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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 18, 2011
Last Updated Date	June 22, 2012
Start Date ^ICMJE	October 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 30, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01483378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 30, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital
Official Title ^ICMJE	Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Condition ^ICMJE	Herpes Zoster
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	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. Epub 2011 Jul 23. 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. Epub 2009 Nov 11. 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. 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. 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. Rimland D, Moanna A. Increasing incidence of herpes zoster among Veterans. Clin Infect Dis. 2010 Apr 1;50(7):1000-5.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	170
Completion Date	February 2012
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	60 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01483378
Other Study ID Numbers ^ICMJE	11-02029
Has Data Monitoring Committee	Yes
Responsible Party	New York University School of Medicine
Study Sponsor ^ICMJE	New York University School of Medicine
Collaborators ^ICMJE	Merck
Investigators ^ICMJE	Not Provided
Information Provided By	New York University School of Medicine
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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