Adult Influenza Vaccinations, Adult PPSV Vaccinations, Adult Tdap/Td Vaccinations
Conditions
Keywords
influenza vaccine, PPSV, Tdap, vaccination, adult
Brief 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).
Detailed 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.
Interventions
BEHAVIORALPillar 1: Convenient Vaccination Services
Extend Vaccination Season: Begin vaccinating for influenza as soon as vaccine arrives; use every visit as opportunity to vaccinate; extend the season for influenza by vaccinating in January and beyond. Use Express Vaccination services such as influenza vaccination clinics, Open access vaccine scheduling (for all vaccines), or dedicated vaccination station. When giving influenza vaccination, screen for need for PPSV/Tdap.
BEHAVIORALPillar 2: Patient notification
Patient Education: notifying patients of doctor recommendations for vaccination; providing information on express vaccination services via email, autodialer, on-hold messages, clinic websites, and/or social media
BEHAVIORALPillar 3: Enhanced Office Systems
Routine assessment for office systems flow to ensure staff consistently promoting vaccination: utilization of EMR prompts, review of Immunization tabs within EMR, and/or checking vaccination status as part of vital signs when rooming. Empower staff to vaccinate by use of a standing orders program (SOP). Order a sufficient supply of vaccination to cover increased rates
BEHAVIORALPillar 4: Motivation
Utilization of an Office Immunization Champion who will track overall progress towards their goal - setting a goal of increased rates of 20 to 25% for influenza vaccine; monitoring and sharing progress with staff regularly; and changing office systems flow as needed to increased vaccination rates.
Sponsors
Centers for Disease Control and Prevention
Baylor College of Medicine
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | % 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pittsburgh Intervention Practices: Represents 10 clinical practices engaged in active intervention in Year 1.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 13 |
| Pittsburgh Intervention Practices: Represents 10 clinical practices engaged in active intervention in Year 1.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 10 |
| Pittsburgh Control/Maintenance Practices: Represents 8 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 17 |
| Pittsburgh Control/Maintenance Practices: Represents 8 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 8 |
| Houston Intervention Practices: Represents 3 clinical practices engaged in active intervention in Year 1.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 19 |
| Houston Intervention Practices: Represents 3 clinical practices engaged in active intervention in Year 1.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 3 |
| Houston Control/Maintenance Practices: Represents 3 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 20 |
| Houston Control/Maintenance Practices: Represents 3 clinical practices who were control practices in Year 1 and who received the intervention in Year 2.
Patients: Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013 (Tdap, pneumococcal) and 8/1/2012 to 1/31/2013 (influenza), Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 (Tdao, pneumococcal) and 8/1/2013 to 1/31/2014 (influenza) and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015 (Tdap, pneumococcal) and 8/1/2014 to 1/31/2015 (influenza). | 3 |
| Total | 93 |
Baseline characteristics
| Characteristic | Pittsburgh Intervention | Pittsburgh Control/Maintenance | Houston Intervention | Houston Control/Maintenance | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 16.7 | 57.8 years STANDARD_DEVIATION 16.6 | 51.0 years STANDARD_DEVIATION 13 | 53.0 years STANDARD_DEVIATION 13 | 55.1 years STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized % Caucasians | 94.3 percentage of participants | 94.2 percentage of participants | 6.0 percentage of participants | 7.0 percentage of participants | 44.3 percentage of participants |
| Sex/Gender, Customized % Female Sex | 56.7 percentage of participants | 57.8 percentage of participants | 72.0 percentage of participants | 71.0 percentage of participants | 65.5 percentage of participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13,186 | 0 / 17,185 | 0 / 6,095 | 0 / 6,223 | 0 / 13,186 | 0 / 17,185 | 0 / 19,274 | 0 / 20,904 | 0 / 3,010 | 0 / 2,779 | 0 / 19,274 | 0 / 20,904 |
| other Total, other adverse events | 0 / 13,186 | 0 / 17,185 | 0 / 6,095 | 0 / 6,223 | 0 / 13,186 | 0 / 17,185 | 0 / 19,274 | 0 / 20,904 | 0 / 3,010 | 0 / 2,779 | 0 / 19,274 | 0 / 20,904 |
| serious Total, serious adverse events | 0 / 13,186 | 0 / 17,185 | 0 / 6,095 | 0 / 6,223 | 0 / 13,186 | 0 / 17,185 | 0 / 19,274 | 0 / 20,904 | 0 / 3,010 | 0 / 2,779 | 0 / 19,274 | 0 / 20,904 |
Outcome results
Primary
Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1
Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1
Time frame: % vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 7.7 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 6.4 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 6.5 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 6.6 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 5.0 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 6.5 percent change in vaccination rates |
| Year 1 RCCT Houston Intervention Sites - Tdap Vaccination | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 9.9 percent change in vaccination rates |
| Year 1 RCCT Houston Control Sites - Tdap Vaccination | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 7.6 percent change in vaccination rates |
| Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 8.7 percent change in vaccination rates |
| Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 6.5 percent change in vaccination rates |
| Year 1 RCCT Houston Intervention Sites - Influenza Vaccination | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 2.7 percent change in vaccination rates |
| Year 1 RCCT Houston Control Sites - Influenza Vaccination | Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 | 5.2 percent change in vaccination rates |
p-value: 0.05Chi-squared
p-value: 0.05Cochran-Armitage trend test
Secondary
Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2
Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2
Time frame: % vaccinated by 1/31/2015
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination | 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 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 2.2 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 5.2 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 2.4 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 1.44 percent change in vaccination rates |
| Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 1.4 percent change in vaccination rates |
| Year 1 RCCT Houston Intervention Sites - Tdap Vaccination | 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 percent change in vaccination rates |
| Year 1 RCCT Houston Control Sites - Tdap Vaccination | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 4.1 percent change in vaccination rates |
| Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 4.6 percent change in vaccination rates |
| Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 6.5 percent change in vaccination rates |
| Year 1 RCCT Houston Intervention Sites - Influenza Vaccination | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 3.6 percent change in vaccination rates |
| Year 1 RCCT Houston Control Sites - Influenza Vaccination | Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2 | 1.7 percent change in vaccination rates |
p-value: 0.05Chi-squared
p-value: 0.05Cochran-Armitage trend test