Reminder SystemsNCT03246100
Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates_2nd Trial in Colorado
A study testing Reminders in people with Reminder Systems and Influenza Vaccines, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are slight changes to methods and a different cohort will be used, thus justifying a 2nd ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in Colorado. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Reminder Systems, Influenza Vaccines
- What is being tested?
- Reminders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,531 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 30 Apr 2019
- 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- have record in Colorado Immunization Information System
- from 6 months through 17 years of age
- have not received an influenza vaccine by start of trial
- must be affiliated with one of our 42 randomly selected primary care practices in Colorado
Who cannot join
- those without a record
- received an influenza vaccine post 9/1/2017
- not affiliated with an eligible study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates, 2nd Trial in Colorado
This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are slight changes to methods and a different cohort will be used, thus justifying a 2nd ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in Colorado. Each state has it's own ClinicalTrials.gov submission.
Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall versus 3) usual care (no R/R) on improving influenza vaccination rates.
The investigators will disseminate the state immunization information system based reminder/recall system to all states for use for both seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.
Read the detailed description
Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the U.S. with high rates of hospitalizations, emergency department and outpatient visits, and medical costs. Children experience significant morbidity from influenza, and also play a critical role in spreading infection to adults. Since 2010, the Advisory Committee on Immunization Practices (ACIP) has recommended influenza vaccination for all children >6 months of age. However, vaccination rates remain very low-- only 56% of children 2-17 years are vaccinated. Low rates are a concern for both seasonal influenza and in preparation for pandemic influenza. One of the nationally recommended strategies for raising childhood influenza vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R despite many studies showing its effectiveness.
Statewide immunization information systems (IISs) now exist in all states to track childhood vaccinations, but they have not been used for R/R for influenza vaccine because of the lack of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess the impact of centralized IIS-based influenza vaccine R/R, and to evaluate the effect of two types of R/R (autodial v. mail R/R) over usual care. The investigators will also develop tools to aid other states in creating efficient IIS R/R systems for seasonal and possible pandemic influenza outbreaks.
In Colorado, evaluate the impact of (a) autodialer reminders and (b) mailed messages versus standard-of-care control on raising influenza vaccination rates among children 6m-17 years of age.
The investigators propose a 3-arm RCT study design with the following study arms:
- Standard of care control
- Autodialer (3 reminders)- with brief education message + practice name + practice phone #
- Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone #
- Conditions
- Reminder Systems, Influenza Vaccines
- Being tested
- Reminders
- Keywords
- centralized reminder/recall, influenza vaccine reminders, childhood influenza vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemindersBehavioural
Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | These patients will receive no reminders from the health department and will receive usual care. |
| Autodialer R/R | Experimental | Autodialer calls (up to 3 reminders)- with brief education message + practice name + practice phone # Receives: Behavioral: Reminders |
| Mail R/R | Experimental | Mailed reminder (up to 3 reminders)-- with brief education message + practice name + practice phone # Receives: Behavioral: Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state
Based on our prior studies, we currently plan to send up to 3 autodialer or postcards (based on randomization arm) reminders, spaced every 5 weeks, beginning in early October, and ending mid-December 2017. Outcomes are assessed at 6 months using IIS data.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start6 Sep 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reminder SystemsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Model description
- Patients will be randomized within practices to one of 3 arms: 1. Standard of care control 2. Autodialer (3 reminders)- with brief education message + practice name + practice phone # (see autodialer scripts) 3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone # (see postcards)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25,531 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Allison Kempe, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246100
- Sponsor's protocol ID
- 15-0570_2
- Status last verified
- Jun 2019
- First submitted
- 7 Aug 2017
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate results will be prepared for publications at the end of the trial.
Publications
Szilagyi PG, Albertin CS, Saville AW, Valderrama R, Breck A, Helmkamp L, Zhou X, Vangala S, Dickinson LM, Tseng CH, Campbell JD, Whittington MD, Roth H, Rand CM, Humiston SG, Hoefer D, Kempe A. Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages. J Pediatr. 2020 Jun;221:123-131.e4. doi: 10.1016/j.jpeds.2020.02.020.
PubMed 32446470
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized IIS-based Reminder/Recall to Increase Childhood Influenza Vaccination Rates, 2nd Trial in Colorado
- ClinicalTrials.gov ID
- NCT03246100
- Acronym / sponsor ID
- 15-0570_2
- Conditions
- Reminder Systems, Influenza Vaccines
- Keywords
- centralized reminder/recall, influenza vaccine reminders, childhood influenza vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25,531 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 Aug 2017 (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.
This study is the second trial related to ClinicalTrials.gov ID: NCT02761551. There are slight changes to methods and a different cohort will be used, thus justifying a 2nd ClinicalTrials.gov submission. This trial is taking place in New York State (not NYC) and in Colorado. Each state has it's own ClinicalTrials.gov submission.
Despite U.S. guidelines for influenza vaccination of all children starting at age 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using three clinical trials in two states. The investigators will assess effectiveness and cost-effectiveness of: 1) autodialer reminder/recall versus 2) postcard reminder/recall versus 3) usual care (no R/R) on improving influenza vaccination rates.
The investigators will disseminate the state immunization information system based reminder/recall system to all states for use for both seasonal and pandemic influenza vaccinations with the goal of lowering influenza morbidity.
Detailed description
Annual epidemics of seasonal influenza cause substantial morbidity and mortality in the U.S. with high rates of hospitalizations, emergency department and outpatient visits, and medical costs. Children experience significant morbidity from influenza, and also play a critical role in spreading infection to adults. Since 2010, the Advisory Committee on Immunization Practices (ACIP) has recommended influenza vaccination for all children >6 months of age. However, vaccination rates remain very low-- only 56% of children 2-17 years are vaccinated. Low rates are a concern for both seasonal influenza and in preparation for pandemic influenza. One of the nationally recommended strategies for raising childhood influenza vaccination rates is to use parent reminder/recall (R/R) by phone or mail, which can raise rates by up to 20 percentage points. However, less than 16% of primary care practices use R/R despite many studies showing its effectiveness.
Statewide immunization information systems (IISs) now exist in all states to track childhood vaccinations, but they have not been used for R/R for influenza vaccine because of the lack of evidence for its effectiveness and lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester, NY) to assess the impact of centralized IIS-based influenza vaccine R/R, and to evaluate the effect of two types of R/R (autodial v. mail R/R) over usual care. The investigators will also develop tools to aid other states in creating efficient IIS R/R systems for seasonal and possible pandemic influenza outbreaks.
In Colorado, evaluate the impact of (a) autodialer reminders and (b) mailed messages versus standard-of-care control on raising influenza vaccination rates among children 6m-17 years of age.
The investigators propose a 3-arm RCT study design with the following study arms:
- Standard of care control
- Autodialer (3 reminders)- with brief education message + practice name + practice phone #
- Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone #
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients will be randomized within practices to one of 3 arms: 1. Standard of care control 2. Autodialer (3 reminders)- with brief education message + practice name + practice phone # (see autodialer scripts) 3. Mailed reminder (3 reminders)-- with brief education message + practice name + practice phone # (see postcards)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –These patients will receive no reminders from the health department and will receive usual care. |
| Autodialer R/R | Experimental | Behavioral: RemindersAutodialer calls (up to 3 reminders)- with brief education message + practice name + practice phone # |
| Mail R/R | Experimental | Behavioral: RemindersMailed reminder (up to 3 reminders)-- with brief education message + practice name + practice phone # |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- have record in Colorado Immunization Information System
- from 6 months through 17 years of age
- have not received an influenza vaccine by start of trial
- must be affiliated with one of our 42 randomly selected primary care practices in Colorado
Key exclusion criteria (3 listed)
- those without a record
- received an influenza vaccine post 9/1/2017
- not affiliated with an eligible study
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 |
|---|---|---|
| RemindersReminders are sent either through autodial or postcards reminding patients to get flu vaccine. | Behavioural | Autodialer R/R, Mail R/R |
Primary outcome
Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state
Time frame: 6 months
Based on our prior studies, we currently plan to send up to 3 autodialer or postcards (based on randomization arm) reminders, spaced every 5 weeks, beginning in early October, and ending mid-December 2017. Outcomes are assessed at 6 months using IIS data.
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 24 Jun 2019.
- Derived from this study: PubMed 32446470Szilagyi PG, Albertin CS, Saville AW, Valderrama R, Breck A, Helmkamp L, Zhou X, Vangala S, Dickinson LM, Tseng CH, Campbell JD, Whittington MD, Roth H, Rand CM, Humiston SG, Hoefer D, Kempe A. Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages. J Pediatr. 2020 Jun;221:123-131.e4. doi: 10.1016/j.jpeds.2020.02.020.
- Individual participant dataSharing planned: No. Aggregate results will be prepared for publications at the end of the trial.
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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.
Allison Kempe, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminders in people with Reminder Systems and Influenza Vaccines, run by University of Colorado, Denver 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 3 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 24 Jun 2019. 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?
Receipt of at least 1 influenza vaccine according to immunization records in the Immunization Information System (IIS) records in each state (time frame: 6 months). 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 NCT03246100, 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 24 Jun 2019.