Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01483378
First received: November 18, 2011
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine general internal medicine physicians' baseline knowledge, attitudes, beliefs, and practices regarding the Herpes Zoster vaccine, and see if education of provides and change in vaccine delivery system will lead to an increase in vaccination among eligible patients. The second part of this study will determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the General Eye Clinic.


Condition Intervention
Herpes Zoster
Behavioral: Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Change in proportion of eligible patients who are vaccinated after 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessed by physician survey. The primary comparison will focus on the differences in the changes from baseline in the mean proportions of patients vaccinated in the intervention groups compared to the no intervention groups. Results will be presented as self-reported vaccination rates obtained from baseline and 1 year follow up surveys.


Secondary Outcome Measures:
  • Correlation between physician characteristics, provider setting, and perceived barriers to vaccination and implemented interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assessed by physician survey. Statistical analysis of baseline and 1 year follow-up survey results regarding differences in physician characteristics, provider setting, and perceived barriers to vaccination between sites that received interventions and sites that did not receive interventions. Results will be presented as differences in survey answers.

  • Patient characteristics associated with vaccination success [ Time Frame: From date of recruitment until the date of first 100 patients are enrolled in Part 2, an expected period of 2 months ] [ Designated as safety issue: No ]
    Assessed by patient survey. Survey of patient characteristics among patients who agreed to vaccination following screening by ophthalmologists compared with patients who decline vaccination. Results will be presented as differences in survey answers.


Enrollment: 170
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Education
    Electronic medical record reminders, baseline survey answers, Medical Grand Rounds presentation, internal communications from Pharmacy, Nursing and the Chief Medical Officer, and availability of the vaccine at the NYU outpatient pharmacy and Bellevue Eye Clinic.
Detailed Description:

This study will have 2 parts. In Part 1 of this study, a confidential survey of general internal medicine physicians (n=330) in various practice settings in an academic medical center will be administered to determine baseline knowledge, attitudes, and practices regarding herpes zoster and the Zostavax vaccine. A 1 year follow up survey will be administered after educational interventions and a change in delivery of the vaccine by providing dedicated hours at the main out-patient pharmacy for a nurse to be available to administer the vaccine.

In part 2 of the study, patient vaccination behaviors will be assessed after 100 doses of the Zostavax vaccine are provided to underserved patients screened by ophthalmologists at the General Eye Clinic at a public hospital that does not normally provide the vaccine. A nurse will be at the clinic to administer the vaccine. Patients will be contacted by phone 1 month later and seen within 3 months in the Eye Clinic to determine whether there were any side effects.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Part 1: Physician in the Division of General Internal Medicine
  • Part 1: New York University (NYU) Langone Medical Center email address
  • Part 2: 60 years of age or older
  • Part 2: Absence of evidence of immune compromise in the medical record
  • Part 2: Ability to speak and read English, Spanish or Chinese and give informed consent

Exclusion Criteria:

  • Part 1: None
  • Part 2: Vulnerable patients, including the cognitively impaired, prisoners and employee
  • Part 2: FDA contraindications for Zostavax vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483378

Locations
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Merck
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01483378     History of Changes
Other Study ID Numbers: 11-02029
Study First Received: November 18, 2011
Last Updated: June 22, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013