Clinical trial NCT01623583: Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
Official title: A Randomized Controlled Study of the Effect of a Needle Phobia or Apprehension Intervention With or Without Synera® on Conversion From Central Venous Catheters to Arteriovenous Fistula or Graft
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Needle Phobia
Phobic Disorders
Keywords: lidocaine
tetracaine
Renal dialysis
Lead sponsor: Davita Clinical Research
Sponsor class: INDUSTRY
Collaborators: name: Nuvo Research Inc.
First posted: 2012-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the eligibility criterial will be asked to participate. Patients will receive either a standard or an enhanced intervention to address their fear of needles. The enhanced intervention includes the standard intervention plus video training about Synera and trying out an actual patch. Over the 4 months following the intervention, how many patients sign up to switch access will be tracked.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire
timeFrame: One week after intervention meeting
Secondary outcomes:
measure: Proportion of patients for whom the intervention was successful
timeFrame: Four months after intervention meeting
Other outcomes:
Locations:
city: Rancho Cordova
country: United States
facility: Sunset Dialysis Center
state: California
city: Sacramento
country: United States
facility: Natomas Dialysis
state: California
city: Asheville
country: United States
facility: Asheville Kidney Center
state: North Carolina
Study officials:
affiliation: Davita Clinical Research
name: Mahesh Krishnan, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References: