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

NCT01623583 | Terminated Phase 4

• 1 other identifier: 2012-02-02-NVO-MI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Needle Phobia; Phobic Disorders

Keywords

lidocaine; tetracaine; Renal dialysis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire

  The primary outcome measure is how many patients progress from a score of 1 or 2 on the questionnaire (precontemplation or contemplation) as measured before the intervention to a score of 3 or 4 (planning or action) after the intervention, and it is measured one week after the intervention.

  One week after intervention meeting

Secondary Outcomes (1)

• Proportion of patients for whom the intervention was successful

  Four months after intervention meeting

Study Arms (2)

Enhanced Needle Phobia Intervention

EXPERIMENTAL

Patients will receive enhanced needle phobia intervention comprising the standard intervention plus demonstration of Synera

Other: Enhanced Needle Phobia Intervention

Standard Needle Phobia Intervention

ACTIVE COMPARATOR

Patients will receive the standard intervention for needle phobia

Other: Standard Needle Phobia Intervention

Interventions

Enhanced Needle Phobia Intervention OTHER

The enhanced intervention will include the standard intervention, with two enhancements: * The video will include a segment with a patient using and discussing the analgesic effects of the Synera patch * Before the intervention, a nurse will explain how Synera works and demonstrate its efficacy by having the patient apply it to the non-dominant forearm and leave it in place for 30 minutes, during the intervention. The patient will then be given the opportunity to gently poke 3 times an area of the forearm at least 3 inches from where the patch was applied, and then poke 3 times the center of the area where the patch was applied. The patient may repeat this process up to 3 times. The patient will be asked if he or she can feel the difference in sensitivity.

Enhanced Needle Phobia Intervention

Standard Needle Phobia Intervention OTHER

The standard intervention will include the following components: 1. Educational material and discussion with the social worker about the benefits of AVF/AVG over catheter. 2. Basic training on relaxation breathing 3. Brief video of a patient overcoming needle phobia 4. Exposure to a cannulation needle while practicing relaxation breathing, ending in the patients physically holding the needle

Standard Needle Phobia Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Davita Clinical Research: lead
• Nuvo Research Inc.: collaborator

Study Sites (3)

Sunset Dialysis Center

Rancho Cordova, California, 95670, United States

Location

Natomas Dialysis

Sacramento, California, 95834, United States

Location

Asheville Kidney Center

Asheville, North Carolina, 28805, United States

Location

MeSH Terms

Conditions

Phobic Disorders

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Mahesh Krishnan, MD, MPH, MBA

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 20, 2012
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 16, 2016

Record last verified: 2015-04

Locations

US (3)