Increase in Use of Immunization RegistryOASISNCT02010372
Optimizing Application And Support Of Immunization Information Systems (OASIS)
A study testing Reminder Recall Report and Audit-Feedback/Immunization Forecasting Reports in people with Increase in Use of Immunization Registry and Increase in HPV Vaccination Rate, run by University of Rochester at 1 site in United States.
Trial summary
The overall purpose of this study is to evaluate the use of features of the New York State Immunization Information System (NYSIIS) by various types of primary care practices and determine how best to promote the use of IIS features and functionality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Increase in Use of Immunization Registry, Increase in HPV Vaccination Rate
- What is being tested?
- Reminder Recall Report and Audit-Feedback/Immunization Forecasting Reports
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NYSIIS administrator at a participating practice
Who cannot join
- Practices already utilizing/running reports used in the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing the Practical Application of Immunization Information System Use in Primary Care Practices
The overall purpose of this study is to evaluate the use of features of the New York State Immunization Information System (NYSIIS) by various types of primary care practices and determine how best to promote the use of IIS features and functionality. The primary goal is to promote the use of NYSIIS for immunization quality improvement (QI) in the practice setting. Customized training sessions will be conducted by study staff to educate practices on NYSIIS' enhanced features.
- Being tested
- Reminder Recall Report, Audit-Feedback/Immunization Forecasting Reports
- Keywords
- Immunization Registry, Human Papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder Recall ReportOther
Practices (administrators) that are randomized to this intervention will receive training in how to run reminder recall reports for patients due to receive any dose of HPV vaccine. After the training has been completed, administrators will be asked to continue running regularly scheduled reports over the course of one year. A tracking log will be sent regularly to the research team.
Audit-Feedback/Immunization Forecasting ReportsOther
Practices (administrators) that are randomized to this intervention will receive training in how to run audit-feedback/immunization forecasting reports for patients due to receive any dose of HPV vaccine and to determine the % of patients in their practice who have received at least one dose of HPV vaccine within the study period. After the training has been completed, administrators will be asked to continue running regularly scheduled reports over the course of one year. A tracking log will be sent regularly to the research team.
| Study group | Role | What they receive |
|---|---|---|
| Reminder Recall Reports | Experimental | Training in how to use reminder-recall reports in the Immunization registry will be given to administrators who will then be asked to regularly run these reports for a period of one year. Receives: Other: Reminder Recall Report |
| Audit-Feedback/Immunization Forecasting Reports | Experimental | Training in how to use audit-feedback/immunization forecasting reports in the Immunization registry will be given to administrators who will then be asked to regularly run these reports for a period of one year. Receives: Other: Audit-Feedback/Immunization Forecasting Reports |
| Control | No intervention | No intervention will be administered to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NYSIIS report usage
Practice NYSIIS administrators will monitor the number of reports their practice generates throughout the 12 month post-training period. These measures for control and intervention practices will be compared in bivariate and multivariate analysis.
Measured: One Year
Secondary outcomes (1)
HPV Vaccination Rate
HPV Vaccination rates will be measured to determine the change in the practice's immunization levels (for the pre-determined immunization QI goal) over the 12-month period following their initial training. Statistical comparisons of control and intervention practice will be performed using bivariate analyses, while multivariate analyses will be used to account for the effects of practice characteristics.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increase in Use of Immunization RegistryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Stanley J Schaffer, MD, University of Rochester
- Investigators
- Stanley J Schaffer, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010372
- Sponsor's protocol ID
- 5U01IP000502
- Acronym
- OASIS
- Status last verified
- Feb 2016
- First submitted
- 9 Dec 2013
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Practical Application of Immunization Information System Use in Primary Care Practices
- ClinicalTrials.gov ID
- NCT02010372
- Acronym / sponsor ID
- OASIS / 5U01IP000502
- Keywords
- Immunization Registry, Human Papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Dec 2013 (estimated)
- 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 overall purpose of this study is to evaluate the use of features of the New York State Immunization Information System (NYSIIS) by various types of primary care practices and determine how best to promote the use of IIS features and functionality. The primary goal is to promote the use of NYSIIS for immunization quality improvement (QI) in the practice setting. Customized training sessions will be conducted by study staff to educate practices on NYSIIS' enhanced features.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reminder Recall Reports | Experimental | Other: Reminder Recall ReportTraining in how to use reminder-recall reports in the Immunization registry will be given to administrators who will then be asked to regularly run these reports for a period of one year. |
| Audit-Feedback/Immunization Forecasting Reports | Experimental | Other: Audit-Feedback/Immunization Forecasting ReportsTraining in how to use audit-feedback/immunization forecasting reports in the Immunization registry will be given to administrators who will then be asked to regularly run these reports for a period of one year. |
| Control | No intervention | –No intervention will be administered to this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- NYSIIS administrator at a participating practice
Key exclusion criteria (1 listed)
- Practices already utilizing/running reports used in the intervention
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 |
|---|---|---|
| Reminder Recall ReportPractices (administrators) that are randomized to this intervention will receive training in how to run reminder recall reports for patients due to receive any dose of HPV vaccine. After the training has been completed, administrators will be asked to continue running regularly scheduled reports over the course of one year. A tracking log will be sent regularly to the research team. | Other | Reminder Recall Reports |
| Audit-Feedback/Immunization Forecasting ReportsPractices (administrators) that are randomized to this intervention will receive training in how to run audit-feedback/immunization forecasting reports for patients due to receive any dose of HPV vaccine and to determine the % of patients in their practice who have received at least one dose of HPV vaccine within the study period. After the training has been completed, administrators will be asked to continue running regularly scheduled reports over the course of one year. A tracking log will be sent regularly to the research team. | Other | Audit-Feedback/Immunization Forecasting Reports |
Primary outcome
NYSIIS report usage
Time frame: One Year
Practice NYSIIS administrators will monitor the number of reports their practice generates throughout the 12 month post-training period. These measures for control and intervention practices will be compared in bivariate and multivariate analysis.
1 secondary outcome
HPV Vaccination Rate
Time frame: One Year
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 25 Feb 2016.
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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.
Stanley J Schaffer, MD, MPH principal investigator
University of Rochester
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 Recall Report and Audit-Feedback/Immunization Forecasting Reports in people with Increase in Use of Immunization Registry and Increase in HPV Vaccination Rate, run by University of Rochester 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 1 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 25 Feb 2016. 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?
NYSIIS report usage (time frame: One Year). 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 25 Feb 2016.