- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609035
Immunization Services Model for Adult Rate Improvement (ImmuSMART)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will investigate immunization rate improvement among adult patients in 250 northeastern US community pharmacies as a result of telephonic prompts during regular automated outbound communiqués. There will be three projects assessing different forms of these appended prompts-appointment-based medication synchronization automated prompts, refill ready automated prompts, and refill reminder automated prompts. Each intervention will occur in one of three pharmacy chains, each with approximately 10,000 patients randomized to control or intervention (receive prompt or no).
Prior to the outbound automated call to the patient, a third-party technology vendor (Scientific Technologies Corporation) will perform an automated immunization status assessment of the patient by submitting a query the state immunization registry to compare the adult patient's existing immunization record to the CDC Recommended Adult Immunization Schedule. Gaps in immunizations that fall within pharmacy scope of practice will be identified. During the automated call (performed by VoicePort, a pharmacy telephonic support vendor) to the patient, they will be prompted to receive identified immunization gap vaccines upon their next pharmacy visit, with priority on pneumococcal, influenza, and herpes zoster vaccinations. If the patient accepts, the vaccination will be delivered when next the patient comes to visit the pharmacy.
After 6 months of running the trial, statistical modeling will be employed to assess vaccination rate differences between control and intervention patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient at least 19 years of age at date of enrollment
- Patient not in long-term care, hospice or otherwise identified as unable to come to pharmacy for receipt of vaccine
- Patient currently missing a record of receipt of at least one of three vaccinations: flu, pneumonia, or shingles
- Patient enrolled in telephonic pharmacy reminder service
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Patients who are either appointment-based medication synchronization calls, refill ready calls, or refill reminder calls at the pharmacy who have been identified as missing at least one vaccination.
These patients will receive a telephonic prompt to get a vaccination.
|
Other Names:
|
|
No Intervention: Control
Patients who are either appointment-based medication synchronization calls, refill ready calls, or refill reminder calls at the pharmacy who have been identified as missing at least one vaccination.
These patients will receive usual pharmacy care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccination rates
Time Frame: 3 months
|
Administration of vaccine will be assessed at 3 months after patient receives the prompt
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00014163
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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