Trial Outcomes & Findings for SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM (NCT NCT01868334)

Results Overview

Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70549 participants

Primary outcome timeframe

% vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)

Results posted on

2023-10-06

Participant Flow

Unit of analysis: clinical practices

Participant milestones

Participant milestones
Measure	Pittsburgh Intervention Sites Practices: Clinical practices were stratified by metropolitan area (e.g., Pittsburgh) and then randomized into the intervention or control arms within strata. 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, PCV) 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 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Year 1 RCCT Study: Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult vaccination rates (N=10). Year 2 Pre-post study: Year 2 Pittsburgh practices were control sites from Year 1 (N=8) who now were actively engaged in the intervention and Year 1 sites who continued active use of the intervention during year 2 (N=4) to increase adult vaccination rates.	Pittsburgh Control/Maintenance Sites Practices: Clinical practices were stratified by metropolitan area (e.g., Pittsburgh) and then randomized into the intervention or control arms within strata. 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, PCV) 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 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Year 1 RCCT study: Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8). Year 2 Pre-post study: Maintenance sites were Pittsburgh practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult vaccination rates during Year 2 (N=6).	Houston Intervention Sites Practices: Clinical practices were stratified by metropolitan area (e.g., Houston) and then randomized into the intervention or control arms within strata. 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, PCV) 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 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Year 1 RCCT study: Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult vaccination rates (N=3). Year 2 Pre-post study: Year 2 Houston practices were control sites from Year 1 (N=3) who now were actively engaged in the intervention to increase adult vaccination rates.	Houston Control/Maintenance Sites Practices: Clinical practices were stratified by metropolitan area (e.g., Houston) and then randomized into the intervention or control arms within strata. 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, PCV) 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 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Year 1 RCCT study: Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3). Year 2 Pre-post study: Maintenance sites were Houston practices who were intervened upon in Year 1 but who did not actively participate in continued engagement of the 4 Pillars Program for raising adult vaccination rates during Year 2 (N=3).
Year 1 RCCT Study STARTED	13186 10	17185 8	19274 3	20904 3
Year 1 RCCT Study COMPLETED	13186 10	17185 8	19274 3	20904 3
Year 1 RCCT Study NOT COMPLETED	0 0	0 0	0 0	0 0
Year 2 Pre-post Study STARTED	22324 12	8047 6	20904 3	19274 3
Year 2 Pre-post Study COMPLETED	22324 12	8047 6	20904 3	19274 3
Year 2 Pre-post Study NOT COMPLETED	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pittsburgh Intervention n=10 clinical practices 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).	Pittsburgh Control/Maintenance n=8 clinical practices 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).	Houston Intervention n=3 clinical practices 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).	Houston Control/Maintenance n=3 clinical practices 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).	Total n=24 clinical practices Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 16.7 • n=5 Participants	57.8 years STANDARD_DEVIATION 16.6 • n=7 Participants	51.0 years STANDARD_DEVIATION 13.0 • n=5 Participants	53.0 years STANDARD_DEVIATION 13.0 • n=4 Participants	55.1 years STANDARD_DEVIATION 15.3 • n=21 Participants
Sex/Gender, Customized % Female Sex	56.7 percentage of participants n=5 Participants	57.8 percentage of participants n=7 Participants	72.0 percentage of participants n=5 Participants	71.0 percentage of participants n=4 Participants	65.5 percentage of participants n=21 Participants
Race/Ethnicity, Customized % Caucasians	94.3 percentage of participants n=5 Participants	94.2 percentage of participants n=7 Participants	6.0 percentage of participants n=5 Participants	7.0 percentage of participants n=4 Participants	44.3 percentage of participants n=21 Participants

PRIMARY outcome

Timeframe: % 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

Outcome measures

Outcome measures
Measure	Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination n=13 Participants 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, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=10).	Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination n=17 Participants 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, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8).	Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc n=6 Participants Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=10).	Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine n=6 Participants Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8).	Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine n=13 Participants Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=10).	Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine n=17 Participants Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8).	Year 1 RCCT Houston Intervention Sites - Tdap Vaccination n=19 Participants 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, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=3).	Year 1 RCCT Houston Control Sites - Tdap Vaccination n=20 Participants 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, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3).	Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine n=3 Participants Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=3).	Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine n=2 Participants Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3).	Year 1 RCCT Houston Intervention Sites - Influenza Vaccination n=19 Participants Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=3).	Year 1 RCCT Houston Control Sites - Influenza Vaccination n=20 Participants Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3).
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	6.4 percent change in vaccination rates	6.5 percent change in vaccination rates	6.6 percent change in vaccination rates	5.0 percent change in vaccination rates	6.5 percent change in vaccination rates	9.9 percent change in vaccination rates	7.6 percent change in vaccination rates	8.7 percent change in vaccination rates	6.5 percent change in vaccination rates	2.7 percent change in vaccination rates	5.2 percent change in vaccination rates

SECONDARY outcome

Timeframe: % 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