SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
This trial is active, not recruiting.
|Conditions||adult influenza vaccinations, adult ppsv vaccinations, adult tdap/td vaccinations|
|Treatments||pillar 1: convenient vaccination services, pillar 2: patient notification, pillar 3: enhanced office systems, pillar 4: motivation|
|Sponsor||University of Pittsburgh|
|Collaborator||Centers for Disease Control and Prevention|
|Start date||April 2013|
|End date||May 2015|
|Trial size||596 participants|
|Trial identifier||NCT01868334, CDC-1U01IP000662-01|
The purpose of this study is to test whether or not the 4 Pillars Toolkit increases adult Influenza, pneumococcal polysaccharide vaccine (PPSV), tetanus, adult diphtheria and acellular pertussis vaccine (Tdap/Td) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practice with electronic medical records (EMRs).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Primary purpose||health services research|
Assessment of adult vaccination rates for influenza, PPSV, Tdap
time frame: Baseline year (for background data): January 1, 2012 to April 30, 2013; Year 1: May 1, 2013 to January 31, 2014; Year 2: February 1, 2014 to January 31, 2015. All reports from baseline year thru year 2 will be via EMR data pulls.
Utilization of the 4 Pillars intervention via the RE-AIM framework - assessment via questionnaires
time frame: Intervention arm: April/May 2013 (pre-survey); December 2013 (mid-season survey); May 2014 (post-survey). Control arm: April/May 2014 (pre-survey); December 2014 (mid-season survey); May 2015 (post-survey)
Male or female participants at least 18 years old.
Practice staff and adults in enrolled clinical sites Inclusion Criteria: Site inclusion criteria: - 1) an appropriate adult population: e.g., adults aged 50 years and older; - 2) currently using an EMR that has prompt ability, such as EpicCare; - 3) having and keeping immunization data within this EMR Patient-level inclusion criteria: - 1) Adults (18 years and above) who are active patients of the enrolled practices (e.g., active patients are those with a visit within the last 12 months) - 2) All unvaccinated adults without a contraindication are eligible to receive Td/Tdap and influenza, regardless of age and at age 65 years or older are eligible for PPSV. Exclusion Criteria: Site exclusion criteria: - 1) consistent SOP use for the 3 vaccines being studied or high vaccination rates (e.g., 80%) Patient-level exclusion criteria: - 1) those with a true contraindication, following the CDC's Guide to Contraindications (attached with the US Recommended Adult Immunization Schedule), such as prior vaccine anaphylaxis.
|Official title||A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM|
|Description||This intervention is a two-region, two-year, stratified randomized cluster trial in 24 primary care practices with EMRs. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; one set of practices randomized to intervention in year 1 and the other to control. In year 2, the other set of practices will receive the intervention and community controls may be sought. These diverse practices consist of: 18 diverse practices from UPMC in western Pennsylvania and 6 diverse practices from large community health centers in a PBRN in Texas.|
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