Viewing Study NCT02609035


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Study NCT ID: NCT02609035
Status: COMPLETED
Last Update Posted: 2017-04-27
First Post: 2015-11-17
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Immunization Services Model for Adult Rate Improvement
Sponsor: Pharmacy Quality Alliance
Organization:

Study Overview

Official Title: Immunization Services Model for Adult Rate Improvement
Status: COMPLETED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ImmuSMART
Brief Summary: ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to improve adult vaccination rates for pneumococcal and herpes zoster vaccines.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: