Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
|Needle Phobia Phobic Disorders||Other: Enhanced Needle Phobia Intervention Other: Standard Needle Phobia Intervention||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|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|
- Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire [ Time Frame: One week after intervention meeting ]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.
- Proportion of patients for whom the intervention was successful [ Time Frame: Four months after intervention meeting ]The secondary outcome measure will be assessed as a two-stage dichotomous indicator of intervention success. Stage 1 will assess if a patient has had dialysis treatment with a fistula or graft as primary access. If yes, the intervention will be considered a success; if no, stage 2 will ask if the patient has had a vein mapping procedure, which would be considered a success.
|Study Start Date:||April 2014|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Enhanced Needle Phobia Intervention
Patients will receive enhanced needle phobia intervention comprising the standard intervention plus demonstration of Synera
Other: Enhanced Needle Phobia Intervention
The enhanced intervention will include the standard intervention, with two enhancements:
Active Comparator: Standard Needle Phobia Intervention
Patients will receive the standard intervention for needle phobia
Other: Standard Needle Phobia Intervention
The standard intervention will include the following components:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623583
|United States, California|
|Sunset Dialysis Center|
|Rancho Cordova, California, United States, 95670|
|Sacramento, California, United States, 95834|
|United States, North Carolina|
|Asheville Kidney Center|
|Asheville, North Carolina, United States, 28805|
|Principal Investigator:||Mahesh Krishnan, MD, MPH, MBA||Davita Clinical Research|