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Immunization Services Model for Adult Rate Improvement (ImmuSMART)

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ClinicalTrials.gov Identifier: NCT02609035
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Samuel Stolpe, Pharmacy Quality Alliance

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.

Condition or disease Intervention/treatment Phase
Pharmacy Immunization Vaccines Behavioral: Telephonic prompt Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Immunization Services Model for Adult Rate Improvement
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

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.
Behavioral: Telephonic prompt
Other Name: Appended message

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.



Primary Outcome Measures :
  1. Vaccination rates [ Time Frame: 3 months ]
    Administration of vaccine will be assessed at 3 months after patient receives the prompt



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Samuel Stolpe, Senior Director, Quality Strategies, Pharmacy Quality Alliance
ClinicalTrials.gov Identifier: NCT02609035    
Other Study ID Numbers: Pro00014163
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs