N/A
Completed N=70,549
SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
Adult Influenza Vaccinations · Adult PPSV Vaccinations · Adult Tdap/Td Vaccinations
Source: ClinicalTrials.gov NCT01868334 ↗
Enrolled (actual)
70,549
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 — 7.7; 6.4; 6.5; 6.6 percent change in vaccination rates — p=0.05
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 |
7.7; 6.4; 6.5; 6.6; 5.0; 6.5 | 0.05 |
| SECONDARY Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 |
6.2; 2.2; 5.2; 2.4; 1.44; 1.4 | 0.05 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01868334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.