Herpes Zoster, Pneumococcal Infections
Conditions
Keywords
Pneumococcal Vaccines, Shingles, Pharmacy, Vaccine, Immunization
Brief summary
The study's aim is to enhance current immunization activities in community pharmacies through targeting the two most commonly available non-seasonal vaccines in community pharmacies, namely pneumococcal and herpes zoster vaccination services. The study will compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies.
Detailed description
Community pharmacies are in a unique position and have potential to help increase immunization rates, especially among those who do not visit their primary care provider regularly. This study seeks to increase the level of pharmacy-based immunization delivery. The study intervention is designed to increase the current level of pharmacy-based immunization delivery and foster practice change to sustain the intervention effect. Our intervention combines evidence-based strategies for improving immunization coverage and strategies to overcome system barriers to increase sustainability of the intervention over time. The study will focus on pneumococcal and herpes zoster vaccination services. Specific aims include: 1. To compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies. The pre-intervention period will correspond to the intervention period. 2. To compare the extent of immunization activity implementation during the intervention period between intervention pharmacies and control pharmacies. 3. To compare the level of sustainability of immunization services over the period of 6 months after the intervention period ends between the intervention group and the control group. 4. To explore facilitators and barriers to implementing immunization services. 5. To explore factors affecting patient acceptance of pharmacist's vaccine recommendations within the intervention pharmacies.
Interventions
BEHAVIORALEnhanced 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.
OTHERImmunization update
Basic immunization update online webinar will summarize changes in immunization schedules.
Sponsors
Keck Graduate Institute of Claremont, California
Merck Sharp & Dohme LLC
Auburn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Alabama and California community pharmacies * Must provide in-store prescription-dispensing service * Must provide pneumococcal vaccine and/or herpes zoster
Exclusion criteria
* Must have no plan to close or change the ownership in the next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Herpes Zoster and Pneumococcal Vaccinations Administered | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Strategies Implemented to Promote Immunization Activities | 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Level of Sustainability of Immunization Services | 24 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| 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. | 30 |
| 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. | 62 |
| 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. | 32 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 32 |
Baseline characteristics
| Characteristic | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Age, Categorical <=18 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical >=65 years | NA Participants | NA Participants | NA Participants |
| Age, Categorical Between 18 and 65 years | NA Participants | NA Participants | NA Participants |
| Annual herpes zoster | 14.90 doses STANDARD_DEVIATION 16.71 | 24.11 doses STANDARD_DEVIATION 28.41 | 19.38 doses STANDARD_DEVIATION 23.32 |
| Annual pneumococcal 13-valent conjugate (PCV13) | 18.45 doses STANDARD_DEVIATION 26.82 | 27.16 doses STANDARD_DEVIATION 54.9 | 22.69 doses STANDARD_DEVIATION 42.51 |
| Annual pneumococcal polysaccharide (PPSV23) | 7.60 doses STANDARD_DEVIATION 12.61 | 3.42 doses STANDARD_DEVIATION 5.58 | 5.56 doses STANDARD_DEVIATION 9.93 |
| Daily prescription volume | 155 prescriptions per day STANDARD_DEVIATION 100 | 229 prescriptions per day STANDARD_DEVIATION 124 | 192 prescriptions per day STANDARD_DEVIATION 118 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 40 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Number of pharmacists trained in vaccine administration | 2.1 pharmacists STANDARD_DEVIATION 1.5 | 2.3 pharmacists STANDARD_DEVIATION 0.7 | 2.3 pharmacists STANDARD_DEVIATION 1.1 |
| Sex: Female, Male Female | 34 Participants | 29 Participants | 63 Participants |
| Sex: Female, Male Male | 12 Participants | 18 Participants | 30 Participants |
| State Alabama | 17 Pharmacy | 18 Pharmacy | 35 Pharmacy |
| State California | 13 Pharmacy | 14 Pharmacy | 27 Pharmacy |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
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.
Time frame: 6 months
Population: The data was reported by the pharmacy unit; participants are part of the pharmacy unit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Immunization Delivery Model | Number of Herpes Zoster and Pneumococcal Vaccinations Administered | Change in the total number of vaccine doses | 4.50 vaccine doses |
| Enhanced Immunization Delivery Model | Number of Herpes Zoster and Pneumococcal Vaccinations Administered | Change in the number of herpes zoster | 1.50 vaccine doses |
| Enhanced Immunization Delivery Model | Number of Herpes Zoster and Pneumococcal Vaccinations Administered | Change in the number of pneumococcal vaccine doses | 3.5 vaccine doses |
| Immunization Update | Number of Herpes Zoster and Pneumococcal Vaccinations Administered | Change in the total number of vaccine doses | 1 vaccine doses |
| Immunization Update | Number of Herpes Zoster and Pneumococcal Vaccinations Administered | Change in the number of herpes zoster | 2 vaccine doses |
| Immunization Update | Number of Herpes Zoster and Pneumococcal Vaccinations Administered | Change in the number of pneumococcal vaccine doses | 0 vaccine doses |
p-value: =0.202Wilcoxon (Mann-Whitney)
Secondary
Number of Strategies Implemented 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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Immunization Delivery Model | Number of Strategies Implemented to Promote Immunization Activities | 8 Process activities engaged |
| Immunization Update | Number of Strategies Implemented to Promote Immunization Activities | 7 Process activities engaged |
p-value: 0.048Wilcoxon (Mann-Whitney)
Other Pre-specified
The Level of Sustainability of Immunization Services
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Enhanced Immunization Delivery Model | The Level of Sustainability of Immunization Services | Change in the number of total vaccine doses | 12 vaccine doses |
| Enhanced Immunization Delivery Model | The Level of Sustainability of Immunization Services | Change in the number of herpes zoster vaccine dose | 4 vaccine doses |
| Enhanced Immunization Delivery Model | The Level of Sustainability of Immunization Services | Change in the number of pneumococcal vaccine doses | 6 vaccine doses |
| Immunization Update | The Level of Sustainability of Immunization Services | Change in the number of total vaccine doses | 8 vaccine doses |
| Immunization Update | The Level of Sustainability of Immunization Services | Change in the number of herpes zoster vaccine dose | 5 vaccine doses |
| Immunization Update | The Level of Sustainability of Immunization Services | Change in the number of pneumococcal vaccine doses | 3 vaccine doses |
p-value: =0.322Wilcoxon (Mann-Whitney)