NCT01483378

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 9, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

1 month

First QC Date

November 18, 2011

Results QC Date

February 19, 2013

Last Update Submit

August 7, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Answers to Survey Questions

    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.

    January 9, 2012 to February 12, 2012

Study Arms (2)

Subjects who received the vaccine

OTHER

Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it.

Other: Choosing to receive the vaccine

Subjects who declined the vaccine

NO INTERVENTION

Interventions

Subjects who received the vaccine

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Vulnerable patients, including the cognitively impaired, prisoners and employee
  • FDA contraindications for Zostavax vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (8)

  • Ghaznawi N, Virdi A, Dayan A, Hammersmith KM, Rapuano CJ, Laibson PR, Cohen EJ. Herpes zoster ophthalmicus: comparison of disease in patients 60 years and older versus younger than 60 years. Ophthalmology. 2011 Nov;118(11):2242-50. doi: 10.1016/j.ophtha.2011.04.002. Epub 2011 Jul 23.

    PMID: 21788078BACKGROUND
  • Hu AY, Strauss EC, Holland GN, Chan MF, Yu F, Margolis TP. Late varicella-zoster virus dendriform keratitis in patients with histories of herpes zoster ophthalmicus. Am J Ophthalmol. 2010 Feb;149(2):214-220.e3. doi: 10.1016/j.ajo.2009.08.030. Epub 2009 Nov 11.

    PMID: 19909942BACKGROUND
  • Hurley LP, Lindley MC, Harpaz R, Stokley S, Daley MF, Crane LA, Dong F, Beaty BL, Tan L, Babbel C, Dickinson LM, Kempe A. Barriers to the use of herpes zoster vaccine. Ann Intern Med. 2010 May 4;152(9):555-60. doi: 10.7326/0003-4819-152-9-201005040-00005.

    PMID: 20439573BACKGROUND
  • Lu PJ, Euler GL, Harpaz R. Herpes zoster vaccination among adults aged 60 years and older, in the U.S., 2008. Am J Prev Med. 2011 Feb;40(2):e1-6. doi: 10.1016/j.amepre.2010.10.012.

    PMID: 21238856BACKGROUND
  • Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005 Jun 2;352(22):2271-84. doi: 10.1056/NEJMoa051016.

    PMID: 15930418BACKGROUND
  • Rimland D, Moanna A. Increasing incidence of herpes zoster among Veterans. Clin Infect Dis. 2010 Apr 1;50(7):1000-5. doi: 10.1086/651078.

    PMID: 20178416BACKGROUND
  • Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38

    BACKGROUND
  • Jung JJ, Elkin ZP, Li X, Goldberg JD, Edell AR, Cohen MN, Chen KC, Perskin MH, Park L, Cohen EJ. Increasing use of the vaccine against zoster through recommendation and administration by ophthalmologists at a city hospital. Am J Ophthalmol. 2013 May;155(5):787-95. doi: 10.1016/j.ajo.2012.11.022. Epub 2013 Feb 6.

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Results Point of Contact

Title
Dr. Elisabeth J. Cohen
Organization
NYU Langone Medical Center

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

December 1, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 9, 2013

Results First Posted

August 9, 2013

Record last verified: 2013-08

Locations