Safety First
True or False: It is best practice to make an AE note for any AEs that are endorsed by the participant, even if they are resolved.
TRUE
Name the 2 kinds of counseling a participant could get in the avenues study
Brief or Intensive
Quit only cigarettes or both cigarettess and e-cigs (dual focused)
What is the name of the mobile EMA app we're using in the Avenues Study?
Insight
Participants will have _____ follow up Calls in the Avenues Study.
4
A participant is randomized at this Visit
Visit 2
You will be prompted to fill out an ________________ if your participant has a Severe, Unresolved Adverse Event.
Incident Log
Name 3 things that you review with participants in their Brief Counseling Session
Discuss: Why they want to quit, copping skills, triggers, cravings, social support, preparing for Quit Day, Motivation to Quit.
How many total questions are in the survey?
36
In total, there are ____ different conditions for the Avenues study
8
Contrary to popular belief, the first Kwik Trip stores were opened in this Wisconsin town.
Eau Claire - in 1965 (they later expanded to LaCrosse!)
True or False: When filling out an SAE report, once you collect your information from a participant, you should mark the SAE as complete, even if it's prior to the study MD reviewing the SAE.
False. Once you complete an SAE, leave it as Incomplete until it's reviewed by the Study MD.
Counseling Session 2 generally occurs approximately when in approximation to their quit day?
Target Quit day +1
What is defined as taking your e-cigarette out and then putting it away?
One vape use
A person has to smoke this many or more cigarettes per day to get a heavy patch dose
11 or more
In what decade was Kraft Mac and Cheese first introduced?
1930s (1937 to be exact!)
Name 4 kinds of SAEs
Pregnancy, Death, Hospitalization, Congenital anomaly, life threatening event, something that results in significant disability, an event that may jeopardize someone's health
True or False:
A participant is in the quitting vaping and smoking condition, and they meet with you at their Session 2 and report abstinent from smoking but lapsed with their vaping. Per the protocol, it is acceptable to discuss their vaping lapse and pick a new vaping quit day if they are willing.
TRUE
CZGOUYX is an example of _________.
A registration Code.
Screening calls: We should attempt to contact a participant _______ times over a 30 day period leaving ___ messages total over this time period.
5, 3
The Call Holding feature in RedCap should be only used for this occasion.
Incarcerated participants
Name the top 2 Study MDs and PhDs for Avenues (total of 4 people).
Brian Williams, Hasmeena Kathuria; Megan Piper and Jessica Cook
Explain briefly what a behavior change plan is
Collaborating with the participant, going back and changing what you would do differently. Develop ways to cope with similar triggers again. Help them add additional coping skills as needed form the handouts. Use chain analysis, can talk about med use, triggers, cravings and any other changes.
What button in the settings menu do we tell participants to press if the app does not function as expected?
Send Logs
If a CO of greater than or equal to _______ is obtained, staff will be instructed to read a script in REDCap.
70
As of today, the FDA has authorized the commercial sale of ____ e-cigarette devices and 13 tobacco-flavored e-liquids in the US.
10