Trial Outcomes & Findings for Enhancing a Sustainable Pharmacy-based Immunization Program in Two States (NCT NCT02615470)
NCT ID: NCT02615470
Last Updated: 2019-08-20
Results Overview
The change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy during the 6-month intervention period from the 6-month baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
6 months
Results posted on
2019-08-20
Participant Flow
Community pharmacies in Montgomery, Jefferson, Mobile, Tuscaloosa, Lee (AL) and San Bernadino, Riverside, Los Angeles, San Diego in CA were identified using Hayes Directory. Pharmacies were recruited via telephone with a maximum of 5 contact attempts. Eligible pharmacies must offer at least pneumococcal or herpes zoster vaccination service.
A randomized block design was used. Eligible community pharmacies within each block (AL and CA) were randomly assigned to each treatment group. Pharmacies with the same ownership were assigned to the same treatment group to prevent potential contamination.
Unit of analysis: Pharmacy
Participant milestones
| Measure |
Enhanced Immunization Delivery Model
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
Immunization Update
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
|---|---|---|
|
Overall Study
STARTED
|
58 30
|
62 32
|
|
Overall Study
Completed the Baseline Surveys
|
46 27
|
47 25
|
|
Overall Study
COMPLETED
|
37 22
|
30 15
|
|
Overall Study
NOT COMPLETED
|
21 8
|
32 17
|
Reasons for withdrawal
| Measure |
Enhanced Immunization Delivery Model
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
Immunization Update
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
32
|
Baseline Characteristics
Missing data points
Baseline characteristics by cohort
| Measure |
Enhanced Immunization Delivery Model
n=30 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
Immunization Update
n=32 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
Total
n=62 Pharmacy
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
NA Participants
n=58 Participants
|
NA Participants
n=62 Participants
|
NA Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
NA Participants
n=58 Participants
|
NA Participants
n=62 Participants
|
NA Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
NA Participants
n=58 Participants
|
NA Participants
n=62 Participants
|
NA Participants
n=120 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=46 Participants • Missing data points
|
29 Participants
n=47 Participants • Missing data points
|
63 Participants
n=93 Participants • Missing data points
|
|
Sex: Female, Male
Male
|
12 Participants
n=46 Participants • Missing data points
|
18 Participants
n=47 Participants • Missing data points
|
30 Participants
n=93 Participants • Missing data points
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=46 Participants • Missing data points
|
5 Participants
n=47 Participants • Missing data points
|
9 Participants
n=93 Participants • Missing data points
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=46 Participants • Missing data points
|
40 Participants
n=47 Participants • Missing data points
|
78 Participants
n=93 Participants • Missing data points
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=46 Participants • Missing data points
|
2 Participants
n=47 Participants • Missing data points
|
6 Participants
n=93 Participants • Missing data points
|
|
State
Alabama
|
17 Pharmacy
n=30 Pharmacy
|
18 Pharmacy
n=32 Pharmacy
|
35 Pharmacy
n=62 Pharmacy
|
|
State
California
|
13 Pharmacy
n=30 Pharmacy
|
14 Pharmacy
n=32 Pharmacy
|
27 Pharmacy
n=62 Pharmacy
|
|
Daily prescription volume
|
155 prescriptions per day
STANDARD_DEVIATION 100 • n=27 Pharmacy • The unit of analysis is pharmacy
|
229 prescriptions per day
STANDARD_DEVIATION 124 • n=25 Pharmacy • The unit of analysis is pharmacy
|
192 prescriptions per day
STANDARD_DEVIATION 118 • n=52 Pharmacy • The unit of analysis is pharmacy
|
|
Number of pharmacists trained in vaccine administration
|
2.1 pharmacists
STANDARD_DEVIATION 1.5 • n=27 Pharmacy • The unit of analysis is pharmacy
|
2.3 pharmacists
STANDARD_DEVIATION 0.7 • n=25 Pharmacy • The unit of analysis is pharmacy
|
2.3 pharmacists
STANDARD_DEVIATION 1.1 • n=52 Pharmacy • The unit of analysis is pharmacy
|
|
Annual pneumococcal polysaccharide (PPSV23)
|
7.60 doses
STANDARD_DEVIATION 12.61 • n=27 Pharmacy • Some pharmacies didn't provide vaccine doses
|
3.42 doses
STANDARD_DEVIATION 5.58 • n=25 Pharmacy • Some pharmacies didn't provide vaccine doses
|
5.56 doses
STANDARD_DEVIATION 9.93 • n=52 Pharmacy • Some pharmacies didn't provide vaccine doses
|
|
Annual pneumococcal 13-valent conjugate (PCV13)
|
18.45 doses
STANDARD_DEVIATION 26.82 • n=27 Pharmacy • Some pharmacies didn't provide vaccine doses
|
27.16 doses
STANDARD_DEVIATION 54.90 • n=25 Pharmacy • Some pharmacies didn't provide vaccine doses
|
22.69 doses
STANDARD_DEVIATION 42.51 • n=52 Pharmacy • Some pharmacies didn't provide vaccine doses
|
|
Annual herpes zoster
|
14.90 doses
STANDARD_DEVIATION 16.71 • n=27 Pharmacy • Some pharmacies didn't provide vaccine doses
|
24.11 doses
STANDARD_DEVIATION 28.41 • n=25 Pharmacy • Some pharmacies didn't provide vaccine doses
|
19.38 doses
STANDARD_DEVIATION 23.32 • n=52 Pharmacy • Some pharmacies didn't provide vaccine doses
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The data was reported by the pharmacy unit; participants are part of the pharmacy unit.
The change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy during the 6-month intervention period from the 6-month baseline.
Outcome measures
| Measure |
Enhanced Immunization Delivery Model
n=22 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
Immunization Update
n=15 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
|---|---|---|
|
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
Change in the total number of vaccine doses
|
4.50 vaccine doses
Interval -1.0 to 15.25
|
1 vaccine doses
Interval -18.0 to 16.0
|
|
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
Change in the number of herpes zoster
|
1.50 vaccine doses
Interval -5.0 to 7.0
|
2 vaccine doses
Interval 0.0 to 4.0
|
|
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
Change in the number of pneumococcal vaccine doses
|
3.5 vaccine doses
Interval -0.25 to 9.5
|
0 vaccine doses
Interval -6.0 to 14.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The unit of analysis was the pharmacy, a representative of each pharmacy unit reported the outcome. Two of the enhanced pharmacy did not provide responses regarding strategies to promote immunization activities.
During the study, pharmacist-technician pairs engaged in on-going strategies used to advertise, market and assess non-seasonal immunization service processes. Of the total of 10 strategies possible, each pair selected strategies that they implemented. Results were reported by a representative from each pharmacy unit.
Outcome measures
| Measure |
Enhanced Immunization Delivery Model
n=25 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
Immunization Update
n=25 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
|---|---|---|
|
Number of Strategies Implemented to Promote Immunization Activities
|
8 Process activities engaged
Interval 7.0 to 9.5
|
7 Process activities engaged
Interval 5.0 to 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: The unit of analysis was the pharmacy. A representative from each pharmacy unit reported the results. Results presented were collected 12 months after the intervention ended. Not all pharmacies that completed the 6 months survey completed the 12 months survey.
Change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from 12 Months Pre- to 12 Months Post-Intervention. A representative of each pharmacy unit reported vaccine doses.
Outcome measures
| Measure |
Enhanced Immunization Delivery Model
n=17 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
Enhanced immunization delivery model: Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
Immunization Update
n=9 Pharmacy
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Immunization update: Basic immunization update online webinar will summarize changes in immunization schedules.
|
|---|---|---|
|
The Level of Sustainability of Immunization Services
Change in the number of total vaccine doses
|
12 vaccine doses
Interval 3.0 to 32.5
|
8 vaccine doses
Interval -6.0 to 23.5
|
|
The Level of Sustainability of Immunization Services
Change in the number of herpes zoster vaccine dose
|
4 vaccine doses
Interval -5.0 to 12.0
|
5 vaccine doses
Interval -4.0 to 12.0
|
|
The Level of Sustainability of Immunization Services
Change in the number of pneumococcal vaccine doses
|
6 vaccine doses
Interval 1.5 to 19.0
|
3 vaccine doses
Interval -1.5 to 19.5
|
Adverse Events
Enhanced Immunization Delivery Model
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immunization Update
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place