Immunization StatusNCT01057888
Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
A study testing Autodialer and Letters in people with Immunization Status and Well Child Care Visit, run by University of California, Los Angeles.
Trial summary
The investigators will design and implement a randomized clinical trial to test, on a community-wide level, the effectiveness of managed care based tracking/reminder/recall on improving vaccination coverage among adolescents. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Immunization Status, Well Child Care Visit
- What is being tested?
- Autodialer and Letters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,599 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Dec 2010
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Member of the Monroe Plan for Medical Care (managed care organization)
- Patient of a participating practice
- Ages 10.75 to <18 years of age
Who cannot join
- Member of the Monroe Plan for Medical care for less than 6 months
- ICD-9 diagnosis of 999.4 for anaphylactic reaction to a vaccine or its components.
- Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause
- Guillain-Barre- ICD-9 code is 357.0
About this study
Official title: Randomized Controlled Trial of an Automated, Managed Care-based Reminder/Recall System on Improving Rates of Immunization and Preventive Care Visits for Publically Insured Adolescents
The investigators will design and implement a randomized clinical trial to test, on a community-wide level, the effectiveness of managed care based tracking/reminder/recall on improving vaccination coverage among adolescents.
The investigators propose a randomized controlled trial to evaluate the effectiveness of reminder/recall for adolescents: 10,599 adolescents within the managed care organization (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone messages or 3) standard of care of their practice (no messages from the intervention).
Read more
Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive services
Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders
Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which have low baseline immunization rates.
Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone reminders.
- Conditions
- Immunization Status, Well Child Care Visit
- Being tested
- Autodialer, Letters
- Keywords
- Immunization status for:, Tdap, Menactra, HPV (if female), Well child care visit
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutodialerOther
Autodialer telephone calls
LettersOther
Mailed reminder letters
| Study group | Role | What they receive |
|---|---|---|
| Autodialer | Experimental | Autodialer reminder/recall Receives: Other: Autodialer |
| Letters | Experimental | Mailed reminder letters Receives: Other: Letters |
| Controls | No intervention | Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))
Measured: 12 months
Well Child Care Status
Received recommended well child care visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- Other trials for Immunization StatusStudies 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
- Investigator
- Enrolment
- 10,599 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Peter G Szilagyi MD MPH, University of Rochester
- Investigators
- Peter G Szilagyi, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057888
- Sponsor's protocol ID
- RSRB00026761
- Status last verified
- Dec 2015
- First submitted
- 25 Jan 2010
- Last updated
- 20 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Automated, Managed Care-based Reminder/Recall System on Improving Rates of Immunization and Preventive Care Visits for Publically Insured Adolescents
- ClinicalTrials.gov ID
- NCT01057888
- Acronym / sponsor ID
- RSRB00026761
- Conditions
- Immunization Status, Well Child Care Visit
- Keywords
- Immunization status for:, Tdap, Menactra, HPV (if female), Well child care visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,599 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Posted 16 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will design and implement a randomized clinical trial to test, on a community-wide level, the effectiveness of managed care based tracking/reminder/recall on improving vaccination coverage among adolescents.
The investigators propose a randomized controlled trial to evaluate the effectiveness of reminder/recall for adolescents: 10,599 adolescents within the managed care organization (MCO) will be randomized into one of three arms: 1) mailed reminders, 2) autodialer telephone messages or 3) standard of care of their practice (no messages from the intervention).
Hypothesis 1: Reminder/recall will increase the receipt of immunizations and preventive services
Hypothesis 2: Telephone (autodialer) reminders will be more effective than mailed reminders
Hypothesis 3: The impact of reminders will be greatest for the most high-risk subgroups which have low baseline immunization rates.
Hypothesis 4: Mailed reminders will be more costly (and less effective) than telephone reminders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autodialer | Experimental | Other: AutodialerAutodialer reminder/recall |
| Letters | Experimental | Other: LettersMailed reminder letters |
| Controls | No intervention | –Controls |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Member of the Monroe Plan for Medical Care (managed care organization)
- Patient of a participating practice
- Ages 10.75 to <18 years of age
Key exclusion criteria (4 listed)
- Member of the Monroe Plan for Medical care for less than 6 months
- ICD-9 diagnosis of 999.4 for anaphylactic reaction to a vaccine or its components.
- Encephalopathy within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause
- Guillain-Barre- ICD-9 code is 357.0
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 |
|---|---|---|
| AutodialerAutodialer telephone calls | Other | Autodialer |
| LettersMailed reminder letters | Other | Letters |
Primary outcome
Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))
Time frame: 12 months
Well Child Care Status
Time frame: 12 months
Received recommended well child care visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 G Szilagyi, MD, MPH principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
A study testing Autodialer and Letters in people with Immunization Status and Well Child Care Visit, run by University of California, Los Angeles.
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 4 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 16 Nov 2012). 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?
Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female)) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 20 Jan 2016.