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| Name | Class |
|---|---|
| Keck Graduate Institute of Claremont, California | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced immunization delivery model | Experimental | 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. |
|
| Immunization update | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced immunization delivery model | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salisa C Westrick, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Auburn | Alabama | 36830 | United States | ||
| Keck Graduate Institute School of Pharmacy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31735650 | Derived | Hastings TJ, Hohmann LA, Huston SA, Ha D, Westrick SC, Garza KB. Enhancing pharmacy personnel immunization-related confidence, perceived barriers, and perceived influence: The We Immunize program. J Am Pharm Assoc (2003). 2020 Mar-Apr;60(2):344-351.e2. doi: 10.1016/j.japh.2019.10.005. Epub 2019 Nov 14. | |
| 30777645 | Derived |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age information was not collected per protocol specifications |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The data was reported by the pharmacy unit; participants are part of the pharmacy unit. | Posted | Median | Inter-Quartile Range | vaccine doses | 6 months | Pharmacy | Pharmacy |
|
No adverse events were monitored during the study period
All cause mortality, serious adverse events and others were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Salisa Westrick | Auburn University | 3348448314 | westrsc@auburn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2015 | Jan 8, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2015 | Jan 8, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| Immunization update | Other | Basic immunization update online webinar will summarize changes in immunization schedules. |
|
| Claremont |
| California |
| 91711 |
| United States |
| Hohmann LA, Hastings TJ, Ha DR, Garza KB, Huston SA, Chen L, Westrick SC. Impact of a multi-component immunization intervention on pneumococcal and herpes zoster vaccinations: A randomized controlled trial of community pharmacies in 2 states. Res Social Adm Pharm. 2019 Dec;15(12):1453-1463. doi: 10.1016/j.sapharm.2019.01.006. Epub 2019 Feb 7. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Pharmacy |
|
| Count of Participants |
| Participants |
| Participants |
|
|
| Sex: Female, Male | Missing data points | Count of Participants | Participants | Participants |
|
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| Ethnicity (NIH/OMB) | Missing data points | Count of Participants | Participants | Participants |
|
|
| State | State in which the pharmacies were located. | Count of Units | Pharmacy | Pharmacy |
|
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| Daily prescription volume | The unit of analysis is pharmacy | Mean | Standard Deviation | prescriptions per day | Pharmacy |
|
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| Number of pharmacists trained in vaccine administration | The unit of analysis is pharmacy | Mean | Standard Deviation | pharmacists | Pharmacy |
|
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| Annual pneumococcal polysaccharide (PPSV23) | Self-reported vaccine dose for pneumococcal polysaccharide (PPSV23) in 2015 | Some pharmacies didn't provide vaccine doses | Mean | Standard Deviation | doses | Pharmacy |
|
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| Annual pneumococcal 13-valent conjugate (PCV13) | Self-reported vaccine doses for pneumococcal 13-valent conjugate (PCV13) in 2015 | Some pharmacies didn't provide vaccine doses | Mean | Standard Deviation | doses | Pharmacy |
|
|
| Annual herpes zoster | Self-reported vaccine doses for herpes zoster vaccine in 2015 | Some pharmacies didn't provide vaccine doses | Mean | Standard Deviation | doses | Pharmacy |
|
|
| OG001 | 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. |
|
|
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| 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. | 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. | Posted | Median | Inter-Quartile Range | Process activities engaged | 6 months | Pharmacy | Pharmacy |
|
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|
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| 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. | 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. | Posted | Median | Inter-Quartile Range | vaccine doses | 24 months | Pharmacy | Pharmacy |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| Unknown or Not Reported |
|
| Change in the number of pneumococcal vaccine doses |
|