2022.