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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01483378
First received: November 18, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to 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
Other: Choosing to receive the vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:
  • Answers to Survey Questions [ Time Frame: January 9, 2012 to February 12, 2012 ] [ Designated as safety issue: No ]
    All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.


Enrollment: 170
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subjects who received the vaccine
Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it.
Other: Choosing to receive the vaccine
No Intervention: Subjects who declined the vaccine

Detailed Description:

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:

  • 60 years of age or older
  • Absence of evidence of immune compromise in the medical record
  • Ability to speak and read English, Spanish or Chinese and give informed consent

Exclusion Criteria:

  • Vulnerable patients, including the cognitively impaired, prisoners and employee
  • FDA contraindications for Zostavax vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483378

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

Publications:
Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38

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
Results First Received: February 19, 2013
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014