A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70,549
- 试验地点
- 4
- 主要终点
- Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Site inclusion criteria:
- •an appropriate adult population: e.g., adults aged 50 years and older;
- •currently using an EMR that has prompt ability, such as EpicCare;
- •having and keeping immunization data within this EMR
- •Patient-level inclusion criteria:
- •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)
- •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.
排除标准
- •Site exclusion criteria:
- •consistent SOP use for the 3 vaccines being studied or high vaccination rates (e.g., 80%)
- •Patient-level exclusion criteria:
- •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.
结局指标
主要结局
Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1
时间窗: % vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)
Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1
次要结局
- Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2(% vaccinated by 1/31/2015)
研究者
Richard Zimmerman MD
Principal Investigator, Professor
University of Pittsburgh