Influenza, HumanNCT03294473
Centralized Reminder Recall - Flu RCT2
A study testing R/R - Autodialers, R/R - Texting and R/R - mailed postcard in people with Influenza, Human and Orthomyxoviridae Infections, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some modifications in relation to the intervention arms as well as the use of a different cohort, thereby justifying the second submission to Clinicaltrials.gov. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections
- What is being tested?
- R/R - Autodialers, R/R - Texting and R/R - mailed postcard
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70,190 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 4 May 2018
- 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
- a record in the New York State Immunization Information System
- in need of at least one influenza vaccination at the time of the beginning of the study
- affiliated with a participating practice (145 randomly selected)
Who cannot join
- no record within the New York State Immunization Information System
- up to date on their influenza vaccination
- not affiliated with an eligible practice
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Centralized IIS-Based Reminder Recall to Increase Influenza Vaccination Rates in New York State - Second Trial in New York State
This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some modifications in relation to the intervention arms as well as the use of a different cohort, thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in New York State, through partnership with the New York State Health Department (excluding New York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this was decided as some of the intervention components are different enough that separate registrations were warranted.
Despite U.S. guidelines for influenza vaccination of all children starting at 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 4 clinical trials (2 per state) in two different states. The investigators will assess effectiveness and cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as compared to 4) standard of care control (no R/R).
Read the detailed description
Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US with high rates of hospitalizations, emergency department visits, outpatient visits, and medical costs. Epidemics cause up to 40,000 deaths/year (mostly elderly) and extensive morbidity among children who play a key role in instigating and expanding epidemics. In addition, concerns about pandemic influenza heighten the importance of new mechanisms to rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.
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. For the 2012-2013 season, only 56% of children 2-17years were vaccinated. Modeling studies suggest that as many as 19 million cases of influenza could be prevented if child vaccination rates were raised to 70% nationally.
The most effective strategy recommended by CDC and the Task Force on Community Preventive Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent by phone or mail, notifying parents of the need to vaccinate their child. We and others have shown that R/R can improve influenza vaccination rates by up to 20%. However, <16% of practices use R/R; barriers are practice costs, insufficient staff time and expertise, and lack of predictability regarding receipt of vaccine supplies.
Statewide immunization information systems (IISs) now exist in all states to track childhood vaccinations, but they have not been used for influenza vaccine R/R because of lack of evidence for their effectiveness and a lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester (lead by personnel at UCLA), NY) to assess the impact of centralized IIS-based influenza vaccine R/R and to evaluate the effect of three types of R/R (autodialer, text message and 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.
For this second R/R trial in New York State, the intent is to evaluate the impact of reminder recalls, in the form of 1) autodialers 2) text messages and 3) postcards versus the standard of care control group, specifically in relation to raising influenza vaccination rates among children 6m-17 years of age.
The proposed design of this 4-arm RCT:
- standard of care control
- autodialer R/R -- with brief educational messages, practice name and practice phone number
- text message R/R-- with brief educational messages, practice name and practice phone number
- mailed (postcards) R/R-- with brief educational messages, practice name and practice phone number
Hypothesis 1: All IIS-C R/R modalities will be more effective than usual care
Hypothesis 2: Text messaging will be more cost-effective than other modalities
- Conditions
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Disease, Respiratory Tract Infections, Respiratory Tract Disease
- Being tested
- R/R - Autodialers, R/R - Texting, R/R - mailed postcard
- Keywords
- reminder recall (R/R), influenza vaccines
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R/R - AutodialersBehavioural
Investigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
R/R - TextingBehavioural
Investigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
R/R - mailed postcardBehavioural
Investigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
| Study group | Role | What they receive |
|---|---|---|
| Autodial R/R | Experimental | R/R Autodialers:Participants in this group will receive up to 3 influenza vaccination reminders via telephone call - with a brief educational message + practice name + practice phone number Receives: Behavioral: R/R - Autodialers |
| Text Message R/R | Experimental | R/R Texting: Participants in this group will receive up to 3 influenza vaccination reminders via text message - with a brief educational message + practice name + practice phone number Receives: Behavioral: R/R - Texting |
| Postcard R/R | Experimental | R/R Mailed Postcard:Participants in this group will receive up to 3 influenza vaccination reminders via postcard - with a brief educational message + practice name + practice phone number Receives: Behavioral: R/R - mailed postcard |
| Standard of Care Control | No intervention | Participants in this group will not receive any influenza vaccination reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R
Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks. This will begin in October 2017 and end in December 2017. Outcomes are assessed at 6 months using IIS data.
Measured: 6 months
Secondary outcomes (1)
Cost of the R/R intervention
A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer, text message or mailed postcard) is the most cost-effective in relation to improving influenza vaccination rates. The cost analysis will also compare autodialer to text, autodialer to postcard, and texting to postcards.
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 posted27 Sep 2017
- Study start18 Oct 2017
- Primary completion19 Apr 2018
- Study completion4 May 2018
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 Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), New York State Department of Health, University of Colorado, Denver
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
- Investigators
- Peter Szilagyi, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294473
- Sponsor's protocol ID
- 17-001153
- Other IDs
- 1R01AI114903, 17-001153
- Status last verified
- Jun 2019
- First submitted
- 22 Sep 2017
- Last updated
- 5 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 publication 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 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized IIS-Based Reminder Recall to Increase Influenza Vaccination Rates in New York State - Second Trial in New York State
- ClinicalTrials.gov ID
- NCT03294473
- Acronym / sponsor ID
- 17-001153
- Conditions
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Disease, Respiratory Tract Infections, Respiratory Tract Disease
- Keywords
- reminder recall (R/R), influenza vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70,190 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), New York State Department of Health, University of Colorado, Denver
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 27 Sep 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 related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some modifications in relation to the intervention arms as well as the use of a different cohort, thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in New York State, through partnership with the New York State Health Department (excluding New York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this was decided as some of the intervention components are different enough that separate registrations were warranted.
Despite U.S. guidelines for influenza vaccination of all children starting at 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 4 clinical trials (2 per state) in two different states. The investigators will assess effectiveness and cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as compared to 4) standard of care control (no R/R).
Detailed description
Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US with high rates of hospitalizations, emergency department visits, outpatient visits, and medical costs. Epidemics cause up to 40,000 deaths/year (mostly elderly) and extensive morbidity among children who play a key role in instigating and expanding epidemics. In addition, concerns about pandemic influenza heighten the importance of new mechanisms to rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.
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. For the 2012-2013 season, only 56% of children 2-17years were vaccinated. Modeling studies suggest that as many as 19 million cases of influenza could be prevented if child vaccination rates were raised to 70% nationally.
The most effective strategy recommended by CDC and the Task Force on Community Preventive Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent by phone or mail, notifying parents of the need to vaccinate their child. We and others have shown that R/R can improve influenza vaccination rates by up to 20%. However, <16% of practices use R/R; barriers are practice costs, insufficient staff time and expertise, and lack of predictability regarding receipt of vaccine supplies.
Statewide immunization information systems (IISs) now exist in all states to track childhood vaccinations, but they have not been used for influenza vaccine R/R because of lack of evidence for their effectiveness and a lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester (lead by personnel at UCLA), NY) to assess the impact of centralized IIS-based influenza vaccine R/R and to evaluate the effect of three types of R/R (autodialer, text message and 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.
For this second R/R trial in New York State, the intent is to evaluate the impact of reminder recalls, in the form of 1) autodialers 2) text messages and 3) postcards versus the standard of care control group, specifically in relation to raising influenza vaccination rates among children 6m-17 years of age.
The proposed design of this 4-arm RCT:
- standard of care control
- autodialer R/R -- with brief educational messages, practice name and practice phone number
- text message R/R-- with brief educational messages, practice name and practice phone number
- mailed (postcards) R/R-- with brief educational messages, practice name and practice phone number
Hypothesis 1: All IIS-C R/R modalities will be more effective than usual care
Hypothesis 2: Text messaging will be more cost-effective than other modalities
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autodial R/R | Experimental | Behavioral: R/R - AutodialersR/R Autodialers:Participants in this group will receive up to 3 influenza vaccination reminders via telephone call - with a brief educational message + practice name + practice phone number |
| Text Message R/R | Experimental | Behavioral: R/R - TextingR/R Texting: Participants in this group will receive up to 3 influenza vaccination reminders via text message - with a brief educational message + practice name + practice phone number |
| Postcard R/R | Experimental | Behavioral: R/R - mailed postcardR/R Mailed Postcard:Participants in this group will receive up to 3 influenza vaccination reminders via postcard - with a brief educational message + practice name + practice phone number |
| Standard of Care Control | No intervention | –Participants in this group will not receive any influenza vaccination reminders |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a record in the New York State Immunization Information System
- in need of at least one influenza vaccination at the time of the beginning of the study
- affiliated with a participating practice (145 randomly selected)
Key exclusion criteria (3 listed)
- no record within the New York State Immunization Information System
- up to date on their influenza vaccination
- not affiliated with an eligible practice
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 |
|---|---|---|
| R/R - AutodialersInvestigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS). | Behavioural | Autodial R/R |
| R/R - TextingInvestigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS). | Behavioural | Text Message R/R |
| R/R - mailed postcardInvestigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS). | Behavioural | Postcard R/R |
Primary outcome
The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R
Time frame: 6 months
Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks. This will begin in October 2017 and end in December 2017. Outcomes are assessed at 6 months using IIS data.
1 secondary outcome
Cost of the R/R intervention
Time frame: 6 months
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 5 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 publication 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.
Peter Szilagyi, MD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R/R - Autodialers, R/R - Texting and R/R - mailed postcard in people with Influenza, Human and Orthomyxoviridae Infections, run by University of California, Los Angeles 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 3 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 5 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?
The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R (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 NCT03294473, 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 5 Jun 2019.