- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010372
Optimizing Application And Support Of Immunization Information Systems (OASIS) (OASIS)
February 23, 2016 updated by: Stanley J Schaffer, MD, University of Rochester
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- NYSIIS administrator at a participating practice
Exclusion Criteria:
- Practices already utilizing/running reports used in the intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reminder Recall Reports
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.
|
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.
|
|
Experimental: Audit-Feedback/Immunization Forecasting Reports
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.
|
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.
|
|
No Intervention: Control
No intervention will be administered to this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
One Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV Vaccination Rate
Time Frame: One Year
|
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.
|
One Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stanley J Schaffer, MD, MPH, University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 11, 2013
First Posted (Estimate)
December 12, 2013
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 5U01IP000502 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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