Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias

Patients with long-term CVCs (> 180 days) will be recruited for study participation by being
asked "Why haven't you gotten a graft or fistula?" Those who indicate fear or discomfort
with needles in the top 3 reasons will be consented into the study and administered the
AVF/AVG Stages of Change Questionnaire.

The Stages of Change questionnaire has been used extensively in research and has been shown
to be highly predictive of people engaging in the behavior of interest. The five stages of
change include: 1) Precontemplation: Patient doesn't know about, or knows about but doesn't
want to think about, a behavior change; 2) Contemplation: Patients knows about and is
beginning to consider behavior change; 3) Planning: Patient is actively investigating and
making plans for behavior change; 4) Action: Patient is committed to make the change and/or
has taken concrete steps to change behavior; and 5) Maintenance: Patient has made the
behavior change and is trying maintain that change.

Patients will be cluster-randomized to receive a standard needle phobia intervention (n =
32), or an enhanced intervention consisting of a standard intervention plus a demonstration
of the Synera patch (n = 32) within 15 days of baseline. The intervention will be
administered by a study team member. In clinics where there is more than 1 patient
randomized to a group, the intervention can be administered to multiple patients
simultaneously. The standard intervention will last approximately 20 to 30 minutes. During
this time, patients will receive information about the advantages of arteriovenous fistula
or graft over central-venous catheter, be taught basic relaxation breathing, see a brief
video of a patient overcoming needle fear, and have the opportunity to safely interact with
a cannulation needle. In the enhanced intervention, the patient will receive the standard
intervention with 2 enhancements: (1) the video will include a segment in which a patient
experiences the analgesic effects of the a Synera patch and (2) a Synera patch will be
applied at the beginning of the intervention, and 30 minutes later the patient will be given
the chance to explore the analgesic effects of Synera.

Patients will complete a Stages of Change questionnaire 1 week after the intervention.
Patients will then be followed for 4 months to determine whether or not they have scheduled
a vein mapping appointment or have had a fistula or graft access placed.

Inclusion Criteria:

- Patient receiving hemodialysis at a DaVita clinic/dialysis center

- Receiving in-center hemodialysis thrice weekly

- Central venous catheter (CVC) use for > 180 days

- Patients report a fear of needles as a top-3-reason for failure to get an
arteriovenous fistula/graft

Exclusion Criteria:

- Patients have a known intolerance or hypersensitivity to Synera

- Patient with a history of or past diagnosis of severe hepatic disease

- Patient is currently receiving any class 1 antiarrhythmic drugs (i.e., tocainide,
mexiletine, etc)

- Patient has a clinically significant illness within 14 days of Screening/Day 1 that,
in the opinion of the investigator, would preclude the subject from participating in
the study

- Patient has an AVF or AVG in place or is scheduled for placement

- Women and men whose partners are of childbearing potential (defined as premenopausal
and not surgically sterilized [ie, bilateral tubal ligation, bilateral oophorectomy,
or hysterectomy] or postmenopausal for < 2 years) agree to practice 1 of the
following medically acceptable methods of birth control and agree to continue with
the regimen throughout the duration of the study: Oral, implantable, or injectable
contraceptives for 3 consecutive months before the Screening Visit; Intrauterine
device (IUD); and double barrier method (ie, condom, sponge, diaphragm, or vaginal
ring with spermicidal jellies or cream)

- Patient has significant disease or condition that, in the PI's opinion, may interfere
with protocol adherence or subjects' ability to provide informed consent

- Patient is unable to read or comprehend English at a 6th grade level

- Patient has a visual impairment and is unable to read the survey instruments

- Patient has a suspected or known access-related infection at the time of enrollment