An interventional study of Enhanced immunization delivery model and Immunization update in Herpes Zoster and Pneumococcal Infections, sponsored by Auburn University. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Auburn University · Not applicable, Interventional, and Health services research
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.
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:
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 120 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Auburn University is the lead sponsor of 72 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Enhanced immunization delivery model · Other: 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.
Other: Immunization update
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.
Basic immunization update online webinar will summarize changes in immunization schedules.
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
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
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
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.
| Milestone | Enhanced Immunization Delivery Model | Immunization Update |
|---|---|---|
| Started | 58 | 62 |
| Completed the baseline surveys | 46 | 47 |
| Completed | 37 | 30 |
| Not completed | 21 | 32 |
| Withdrew: Lost to follow-up | 21 | 32 |
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.
| vaccine doses | Enhanced Immunization Delivery Model | Immunization Update |
|---|---|---|
| Change in the total number of vaccine doses | 4.50 (-1 to 15.25) | 1 (-18 to 16) |
| Change in the number of herpes zoster | 1.50 (-5 to 7) | 2 (0 to 4) |
| Change in the number of pneumococcal vaccine doses | 3.5 (-.25 to 9.5) | 0 (-6 to 14) |
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.
| Process activities engaged | Enhanced Immunization Delivery Model | Immunization Update |
|---|---|---|
| Number of Strategies Implemented to Promote Immunization Activities | 8 (7 to 9.5) | 7 (5 to 9) |
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.
| vaccine doses | Enhanced Immunization Delivery Model | Immunization Update |
|---|---|---|
| Change in the number of total vaccine doses | 12 (3 to 32.5) | 8 (-6 to 23.5) |
| Change in the number of herpes zoster vaccine dose | 4 (-5 to 12) | 5 (-4 to 12) |
| Change in the number of pneumococcal vaccine doses | 6 (1.5 to 19) | 3 (-1.5 to 19.5) |
Collected over No adverse events were monitored during the study period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Immunization Delivery Model | — | — | — |
| Immunization Update | — | — | — |
| Age, Categorical(Participants) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| <=18 years | NA | NA | NA |
| Between 18 and 65 years | NA | NA | NA |
| >=65 years | NA | NA | NA |
| Sex: Female, Male(Participants) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Female | 34 | 29 | 63 |
| Male | 12 | 18 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 9 |
| Not Hispanic or Latino | 38 | 40 | 78 |
| Unknown or Not Reported | 4 | 2 | 6 |
| State(Pharmacy) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Alabama | 17 | 18 | 35 |
| California | 13 | 14 | 27 |
| Daily prescription volume(prescriptions per day) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Mean | 155 ± 100 | 229 ± 124 | 192 ± 118 |
| Number of pharmacists trained in vaccine administration(pharmacists) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Mean | 2.1 ± 1.5 | 2.3 ± 0.7 | 2.3 ± 1.1 |
| Annual pneumococcal polysaccharide (PPSV23)(doses) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Mean | 7.60 ± 12.61 | 3.42 ± 5.58 | 5.56 ± 9.93 |
| Annual pneumococcal 13-valent conjugate (PCV13)(doses) | Enhanced Immunization Delivery Model | Immunization Update | Total |
|---|---|---|---|
| Mean | 18.45 ± 26.82 | 27.16 ± 54.90 | 22.69 ± 42.51 |
1 further baseline measures are reported on the registry.
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