Herpes Zoster
Conditions
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.
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.
Interventions
OTHERChoosing to receive the vaccine
Sponsors
Merck Sharp & Dohme LLC
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Answers to Survey Questions | January 9, 2012 to February 12, 2012 | 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. |
Countries
United States
Participant flow
Recruitment details
We prospectively recruited eligible patients from the Bellevue Eye clinic until 100 patients were prescribed and received the vaccine. Recruitment occurred from January 9, 2012 to February 12, 2012.
Participants by arm
| Arm | Count |
|---|---|
| Survey Participants | 166 |
| Total | 166 |
Baseline characteristics
| Characteristic | Survey Participants |
|---|---|
| Age Continuous Age | 68 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 166 participants |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 100 | 0 / 0 |
| serious Total, serious adverse events | 0 / 100 | 0 / 0 |
Outcome results
Primary
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.
Time frame: January 9, 2012 to February 12, 2012
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Who Received the Herpes Zoster Vaccine | Answers to Survey Questions | Subject reported receiving flu Vaccine last year | 89 Percentage of responders |
| Patients Who Received the Herpes Zoster Vaccine | Answers to Survey Questions | Reported would receive the vaccine if recommended | 98 Percentage of responders |
| Patients Who Declined the Herpes Zoster Vaccine | Answers to Survey Questions | Subject reported receiving flu Vaccine last year | 71.2 Percentage of responders |
| Patients Who Declined the Herpes Zoster Vaccine | Answers to Survey Questions | Reported would receive the vaccine if recommended | 74 Percentage of responders |